Rutra 1 mg/2 mg/3 mg/4 mg Tablets

RUTRA TABLETS is used in the treatment of:

• acute and chronic schizophrenic psychoses and related psychosis in which positive symptoms (such as hallucinations, delusions, thought disturbances, hostility, suspiciousness) and/or the negative symptoms (such as blunted affect, emotional and social withdrawal, poverty of speech) are prominent. RUTRA TABLETS also alleviates affective symptoms (such as depression, guilt feelings, anxiety) associated with schizophrenia. In patients who have shown an initial treatment response, RUTRA TABLETS is also effective in maintaining the clinical improvement;
• behavioral disturbances in patients with dementia in whom symptoms such as aggressiveness (verbal outbursts, physical violence), activity disturbances (agitation, wandering) or psychotic symptoms are prominent;
• conduct and other disruptive behaviour disorders in children (aged 5 - 12 years), with sub average intellectual functioning or mental retardation in whom destructive behaviours (e.g. aggression, impulsivity and self-injurious behaviours) are prominent.

If you are taking other medicines on a regular basis, including complementary or traditional medicines, the use of RUTRA TABLETS with these medicines may cause undesirable interactions. Please consult your doctor, pharmacist or other healthcare professional, for advice.

Do not take RUTRA TABLETS:

• If you are hypersensitive (allergic) to Risperidone or any of the other ingredients of RUTRA TABLETS.
• If you are pregnant or lactating.
• Not for children under the age of 5 years.

Take special care with RUTRA TABLETS:

• It is recommended to halve both the starting dose and the subsequent dose increments in geriatric patients and patients with renal or liver insufficiency.
• Orthostatic hypertension can occur, especially during the initial dose-titration period.
• RUTRA TABLETS should be used with caution in patients with known cardiovascular disease, and the dosage should be gradually titrated as recommended. A dose reduction should be considered if hypotension occurs.
• Caution should be used when prescribing RUTRA TABLETS to patients with Parkinson disease since, theoretically, it might cause a deterioration of the disease.
• Patients may be advised to refrain from excessive eating in view of the possibility of weight gain.

Driving and using machinery: RUTRA TABLETS may impair mental alertness. Therefore patients should be advised not to drive or operate machinery until their individual susceptibility is known.

Pregnancy and Breast-feeding: Safety of RUTRA TABLETS in pregnant and lactating women has not been established. Women receiving RUTRA TABLETS should not breast feed. If you are pregnant or breast feeding your baby while taking this medicine, please consult your doctor, pharmacist or other healthcare professional for advice.

Taking other medicines with RUTRA TABLETS: RUTRA TABLETS interacts with alcohol, other centrally acting medicines, levodopa, carbamazepine, Phenothiazines, tricyclic antidepressants, some beta-blockers and fluoxetine.

Always take RUTRA TABLETS exactly as your doctor has instructed you. You should check with your doctor or pharmacist if you are unsure.

If you have the impression that the effect of RUTRA TABLETS is too strong or too weak, talk to your doctor or pharmacist.

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

Adults: RUTRA TABLETS may be given once or twice daily. Patients should start with 2 mg/day orally RUTRA TABLETS. The dosage may be increased on the second day to 4 mg/day. From then on, the dosage can be maintained unchanged, or further individualized, if needed. Most patients will benefit from daily doses of between 4 mg/day and 8 mg/day. Doses above 6 mg/day (when administered twice daily) were associated with more extrapyramidal symptoms and other adverse effects and are not generally recommended. In some patients, particularly with first episode acute psychosis, a slower titration phase and a lower starting and maintenance dose may be appropriate. Doses above 10 mg/day have not been shown to be superior in efficacy to lower doses and may cause an increased incidence of side-effects such as extrapyramidal symptoms. Dosages above 10 mg/day should only be considered if the benefits outweigh the risk. The maximum total daily dose is 16 mg/day. A benzodiazepine may be added to RUTRA TABLETS if additional sedation is required.

Renal- and liver-diseased patients: Caution should be exercised with these groups of patients, as clinical experience is lacking in these patient populations. It is recommended to halve both the starting dose and the subsequent dose increments.

El derly patients: A starting dose of 0.5 mg bid. is recommended. This dosage can be individually adjusted with 0.5 mg b.i.d. increments to 1 – 2 mg b.i.d.

Children: Not for children under 15 years as efficacy and safety in children under the age of 15 years have not been demonstrated in schizophrenia. Behavioural disturbances in patients with dementia: A starting dose of 0.25 mg b.i.d. orally is recommended. This dosage can be individually adjusted by increments of 0.25 mg b.i.d, not more frequently than every other day, if needed. The optimum dose is 0.5 mg b.i.d. for most patients. Some patients, however, may benefit from doses up to 1 mg b.i.d. Once patients have reached their target dose, a once-daily dosing regimen can be considered. Conduct and other disruptive behaviour disorders in children 5 - 12 years of age: Subjects <50 kg: A starting dose of 0.01 mg/kg once daily is recommended. This dosage can be individually adjusted by increments of 0.01 mg/kg once daily not more frequently than every other day, if needed, The recommended maintenance dose is 0.02 – 0.04 mg/kg once daily. The mean dose is 0.03 mg/kg once daily.

RUTRA TABLETS can have side effects.

Gastrointestinal disorders: Less frequent: Dyspepsia, nausea, vomiting, constipation, abdominal pain.

Nervous system disorders: Frequent: Headache, anxiety, insomnia, agitation, extrapyramidal disorder. Sedation has been reported more frequently in children and adolescents than in adults. Less frequent: Dizziness, fatigue, concentration difficulties. Frequency unknown: Seizures.

Endocrine disorders: Less frequent: Weight gain.

Respiratory, thoracic and mediastinal disorders: Less frequent: Rhinitis.

Reproductive system and breast disorders: Less frequent: Priapism, erectile dysfunction, ejaculatory dysfunction, orgastic dysfunction.

Renal and urinary disorders: Less frequent: Urinary incontinence.

Skin and subcutaneous tissue disorders: Less frequent: Rash and other allergic reactions have been observed.

Vascular disorders: Orthostatic hypotension Less frequent: Hypertension, reflex tachycardia. Cerebrovascular accidents have been observed during treatment with risperidone.

Investigations: Mild fall in neutrophil and/or thrombocytes count has been reported. A dose-dependent increase in plasma prolactin concentration. Possible associated manifestations are: galactorrhoea, gynaecomastia, disturbances of the menstrual cycle and amenorrhoea. Premenopausal women who develop secondary amenorrhea of greater than six months duration should receive appropriate preventative therapy to avoid hypo-oestrogenic bone loss.

The following dose dependent extrapyramidal symptoms have been observed: tremor, rigidity, hypersalivation, bradykinesia, oculogyric crisis, akathisia (hyperkinesia) and acute dystonia, hypokinesia. These are usually mild and reversible upon dose reduction and/or administration of anti-Parkinson medication, if necessary. Tardive dyskinesia (TD), a syndrome consisting of potentially irreversible, involuntary dyskinetic movements may develop in patients treated with conventional neuroleptics. Although this syndrome of TD appears to be most prevalent in the elderly, especially elderly females, it is impossible to predict at the onset of treatment which patients are likely to develop TD. It has been suggested that the occurrence of Parkinsonian side-effects is a predictor for the development of TD. The risk of developing TD and the likelihood that it will become irreversible are believed to increase as the duration of treatment and the total cumulative dose of the antipsychotic administered to the patient increase. However, the syndrome can develop, although less commonly, after relatively brief periods of treatment at low doses. There is no known treatment for an established case of TD. The syndrome may remit partially or completely if the antipsychotic medicine treatment is withdrawn. The antipsychotic drug treatment itself however, may suppress the signs and symptoms of TD, thereby masking the underlying process. The effect of symptom suppression upon the long-term course of TD is unknown. In view of these considerations, RUTRA TABLETS should be prescribed in a manner that is most likely to minimize the risk of TD. As with any antipsychotic medicine, RUTRA TABLETS should be reserved for patients who appear to be obtaining substantial benefit from the medicine. In such patients the smallest dose and the shortest duration of treatment should be sought. The benefit for continued treatment should be reassessed periodically. If signs and symptoms of TD appear in a patient on antipsychotics, medicine discontinuation should be considered. However, some patients may require treatment despite the presence of this syndrome.

Store below 30 °C. Do not remove from carton until required for use. KEEP ALL MEDICINES OUT OF THE REACH AND SIGHT OF CHILDREN. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).