Rispenol-D 3

Rispenol-D 3

- 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  
  alpha 2-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 neuroleptics. Balanced central serotonin and dopamine antagonism 
  may reduce extrapyramidal side effect liability and extend the therapeutic activity to the 
  negative and effective symptoms of schizophrenia.
Pharmacokinetic properties: 
- Risperidone is completely absorbed after oral administration, reaching peak plasma
  concentrations within 1 to 2 hours. The absorption is not affected by food and thus 
  risperidone can be given with or without meals. Risperidone is metabolized by cytochrome 
  P-450 IID6 to 9-hydroxy-risperidone which has a similar pharmacological activity as 
  risperidone.  After oral administration to psychotic patients, risperidone is eliminated with
  a half-life of about 3 hours. The elimination half-life of 9-hydroxy-risperidone and of the 
  active antipsychotic fraction is 24 hours. Risperidone is rapidly distributed. The volume of 
  distribution is 1- 2 L/kg. The plasma protein binding of risperidone is 88%, that of 
  9-hydroxy-risperidone is 77%  one week after administration, 70% of the dose is excreted 
  in the urine and 14% in the faeces. In urine, risperidone plus 9-hydroxy-risperidone 
  represent 35 - 45% of the dose. The reminder are inactive metabolites.

-  Each Film Coated tablet of     Rispenol-D ®  contains: 
    Risperidone                    1 mg
    Risperidone                    2 mg
    Risperidone                    3 mg
    Risperidone                    4 mg

This product is contraindicated in patients with a known hypersensitivity to Risperidone. 

- The patient should talk to doctor or pharmacist if he or she is taking any of the Following: 
- Drugs that work on the brain such as benzodiazepines or opiates, some antihistamines,  
   Rispenol-D® may increase the sedative effect of all of these. 
- Medicine that may change the electrical activity of the heart, such as medicines for malaria,
  heart rhythm problems (such as quinidine), allergies (anti-histamines), some antidepressants 
  or other medicines for mental problems. 
- Drugs that cause a slow heart beat. Drugs that cause low blood potassium (e.g. certain 
- Drugs to treat elevated blood pressure.  Rispenol-D® Tablets can lower blood pressure. 
- Drugs for Parkinson's disease (such as levodopa), Water tablets (diuretics) used for heart 
  problems or swelling of parts of the body due to a build up of too much fluid (such as 
  furosemide or chlorothiazide). 
-  Rispenol-D® Tablets taken by itself or with furosemide, may have an increased risk of stroke or 
  death in elderly people with dementia.
- The following drugs may reduce the effect of Risperidone: Rifampicin, Carbamazepine,  
  Phenobarbital,  Phenytoin.
- The following drugs may increase the effect of Risperidone: Quinidine, Antidepressants,  
   beta blockers, Phenothiazines, Cimetidine, ranitidine.
- If the patient start or stop taking such medicines he/she may need a different dose of 

- Symptoms resulting from an exaggeration of the drug :drowsiness and sedation, tachycardia 
  and hypotension, and extrapyramidal symptoms. Rare cases of QT-prolongation. The
  alpha-blocking properties of bretylium might be additive to those of risperidone, resulting in
  problematic hypotension. 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. 
- There is no specific antidote to  Rispenol-D® . Therefore appropriate supportive measures should 
   be instituted. 

-  Non-teratogenic Effects: Neonates exposed to antipsychotic drugs during the third trimester 
   of pregnancy are at risk for extra pyramidal and/or withdrawal symptoms following 
   delivery, there have been reports of agitation, hypertonia, tremor, somnolence, respiratory 
   distress and feeding disorder in these neonates.
• Antipsychotics should be used during pregnancy only if the potential benefit justifies the 
  potential risk to the fetus.
- Risperidone and 9-hydroxy-risperidone are also excreted in human breast milk. Therefore,  
  women receiving Risperidone should not breast feed. 

 Very Common: 
- Parkinsonism includes: increase in saliva secretion or watery mouth, musculoskeletal stiffness, 
  drooling, jerks when bending the limbs, slow, reduced or impaired body movements, no
  expression on the face. 
- Muscle tightness, stiff neck, muscle stiffness, small, shuffling, hurried steps and lack of normal 
  arm movements when walking, persistent blinking in response to tapping of the forehead (an 
  abnormal reflex). 
- Headache, difficulty falling or staying a sleep. 
- Drowsiness, fatigue, restlessness, inability to sit still, irritability, anxiety, sleepiness, dizziness, 
  poor attention, feeling exhausted, sleep disorder. 
- Vomiting, diarrhea, constipation, nausea, increased appetite, abdominal pain or discomfort, sore 
   throat, dry mouth. 
- Weight increased, increase in body temperature, decreased appetite 
- Difficulty breathing, lung infection (pneumonia), flu, infection of the breathing passages, 
  blurred vision, nose congestion, nose bleeding, cough. 
- Urinary tract infection, bed wetting. 
- Muscle spasm, involuntary movements of face or arms and legs, joint pain, back pain, swelling 
  of arms and legs, pain in arms and legs. 
- Rash, skin redness. 
- Fast beating heart, chest pain. 
- Blood prolactin hormone level increased.

Special warnings and special precautions for use: 
- Due to alpha-blocking activity of  Rispenol-D®, (orthostatic) hypotension can occur, especially 
  during the initial dose-titration period.  Rispenol-D® 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. 
- Patients with diabetes mellitus who are started on atypical antipsychotic should be monitored 
  regularly for worsening of glucose control. Patients with risk factors for diabetes mellitus who
  are starting treatment with atypical antipsychotic should undergo fasting blood glucose testing 
  at the beginning of treatment and periodically during treatment. Patients who develop symptoms
  of hyperglycemia during treatment with atypical antipsychotic should undergo fasting blood 
  glucose testing. In some cases, hyperglycemia has resolved when the atypical antipsychotic was 
  discontinued;  however, some patients required continuation of anti-diabetic treatment. 
- Dopamine antagonistic drugs have been associated with the induction of tardive dyskinesia
   characterized by rhythmical involuntary movements. Because  Rispenol-D® has a lower potential to
   induce extrapyramidal symptoms than classical neuroleptics, it should have a reduced risk of 
   inducing as compared to classical neuroletics. If signs and symptoms of tardive dyskinesia
   appear, the discontinuation of all antipsychotic drugs should be considered.
-  As for all antipsychotic drugs, including  Rispenol-D® should be discontinued if signs and 
   symptoms of the Neuroleptic Malignant Syndrome appear. 
-  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 is also due when prescribing  Rispenol-D® to patients with Parkinson's disease since, 
  theoretically, it might cause a deterioration of the disease. 
- Classical neuroleptics are known to lower the seizure threshold. Caution is recommended when 
   treating patients with epilepsy. 
- Patients may be advised to refrain from excessive eating in view of the possibility of weight 
- Patients should be advised to avoid alcohol while taking  Rispenol-D®.
- Make sure your doctor knows if you are pregnant.

 Rispenol-D ® : Blister of 10 tablets, pack of 2 blisters.

- Store in a dry place below 30ºC.