Lévofloxacine may be available in the countries listed below.
Lévofloxacine (DCF) is known as Levofloxacin in the US.
International Drug Name Search
Glossary
| DCF | Dénomination Commune Française |
Ambroxol Best may be available in the countries listed below.
Ambroxol is reported as an ingredient of Ambroxol Best in the following countries:
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Cidrops may be available in the countries listed below.
Ciprofloxacin hydrochloride (a derivative of Ciprofloxacin) is reported as an ingredient of Cidrops in the following countries:
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Grammidin may be available in the countries listed below.
Gramicidin is reported as an ingredient of Grammidin in the following countries:
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Alendronate Mylan may be available in the countries listed below.
Alendronic Acid sodium trihydrate (a derivative of Alendronic Acid) is reported as an ingredient of Alendronate Mylan in the following countries:
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ADTzimaia may be available in the countries listed below.
Amitriptyline is reported as an ingredient of ADTzimaia in the following countries:
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Glucaminol may be available in the countries listed below.
Metformin hydrochloride (a derivative of Metformin) is reported as an ingredient of Glucaminol in the following countries:
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Flubenol KH may be available in the countries listed below.
In some countries, this medicine may only be approved for veterinary use.
Flubendazole is reported as an ingredient of Flubenol KH in the following countries:
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Clonac may be available in the countries listed below.
Diclofenac sodium salt (a derivative of Diclofenac) is reported as an ingredient of Clonac in the following countries:
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Funzal may be available in the countries listed below.
Clotrimazole is reported as an ingredient of Funzal in the following countries:
Fluconazole is reported as an ingredient of Funzal in the following countries:
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Glimeprid may be available in the countries listed below.
Glimepiride is reported as an ingredient of Glimeprid in the following countries:
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Rec.INN
N07CA04
0000099-15-0
C8-H15-N-O3
173
Antiemetic
Antivertigo agent
DL-Leucine, N-acetyl-
International Drug Name Search
Glossary
| DCF | Dénomination Commune Française |
| IS | Inofficial Synonym |
| OS | Official Synonym |
| Rec.INN | Recommended International Nonproprietary Name (World Health Organization) |
Phenobarbiton natrijum may be available in the countries listed below.
Phenobarbital is reported as an ingredient of Phenobarbiton natrijum in the following countries:
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Cipla-Nevirapine may be available in the countries listed below.
Nevirapine is reported as an ingredient of Cipla-Nevirapine in the following countries:
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Phenelzine Sulphate may be available in the countries listed below.
Phenelzine Sulphate (BANM) is known as Phenelzine in the US.
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Glossary
| BANM | British Approved Name (Modified) |
In some countries, this medicine may only be approved for veterinary use.
Tylosin phosphate (a derivative of Tylosin) is reported as an ingredient of Baby Pig Premix in the following countries:
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Malarex may be available in the countries listed below.
Chloroquine phosphate (a derivative of Chloroquine) is reported as an ingredient of Malarex in the following countries:
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Lithium Apogepha may be available in the countries listed below.
Lithium carbonate (a derivative of Lithium) is reported as an ingredient of Lithium Apogepha in the following countries:
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Pirolam may be available in the countries listed below.
Ciclopirox is reported as an ingredient of Pirolam in the following countries:
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Kanamicina may be available in the countries listed below.
Kanamicina (DCIT) is known as Kanamycin in the US.
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Glossary
| DCIT | Denominazione Comune Italiana |
Troxérutine Qualimed may be available in the countries listed below.
Troxerutin is reported as an ingredient of Troxérutine Qualimed in the following countries:
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Tim-Ophtal may be available in the countries listed below.
Timolol maleate (a derivative of Timolol) is reported as an ingredient of Tim-Ophtal in the following countries:
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Médérantil may be available in the countries listed below.
In some countries, this medicine may only be approved for veterinary use.
Brotizolam is reported as an ingredient of Médérantil in the following countries:
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Tinidafyl may be available in the countries listed below.
Tinidazole is reported as an ingredient of Tinidafyl in the following countries:
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Chloramphenicol Bidiphar may be available in the countries listed below.
Chloramphenicol is reported as an ingredient of Chloramphenicol Bidiphar in the following countries:
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Advaferon may be available in the countries listed below.
Interferon alfacon-1 is reported as an ingredient of Advaferon in the following countries:
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Tretinak may be available in the countries listed below.
Isotretinoin is reported as an ingredient of Tretinak in the following countries:
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Equiworm F may be available in the countries listed below.
In some countries, this medicine may only be approved for veterinary use.
Fenbendazole is reported as an ingredient of Equiworm F in the following countries:
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Gatofen may be available in the countries listed below.
Ketoprofen is reported as an ingredient of Gatofen in the following countries:
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Cipla-Warfarin may be available in the countries listed below.
Warfarin is reported as an ingredient of Cipla-Warfarin in the following countries:
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Benzmaron may be available in the countries listed below.
Benzbromarone is reported as an ingredient of Benzmaron in the following countries:
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Imalgene may be available in the countries listed below.
In some countries, this medicine may only be approved for veterinary use.
Ketamine hydrochloride (a derivative of Ketamine) is reported as an ingredient of Imalgene in the following countries:
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Lipobalsamo may be available in the countries listed below.
Eucalyptol is reported as an ingredient of Lipobalsamo in the following countries:
Guaiacol is reported as an ingredient of Lipobalsamo in the following countries:
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Tetra may be available in the countries listed below.
In some countries, this medicine may only be approved for veterinary use.
Retinol palmitate (a derivative of Retinol) is reported as an ingredient of Tetra in the following countries:
Tetracycline hydrochloride (a derivative of Tetracycline) is reported as an ingredient of Tetra in the following countries:
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Cefadril may be available in the countries listed below.
Cefadroxil monohydrate (a derivative of Cefadroxil) is reported as an ingredient of Cefadril in the following countries:
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Colypan may be available in the countries listed below.
Trimebutine maleate (a derivative of Trimebutine) is reported as an ingredient of Colypan in the following countries:
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Roxam may be available in the countries listed below.
Piroxicam is reported as an ingredient of Roxam in the following countries:
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Pacinone may be available in the countries listed below.
Halazepam is reported as an ingredient of Pacinone in the following countries:
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Trimebutina La Santé may be available in the countries listed below.
Trimebutine is reported as an ingredient of Trimebutina La Santé in the following countries:
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Pegetron may be available in the countries listed below.
Peginterferon Alfa 2-b is reported as an ingredient of Pegetron in the following countries:
Ribavirin is reported as an ingredient of Pegetron in the following countries:
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Citrate de Bétaïne EG may be available in the countries listed below.
Betaine citrate (a derivative of Betaine) is reported as an ingredient of Citrate de Bétaïne EG in the following countries:
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Benzhexol may be available in the countries listed below.
Benzhexol (BAN) is known as Trihexyphenidyl in the US.
International Drug Name Search
Glossary
| BAN | British Approved Name |
Fostipur may be available in the countries listed below.
Urofollitropin is reported as an ingredient of Fostipur in the following countries:
International Drug Name Search
In the US, Inderide (hydrochlorothiazide/propranolol systemic) is a member of the drug class antihypertensive combinations and is used to treat High Blood Pressure.
US matches:
Hydrochlorothiazide is reported as an ingredient of Inderide in the following countries:
Propranolol hydrochloride (a derivative of Propranolol) is reported as an ingredient of Inderide in the following countries:
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Aideito may be available in the countries listed below.
Allopurinol is reported as an ingredient of Aideito in the following countries:
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Bisostad plus may be available in the countries listed below.
Bisoprolol fumarate (a derivative of Bisoprolol) is reported as an ingredient of Bisostad plus in the following countries:
Hydrochlorothiazide is reported as an ingredient of Bisostad plus in the following countries:
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Mirtazapina Jaba may be available in the countries listed below.
Mirtazapine is reported as an ingredient of Mirtazapina Jaba in the following countries:
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Cefalexin Teva may be available in the countries listed below.
Cefalexin is reported as an ingredient of Cefalexin Teva in the following countries:
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Pazeadin R may be available in the countries listed below.
Diltiazem hydrochloride (a derivative of Diltiazem) is reported as an ingredient of Pazeadin R in the following countries:
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Emovat may be available in the countries listed below.
Clobetasone 17α-butyrate (a derivative of Clobetasone) is reported as an ingredient of Emovat in the following countries:
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PMS-Vitamin D3 may be available in the countries listed below.
Colecalciferol is reported as an ingredient of PMS-Vitamin D3 in the following countries:
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AdreView S may be available in the countries listed below.
Iobenguane (131I) is reported as an ingredient of AdreView S in the following countries:
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Bikalutamid Pliva may be available in the countries listed below.
Bicalutamide is reported as an ingredient of Bikalutamid Pliva in the following countries:
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Rhonepride may be available in the countries listed below.
Cisapride is reported as an ingredient of Rhonepride in the following countries:
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In the US, Eldepryl (selegiline systemic) is a member of the following drug classes: dopaminergic antiparkinsonism agents, monoamine oxidase inhibitors and is used to treat ADHD, Depression and Parkinson's Disease.
US matches:
UK matches:
Selegiline hydrochloride (a derivative of Selegiline) is reported as an ingredient of Eldepryl in the following countries:
International Drug Name Search
Glossary
| SPC | Summary of Product Characteristics (UK) |
Mirtazelon may be available in the countries listed below.
Mirtazapine is reported as an ingredient of Mirtazelon in the following countries:
International Drug Name Search
In some countries, this medicine may only be approved for veterinary use.
Oxytetracycline dihydrate (a derivative of Oxytetracycline) is reported as an ingredient of Agrimycin in the following countries:
Oxytetracycline hydrochloride (a derivative of Oxytetracycline) is reported as an ingredient of Agrimycin in the following countries:
International Drug Name Search
Flogol may be available in the countries listed below.
Etofenamate is reported as an ingredient of Flogol in the following countries:
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Promoxil may be available in the countries listed below.
Amoxicillin is reported as an ingredient of Promoxil in the following countries:
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Bisoprolol HCT Synthon may be available in the countries listed below.
Bisoprolol fumarate (a derivative of Bisoprolol) is reported as an ingredient of Bisoprolol HCT Synthon in the following countries:
Hydrochlorothiazide is reported as an ingredient of Bisoprolol HCT Synthon in the following countries:
International Drug Name Search
Trimeto Tad may be available in the countries listed below.
In some countries, this medicine may only be approved for veterinary use.
Sulfadiazine sodium (a derivative of Sulfadiazine) is reported as an ingredient of Trimeto Tad in the following countries:
Trimethoprim is reported as an ingredient of Trimeto Tad in the following countries:
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Prof may be available in the countries listed below.
Ibuprofen is reported as an ingredient of Prof in the following countries:
International Drug Name Search
Eritromagis may be available in the countries listed below.
Erythromycin propionate (a derivative of Erythromycin) is reported as an ingredient of Eritromagis in the following countries:
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Fructon may be available in the countries listed below.
Fructose is reported as an ingredient of Fructon in the following countries:
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Recoveron may be available in the countries listed below.
Acexamic Acid calcium salt (a derivative of Acexamic Acid) is reported as an ingredient of Recoveron in the following countries:
Acexamic Acid sodium salt (a derivative of Acexamic Acid) is reported as an ingredient of Recoveron in the following countries:
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Gliper may be available in the countries listed below.
Glimepiride is reported as an ingredient of Gliper in the following countries:
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Carboplatin Hospira may be available in the countries listed below.
Carboplatin is reported as an ingredient of Carboplatin Hospira in the following countries:
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Clofamox may be available in the countries listed below.
Amoxicillin is reported as an ingredient of Clofamox in the following countries:
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Ciper-Pulvizoo may be available in the countries listed below.
In some countries, this medicine may only be approved for veterinary use.
Cypermethrin is reported as an ingredient of Ciper-Pulvizoo in the following countries:
International Drug Name Search
Heksavit may be available in the countries listed below.
Pyridoxine hydrochloride (a derivative of Pyridoxine) is reported as an ingredient of Heksavit in the following countries:
International Drug Name Search
Metformin-R.A.N may be available in the countries listed below.
Metformin hydrochloride (a derivative of Metformin) is reported as an ingredient of Metformin-R.A.N in the following countries:
International Drug Name Search
Geralgine-P may be available in the countries listed below.
Paracetamol is reported as an ingredient of Geralgine-P in the following countries:
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Actonel Semanal may be available in the countries listed below.
Risedronic Acid monosodium (a derivative of Risedronic Acid) is reported as an ingredient of Actonel Semanal in the following countries:
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Isoprenaline Sulphate may be available in the countries listed below.
Isoprenaline Sulphate (BANM) is also known as Isoprenaline (Rec.INN)
International Drug Name Search
Glossary
| BANM | British Approved Name (Modified) |
| Rec.INN | Recommended International Nonproprietary Name (World Health Organization) |
Isoniazid Oba may be available in the countries listed below.
Isoniazid is reported as an ingredient of Isoniazid Oba in the following countries:
International Drug Name Search
Bendazac Lysine may be available in the countries listed below.
Bendazac Lysine (BANM) is also known as Bendazac (Rec.INN)
International Drug Name Search
Glossary
| BANM | British Approved Name (Modified) |
| Rec.INN | Recommended International Nonproprietary Name (World Health Organization) |
Metformina Cinfa may be available in the countries listed below.
Metformin is reported as an ingredient of Metformina Cinfa in the following countries:
Metformin hydrochloride (a derivative of Metformin) is reported as an ingredient of Metformina Cinfa in the following countries:
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Induxin may be available in the countries listed below.
Oxytocin is reported as an ingredient of Induxin in the following countries:
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Rafen may be available in the countries listed below.
Ibuprofen is reported as an ingredient of Rafen in the following countries:
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In the US, Mirtazapine (mirtazapine systemic) is a member of the drug class tetracyclic antidepressants and is used to treat Anxiety, Depression, Hot Flashes and Insomnia.
US matches:
UK matches:
Rec.INN
N06AX11
0061337-67-5
C17-H19-N3
265
Antidepressant, tetracyclic
Antidepressant: α₂-adrenoceptor antagonist
1,2,3,4,10,14b-Hexahydro-2-methylpyrazino[2,1-a]pyrido[2,3-c][2]benzazepine
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) |
| SPC | Summary of Product Characteristics (UK) |
| USAN | United States Adopted Name |
Irinotecan Teva may be available in the countries listed below.
Irinotecan hydrochloride trihydrate (a derivative of Irinotecan) is reported as an ingredient of Irinotecan Teva in the following countries:
International Drug Name Search
Gen-Medroxy may be available in the countries listed below.
Medroxyprogesterone 17α-acetate (a derivative of Medroxyprogesterone) is reported as an ingredient of Gen-Medroxy in the following countries:
International Drug Name Search
Tenace may be available in the countries listed below.
Enalapril maleate (a derivative of Enalapril) is reported as an ingredient of Tenace in the following countries:
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Meladinine may be available in the countries listed below.
Methoxsalen is reported as an ingredient of Meladinine in the following countries:
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Anabact may be available in the countries listed below.
Metronidazole is reported as an ingredient of Anabact in the following countries:
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Rinoster may be available in the countries listed below.
Budesonide is reported as an ingredient of Rinoster in the following countries:
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Clob may be available in the countries listed below.
Clobazam is reported as an ingredient of Clob in the following countries:
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Klorfeson may be available in the countries listed below.
Chloramphenicol is reported as an ingredient of Klorfeson in the following countries:
Prednisolone is reported as an ingredient of Klorfeson in the following countries:
International Drug Name Search
Xinamod may be available in the countries listed below.
Amoxicillin trihydrate (a derivative of Amoxicillin) is reported as an ingredient of Xinamod in the following countries:
Clavulanic Acid potassium (a derivative of Clavulanic Acid) is reported as an ingredient of Xinamod in the following countries:
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Loratan may be available in the countries listed below.
Loratadine is reported as an ingredient of Loratan in the following countries:
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Lykamilox may be available in the countries listed below.
Amlodipine is reported as an ingredient of Lykamilox in the following countries:
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Cardioaspirina may be available in the countries listed below.
Acetylsalicylic Acid is reported as an ingredient of Cardioaspirina in the following countries:
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In the US, Ioxilan is a member of the drug class non-ionic iodinated contrast media and is used to treat Aortography, Body Imaging, Cerebral Arteriography, Coronary Arteriography, Head Imaging, Intravenous Urography, Left Ventriculography, Peripheral Arteriography and Visceral Arteriography.
Rec.INN
V08AB12
0107793-72-6
C18-H24-I3-N3-O8
791
Contrast medium
Diagnostic agent
(+/-)-N-(2,3-Dihydroxypropyl)-5-[N-(2,3-dihydroxypropyl)acetamido]-N'-(2-hydroxyethyl)-2,4,6-triiodisophthalamid (IUPAC)
1,3-Benzenedicarboxamide, 5-[acetyl(2,3-dihydroxypropyl)amino]-N-(2,3-dihydroxypropyl)-N'-(2-hydroxyethyl)-2,4,6-triiodo- (USAN)
5-[Acetyl(2,3-dihydroxypropyl)amino]-N-(2,3-dihydroxypropyl)-N'-(2-hydroxyethyl)-2,4,6-triiodo-1,3-benzenedicarboxamide
N-(2,3-dihydroxypropyl)-5-[N-(2,3-dihydroxypropyl)acetamido]-N'-(2-hydroxyethyl)-2,4,6-triiodoisophthalamide (WHO)
International Drug Name Search
Glossary
| IUPAC | International Union of Pure and Applied Chemistry |
| IS | Inofficial Synonym |
| OS | Official Synonym |
| PH | Pharmacopoeia Name |
| Rec.INN | Recommended International Nonproprietary Name (World Health Organization) |
| USAN | United States Adopted Name |
| WHO | World Health Organization |
Fenilefrina Cloridrato Dynacren may be available in the countries listed below.
Phenylephrine hydrochloride (a derivative of Phenylephrine) is reported as an ingredient of Fenilefrina Cloridrato Dynacren in the following countries:
International Drug Name Search
Flixonase Aqua may be available in the countries listed below.
Fluticasone propionate (a derivative of Fluticasone) is reported as an ingredient of Flixonase Aqua in the following countries:
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Propil may be available in the countries listed below.
Propylthiouracil is reported as an ingredient of Propil in the following countries:
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Risperidone 2mg Film-coated Tablets
Each tablet contains 2mg of the active substance risperidone.
Excipient: 122.50mg lactose monohydrate per tablet.
For a full list of excipients, see section 6.1
Film coated Tablet
White 10 x 5mm, oval biconvex, scored, coated tablet, marking "T2".
The tablet can be divided into equal halves.
Risperidone tablets are indicated for the treatment of acute and chronic schizophrenic psychoses, and other psychotic conditions, in which positive symptoms (such as hallucinations, delusions, thought disturbances, hostility, suspiciousness), and/or negative symptoms (such as blunted affect, emotional and social withdrawal, poverty of speech) are prominent. Risperidone tablets also alleviate affective symptoms (such as depression, guilt feelings, anxiety) associated with schizophrenia.
Risperidone tablets are also effective in maintaining the clinical improvement during continuation therapy in patients who have shown an initial treatment response.
Risperidone tablets are indicated for the treatment of mania in bipolar disorder. These episodes are characterized by symptoms such as elevated, expansive or irritable mood, inflated self-esteem, decreased need for sleep, pressured speech, racing thoughts, distractibility, or poor judgment, including disruptive or aggressive behaviours.
Risperidone tablets are not licensed for the treatment of behavioural symptoms of dementia (see section 4.4).
4.2. a Schizophrenia:
Switching from other antipsychotics: where medically appropriate, gradual discontinuation of the previous treatment while Risperidone therapy is initiated is recommended. Where medically appropriate when switching patients from depot antipsychotics, consider initiating Risperidone therapy in place of the next scheduled injection. The need for continuing existing antiparkinson medication should be re-evaluated periodically.
Adults
Risperidone tablets may be given once or twice daily. All patients, whether acute or chronic, should start with 2 mg/day Risperidone tablets. The dosage may be increased to 4 mg/day on the second day. Some patients, such as first episode patients, may benefit from a slower rate of titration. From then on the dosage can be maintained unchanged, or further individualised, if needed. Most patients will benefit from daily doses between 4 and 6 mg/day although in some, an optimal response may be obtained at lower doses.
Doses above 10 mg/day generally have not been shown to provide additional efficacy to lower doses and may increase the risk of extrapyramidal symptoms. Doses above 10 mg/day should only be used in individual patients if the benefit is considered to outweigh the risk. Doses above 16 mg/day have not been extensively evaluated for safety and therefore should not be used.
Elderly
A starting dose of 0.5 mg bd is recommended. This dosage can be individually adjusted with 0.5 mg bd increments to 1 to 2 mg bd.
Children
Use of Risperidone tablets for schizophrenia in children aged less than 15 years has not been formally evaluated.
Renal and liver disease
A starting dose of 0.5 mg bd is recommended. This dosage can be individually adjusted with 0.5 mg bd increments to 1 to 2 mg bd.
Risperidone tablets should be used with caution in this group of patients until further experience is gained.
4.2. b Bipolar Mania:
Adults
Risperidone should be administered on a once daily schedule, starting with 2 mg. Dosage adjustments, if indicated, should occur at intervals of not less than 24 hours and in dosage increments of 1 mg per day. A dosing range between 1 and 6 mg per day is recommended.
As with all symptomatic treatments, the continued use of Risperidone tablets must be evaluated and justified on an ongoing basis.
Elderly
A starting dose of 0.5 mg bd is recommended. This dosage can be individually adjusted with 0.5 mg bd increments to 1 to 2 mg bd.
Renal and liver disease
A starting dose of 0.5 mg bd is recommended. This dosage can be individually adjusted with 0.5 mg bd increments to 1 to 2 mg bd.
Risperidone tablets should be used with caution in this group of patients until further experience is gained.
Combined use with mood stabilisers
There is limited information on the combined use of Risperidone tablets with carbamazepine in bipolar mania. Carbamazepine has been shown to induce the metabolism of risperidone producing lower plasma levels of the antipsychotic fraction of Risperidone tablets (see Section 4.5). It is therefore not recommended to co-administer Risperidone tablets with carbamazepine in bipolar mania patients until further experience is gained. The combined use with lithium or valproate does not require any adjustment of the dose of Risperidone tablets.
Method of administration
Oral use.
Risperidone tablets are contraindicated in patients with a known hypersensitivity to risperidone or any other ingredients in the product.
Elderly patients with dementia
Elderly patients with dementia treated with atypical antipsychotic drugs had an increased mortality compared to placebo in a meta-analysis of 17 controlled trials of atypical antipsychotic drugs, 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 mean age (range) of patients who died was 86 years (67-100).
In these trials treatment with furosemide plus risperidone was associated with a higher incidence of mortality compared to treatment with risperidone or furosemide alone, however, the mechanism for an interaction is unclear. Concomitant use of risperidone with other diuretics (mainly thiazide diuretics used in low dose) was not associated with similar findings.
No consistent pattern for cause of death observed. Nevertheless caution should be exercised and the risks and benefits of the combination of risperidone and furosemide or co-medication with other potent diuretics considered prior to the decision to use. 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 (CAE)
Risperidone tablets are not recommended for the treatment of behavioural symptoms of dementia because of an increased risk of cerebrovascular adverse events (including cerebrovascular accidents and transient ischaemic attacks). Treatment of acute psychoses in patients with a history of dementia should be limited to short term only and should be under specialist advice.
Data from randomised clinical trials conducted in elderly >65 years) patients with dementia indicate that there is an approximately 3-fold increased risk of cerebrovascular adverse events (including cerebrovascular accidents and transient ischaemic attacks) with risperidone, compared with placebo. Cerebrovascular adverse events occurred in 3.3% (33/989) of patients treated with risperidone and 1.2% (8/693) of patients treated with placebo. The Odds Ratio (95% exact confidence interval) was 2.96 (1.33, 7.45).
Physicians should consider carefully the risk of cerebrovascular adverse events with Risperidone tablets (given the observations in elderly patients with dementia detailed above) before treating any patient with a previous history of CVA/TIA. Consideration should also be given to other risk factors for cerebrovascular disease including hypertension, diabetes, current smoking, atrial fibrillation, etc.
Alpha-blocking activity
Due to the alpha-blocking activity of Risperidone tablets, orthostatic hypotension can occur, especially during the initial dose-titration period. A dose reduction should be considered if hypotension occurs.
Risperidone tablets should be used with caution in patients with known cardiovascular disease including those associated with prolongation of the QT interval and the dose should be gradually titrated. In clinical trials, Risperidone was not associated with an increase in QTc intervals. As with other antipsychotics, caution is advised when prescribing with medications known to prolong the QT interval.
If further sedation is required, an additional drug (such as a benzodiazepine) should be administered rather than increasing the dose of Risperidone tablets.
Tardive Dyskinesia/Extrapyramidal Symptoms (TD/EPS)
Drugs 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. It has been reported that the occurrence of extrapyramidal symptoms is a risk factor for the development of tardive dyskinesia. If signs and symptoms of tardive dyskinesia appear, the discontinuation of all antipsychotic drugs should be considered.
Neuroleptic Malignant Syndrome (NMS)
Neuroleptic malignant syndrome, characterised by hyperthermia, muscle rigidity, autonomic instability, altered consciousness and elevated CPK levels, has been reported to occur with neuroleptics. In this event all antipsychotic drugs including risperidone should be discontinued.
It is recommended to halve both the starting dose and the subsequent dose increments in geriatric patients and in patients with renal or liver insufficiency.
Caution should also be exercised when prescribing Risperidone tablets to patients with Parkinson's disease since, theoretically, it may cause a deterioration of the disease.
Hyperglycaemia
Hyperglycaemia or exacerbation of pre-existing diabetes has been reported in very rare cases during treatment with Risperdal. Appropriate clinical monitoring is advisable in diabetic patients and in patients with risk factors for the development of diabetes mellitus (see also section 4.8 Undesirable effects).
Venous thromboembolism (VTE)
Cases of venous thrombolembolism (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 preventative measures undertaken.
Other
Classical neuroleptics are known to lower the seizure threshold. Caution is recommended when treating patients with epilepsy.
As with other antipsychotics, patients should be advised of the potential for weight gain.
Acute withdrawal symptoms, including nausea, vomiting, sweating, and insomnia have very rarely been described after abrupt cessation of high doses of antipsychotic drugs. Recurrence of psychotic symptoms may also occur, and the emergence of involuntary movement disorders (such as akathisia, dystonia and dyskinesia) has been reported. Therefore, gradual withdrawal is advisable.
Possible interactions of Risperidone tablets with other drugs have not been systematically evaluated. Given the primary CNS effects of risperidone, it should be used with caution in combination with other centrally acting drugs including alcohol.
Risperidone tablets may antagonise the effect of levodopa and other dopamine-agonists.
Carbamazepine has been shown to decrease the plasma levels of the antipsychotic fraction of Risperidone tablets. A similar effect might be anticipated with other drugs which stimulate metabolising enzymes in the liver. On initiation of carbamazepine or other hepatic enzyme-inducing drugs, the dosage of Risperidone tablets should be re-evaluated and increased if necessary. Conversely, on discontinuation of such drugs, the dosage of Risperidone tablets should be re-evaluated and decreased if necessary.
Phenothiazines, tricyclic antidepressants and some beta-blockers may increase the plasma concentrations of risperidone but not those of the active antipsychotic fraction. Fluoxetine and paroxetine, CYP2D6 inhibitors, may increase the plasma concentration of risperidone but less so of the active antipsychotic fraction. When concomitant fluoxetine or paroxetine is initiated or discontinued, the physician should re-evaluate the dosing of Risperidone. Based on in vitro studies, the same interaction may occur with haloperidol. 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 cholinesterase inhibitor galantamine does not show a clinically relevant effect on the pharmacokinetics of risperidone and the active antipsychotic fraction. A study of donepezil in non-elderly healthy volunteers also showed no clinically relevant effect on the pharmacokinetics of risperidone and the antipsychotic fraction.
When Risperidone tablets are taken together with other highly protein-bound drugs, there is no clinically relevant displacement of either drug from the plasma proteins.
See section 4.4 (Special warnings and special precautions for use) regarding increased mortality in elderly patients with dementia concomitantly receiving furosemide.
Risperidone does not show a clinically relevant effect on the pharmacokinetics of valproate or topiramate. The potential for reduced toleration of the combination treatment should be taken into consideration when co-administering risperidone and topiramate.
In patients on long-term lithium and older/typical neuroleptic therapy, no significant change occurred in the pharmacokinetics of lithium after substitution of the concomitant neuroleptic with risperidone.
Food does not affect the absorption of risperidone.
Pregnancy
Although, in experimental animals, risperidone did not show direct reproductive toxicity, some indirect, prolactin- and CNS-mediated effects were observed, typically delayed oestrus and changes in mating and nursing behaviour in rats. No teratogenic effect of risperidone was noted in any study. The safety of Risperidone tablets for use during human pregnancy has not been established. Reversible extrapyramidal symptoms in the neonate were observed following postmarketing use of risperidone during the last trimester of pregnancy. Therefore, Risperidone should only be used during pregnancy if the benefits outweigh the risks.
Lactation
In animal studies, risperidone and 9-hydroxyrisperidone are excreted in the milk. It has been demonstrated that risperidone and 9-hydroxyrisperidone are also excreted in human breast milk. Therefore, women receiving Risperidone should not breast feed.
Risperidone may interfere with activities requiring mental alertness. Therefore, patients should be advised not to drive or operate machinery until their individual susceptibility is known.
Risperidone tablets are generally well tolerated and in many instances it has been difficult to differentiate adverse events from symptoms of the underlying disease. Adverse events observed in association with the use of Risperidone tablets include:
Common: insomnia, agitation, anxiety, headache.
Less common: somnolence, fatigue, dizziness, impaired concentration, constipation, dyspepsia, nausea/vomiting, abdominal pain, blurred vision, priapism, erectile dysfunction, ejaculatory dysfunction, orgasmic dysfunction, urinary incontinence, rhinitis, rash and other allergic reactions.
Cerebrovascular accidents have been observed during treatment with risperidone. (see Section 4.4 Special warnings and precautions for use).
Hyperglycaemia and exacerbation of pre-existing diabetes have been reported in very rare cases during risperidone treatment.
The incidence and severity of extrapyramidal symptoms are significantly less than with haloperidol. However, in some cases the following extrapyramidal symptoms may occur: tremor, rigidity, hypersalivation, bradykinesia, akathisia, acute dystonia. If acute in nature, these symptoms are usually mild and are reversible upon dose reduction and/or administration of antiparkinson medication, if necessary. In clinical trials in patients with acute mania risperidone treatment resulted in an incidence of EPS>10%. This is lower than the incidence observed in patients treated with classical neuroleptics.
Occasionally, orthostatic dizziness, hypotension including orthostatic, tachycardia including reflex tachycardia and hypertension have been observed following administration of Risperidone tablets.
Risperidone tablets can induce a dose-dependent increase in plasma prolactin concentration. Possible associated manifestations are: galactorrhoea, gynaecomastia, disturbances of the menstrual cycle and amenorrhoea.
Weight gain, oedema and increased hepatic enzyme levels have been observed during treatment with Risperidone tablets.
A decrease in neutrophil and/or thrombocyte count has been reported.
As with classical neuroleptics, rare cases of the following have been reported in schizophrenic patients: water intoxication with hyponatraemia, either due to polydipsia or to the syndrome of inappropriate secretion of antidiuretic hormone (SIADH); tardive dyskinesia, body temperature dysregulation and seizures.
Benign pituitary adenomas have been reported very rarely in risperidone users during postmarketing surveillance. No causal association has been established.
Very rare cases of angioedema have been reported in postmarketing experience.
Sedation has been reported more frequently in children and adolescents than in adults. In general, sedation is mild and transient.
Withdrawal reactions have been reported in association with antipsychotic drugs (see section 4.4 Special warnings and special precautions for use).
Cases of venous thromboembolism, including cases of pulmonary embolism and cases of deep vein thrombosis have been reported with antipsychotic drugs-Frequency unknown.
In general, reported signs and symptoms have been those resulting from an exaggeration of the drug's known pharmacological effects. These include drowsiness and sedation, tachycardia and hypotension, and extrapyramidal symptoms. In overdose, rare cases of QT-prolongation have been reported. In case of acute overdosage, the possibility of multiple drug involvement should be considered.
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. Cardiovascular monitoring should commence immediately and should include continuous electrocardiographic monitoring to detect possible arrhythmias.
There is no specific antidote to Risperidone tablets. 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, anticholinergic medication should be administered. Close medical supervision and monitoring should continue until the patient recovers.
Pharmacotherapeutic group: Other antipsychotics
ATC code: N05AX
Risperidone is a novel antipsychotic belonging to a new class of antipsychotic agents, the benzisoxazole-derivatives.
Risperidone is a selective monoaminergic antagonist with a high affinity for both serotonergic 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, that is considered to improve the positive symptoms of schizophrenia, it causes less depression of motor activity and induction of catalepsy than classical neuroleptics. Balanced central serotonin and dopamine antagonism may reduce the tendency to cause extrapyramidal side effects, and extend the therapeutic activity to the negative and affective symptoms of schizophrenia.
Risperidone is completely absorbed after oral administration, reaching peak plasma concentrations within 1 to 2 hours. The absorption of risperidone is not affected by food.
The most important route of metabolism of risperidone is hydroxylation by cytochrome CYP 2D6 to 9-hydroxy-risperidone which has a similar pharmacological activity to risperidone. This hydroxylation is subject to debrisoquine-type genetic polymorphism but this does not affect the active antipsychotic fraction since this consists of risperidone and its active metabolite 9-hydroxyrisperidone. After oral administration, the elimination half-life of the active antipsychotic fraction is 24 hours.
A single-dose study showed higher active plasma concentrations and a slower elimination of risperidone in the elderly and in patients with renal insufficiency. Risperidone plasma concentrations were normal in patients with liver insufficiency.
Topiramate modestly reduces the bioavailability of risperidone, but not that of the active antipsychotic fraction. Therefore, this interaction is unlikely to be of clinical significance. The bioavailability of topiramate is slightly decreased when administered in combination with risperidone. This interaction is not likely to be clinically significant.
There are no preclinical data of relevance to the prescriber other than those already provided in other sections of the SPC.
Lactose anhydrous
Cellulose, microcrystalline
Starch pregelatinised
Magnesium stearate
Hypromellose 6
Macrogol 6000
Titanium dioxide (E171)
No incompatibilities known.
2 years (bottle) or 3 years (blister)
This medicinal product does not require any special storage conditions
Blister pack: PVC-PVDC / Al foil Pack sizes 14, 20, 28, 30, 42, 56 or 60 film coated tablets
HDPE Container with LDPE Cap. Pack sizes 20, 40, 60 or 100 film coated tablets
Not all pack sizes may be marketed
No special requirements.
Actavis Group PTC ehf
Reykjavíkurvegi 76-78
220 Hafnarfjordur
Iceland.
PL 30306/0092
01 /04/2008
17th February 2010
IF APPLICABLE
IF APPLICABLE
