Each Film Coated tablet of Respimod® contains: 

• Risperidone                    1 mg
• Risperidone                    2 mg
• Risperidone                    3 mg
• Risperidone                    4 mg

Respimod® is used to treat the following:

• Schizophrenia, where you may see, hear or feel things that are not there, believe things that are not true or feel unusually suspicious or confused.
• Mania, where you may feel very excited, elated, agitated, enthusiastic or hyperactive. Mania occurs in an illness called "bipolar disorder".
• Short-term treatment (up to 6 weeks) of long-term aggression in people with Alzheimer’s dementia, who harm themselves or others. Alternative (non-drug) treatments should have been used previously.

• 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, Respimod® may increase the sedative effect of all of these. 
• Medicines 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 diuretics).
• Drugs to treat elevated blood pressure.Respimod® 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). 
• Respimod® 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 and Phenytoin.
• The following drugs may increase the effect of Risperidone: Quinidine, Antidepressants, beta blockers, Phenothiazines, Cimetidine and Ranitidine.
• If the patient start or stop taking such medicines he/she may need a different dose of Risperidone.

• Non-teratogenic Effects: Neonates exposed to antipsychotic drugs during the third trimester of pregnancy are at risk for extrapyramidal 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 and 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. 

Common:

• 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.

Overdose:

• 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.

Treatment:

• 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 Respimod® Therefore appropriate supportive measures should be instituted. 

For the treatment of schizophrenia:
⇒ Adults:

• The usual starting dose is 2 mg per day; this may be increased to 4 mg per day on the second day, the dose may then be adjusted by the doctor depending on how the patient responds to the treatment,
• most people feel better with daily doses of 4 to 6 mg.
• This total daily dose can be divided into either one or two doses a day. The doctor will tell the patient which is the best for him/her.

⇒ Children and adolescents:

• Children and adolescents under 18 years old should not be treated with Respimod® for schizophrenia.

For the treatment of mania:
⇒ Adults: The starting dose will usually be 2 mg once a day. The dose may then be gradually adjusted by the doctor depending on  how the patient responds to the treatment.

⇒ Most people feel better with doses of 1 to 6 mg once a day.
⇒ Children and adolescents: Children and adolescents under 18 years old should not be treated with Rispid® for mania.
⇒ Elderly people: (Either Schizophrenia or Mania ) : the starting dose will usually be 0.5 mg twice a day. The dose may then be gradually adjusted by the doctor to 1 mg to 2 mg twice a day depending on how much the patient responds to the treatment.

For the treatment of  long-standing aggression in people with Alzheimer's dementia:
⇒ Adults (including elderly people):

• The starting dose will normally be 0.25 mg twice a day. The dose may then be gradually adjusted by the doctor depending on how the patient responds to the treatment.
• Most people feel better with 0.5 mg twice a day. Some patients may need 1 mg twice a day.
• Treatment duration in patients with Alzheimer’s dementia should not be more than 6 weeks.

⇒ People with kidney or liver problems:

• Regardless of the disease to be treated, all starting doses and following doses of Respimod® should be halved. Dose increases should be slower in these patients. Respimod® should be used with caution in this patient group.

¤ Do not stop using this medicine suddenly without asking your doctor.

• Due to alpha-blocking activity of Respimod® , (orthostatic) hypotension can occur, especially during the initial dose-titration period. Respimod® 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 Respimod® 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 Respimod® 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 Respimod® 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 gain.
• Patients should be advised to avoid alcohol while taking Respimod®.
• Make sure your doctor knows if you are pregnant.

• Respimod®: Blister of 10 tablets, pack of 2 blisters.

• Store in a dry place below 25ºC.