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PSYCHODAL

PSYCHODAL
PSYCHODAL 1,2,3 & 4 mg F.C.Tablets
Composition: 
Each tablet Contains: 
Risperidone 1, 2, 3mg or 4mg 
Psychodal (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. 
Rispendone binds also to siphal - adrenergic receptors and with lower affinity to histaminergic and alpha2 - adrenergic receotors 
Pharmacokinetics: —Psye*iodaHw completely absorbed after oral administration reaching peak plasma concentration after ito 2 hours the absorption is not affected by food ,Risperidone is metabolized to 9 - hydroxyrisperidone, which has a similar pharmacological activity as risperidone The elimination half - life of g hydroxyrisperidone is 24 hours. Indications: -Treatment of acute and chronic schizophrenic psychoses and other psychotic conditions in which positive symptoms (such as hallucinations, delusion,thought disturbances , hostility, suspiciousness) and / or negative 
symptoms(such as blunted affect, emotional and social withdrawal, poverty of speech) are prominent. 
- Alleviates affective symptoms 
( such as depression, guilt feelings, anxiety) associated with schizophrenia.
Dosge and administration: Switching from other antipsychotics, where medically appropriate, gradual withdrawal of the previous treatment v1iile Psychodal (risperidone) therapy is recommended. Adults: All patients whether acute or chronic cases, should start with 2 mg/day risperidone, The dosage should be increased to 4 mg/day on the second day and 6 mg /day on the third day, then the dose can be maintained unchanged.The usual optimum dose is 4-8 mg/day however, some patients may benefit from lower doses. 
- 
Special population: Elderh, eb’!iffit,d, patients with severe renal or hepatic impairment, and patients either predisposed to hypotension or for whom hypotension wauld pose a risk; 
A starting dose of 0.5 mg twice daily is recommended , this dose can be increased tol -2 mg twice daily. 
Children: Experience is lacking in children aged less than 15 years. Contraindications: Risperidone is contraindicated in patients with hypersensitivity to the product. Precautions: - Due to the alpha - blocking activity of risperidone, Orthostatic hypotension can occur. 
- Risperidone should be used with cautions in patients with cardiovascular diseases. 
- Caution should be exercised when prescribing risperidone to patients With parkinson’s disease since , theoretically, it
may cause deterioration of the disease. Use during pregnancy and lactation: - The safety of risperidone for use during humarrregnancy has not been established, therefore, Risperidone should only be used during pregnancy if the benefits outweigh the risks 
- 
It is not known whether risperidone is excreted in human milk , therefore, women receiving 
risperidone should not breast-feed. Effect on driving ability 
and operation of machinery: 
Patients should not drive or operate machine until their individual susceptibility is known. 
Sete e 
- Insomnia , agitation and headache are common. 
- Fatigue, dizziness and constipation are less common 
- Off hostatic hypotension occasionally occurs. 
Storage Conditions: 
Store between 15-30°C in a 
dry place and protect from light. Pack: Boxes containing 10 or 30 tablets each of 1 mg. Boxes containing 10 or 30 tablets each of 2 mg. Boxes containing 10 or 30 tablets each of 3 mg. Boxes containing 10 or 30 tablets each of 4 mg. 
Keep out of the reach of children 
Produced by 
DELTA PHARMAS.A.E 
Tenth of Ramadan City, ARE.

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