MEDORISPER 2 mg. 20 tablets

WHAT MEDORISPER AND WHAT IT IS USED
MEDORISPER belongs to a group of medicines called "antipsychotics".

MEDORISPER 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 6 weeks) of long-term aggression in intellectually disabled children (at least 5 years) and adolescents with conduct disorder.
2. BEFORE YOU TAKE MEDORISPER
Do not take Medorisper if:
You are allergic (hypersensitive) to the active substance, risperidone, or to any of the other ingredients of Medorisper (listed in section 6 below).
Take special care with Medorisper
Before treatment with MEDORISPER 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. MEDORISPER can cause low blood pressure. Your dose may need to be adapted;
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 are diabetic;
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 MEDORISPER, 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 an abnormally high level of the hormone prolactin in the blood, or if you have a tumor, which may be dependent on prolactin;
If you are pregnant, trying to become pregnant or breast-feeding (see. Section "Pregnancy and breast-feeding" below).
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 you, talk to your doctor or pharmacist before using MEDORISPER.

MEDORISPER 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 period of time. These may be symptoms of a stroke.

Children and adolescents
Before starting the treatment of conduct disorder should be excluded other causes of aggressive behavior. If during treatment with risperidone tiredness occurs, the change in the time of administration of the medicament may improve the difficulties that have arisen.

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 and herbal preparations.

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 problems (such as quinidine), 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 high blood pressure. MEDORISPER can lower blood pressure;
Drugs 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). MEDORISPER when taken alone or with furosemide, may increase the risk of stroke or death in elderly patients with dementia.
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;
Drugs known as beta-blockers;
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 MEDORISPER.

Taking Medorisper with food and drink
You may take this medicine with or without food. You should avoid drinking alcohol when taking MEDORISPER.

Pregnancy and lactation
Ask your doctor before taking MEDORISPER if you are pregnant, trying to become pregnant, or breastfeeding. The doctor will decide whether you are taking MEDORISPER;
The following symptoms may occur in the newborns if their mothers are taking risperidone during the last trimester (last three months of pregnancy): shaking, muscle stiffness and / or weakness, sleepiness, agitation, breathing problems and feeding problems. If your baby develops any of these symptoms you may need to contact your doctor.

Ask your doctor or pharmacist before taking any medicine.

Driving and using machines
When treatment with MEDORISPER 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 risperidone
Medorisper contains lactose monohydrate. If your doctor has told you that you have an intolerance to some sugars, contact your doctor before taking this product.
2 mg tablets contain the color orange yellow (E110) which may cause allergic reactions.

3. HOW TO TAKE MEDORISPER
How much to take
For the treatment of schizophrenia
Mature
The usual starting dose of 2 mg daily, which 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 patients feel better with a daily dose of 4 to 6 mg;
This total daily dose may be given at one time or be divided in two;
Your doctor will tell you which is best for you.
Elderly
Your initial dosage will be typically 0,5 mg twice a day;
Your dose will be gradually increased by your doctor to 1 mg to 2 mg twice a day;
Your doctor will tell you which is best for you.
Children and adolescents
Children and adolescents below 18 years should not be treated with MEDORISPER for schizophrenia.
For the treatment of mania
Mature
Your initial dosage will usually be 2 mg once a day;
Your dose will be gradually adjusted by your doctor depending on how you respond to treatment;
Most patients feel better with doses of 1 to 6 mg once a day.
Elderly
Your initial dosage will be typically 0,5 mg twice a day;
Your dose will 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 MEDORISPER bipolar mania.
For the treatment of long-standing aggression in people with Alzheimer's dementia
Adults (including the elderly)
The initial dosage will usually be 0,25 mg twice a day;
Your dose will be gradually adjusted by your doctor depending on how you respond to treatment;
Most patients 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 per day;
The dose may be increased every other day in steps of 0,25 mg per day;
The usual maintenance dose is 0,25 mg to 0,75 mg once daily.
For children who weigh 50 kilograms and more
The initial dose is typically 0,5 mg per day;
The dose may be increased every other day in steps of 0,5 mg per day;
The usual maintenance dose is 0,5 mg to 1 mg once daily.
The duration of treatment in patients with conduct disorder should not be more than 6 weeks.
Children under 5 years of age should not be treated with MEDORISPER for conduct disorder.

Patients with kidney problems or liver
Although the disease is treated, all starting doses and following doses of risperidone should be divided. Increasing the dose should be slower in these patients. Risperidone should be used with caution in these patients.

How to take MEDORISPER
Always take MEDORISPER exactly 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". You must take the tablet with water.

If you take more dose Medorisper
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, it may feel dizzy due to low blood pressure, or have abnormal heartbeat or seizures.
If you forget to take Medorisper
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 Medorisper
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, Medorisper 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;
Unknown: frequency 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, convulsions in 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, dizziness, impaired concentration, feelings of exhaustion, sleep disorders;
Vomiting, diarrhea, constipation, nausea, increased appetite, abdominal pain or discomfort, sore throat, dry mouth;
Weight gain, increase in body temperature, decreased appetite;
Difficulty breathing, lung infection (pneumonia), flu, respiratory tract infections, blurred vision, nasal congestion, nosebleeds, cough;
Blood clots in the veins especially 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 medical advice immediately;
Urinary tract infections, wetting the bed;
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, redness of the skin;
Rapid heartbeat, chest pain;
Increased level of 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;
Infections of the lung caused by inhalation of food into the airways, bladder infections, "pink eye", sinus infection, viral infections, infections of the tonsils, infections in the skin, eye infections, infections of the gastric secretions of the eye , fungal nail infections;
Pathological conductivity, low blood pressure when standing, low blood pressure, dizziness after a change in body position, heart rate, abnormal electrical activity of the heart (ECG) rhythm disturbance, feeling palpitations, rapid or weak pulse;
Urinary incontinence, pain during urination, frequent urination;
Confusion, disturbance in attention, decreased level of consciousness, extreme sleepiness, nervousness, elevated mood (mania), low energy and interest;
Increases in blood sugar, elevated liver enzymes, decreased white blood cells, low hemoglobin and low number of red blood cells (anemia), increased eosinophils (special white blood cells), increased blood creatine phosphokinase, reduction in the number of platelets (blood cells that help stop bleeding);
Muscle weakness, muscle pain, ear pain, neck pain, joint swelling, abnormal posture, joint stiffness, pain of muscles and bones in the chest, chest discomfort;
Skin lesions, skin damage, dry skin, intense itching of the skin, acne, hair loss, skin inflammation caused by pests, discoloration of the skin, hardening of the skin, redness, decreased skin sensitivity to pain and touch, inflammation oily skin;
Absence of menstruation, sexual dysfunction, erectile dysfunction, ejaculation disorders, Breast discharge, breast enlargement in men, decreased sexual drive, irregular menstruation, vaginal discharge;
Fainting, gait disturbance, sluggishness, decreased appetite resulting in malnutrition and low body weight, malaise, balance disorder, allergy, edema, speech disorder, chills, incoordination;
Painful sensitivity to light, increased blood flow to the eyes, swelling of the eyes, dry eyes, increased lacrimation;
Damage of respiratory tract, pulmonary congestion, wheezing rattling of the lungs, respiratory tract congestion, difficulty speaking, difficulty swallowing, cough, rough / wheezing when breathing, flu-like illness, sinus congestion;
No response to stimulation, 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