SPERIDAN 4 mg. 30 tablets

WHAT SPERIDAN AND WHAT IT IS USED
Speridan belongs to a group of medicines called "antipsychotics". Speridan 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. Before that must be implemented Alternative (non-drug).
• Short-term treatment (up to weeks b) of long-term aggression in intellectually disabled children (at least 5 years) and adolescents with conduct disorder.

2. Before USE SPERIDAN

Do not take Speridan
• If you are allergic (hypersensitive) to risperidone or any of the other ingredients of Speridan (listed in section 6 below).
-If You are not sure that the above applies to you, ask your doctor or pharmacist before taking Speridan.
Take special care with Speridan
Before treatment with Speridan consult your doctor or pharmacist:
• If you have a heart problem. Examples include an irregular heart rhythm or if you are prone to low blood pressure or if you are using medicines for your blood pressure. Speridan can cause low blood pressure. Your dose may need to be adjusted.
• If you know of any factors which would favor you having a stroke, such as high blood pressure, cardiovascular disorder or blood vessel problems in the brain.
• If you have Parkinson's disease or dementia.
• If you have diabetes.
• If you have epilepsy.
• If you are a man and you have ever had a prolonged or painful erection. If you receive such complaints while taking Speridan, contact your doctor immediately.
• If you have problems controlling your body temperature or overheating.
• If you have kidney problems.
• If you have liver problems.
• If you have abnormally high levels of the hormone prolactin in the blood, or if you have a tumor, which may be dependent on prolactin.
-If You or someone otVashata family had in par thrombus formation (blood clots) in the veins, as the use of drugs like Speridan is associated with the formation of such blood clots.
Talk to your doctor immediately if you experience
• involuntary rhythmic movements of the tongue, mouth and face. It may need discontinuation of risperidone.
• fever, severe muscle stiffness, sweating or a lowered level of consciousness (a disorder called neuroleptic malignant syndrome). It may need immediate medical treatment.
-If You are not sure if any of the above applies to Bass, talk to your doctor or pharmacist before using Speridan. Speridan can lead to weight gain.
Elderly people with dementia
In elderly patients with dementia have an increased risk of stroke. You should not take risperidone if you have dementia caused by stroke. During treatment with risperidone you should frequently see your doctor.
You should immediately seek medical treatment if you or the person who cares about you, you notice a sudden change in your mental state or sudden weakness or numbness of the face, arms or legs, especially on one side, or slurred speech, even for a short a period of time. These may be symptoms of a stroke.
Children and adolescents
Before starting the treatment of conduct disorder should be resolved other causes of aggressive behavior.
If during treatment with risperidone tiredness occurs, changing the time of administration may lead to an improvement of attention.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. It is particularly important to talk to your doctor or pharmacist if you are taking any of the following medications:
• Drugs that act on the brain to help you calm down (benzodiazepines) or some painkillers (opioids), allergy medications (antihistamines), risperidone may increase the sedative effect of all of them.
• Medicines that may change the electrical activity of the heart, such as medicines for malaria, medicines for heart rhythm disturbances (katohinidin), allergy (antihistamines), some antidepressants or other medicines for mental problems.
• Medicines that cause a slow heart beat.
• Medicines that cause low blood potassium (eg. Some diuretics).
• Medicines to treat elevated blood pressure. Speridan can lower blood pressure.
• Medicines for Parkinson's disease (such as levodopa).
• Water tablets (diuretics) used for heart problems or swelling of parts of your body due to too much fluid (such as furosemide or chlorothiazide) .Speridan when taken alone or with furosemide, may increase the risk of stroke or death in elderly sdementsiya.
The following medicines may reduce the effect of risperidone:
• Rifampicin (a medicine for treating some infections).
• Carbamazepine, phenytoin (medicines for epilepsy).
• Phenobarbital.
If you start or stop taking such medicines you may need a different dose of risperidone.
The following medicines may increase the effect of risperidone
• quinidine (used for certain types of cardiac disorders).
• antidepressants such as paroxetine, fluoxetine, tricyclic antidepressants.
• Medicines known as beta blockers. (used to treat high blood pressure)
• Phenothiazines (eg. Used to treat psychosis or mental health problems).
• cimetidine, ranitidine (blockers of gastric acidity).
If you start or stop taking such medicines you may need a different dose of risperidone.
If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before using Speridan.
Taking Speridan with food and drink
You may take this medicine with or without food. You should avoid drinking alcohol when taking Speridan.
Pregnancy and lactation
• Ask your doctor before taking Speridan if you are pregnant, trying to become pregnant, or breastfeeding. The doctor will decide whether you can take Speridan.
• When Speridan used during the last trimester of pregnancy, newborn babies observed tremors, muscle stiffness and problems feeding, all of which are reversible. Ask your doctor or pharmacist before taking any medicine.
Driving and using machines
When treatment with Speridan may occur dizziness, fatigue and impaired vision. Do not drive or use any tools or machines without talking to your doctor first.
Important information about some of the ingredients of Speridan
If your doctor has told you have an intolerance to some sugars, please contact him before taking this product.
3. HOW TO TAKE SPERIDAN
How much to take
For the treatment of schizophrenia Adults
• usual starting dose is 2 mg per day, and may be increased to 4 mg per day on the second day.
• Your dose may be adjusted by your doctor depending on how you respond to the treatment.
• Most people feel better with daily doses of 4 to 6 mg.
• This total daily dose may be given at one time or be divided into two times. Your doctor will tell you which is best for you.
Elderly
-Your Starting dose will normally be 0.5 mg twice a day.
• Your dose may then be gradually increased by your doctor to 1 to 2 mg twice a day.
• Your doctor will tell you which is best for you. Children and adolescents
• Children and adolescents under 18 years old should not be treated with Speridan for schizophrenia.
For the treatment of mania Adults
• Your starting dose will usually be 2 mg once a day.
• Your dose may then be gradually adjusted by your doctor depending on how you respond to treatment.
• Most people feel better with doses of 1 to 6 mg once daily
Elderly
• Your starting dose will normally be 0,5 mg twice a day.
• Your dose may then be gradually adjusted by your doctor to 1 mg or 2 mg twice daily depending on how you respond to treatment.
Children and adolescents
• Children and adolescents under 18 years of age should not be treated with Speridan bipolar mania.
For the treatment of long-standing aggression in people with Alzheimer's dementia. Adults (including the elderly)
• The starting dose will normally be 0,25 mg twice a day.
• Your dose may then be gradually adjusted by your doctor depending on how you respond to treatment.
• Most people feel better with 0,5 mg twice daily. Some patients in need of 1 mg twice a day.
• Treatment duration in patients with Alzheimer's dementia should not be more than six weeks.
For the treatment of conduct disorder in children and adolescents
The dose depends on the weight of your child:
For children who weigh less than 50 kg:
• The starting dose is usually 0,25 mg daily.
• The dose may be increased gradually every day to 0,25 mg per day.
• The usual maintenance dose is 0,25 mg to 0,75 mg once daily. For children who weigh 50 kg or more:
• The initial dose is typically 0,5 mg per day.
• The dose may be increased gradually every day 0,5 mg per day.
• Simple maintenance dose is 0,5 mg to 1,5 mg once daily. The duration of treatment in patients with conduct disorder should not be more than b weeks.
Children under 5 years of age should not be treated with Speridan for conduct disorder.
Patients with kidney problems or liver
Regardless of the disease to be treated, all starting doses and the subsequent doses of risperidone should be separated. Increasing the dose should be slower in these patients.
Risperidone should be used with caution in these patients.
How to take Speridan
Always take Speridan just as you have been told by your doctor. If you're not sure, ask your doctor or pharmacist. Your doctor will tell you how much medicine to take and for how long. It depends on your condition and is different for different people. The amount of medicine you should take is explained in the "How to take".
Speridan filminirani tablets
• You must take the tablet with a glass of water.
If you take more dose Speridan
• You should immediately see a doctor. Take the medicine pack with you.
• In case of overdose you may feel sleepy or tired, or appear abnormal body movements, you may get problems standing and walking, you may feel dizzy due to low blood pressure, or have abnormal heartbeat or seizures .
If you forget to take Speridan
• If you miss a dose, take it as soon as you remember it. However, if it is almost time for your next dose, skip the missed dose and continue as-usual. If you miss two or more doses, contact your doctor.
• Do not take a double dose (two doses at once) to make up for a missed dose.
If you stop taking Speridan
You should not stop taking this medicine unless your doctor tells you to. Your symptoms may return. If your doctor decides to stop this treatment, the dose should be reduced gradually over a few days. If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Speridan can cause side effects, although not everybody gets them.
Very common: affects more than 1 in 10 patients.
Common: affects 1 to 10 patients in 100.
Uncommon: affects 1 to 10 patients in 1000.
Rare: affects 1 to 10 patients in 10,000.
Very rare: affects less than 1 in 10,000 patients.
Not known: can not be estimated from the available data.
You can obtain the following side effects:
Very common (affecting more than 1 in 10 people):
• Parkinsonism. This is a medical term that includes many symptoms. Each individual symptom may occur less frequently than 1 in 10 patients. Parkinsonism includes: increase in saliva secretion or watery mouth, musculoskeletal stiffness, drooling, spasms when bending the limbs, slow, reduced or impaired body movements, expressionless 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 asleep. Common (affects 1 to 10 people in 100):
• Drowsiness, fatigue, restlessness, inability to sit still, irritability, anxiety, drowsiness, dizziness, impaired concentration, feelings of exhaustion, sleep disturbances, tremors.
• Vomiting, diarrhea, constipation, nausea, increased appetite, abdominal pain or discomfort, sore throat, dry mouth.
• Weight increased, increase in body temperature, decreased appetite.
• Difficulty in breathing, an infection of the lungs (pneumonia), influenza, respiratory tract infections, blurred vision, nasal congestion, nasal bleeding, cough.
• Urinary tract infections, enuresis.
• Muscle spasm, involuntary movements of the face or hands and feet, joint pain, back pain, swelling of arms and legs, pain in arms and legs.
• Rash, reddening of the skin.
• Rapid heart rate, chest pain.
• Increased levels of the hormone prolactin in the blood. Uncommon (affects 1 to 10 people in 1000):
• Drinking too much water, faecal incontinence, thirsty, very hard faeces, hoarseness or voice changes.
• difficulty in swallowing, cough, rough / wheezing when breathing, flu-like illness, sinus congestion.
• No response to stimulation, loss of consciousness, sudden swelling of lips and eyes along with difficulty breathing, sudden weakness or numbness of the face, arms or legs, especially unilateral, or episodes of slurred speech that lasted less than 24 hours (these are called mini-strokes or strokes), involuntary movements of the face, arms or legs, ringing in the ears, face edema.
Rare (affects 1 to 10 persons per 10,000):
• Inability to reach orgasm, menstrual disorders.
• Dandruff.
• Drug allergy, cold extremities, swelling of lips, sore lips.
• Glaucoma, reduced visual clarity, crusting on the edges of the eyelids, eye-rolling.
• Lack of emotion.
• Change in consciousness with increased body temperature and twitching muscles, swelling of the whole body, withdrawal symptoms when stopping the drug, drop in body temperature.
• Rapid and shallow breathing, difficulty breathing during sleep, chronic otitis media.
• Obstruction of the bowel.
• Reduced cerebral blood flow.
• Reduction of the white blood cells, inappropriate secretion of a hormone which regulates the volume of urine.
• Breakdown of muscle fibers and pain in muscles (rhabdomyolysis), movement disorder.
• Coma due to uncontrolled diabetes.
• Yellowing of the skin and eyes (jaundice).
• Inflammation of the pancreas.
Very rare (affects less than 1 patient in 10,000):
• Life-threatening complications of uncontrolled diabetes.
Not known (from the available data can not be estimated)
• Severe allergic reaction resulting in difficulty in breathing and shock.
• Lack of granulocytes (a type of white blood cells that help against infection).
• Prolonged and painful erection.
• Too much drinking water, which is dangerous.
• formation of thrombi (blood clots) in the veins and in particular those in the legs (symptoms include swelling, pain and redness in the leg), which may travel through blood vessels to the lungs, causing chest pain and difficulty breathing . If you notice any of these symptoms, seek immediate medical advice.
Reported the following adverse reactions to injectable risperidone. Even if you are being treated with the injectable form of risperidone but you experience any of these, talk to your doctor.
• infection of the intestine
• Subcutaneous abscess, burning, tingling, pricking the skin, eczema
• Reduction of the number of white blood cells which help to protect against bacterial infections
• Depression
• Seizures
• Painful contraction of eyes
• Sense of rotation or swinging
• Slow heart rate, high blood pressure
• Toothache, tongue spasm
• Pain in the buttock
• weight loss
If any of the side effects gets serious, or you notice other effects not listed in this leaflet, please tell your doctor or pharmacist.