RISPERIDONE Film-coated tablet (2019)
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Περιεχόμενα
Name of the medicinal product
Risperidone 0.5 mg Film-coated Tablets. Risperidone 1 mg Film-coated Tablets. Risperidone 2 mg Film-coated Tablets. Risperidone 3 mg Film-coated Tablets. Risperidone 4 mg Film-coated Tablets. Risperidone ...
Qualitative and quantitative composition
Each film-coated tablet contains 0.5 mg of risperidone. Excipient with known effect: Each film-coated tablet contains 63.65 mg lactose (as lactose monohydrate). Each film-coated tablet contains 1 mg of ...
Pharmaceutical form
Film-coated tablet. Risperidone Accord 0.5 mg film-coated tablets are brick red coloured, round, biconvex, film-coated tablet, plain on both sides. Risperidone Accord 1 mg film-coated tablets are white ...
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 ...
Posology and method of administration
Posology Schizophrenia Adults Risperidone may be given once or twice daily. Patient should start with 2 mg/day risperidone. The dosage may be increased on the second day to 4 mg. Subsequently, the dosage ...
Contraindications
Hypersensitivity to Risperidone or to any of the excipients listed in section 6.1.
Special warnings and precautions for use
Elderly patients with dementia Increased Mortality in Elderly People with Dementia In a meta-analysis of 17 controlled trials of atypical antipsychotic drugs, including Risperidone, elderly patients with ...
Interaction with other medicinal products and other forms of interaction
Pharmacodynamic-related Interactions Drugs known to prolong the QT interval As with other antipsychotics, caution is advised when prescribing risperidone with medicinal products known to prolong the QT ...
Fertility, pregnancy and lactation
Pregnancy There are no adequate data from the use of risperidone in pregnant women. Risperidone was not teratogenic in animal studies but other types of reproductive toxicity were seen (see section 5.3). ...
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 ...
Undesirable effects
The most frequently reported adverse drug reactions (ADRs) (incidence ≥10%) are: Parkinsonism, sedation/somnolence, headache, and insomnia. The ADRs that appeared to be dose-related included parkinsonism ...
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 ...
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 ...
Pharmacokinetic properties
Risperidone is metabolised to 9-hydroxy-risperidone, which has a similar pharmacological activity to risperidone (see Biotransformation and Elimination). Absorption Risperidone is completely absorbed after ...
Preclinical safety data
In (sub)chronic toxicity studies, in which dosing was started in sexually immature rats and dogs, dose-dependant effects were present in male and female genital tract and mammary gland. These effects were ...
List of excipients
Tablet Core: Lactose monohydrate Maize starch Cellulose microcrystalline (E460) Sodium laurilsulfate Colloidal anhydrous silica (E551) Purified talc (E553b) Magnesium stearate (E572) Tablet coating (for ...
Incompatibilities
Not applicable.
Shelf life
Shelf life: 2 years.
Special precautions for storage
Do not store above 30°C.
Nature and contents of container
Risperidone is packed in PVC/PVdC/Al blister of 20, 28, 30, 50, 60, 90, 100 and 120 tablets. Not all pack sizes may be marketed.
Special precautions for disposal and other handling
Any unused product or waste material should be disposed of in accordance with local requirements.
Marketing authorization holder
Accord Healthcare Limited, Sage House, 319, Pinner Road, North Harrow, Middlesex, HA1 4 HF, United Kingdom
Marketing authorization number(s)
Risperidone 0.5 mg Film-coated Tablets: PL 20075/0007 Risperidone 1 mg Film-coated Tablets: PL 20075/0008 Risperidone 2 mg Film-coated Tablets: PL 20075/0009 Risperidone 3 mg Film-coated Tablets: PL 20075/0010 ...
Date of first authorization / renewal of the authorization
16/09/2008
Date of revision of the text
27/02/2019
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