Perti

Perti may be available in the countries listed below.

Ingredient matches for Perti

Pefloxacin

Pefloxacin mesilate (a derivative of Pefloxacin) is reported as an ingredient of Perti in the following countries:

• Venezuela

International Drug Name Search

Trofuran

Trofuran may be available in the countries listed below.

Ingredient matches for Trofuran

Nitrofural

Nitrofural is reported as an ingredient of Trofuran in the following countries:

• Peru

International Drug Name Search

Aknoren

Aknoren may be available in the countries listed below.

Ingredient matches for Aknoren

Azelaic Acid

Azelaic Acid is reported as an ingredient of Aknoren in the following countries:

• Czech Republic

International Drug Name Search

Cefpodoxime Winthrop

Cefpodoxime Winthrop may be available in the countries listed below.

Ingredient matches for Cefpodoxime Winthrop

Cefpodoxime

Cefpodoxime proxetil (a derivative of Cefpodoxime) is reported as an ingredient of Cefpodoxime Winthrop in the following countries:

• France

International Drug Name Search

Amcinonide

Scheme

Rec.INN

ATC (Anatomical Therapeutic Chemical Classification)

D07AC11

CAS registry number (Chemical Abstracts Service)

0051022-69-6

Chemical Formula

C28-H35-F-O7

Molecular Weight

502

Therapeutic Category

Adrenal cortex hormone, glucocorticoid

Chemical Name

Pregna-1,4-diene-3,20-dione, 21-(acetyloxy)-16,17-[cyclopentylidenebis(oxy)]-9-fluoro-11-hydroxy-, (11ß,16α)-

Foreign Names

• Amcinonidum (Latin)
• Amcinonid (German)
• Amcinonide (French)
• Amcinonida (Spanish)

Generic Names

• Amcinonide (OS: DCF, USAN, BAN)
• Amcinopol (IS)
• CL 34699 (IS: Lederle)
• Triamcinolonacetatcyclopentanonid (IS)
• Amcinonide (PH: USP 32)

Brand Names

• Amciderm
  Almirall Hermal, Germany



• Amcinonide
  Nycomed, United States; Taro, United States



• Amicla
  Erfa, Belgium; Erfa, Luxembourg



• Cyclocort
  Astellas, United States; Stiefel, Canada



• ratio-Amcinonide
  ratiopharm, Canada



• Taro-Amcinonide
  Taro, Canada



• Visderm
  Teikoku Seiyaku, Japan

International Drug Name Search

Glossary

BAN	British Approved Name
DCF	Dénomination Commune Française
IS	Inofficial Synonym
OS	Official Synonym
PH	Pharmacopoeia Name
Rec.INN	Recommended International Nonproprietary Name (World Health Organization)
USAN	United States Adopted Name

Click for further information on drug naming conventions and International Nonproprietary Names.

Phenothrin

In some countries, this medicine may only be approved for veterinary use.

Scheme

Rec.INN

ATC (Anatomical Therapeutic Chemical Classification)

P03AC03

CAS registry number (Chemical Abstracts Service)

0026002-80-2

Chemical Formula

C23-H26-O3

Molecular Weight

350

Therapeutic Category

Insecticide

Chemical Name

Cyclopropanecarboxylic acid, 2,2-dimethyl-3-(2-methyl-1-propenyl)-, (3-phenoxyphenyl)methyl ester

Foreign Names

• Phenothrinum (Latin)
• Phenothrin (German)
• Phénothrine (French)
• Fenotrina (Spanish)

Generic Names

• Phenothrin (OS: BAN)
• Phénothrine (OS: DCF)

Brand Names

• Anti-Bit Sampuan
  Eczacibasi, Turkey



• Anti-Bit
  Eczacibasi, Russian Federation



• Cif Candiol (Phenothrin and Tetramethrin)
  Papaellinas, Greece



• Full Marks
  SSL, New Zealand



• Hégor Antipoux
  Incomex, Monaco; Procter & Gamble, Luxembourg



• Herklin
  Armstrong, Mexico



• Indorex Duo-Aktiv (Phenothrin and Pyriproxyfen, + Bioallethrin (veterinary use))
  Virbac, Germany



• Itax
  Pierre Fabre, Russian Federation; Pierre Fabre Médicament, France



• Item Antipoux
  Dermophil Indien, France



• Ivaliten
  Lavipharm, Greece



• Parasidose
  Gilbert, France; Multichem, New Zealand



• Sumo
  Interbelle, Argentina

International Drug Name Search

Glossary

BAN	British Approved Name
DCF	Dénomination Commune Française
OS	Official Synonym
Rec.INN	Recommended International Nonproprietary Name (World Health Organization)

Click for further information on drug naming conventions and International Nonproprietary Names.

Bricanyl

In some countries, this medicine may only be approved for veterinary use.

In the US, Bricanyl (terbutaline systemic) is a member of the following drug classes: adrenergic bronchodilators, tocolytic agents and is used to treat Asthma - acute, Asthma - Maintenance and Premature Labor.

US matches:

• Bricanyl

UK matches:

• Bricanyl Respules 2.5 mg/ml Nebuliser Solution
• Bricanyl 0.3 mg/ml Syrup
• Bricanyl Injection, 0.5 mg/ml, solution for injection or infusion
• Bricanyl Tablets 5mg
• Bricanyl Turbohaler, 0.5mg/dose, inhalation powder
• Bricanyl Respules 2.5 mg/ml Nebuliser Solution (SPC)
• Bricanyl 0.3 mg/ml Syrup (SPC)
• Bricanyl Tablets 5mg (SPC)
• Bricanyl Turbohaler, 0.5mg/dose, inhalation powder (SPC)

Ingredient matches for Bricanyl

Terbutaline

Terbutaline is reported as an ingredient of Bricanyl in the following countries:

• Tunisia

Terbutaline sulfate (a derivative of Terbutaline) is reported as an ingredient of Bricanyl in the following countries:

• Argentina


• Australia


• Austria


• Bahrain


• Belgium


• Brazil


• Burundi


• Canada


• China


• Czech Republic


• Denmark


• Egypt


• Finland


• France


• Georgia


• Germany


• Greece


• Hong Kong


• Hungary


• Iceland


• India


• Iraq


• Ireland


• Italy


• Japan


• Jordan


• Kuwait


• Lebanon


• Libya


• Luxembourg


• Malaysia


• Netherlands


• Norway


• Oman


• Peru


• Philippines


• Qatar


• Reunion


• Saudi Arabia


• Singapore


• South Africa


• Sri Lanka


• Sweden


• Switzerland


• Syria


• Taiwan


• Thailand


• Turkey


• United Arab Emirates


• United Kingdom


• Vietnam


• Yemen

International Drug Name Search

Glossary

SPC	Summary of Product Characteristics (UK)

Click for further information on drug naming conventions and International Nonproprietary Names.

Lenobio

Lenobio may be available in the countries listed below.

Ingredient matches for Lenobio

Lenograstim

Lenograstim is reported as an ingredient of Lenobio in the following countries:

• Argentina

International Drug Name Search

Rivanolum roztwór

Rivanolum roztwór may be available in the countries listed below.

Ingredient matches for Rivanolum roztwór

Ethacridine

Ethacridine lactate (a derivative of Ethacridine) is reported as an ingredient of Rivanolum roztwór in the following countries:

• Poland

International Drug Name Search

Procain Leciva

Procain Leciva may be available in the countries listed below.

Ingredient matches for Procain Leciva

Procaine

Procaine hydrochloride (a derivative of Procaine) is reported as an ingredient of Procain Leciva in the following countries:

• Czech Republic


• Slovakia

International Drug Name Search

Esketamine

Scheme

Rec.INN

ATC (Anatomical Therapeutic Chemical Classification)

N01AX14

CAS registry number (Chemical Abstracts Service)

0033643-46-8

Chemical Formula

C13-H16-Cl-N-O

Molecular Weight

237

Therapeutic Categories

Agent for procedural sedation

Anesthetic, injectable

Chemical Names

(S)-2-(o-chlorophenyl)-2-(methylamino)cyclohexanone (WHO)

2-(2-Chlorophenyl)-2-(methylamino)cyclohexanone (IUPAC)

Cyclohexanone, 2-(2-chlorophenyl)-2-(methylamino)-, (2S)-

Foreign Names

• Esketaminum (Latin)
• Esketamin (German)
• Eskétamine (French)
• Esketamina (Spanish)

Generic Names

• (-)-Ketamine (IS)
• (S)-Ketamine (IS)
• Esketamine Hydrochloride (PH: BP 2010)
• Esketamine hydrochloride (PH: Ph. Eur. 6, BP 2010)

Brand Names

• Ketanest
  Pfizer, Germany



• S-Ketamin Pfizer
  Pfizer, Denmark

International Drug Name Search

Glossary

IUPAC	International Union of Pure and Applied Chemistry
IS	Inofficial Synonym
PH	Pharmacopoeia Name
Rec.INN	Recommended International Nonproprietary Name (World Health Organization)
WHO	World Health Organization

Click for further information on drug naming conventions and International Nonproprietary Names.

Thioprine

Thioprine may be available in the countries listed below.

Ingredient matches for Thioprine

Azathioprine

Azathioprine is reported as an ingredient of Thioprine in the following countries:

• Australia

International Drug Name Search

Milophene

In the US, Milophene is a member of the drug class synthetic ovulation stimulants and is used to treat Female Infertility, Lactation Suppression, Oligospermia and Ovulation Induction.

Ingredient matches for Milophene

Clomifene

Clomifene citrate (a derivative of Clomifene) is reported as an ingredient of Milophene in the following countries:

• United States

International Drug Name Search

Epilepsin

Epilepsin may be available in the countries listed below.

Ingredient matches for Epilepsin

Carbamazepine

Carbamazepine is reported as an ingredient of Epilepsin in the following countries:

• Myanmar

International Drug Name Search

Glukenil

Glukenil may be available in the countries listed below.

Ingredient matches for Glukenil

Repaglinide

Repaglinide is reported as an ingredient of Glukenil in the following countries:

• Argentina

International Drug Name Search

Tinidazol

Tinidazol may be available in the countries listed below.

Ingredient matches for Tinidazol

Tinidazole

Tinidazole is reported as an ingredient of Tinidazol in the following countries:

• Chile


• Colombia


• Ecuador


• Georgia


• Lithuania


• Peru


• Venezuela

International Drug Name Search

Limaprost Alfadex

Limaprost Alfadex may be available in the countries listed below.

Ingredient matches for Limaprost Alfadex

Limaprost

Limaprost Alfadex (JAN) is also known as Limaprost (Rec.INN)

International Drug Name Search

Glossary

JAN	Japanese Accepted Name
Rec.INN	Recommended International Nonproprietary Name (World Health Organization)

Click for further information on drug naming conventions and International Nonproprietary Names.

Penicillinum procainicum L

Penicillinum procainicum L may be available in the countries listed below.

Ingredient matches for Penicillinum procainicum L

Benzylpenicillin

Benzylpenicillin procaine (a derivative of Benzylpenicillin) is reported as an ingredient of Penicillinum procainicum L in the following countries:

• Poland

International Drug Name Search

Feiba NF

Feiba NF may be available in the countries listed below.

Ingredient matches for Feiba NF

Prothrombin Complex, Activated

Prothrombin Complex, Activated is reported as an ingredient of Feiba NF in the following countries:

• Switzerland

International Drug Name Search

Cefaclor Alkaloid

Cefaclor Alkaloid may be available in the countries listed below.

Ingredient matches for Cefaclor Alkaloid

Cefaclor

Cefaclor is reported as an ingredient of Cefaclor Alkaloid in the following countries:

• Bulgaria

International Drug Name Search

Engemycine

Engemycine may be available in the countries listed below.

In some countries, this medicine may only be approved for veterinary use.

Ingredient matches for Engemycine

Oxytetracycline

Oxytetracycline hydrochloride (a derivative of Oxytetracycline) is reported as an ingredient of Engemycine in the following countries:

• Belgium


• France


• Luxembourg


• Netherlands

International Drug Name Search

Cefpodoxime Domesco

Cefpodoxime Domesco may be available in the countries listed below.

Ingredient matches for Cefpodoxime Domesco

Cefpodoxime

Cefpodoxime proxetil (a derivative of Cefpodoxime) is reported as an ingredient of Cefpodoxime Domesco in the following countries:

• Vietnam

International Drug Name Search

Multosin

Multosin may be available in the countries listed below.

Ingredient matches for Multosin

Estramustine

Estramustine 17ß-(disodium phosphate) (a derivative of Estramustine) is reported as an ingredient of Multosin in the following countries:

• Germany

International Drug Name Search

Greini

Greini may be available in the countries listed below.

Ingredient matches for Greini

Amikacin

Amikacin sulfate (a derivative of Amikacin) is reported as an ingredient of Greini in the following countries:

• Argentina

International Drug Name Search

Exflam

Exflam may be available in the countries listed below.

Ingredient matches for Exflam

Diclofenac

Diclofenac potassium salt (a derivative of Diclofenac) is reported as an ingredient of Exflam in the following countries:

• Chile

International Drug Name Search

Clarosip

Clarosip may be available in the countries listed below.

Ingredient matches for Clarosip

Clarithromycin

Clarithromycin is reported as an ingredient of Clarosip in the following countries:

• Chile


• Colombia


• Czech Republic


• Germany


• Netherlands


• Peru


• Poland


• Slovakia


• Slovenia

International Drug Name Search

Lizinocor

Lizinocor may be available in the countries listed below.

Ingredient matches for Lizinocor

Lisinopril

Lisinopril is reported as an ingredient of Lizinocor in the following countries:

• Georgia

International Drug Name Search

Cassadan

Cassadan may be available in the countries listed below.

Ingredient matches for Cassadan

Alprazolam

Alprazolam is reported as an ingredient of Cassadan in the following countries:

• Germany

International Drug Name Search

Ranifur

Ranifur may be available in the countries listed below.

Ingredient matches for Ranifur

Ranitidine

Ranitidine is reported as an ingredient of Ranifur in the following countries:

• Mexico


• Peru

Ranitidine hydrochloride (a derivative of Ranitidine) is reported as an ingredient of Ranifur in the following countries:

• Mexico

International Drug Name Search

Prontoflex

Prontoflex may be available in the countries listed below.

Ingredient matches for Prontoflex

Ketoprofen

Ketoprofen is reported as an ingredient of Prontoflex in the following countries:

• Czech Republic

International Drug Name Search

Epirubicine Intsel Chimos

Epirubicine Intsel Chimos may be available in the countries listed below.

Ingredient matches for Epirubicine Intsel Chimos

Epirubicin

Epirubicin hydrochloride (a derivative of Epirubicin) is reported as an ingredient of Epirubicine Intsel Chimos in the following countries:

• France

International Drug Name Search

Clotrimazol Genericon

Clotrimazol Genericon may be available in the countries listed below.

Ingredient matches for Clotrimazol Genericon

Clotrimazole

Clotrimazole is reported as an ingredient of Clotrimazol Genericon in the following countries:

• Austria

International Drug Name Search

Protirelina

Protirelina may be available in the countries listed below.

Ingredient matches for Protirelina

Protirelin

Protirelina (DCIT) is known as Protirelin in the US.

International Drug Name Search

Glossary

DCIT	Denominazione Comune Italiana

Click for further information on drug naming conventions and International Nonproprietary Names.

Thamesol

Thamesol may be available in the countries listed below.

Ingredient matches for Thamesol

Trometamol

Trometamol is reported as an ingredient of Thamesol in the following countries:

• Italy

International Drug Name Search

Flatoril

Flatoril may be available in the countries listed below.

Ingredient matches for Flatoril

Clebopride

Clebopride malate (a derivative of Clebopride) is reported as an ingredient of Flatoril in the following countries:

• Bahrain

Simeticone

Simeticone is reported as an ingredient of Flatoril in the following countries:

• Venezuela

International Drug Name Search

Modium

Modium may be available in the countries listed below.

Ingredient matches for Modium

Lorazepam

Lorazepam is reported as an ingredient of Modium in the following countries:

• Greece

International Drug Name Search

Paracetamol G. E.S

Paracetamol G.E.S. may be available in the countries listed below.

Ingredient matches for Paracetamol G.E.S.

Paracetamol

Paracetamol is reported as an ingredient of Paracetamol G.E.S. in the following countries:

• Spain

International Drug Name Search

Auranofin

In some countries, this medicine may only be approved for veterinary use.

In the US, Auranofin (auranofin systemic) is a member of the drug class antirheumatics and is used to treat Felty's Syndrome, Pemphigus, Psoriatic Arthritis and Rheumatoid Arthritis.

US matches:

• Auranofin

Scheme

Rec.INN

ATC (Anatomical Therapeutic Chemical Classification)

M01CB03

CAS registry number (Chemical Abstracts Service)

0034031-32-8

Chemical Formula

C20-H34-Au-O9-P-S

Molecular Weight

678

Therapeutic Categories

Anti-inflammatory agent

Disease-modifying antirheumatic drug, DMARD

Chemical Name

Gold, (1-thio-ß-D-glucopyranose 2,3,4,6-tetraacetato-S)(triethylphosphine)-

Foreign Names

• Auranofinum (Latin)
• Auranofin (German)
• Auranofine (French)
• Auranofina (Spanish)

Generic Names

• Auranofin (OS: USAN, JAN, DCIT, BAN)
• Auranofine (OS: DCF)
• SKF D-39162 (IS)

Brand Names

• Auropan
  Krka, Georgia



• Goldar
  Zydus Cadila, India



• Grelyse
  Daito, Japan



• Ridaura
  Astellas, Belgium; Astellas, United Kingdom; GlaxoSmithKline, United Arab Emirates; GlaxoSmithKline, Bahrain; GlaxoSmithKline, Iran; GlaxoSmithKline, Japan; GlaxoSmithKline, Kuwait; GlaxoSmithKline, Qatar; Goldshield, Austria; Goldshield, Australia; Goldshield, Denmark; Goldshield, Finland; Goldshield, Hong Kong; Goldshield, Ireland; Goldshield, Israel; Goldshield, Norway; Goldshield, New Zealand; Prometheus, United States



• Ridaura (veterinary use)
  Astellas, United Kingdom



• Ridauran
  Pierre Fabre Médicament, France



• Rizast
  Medisa Shinyaku, Japan

International Drug Name Search

Glossary

BAN	British Approved Name
DCF	Dénomination Commune Française
DCIT	Denominazione Comune Italiana
IS	Inofficial Synonym
JAN	Japanese Accepted Name
OS	Official Synonym
Rec.INN	Recommended International Nonproprietary Name (World Health Organization)
USAN	United States Adopted Name

Click for further information on drug naming conventions and International Nonproprietary Names.

Ketorolac Trometamol

Ketorolac Trometamol may be available in the countries listed below.

Ingredient matches for Ketorolac Trometamol

Ketorolac

Ketorolac Trometamol (BANM) is known as Ketorolac in the US.

International Drug Name Search

Glossary

BANM	British Approved Name (Modified)

Click for further information on drug naming conventions and International Nonproprietary Names.

Acyvir

Acyvir may be available in the countries listed below.

Ingredient matches for Acyvir

Acyclovir

Aciclovir is reported as an ingredient of Acyvir in the following countries:

• Bangladesh


• Ecuador


• Hong Kong


• Italy

International Drug Name Search

Rubidium Chloride Rb 82

Rubidium Chloride Rb 82 may be available in the countries listed below.

Ingredient matches for Rubidium Chloride Rb 82

Rubidium Rb82

Rubidium Chloride Rb 82 (USAN) is also known as Rubidium Rb82

International Drug Name Search

Glossary

USAN	United States Adopted Name

Click for further information on drug naming conventions and International Nonproprietary Names.

Fosfobion

Fosfobion may be available in the countries listed below.

Ingredient matches for Fosfobion

Adenosine Triphosphate

Adenosine Triphosphate sodium salt (a derivative of Adenosine Triphosphate) is reported as an ingredient of Fosfobion in the following countries:

• Romania

International Drug Name Search

Thiopental Biochemie

Thiopental Biochemie may be available in the countries listed below.

Ingredient matches for Thiopental Biochemie

Thiopental

Thiopental Sodium is reported as an ingredient of Thiopental Biochemie in the following countries:

• Bangladesh


• Georgia

International Drug Name Search

Altsamin

Altsamin may be available in the countries listed below.

Ingredient matches for Altsamin

Sucralfate

Sucralfate is reported as an ingredient of Altsamin in the following countries:

• Japan

International Drug Name Search

Loisan

Loisan may be available in the countries listed below.

Ingredient matches for Loisan

Loratadine

Loratadine is reported as an ingredient of Loisan in the following countries:

• Argentina

International Drug Name Search

Levomepromazina

Levomepromazina may be available in the countries listed below.

Ingredient matches for Levomepromazina

Levomepromazine

Levomepromazina (DCIT) is also known as Levomepromazine (Rec.INN)

Levodropropizine

Levodropropizine is reported as an ingredient of Levomepromazina in the following countries:

• Peru

International Drug Name Search

Glossary

DCIT	Denominazione Comune Italiana
Rec.INN	Recommended International Nonproprietary Name (World Health Organization)

Click for further information on drug naming conventions and International Nonproprietary Names.

Ciprofibrate Almus

Ciprofibrate Almus may be available in the countries listed below.

Ingredient matches for Ciprofibrate Almus

Ciprofibrate

Ciprofibrate is reported as an ingredient of Ciprofibrate Almus in the following countries:

• France

International Drug Name Search

Felsol

Felsol may be available in the countries listed below.

Ingredient matches for Felsol

Fluconazole

Fluconazole is reported as an ingredient of Felsol in the following countries:

• Chile

International Drug Name Search

Fucidin-Hydrocortison

Fucidin-Hydrocortison may be available in the countries listed below.

Ingredient matches for Fucidin-Hydrocortison

Fusidic Acid

Fusidic Acid is reported as an ingredient of Fucidin-Hydrocortison in the following countries:

• Denmark


• Finland


• Sweden

Fusidic Acid hemihydrate (a derivative of Fusidic Acid) is reported as an ingredient of Fucidin-Hydrocortison in the following countries:

• Norway

Hydrocortisone

Hydrocortisone is reported as an ingredient of Fucidin-Hydrocortison in the following countries:

• Denmark

Hydrocortisone 21-acetate (a derivative of Hydrocortisone) is reported as an ingredient of Fucidin-Hydrocortison in the following countries:

• Finland

International Drug Name Search

Amoxicilina Forte

Amoxicilina Forte may be available in the countries listed below.

Ingredient matches for Amoxicilina Forte

Amoxicillin

Amoxicillin trihydrate (a derivative of Amoxicillin) is reported as an ingredient of Amoxicilina Forte in the following countries:

• Romania

International Drug Name Search

Acido Valproico Genfarma

Acido Valproico Genfarma may be available in the countries listed below.

Ingredient matches for Acido Valproico Genfarma

Valproic Acid

Valproic Acid sodium (a derivative of Valproic Acid) is reported as an ingredient of Acido Valproico Genfarma in the following countries:

• Spain

International Drug Name Search

Adco-Metrostat

Adco-Metrostat may be available in the countries listed below.

Ingredient matches for Adco-Metrostat

Metronidazole

Metronidazole is reported as an ingredient of Adco-Metrostat in the following countries:

• South Africa

International Drug Name Search

Lansoprazole Zydus

Lansoprazole Zydus may be available in the countries listed below.

Ingredient matches for Lansoprazole Zydus

Lansoprazole

Lansoprazole is reported as an ingredient of Lansoprazole Zydus in the following countries:

• France

International Drug Name Search

Adco-Efavirenz

Adco-Efavirenz may be available in the countries listed below.

Ingredient matches for Adco-Efavirenz

Efavirenz

Efavirenz is reported as an ingredient of Adco-Efavirenz in the following countries:

• South Africa

International Drug Name Search

Actualene

Actualene may be available in the countries listed below.

Ingredient matches for Actualene

Cabergoline

Cabergoline is reported as an ingredient of Actualene in the following countries:

• Italy

International Drug Name Search

Pharmaniaga Theophylline

Pharmaniaga Theophylline may be available in the countries listed below.

Ingredient matches for Pharmaniaga Theophylline

Theophylline

Theophylline is reported as an ingredient of Pharmaniaga Theophylline in the following countries:

• Malaysia

International Drug Name Search

Pravinat

Pravinat may be available in the countries listed below.

Ingredient matches for Pravinat

Pravastatin

Pravastatin sodium salt (a derivative of Pravastatin) is reported as an ingredient of Pravinat in the following countries:

• Indonesia

International Drug Name Search

Acetaminophen and Pentazocine hydrochloride

Ingredient matches for Acetaminophen and Pentazocine hydrochloride

Paracetamol

Paracetamol is reported as an ingredient of Acetaminophen and Pentazocine hydrochloride in the following countries:

• United States

Pentazocine

Pentazocine hydrochloride (a derivative of Pentazocine) is reported as an ingredient of Acetaminophen and Pentazocine hydrochloride in the following countries:

• United States

International Drug Name Search

Lopéramide Teva

Lopéramide Teva may be available in the countries listed below.

Ingredient matches for Lopéramide Teva

Loperamide

Loperamide hydrochloride (a derivative of Loperamide) is reported as an ingredient of Lopéramide Teva in the following countries:

• France

International Drug Name Search

Tetradure

In some countries, this medicine may only be approved for veterinary use.

Ingredient matches for Tetradure

Oxytetracycline

Oxytetracycline hydrochloride (a derivative of Oxytetracycline) is reported as an ingredient of Tetradure in the following countries:

• United States

International Drug Name Search

Risperidone 1 mg Tablets

1. Name Of The Medicinal Product

Risperidone 1mg Tablets

2. Qualitative And Quantitative Composition

Each tablet contains 1 mg risperidone

Excipients:

Each tablet contains 40 mg Lactose-Monohydrate.

For a full list of excipients, see section 6.1

3. Pharmaceutical Form

Film-coated tablet

Product description:

White, biconvex, oblong tablets with score line on one side

4. Clinical Particulars

4.1 Therapeutic Indications

Risperidone is indicated for the treatment of schizophrenia.

Risperidone is indicated for the treatment of moderate to severe manic episodes associated with bipolar disorders.

Risperidone is indicated for the short-term treatment (up to 6 weeks) of persistent aggression in patients with moderate to severe Alzheimer's dementia unresponsive to non pharmacological approaches and when there is a risk of harm to self or others.

Risperidone is indicated for the short-term symptomatic treatment (up to 6 weeks) of persistent aggression in conduct disorder in children from the age of 5 years and adolescents with subaverage intellectual functioning or mental retardation diagnosed according to DSM-IV criteria, in whom the severity of aggressive or other disruptive behaviours require pharmacologic treatment. Pharmacological treatment should be an integral part of a more comprehensive treatment programme, including psychosocial and educational intervention. It is recommended that risperidone be prescribed by a specialist in child neurology and child and adolescent psychiatry or physicians well familiar with the treatment of conduct disorder of children and adolescents.

4.2 Posology And Method Of Administration

Schizophrenia

Adults

Risperidone may be given once daily or twice daily. Patients should start with 2 mg/day risperidone. The dosage may be increased on the second day to 4 mg.

Subsequently, the dosage can be maintained unchanged, or further individualised, if needed. Most patients will benefit from daily doses between 4 and 6 mg. In some patients, a slower titration phase and a lower starting and maintenance dose may be appropriate.

Doses above 10 mg/day have not demonstrated superior efficacy to lower doses and may cause increased incidence of extrapyramidal symptoms. Safety of doses above 16 mg/day has not been evaluated, and are therefore not recommended.

Elderly

A starting dose of 0.5 mg* twice daily is recommended. This dosage can be individually adjusted with 0.5 mg* twice daily increments to 1 to 2 mg twice daily.

* for doses not achievable with Risperidone other risperidone presentations are available

Paediatric population

Risperidone is not recommended for use in children below age 18 with schizophrenia due to a lack of data on efficacy.

Manic episodes in bipolar disorder

Adults

Risperidone should be administered on a once daily schedule, starting with 2 mg risperidone. Dosage adjustments, if indicated, should occur at intervals of not less than 24 hours and in dosage increments of 1 mg per day. Risperidone can be administered in flexible doses over a range of 1 to 6 mg per day to optimize each patient's level of efficacy and tolerability. Daily doses over 6 mg risperidone have not been investigated in patients with manic episodes.

As with all symptomatic treatments, the continued use of Risperidone must be evaluated and justified on an ongoing basis.

Elderly

A starting dose of 0.5 mg* twice daily is recommended. This dosage can be individually adjusted with 0.5 mg* twice daily increments to 1 to 2 mg twice daily. Since clinical experience in elderly is limited, caution should be exercised.

* for doses not achievable with Risperidone other risperidone presentations are available

Paediatric population

Risperidone is not recommended for use in children below age 18 with bipolar mania due to a lack of data on efficacy.

Persistent aggression in patients with moderate to severe Alzheimer's dementia

A starting dose of 0.25 mg* twice daily is recommended. This dosage can be individually adjusted by increments of 0.25 mg* twice daily, not more frequently than every other day, if needed. The optimum dose is 0.5 mg* twice daily for most patients. Some patients, however, may benefit from doses up to 1 mg twice daily.

Risperidone should not be used more than 6 weeks in patients with persistent aggression in Alzheimer's dementia. During treatment, patients must be evaluated frequently and regularly, and the need for continuing treatment reassessed.

* for doses not achievable with Risperidone other risperidone presentations are available

Conduct disorder

Children and adolescents from 5 to 18 years of age

For subjects

* for doses not achievable with Risperidone other risperidone presentations are available

As with all symptomatic treatments, the continued use of Risperidone must be evaluated and justified on an ongoing basis.

Risperidone is not recommended in children less than 5 years of age, as there is no experience in children less than 5 years of age with this disorder.

Renal and hepatic impairment

Patients with renal impairment have less ability to eliminate the active antipsychotic fraction than in adults with normal renal function. Patients with impaired hepatic function have increases in plasma concentration of the free fraction of risperidone.

Irrespective of the indication, starting and consecutive dosing should be halved, and dose titration should be slower for patients with renal or hepatic impairment.

Risperidone should be used with caution in these groups of patients.

Method of administration

Risperidone is for oral use. Food does not affect the absorption of Risperidone.

Upon discontinuation, gradual withdrawal is advised. Acute withdrawal symptoms, including nausea, vomiting, sweating, and insomnia have very rarely been described after abrupt cessation of high doses of antipsychotic medicines (see section 4.8). Recurrence of psychotic symptoms may also occur, and the emergence of involuntary movement disorders (such as akathisia, dystonia and dyskinesia) has been reported.

Switching from other antipsychotics.

When medically appropriate, gradual discontinuation of the previous treatment while Risperidone therapy is initiated is recommended. Also, if medically appropriate, when switching patients from depot antipsychotics, initiate Risperidone therapy in place of the next scheduled injection. The need for continuing existing anti-Parkinson medicines should be re-evaluated periodically.

4.3 Contraindications

Hypersensitivity to the active substance or to any of the excipients. (for excipients see section 6.1)

4.4 Special Warnings And Precautions For Use

Elderly patients with dementia

Overall mortality

Elderly patients with dementia treated with atypical antipsychotics have an increased mortality compared to placebo in a meta-analysis of 17 controlled trials of atypical antipsychotics, including Risperidone. In placebo-controlled trials with Risperidone in this population, the incidence of mortality was 4.0% for Risperidone -treated patients compared to 3.1% for placebo-treated patients. The odds ratio (95% exact confidence interval) was 1.21 (0.7, 2.1). The mean age (range) of patients who died was 86 years (range 67-100).

Concomitant use with furosemide

In the Risperidone placebo-controlled trials in elderly patients with dementia, a higher incidence of mortality was observed in patients treated with furosemide plus risperidone (7.3%; mean age 89 years, range 75-97) when compared to patients treated with risperidone alone (3.1%; mean age 84 years, range 70-96) or furosemide alone (4.1%; mean age 80 years, range 67-90). The increase in mortality in patients treated with furosemide plus risperidone was observed in two of the four clinical trials. Concomitant use of risperidone with other diuretics (mainly thiazide diuretics used in low dose) was not associated with similar findings.

No pathophysiological mechanism has been identified to explain this finding, and no consistent pattern for cause of death observed. Nevertheless, caution should be exercised and the risks and benefits of this combination or co-treatment with other potent diuretics should be considered prior to the decision to use.

There was no increased incidence of mortality among patients taking other diuretics as concomitant treatment with risperidone. Irrespective of treatment, dehydration was an overall risk factor for mortality and should therefore be carefully avoided in elderly patients with dementia.

Cerebrovascular Adverse Events (CVAE)

In placebo-controlled trials in elderly patients with dementia there was a significantly higher incidence (approximately 3-fold increased) of CVAEs, such as stroke (including fatalities) and transient ischaemic attack in patients treated with Risperidone compared with patients treated with placebo (mean age 85 years; range 73 to 97). The pooled data from six placebo-controlled studies in mainly elderly patients (>65 years of age) with dementia showed that CVAEs (serious and non-serious, combined) occurred in 3.3% (33/1009) of patients treated with risperidone and 1.2% (8/712) of patients treated with placebo. The odds ratio (95% exact confidence interval) was 2.96 (1.34, 7.50). The mechanism for this increased risk is not known. An increased risk cannot be excluded for other antipsychotics or other patient populations.

Risperidone should be used with caution in patients with risk factors for stroke.

The risk of CVAEs was significantly higher in patients with mixed or vascular type of dementia when compared to Alzheimer's dementia. Therefore, patients with other types of dementias than Alzheimer's should not be treated with risperidone.

Physicians are advised to assess the risks and benefits of the use of Risperidone in elderly patients with dementia, taking into account risk predictors for stroke in the individual patient. Patients/caregivers should be cautioned to immediately report signs and symptoms of potential CVAEs such as sudden weakness or numbness in the face, arms or legs, and speech or vision problems. All treatment options should be considered without delay, including discontinuation of risperidone.

Risperidone should only be used short term for persistent aggression in patients with moderate to severe Alzheimer's dementia to supplement non-pharmacological approaches which have had limited or no efficacy and when there is potential risk of harm to self or others.

Patients should be reassessed regularly, and the need for continuing treatment reassessed.

Orthostatic hypotension

Due to the alpha-blocking activity of risperidone, (orthostatic) hypotension can occur, especially during the initial dose-titration period. Clinically significant hypotension has been observed postmarketing with concomitant use of risperidone and antihypertensive treatment. Risperidone should be used with caution in patients with known cardiovascular disease (e.g., heart failure, myocardial infarction, conduction abnormalities, dehydration, hypovolemia, or cerebrovascular disease), and the dosage should be gradually titrated as recommended (see section 4.2). A dose reduction should be considered if hypotension occurs.

Tardive dyskinesia/extrapyramidal symptoms (TD/EPS)

Medicines with dopamine receptor antagonistic properties have been associated with the induction of tardive dyskinesia characterised by rhythmical involuntary movements, predominantly of the tongue and/or face.

The onset of extrapyramidal symptoms is a risk factor for tardive dyskinesia. If signs and symptoms of tardive dyskinesia appear, the discontinuation of all antipsychotics should be considered.

Neuroleptic malignant syndrome (NMS)

Neuroleptic Malignant Syndrome, characterised by hyperthermia, muscle rigidity, autonomic instability, altered consciousness and elevated serum creatine phosphokinase levels has been reported to occur with antipsychotics. Additional signs may include myoglobinuria (rhabdomyolysis) and acute renal failure. In this event, all antipsychotics, including Risperidone, should be discontinued.

Parkinson's disease and dementia with Lewy bodies

Physicians should weigh the risks versus the benefits when prescribing antipsychotics, including Risperidone, to patients with Parkinson's Disease or Dementia with Lewy Bodies (DLB). Parkinson's Disease may worsen with risperidone. Both groups may be at increased risk of Neuroleptic Malignant Syndrome as well as having an increased sensitivity to antipsychotic medicinal products; these patients were excluded from clinical trials. Manifestation of this increased sensitivity can include confusion, obtundation, postural instability with frequent falls, in addition to extrapyramidal symptoms.

Hyperglycemia

Hyperglycemia or exacerbation of pre-existing diabetes has been reported in very rare cases during treatment with Risperidone. Appropriate clinical monitoring is advisable in diabetic patients and in patients with risk factors for the development of diabetes mellitus.

Hyperprolactinaemia

Tissue culture studies suggest that cell growth in human breast tumours may be stimulated by prolactin.

Although no clear association with the administration of antipsychotics has so far been demonstrated in clinical and epidemiological studies, caution is recommended in patients with relevant medical history.

Risperidone should be used with caution in patients with pre-existing hyperprolactinaemia and in patients with possible prolactin-dependent tumours.

QT prolongation

QT prolongation has very rarely been reported postmarketing. As with other antipsychotics, caution should be exercised when risperidone is prescribed in patients with known cardiovascular disease, family history of QT prolongation, bradycardia, or electrolyte disturbances (hypokalaemia, hypomagnesaemia), as it may increase the risk of arrhythmogenic effects, and in concomitant use with medicines known to prolong the QT interval.

Seizures

Risperidone should be used cautiously in patients with a history of seizures or other conditions that potentially lower the seizure threshold.

Priapism

Priapism may occur with Risperidone treatment due to its alpha-adrenergic blocking effects.

Body temperature regulation

Disruption of the body's ability to reduce core body temperature has been attributed to antipsychotic medicines. Appropriate care is advised when prescribing Risperidone to patients who will be experiencing conditions which may contribute to an elevation in core body temperature, e.g., exercising strenuously, exposure to extreme heat, receiving concomitant treatment with anticholinergic activity, or being subject to dehydration.

Venous thromboembolism

Cases of venous thromboembolism (VTE) have been reported with antipsychotic drugs. Since patients treated with antipsychotics often present with acquired risk factors for VTE, all possible risk factors for VTE should be identified before and during treatment with Risperidone and preventive measures undertaken.

Children and adolescents

Before risperidone is prescribed to a child or adolescent with conduct disorder they should be fully assessed for physical and social causes of the aggressive behaviour such as pain or inappropriate environmental demands.

The sedative effect of risperidone should be closely monitored in this population because of possible consequences on learning ability. A change in the time of administration of risperidone could improve the impact of the sedation on attention faculties of children and adolescents.

Risperidone was associated with mean increases in body weight and body mass index (BMI). Changes in height in the long-term open-label extension studies were within expected age-appropriate norms. The effect of long-term risperidone treatment on sexual maturation and height have not been adequately studied. Because of the potential effects of prolonged hyperprolactinemia on growth and sexual maturation in children and adolescents, regular clinical evaluation of endocrinological status should be considered, including measurements of height, weight, sexual maturation, monitoring of menstrual functioning, and other potential prolactin-related effects.

During treatment with risperidone regular examination for extrapyramidal symptoms and other movement disorders should also be conducted.

For specific posology recommendations in children and adolescents see Section 4.2.

Excipients

The film-coated tablets contain lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

As with other antipsychotics, caution is advised when prescribing risperidone with medicinal products known to prolong the QT interval, e.g., class Ia antiarrhythmics (e.g., quinidine, dysopiramide, procainamide), class III antiarrhythmics (e.g., amiodarone, sotalol), tricyclic antidepressant (i.e., amitriptyline), tetracyclic antidepressants (i.e., maprotiline), some antihistaminics, other antipsychotics, some antimalarials (i.e., chinice and mefloquine), and with medicines causing electrolyte imbalance (hypokalaemia, hypomagnesiaemia), bradycardia, or those which inhibit the hepatic metabolism of risperidone. This list is indicative and not exhaustive.

Potential for Risperidone to affect other medicinal products

Risperidone should be used with caution in combination with other centrally-acting substances notably including alcohol, opiates, antihistamines and benzodiazepines due to the increased risk of sedation.

Risperidone may antagonise the effect of levodopa and other dopamine agonists. If this combination is deemed necessary, particularly in end-stage Parkinson's disease, the lowest effective dose of each treatment should be prescribed.

Clinically significant hypotension has been observed postmarketing with concomitant use of risperidone and antihypertensive treatment.

Risperidone does not show a clinically relevant effect on the pharmacokinetics of lithium, valproate, digoxin or topiramate.

Potential for other medicinal products to affect Risperidone

Carbamazepine has been shown to decrease the plasma concentrations of the active antipsychotic fraction of risperidone. Similar effects may be observed with e.g. rifampicin, phenytoin and phenobarbital which also induce CYP 3A4 hepatic enzyme as well as P-glycoprotein. When carbamazepine or other CYP 3A4 hepatic enzyme/P-glycoprotein (P-gp) inducers are initiated or discontinued, the physician should re-evaluate the dosing of Risperidone.

Fluoxetine and paroxetine, CYP 2D6 inhibitors, increase the plasma concentration of risperidone, but less so of the active antipsychotic fraction. It is expected that other CYP 2D6 inhibitors, such as quinidine, may affect the plasma concentrations of risperidone in a similar way. When concomitant fluoxetine or paroxetine is initiated or discontinued, the physician should re-evaluate the dosing of Risperidone.

Verapamil, an inhibitor of CYP 3A4 and P-gp, increases the plasma concentration of risperidone. Galantamine and donepezil do not show a clinically relevant effect on the pharmacokinetics of risperidone and on the active antipsychotic fraction.

Phenothiazines, tricyclic antidepressants, and some beta-blockers may increase the plasma concentrations of risperidone but not those of the active antipsychotic fraction. Amitriptyline does not affect the pharmacokinetics of risperidone or the active antipsychotic fraction. Cimetidine and ranitidine increase the bioavailability of risperidone, but only marginally that of the active antipsychotic fraction. Erythromycin, a CYP 3A4 inhibitor, does not change the pharmacokinetics of risperidone and the active antipsychotic fraction.

The combined use of psychostimulants (e.g., methylphenidate) with Risperidone in children and adolescents did not alter the pharmacokinetics and efficacy of Risperidone.

See section 4.4 regarding increased mortality in elderly patients with dementia concomitantly receiving furosemide.

Concomitant use of oral Risperidone with paliperidone is not recommended as paliperidone is the active metabolite of risperidone and the combination of the two may lead to additive active antipsychotic fraction exposure.

4.6 Pregnancy And Lactation

Pregnancy

There are no adequate data from the use of risperidone in pregnant women. According to postmarketing data reversible extrapyramidal symptoms in the neonate were observed following the use of risperidone during the last trimester of pregnancy. Consequently newborns should be monitored carefully. Risperidone was not teratogenic in animal studies but other types of reproductive toxicity were seen (see section 5.3). The potential risk for humans is unknown. Therefore, Risperidone should not be used during pregnancy unless clearly necessary. If discontinuation during pregnancy is necessary, it should not be done abruptly.

Lactation

In animal studies, risperidone and 9-hydroxy-risperidone are excreted in the milk. It has been demonstrated that risperidone and 9-hydroxy-risperidone are also excreted in human breast milk in small quantities. There are no data available on adverse reactions in breast-feeding infants. Therefore, the advantage of breastfeeding should be weighed against the potential risks for the child.

4.7 Effects On Ability To Drive And Use Machines

Risperidone can have minor or moderate influence on the ability to drive and use machines due to potential nervous system and visual effects (see section 4.8). Therefore, patients should be advised not to drive or operate machinery until their individual susceptibility is known.

4.8 Undesirable Effects

The most frequently reported adverse drug reactions (ADRs) (incidence

The following are all the ADRs that were reported in clinical trials and postmarketing. The following terms and frequencies are applied: very common (

Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.

Adverse Drug Reactions by System Organ Class and Frequency

Investigations

Common	Blood prolactin increaseda, Weight increased
Uncommon	Electrocardiogram QT prolonged, Electrocardiogram abnormal, Blood glucose increased, Transaminases increased, White blood cell count decreased Body temperature increased, Eosinophil count increased,Haemoglobin decreased, Blood creatine phosphokinase increased
Rare	Body temperature decreased

Cardiac disorders

Common	Tachycardia
Uncommon	Atrioventricular block, Bundle branch block, Atrial fibrillation, Sinus bradycardia, Palpitations

Blood and lymphatic system disorders

Uncommon	Anaemia, Thrombocytopenia
Rare	Granulocytopenia
Not known	Agranulocytosis

Nervous system disorders

Very common	Parkinsonismb, Headache
Common	Akathisiab, Dizziness, Tremorb, Dystoniab, Somnolence, Sedation, Lethargy, Dyskinesiab
Uncommon	Unresponsive to stimuli, Loss of consciousness, Syncope, Depressed level of consciousness, Cerebrovascular accident, Transient ischaemic attack, Dysarthria, Disturbance in attention, Hypersomnia, Dizziness postural, Balance disorder, Tardive dyskinesia, Speech disorder, Coordination abnormal, Hypoaesthesia
Rare	Neuroleptic malignant syndrome, Diabetic coma, Cerebrovascular disorder, Cerebral ischaemia, Movement disorder

Eye disorders

Common	Vision blurred
Uncommon	Conjunctivitis, Ocular hyperaemia, Eye discharge, Eye swelling, Dry eye, Lacrimation increased, Photophobia
Rare	Visual acuity reduced, Eye rolling, Glaucoma

Ear and labyrinth disorders

Uncommon

Ear pain, Tinnitus

Respiratory, thoracic and mediastinal disorders

Common	Dyspnoea, Epistaxis, Cough, Nasal congestion, Pharyngolaryngeal Pain
Uncommon	Wheezing, Pneumonia aspiration, Pulmonary congestion, Respiratory disorder, Rales, Respiratory tract congestion, Dysphonia
Rare	Sleep apnea syndrome, Hyperventilation

Gastrointestinal disorders

Common	Vomiting, Diarrhoea, Constipation, Nausea, Abdominal pain, Dyspepsia, Dry mouth, Stomach discomfort
Uncommon	Dysphagia, Gastritis, Faecal incontinence, Faecaloma
Rare	Intestinal obstruction, Pancreatitis, Lip swelling, Cheilitis

Renal and urinary disorders

Common	Enuresis
Uncommon	Dysuria, Urinary incontinence, Pollakiuria

Skin and subcutaneous tissue disorders

Common	Rash, Erythema
Uncommon	Angioedema, Skin lesion, Skin disorder, Pruritus, Acne, Skin discolouration, Alopecia, Seborrhoeic dermatitis, Dry skin, Hyperkeratosis
Rare	Dandruff

Musculoskeletal and connective tissue disorders

Common	Arthralgia, Back pain, Pain in extremity
Uncommon	Muscular weakness, Myalgia, Neck pain, Joint swelling, Posture abnormal, Joint stiffness, Musculoskeletal chest pain
Rare	Rhabdomyolysis

Endocrine disorders

Rare	Inappropriate antidiuretic hormone secretion

Metabolism and nutrition disorders

Common	Increased appetite, Decreased appetite
Uncommon	Anorexia, Polydipsia
Very rare	Diabetic ketoacidosis
Not known	Water intoxication

Infections and infestations

Common	Pneumonia, Influenza, Bronchitis, Upper respiratory tract infection, Urinary tract infection
Uncommon	Sinusitis, Viral infection, Ear infection, Tonsillitis, Cellulitis, Otitis media, Eye infection, Localised infection, Acarodermatitis, Respiratory tract infection, Cystitis, Onychomycosis
Rare	Otitis media chronic

Vascular disorders

Uncommon	Hypotension, Orthostatic hypotension, Flushing
Not known	Cases of venous thromboembolism, including cases of pulmonary embolism and cases of deep vein thrombosis have been reported with antipsychotic drugs

General disorders and administration site conditions

Common	Pyrexia, Fatigue, Peripheral oedema, Asthenia, Chest pain
Uncommon	Face oedema, Gait disturbance, Feeling abnormal, Sluggishness, Influenza like illness, Thirst, Chest discomfort, Chills
Rare	Generalised oedema, Hypothermia, Drug withdrawal syndrome, Peripheral coldness

Immune system disorders

Uncommon	Hypersensitivity
Rare	Drug hypersensitivity
Not known	Anaphylactic reaction

Hepatobiliary disorders

Rare

Jaundice

Reproductive system and breast disorders

Uncommon	Amenorrhoea, Sexual dysfunction, Erectile dysfunction, Ejaculation disorder, Galactorrhoea, Gynaecomastia, Menstrual disorder, Vaginal discharge,
Not known	Priapism

Psychiatric disorders

Very common	Insomnia
Common	Anxiety, Agitation, Sleep disorder
Uncommon	Confusional state, Mania, Libido decreased, Listless, Nervousness
Rare	Anorgasmia, Blunted affect

^a) Hyperprolactinemia can in some cases lead to gynaecomastia, menstrual disturbances, amenorrhoea, galactorrhea.

^b) Extrapyramidal disorder may occur: Parkinsonism (salivary hypersecretion, musculoskeletal stiffness, parkinsonism, drooling, cogwheel rigidity, bradykinesia, hypokinesia, masked facies, muscle tightness, akinesia, nuchal rigidity, muscle rigidity, parkinsonian gait, and glabellar reflex abnormal),akathisia ( akathisia, restlessness, hyperkinesia, and restless leg syndrome), tremor, dyskinesia (dyskinesia, muscle twitching, choreoathetosis, athetosis, and myoclonus), dystonia.

Dystonia includes dystonia, muscle spasms, hypertonia, torticollis, muscle contractions involuntary, muscle contracture, blepharospasm, oculogyration, tongue paralysis, facial spasm, laryngospasm, myotonia, opisthotonus, oropharyngeal spasm, pleurothotonus, tongue spasm, and trismus. Tremor includes tremor and parkinsonian rest tremor. It should be noted that a broader spectrum of symptoms are included, that do not necessarily have an extrapyramidal origin.

Class effects

As with other antipsychotics, very rare cases of QT prolongation have been reported postmarketing with risperidone. Other class-related cardiac effects reported with antipsychotics which prolong QT interval include ventricular arrhythmia, ventricular fibrillation, ventricular tachycardia, sudden death, cardiac arrest and Torsades de Pointes.

Weight gain

The proportions of Risperidone and placebo-treated adult patients with schizophrenia meeting a weight gain criterion of

In a population of children and adolescents with conduct and other disruptive behaviour disorders, in longterm studies, weight increased by a mean of 7.3 kg after 12 months of treatment. The expected weight gain for normal children between 5-12 years of age is 3 to 5 kg per year. From 12-16 years of age, this magnitude of gaining 3 to 5 kg per year is maintained for girls, while boys gain approximately 5 kg per year.

Additional information on special populations

Adverse drug reactions that were reported with higher incidence in elderly patients with dementia or paediatric patients than in adult populations are described below:

Elderly patients with dementia

Transient ischaemic attack and cerebrovascular accident were ADRs reported in clinical trials with a frequency of 1.4% and 1.5%, respectively, in elderly patients with dementia. In addition, the following ADRs were reported with a frequency

Paediatric patients

The following ADRs were reported with a frequency

4.9 Overdose

Symptoms

In general, reported signs and symptoms have been those resulting from an exaggeration of the known pharmacological effects of risperidone. These include drowsiness and sedation, tachycardia and hypotension, and extrapyramidal symptoms. In overdose, QT-prolongation and convulsions have been reported. Torsade de Pointes has been reported in association with combined overdose of Risperidone and paroxetine.

In case of acute overdose, the possibility of multiple drug involvement should be considered.

Treatment

Establish and maintain a clear airway and ensure adequate oxygenation and ventilation. Gastric lavage (after intubation, if the patient is unconscious) and administration of activated charcoal together with a laxative should be considered only when drug intake was less than one hour before. Cardiovascular monitoring should commence immediately and should include continuous electrocardiographic monitoring to detect possible arrhythmias.

There is no specific antidote to Risperidone. Therefore, appropriate supportive measures should be instituted. Hypotension and circulatory collapse should be treated with appropriate measures such as intravenous fluids and/or sympathomimetic agents. In case of severe extrapyramidal symptoms, an anticholinergic medicinal product should be administered. Close medical supervision and monitoring should continue until the patient recovers.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Pharmacotherapeutic group: Other antipsychotics, ATC-code: N05AX08

Mechanism of action

Risperidone is a selective monoaminergic antagonist with unique properties. It has a high affinity for serotoninergic 5-HT2 and dopaminergic D2 receptors. Risperidone binds also to alpha1-adrenergic receptors, and, with lower affinity, to H1-histaminergic and alpha2 adrenergic receptors. Risperidone has no affinity for cholinergic receptors. Although risperidone is a potent D2 antagonist, which is considered to improve the positive symptoms of schizophrenia, it causes less depression of motor activity and induction of catalepsy than classical antipsychotics. Balanced central serotonin and dopamine antagonism may reduce extrapyramidal side effect liability and extend the therapeutic activity to the negative and affective symptoms of schizophrenia.

Pharmacodynamic effects

Schizophrenia

The efficacy of risperidone in the short-term treatment of schizophrenia was established in four studies, 4- to 8-weeks in duration, which enrolled over 2500 patients who met DSM-IV criteria for schizophrenia. In a 6-week, placebo-controlled trial involving titration of risperidone in doses up to 10 mg/day administered twice daily, risperidone was superior to placebo on the Brief Psychiatric Rating Scale (BPRS) total score. In an 8- week, placebo-controlled trial involving four fixed doses of risperidone (2, 6, 10, and 16 mg/day, administered twice daily), all four risperidone groups were superior to placebo on the Positive and Negative Syndrome Scale (PANSS) total score. In an 8-week, dose comparison trial involving five fixed doses of risperidone (1, 4, 8, 12, and 16 mg/day administered twice-daily), the 4, 8, and 16 mg/day risperidone dose groups were superior to the 1 mg risperidone dose group on PANSS total score. In a 4-week, placebocontrolled dose comparison trial involving two fixed doses of risperidone (4 and 8 mg/day administered once daily), both risperidone dose groups were superior to placebo on several PANSS measures, including total PANSS and a response measure (>20% reduction in PANSS total score). In a longer-term trial, adult outpatients predominantly meeting DSM-IV criteria for schizophrenia and who had been clinically stable for at least 4 weeks on an antipsychotic medicinal product were randomised to risperidone 2 to 8 mg/day or to haloperidol for 1 to 2 years of observation for relapse. Patients receiving risperidone experienced a significantly longer time to relapse over this time period compared to those receiving haloperidol.

Manic episodes in bipolar disorder

The efficacy of risperidone monotherapy in the acute treatment of manic episodes associated with bipolar I disorder was demonstrated in three double-blind, placebo-controlled monotherapy studies in approximately 820 patients who had bipolar I disorder, based on DSM-IV criteria. In the three studies, risperidone 1 to 6 mg/day (starting dose 3 mg in two studies and 2 mg in one study) was shown to be significantly superior to placebo on the pre-specified primary endpoint, i.e., the change from baseline in total Young Mania Rating Scale (YMRS) score at Week 3. Secondary efficacy outcomes were generally consistent with the primary outcome. The percentage of patients with a decrease of

The efficacy of risperidone in addition to mood stabilisers in the treatment of acute mania was demonstrated in one of two 3-week double-blind studies in approximately 300 patients who met the DSM-IV criteria for bipolar I disorder. In one 3-week study, risperidone 1 to 6 mg/day starting at 2 mg/day in addition to lithium or valproate was superior to lithium or valproate alone on the pre-specified primary endpoint, i.e., the change from baseline in YMRS total score at Week 3. In a second 3-week study, risper