Medorisper 2mg. 20 tablets

What Medorisper is and what it is used for
Medorisper belongs to a group of medicines called 'antipsychotics'.
Medorisper is used to treat the following:

Schizophrenia, in which you may see, hear, or feel things that do not exist, believe things that are not true, or feel unusually suspicious or confused.
Mania in which you may feel very excited, excited, upset, enthusiastic or overactive. Mania occurs in a condition called "bipolar disorder."
Short-term treatment (up to 6 weeks) of long-lasting aggression in people with Alzheimer's dementia, prone to self-harm or injury to others. Alternative (non-drug) approaches must first be applied.
Short-term treatment (up to 6 weeks) of long-term aggression in intellectually retarded children (at least 5 years old) and adolescents with behavioral disorders. Medorisper can help relieve the symptoms of your disease and prevent them from recurring.
2. What you need to know before you take Medorisper
Do not take Medorisper:
if you are allergic to risperidone or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor or pharmacist before taking Medorisper:

If you have a heart problem. Examples include an arrhythmia, either if you are prone to low blood pressure or if you are taking medication for your blood pressure. Medorisper can cause low blood pressure. Your dose may need to be adjusted.
If you know of factors that predispose you to having a stroke, such as high blood pressure, a cardiovascular disorder, or problems with the blood vessels in the brain.
If you have ever had involuntary movements of the tongue, mouth or face
If you have ever had a condition whose symptoms include fever, muscle stiffness, sweating or low consciousness (also known as Neuroleptic Malignant Syndrome)
If you have Parkinson's disease or dementia
If you know you have had low white blood cell counts in the past (which may or may not have been caused by other medicines)
If you have diabetes
If you have epilepsy
If you are a man and have ever had a prolonged or painful erection.
If you have problems controlling your body temperature or overheating
If you have kidney problems
If you have liver problems
If you have unusually high levels of the hormone prolactin in your blood or if you have a tumor that may be prolactin dependent.
If you or someone in your family has had blood clots, as medicines such as this are associated with blood clots.
If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before taking Medorisper.

Because patients taking risperidone very rarely have a dangerously low number of certain types of white blood cells in their blood needed to fight infections, your doctor may test your white blood cell count.

Medorisper may cause you to gain weight. Significant weight gain can adversely affect your health. Your doctor will measure your weight regularly.

Because patients taking risperidone have been diagnosed with diabetes or worsening of pre-existing diabetes, your doctor will examine you for signs of high blood sugar. In patients with pre-existing diabetes mellitus, blood glucose levels should be monitored regularly.

During cataract surgery, the pupil (the black circle in the middle of your eye) may not increase in size as needed. In addition, during surgery, the iris (the colored part of the eye) may lose tone, which can lead to eye damage. If you are planning eye surgery, you need to tell your eye doctor that you are taking this medicine.

Elderly people with dementia
Elderly patients with dementia are at increased risk of stroke. You don't have to
you are taking risperidone if you have dementia leading to a stroke. You should often consult your doctor during treatment with risperidone.
Medical treatment should be sought immediately if you or the person caring for you notice a sudden change in your mental state or a sudden weakness or stiffness in your face, arms or legs, especially on one side, or slurred speech, even for a short time. period of time. These may be symptoms of a stroke.

Children and adolescents
Other causes of aggressive behavior should be ruled out before starting treatment for a behavioral disorder.
If fatigue occurs during treatment with risperidone, a change in the timing of the medicine may improve the difficulties encountered.
Before starting treatment, your or your child's weight can be measured and can be measured regularly during treatment.
Medorisper with food, drinks and alcohol
You can take this medicine with or without food. You should avoid drinking alcohol while taking Medorisper.

Pregnancy, lactation and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Your doctor will decide if you can take it.
The following symptoms may occur in newborns if mothers have taken risperidone during the last trimester of pregnancy (last 3 months of pregnancy): tremors, muscle stiffness and / or weakness, drowsiness, agitation, breathing problems and eating problems. If your baby develops any of these symptoms, you may need to contact your doctor.
Medorisper may increase levels of a hormone called prolactin, which may affect fertility (see Possible side effects).

Driving and using machines
Dizziness, fatigue and impaired vision may occur when you are being treated with Medorisper. Do not drive or use any tools or machines without first talking to your doctor.

Medorisper contains lactose and orange yellow (E110)
Medorisper contains lactose monohydrate. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
One of the ingredients of Medorisper 2 mg - orange yellow (E110) can cause allergic reactions.

3. How to take Medorisper
Always take this medicine exactly as your doctor has told you. If you are not sure, talk to your doctor or pharmacist.

The recommended dose is as follows:
For the treatment of schizophrenia
Adults

The starting dose is usually 2 mg daily, and may be increased to 4 mg daily on the second day.
Your dose may be adjusted by your doctor according to how you respond to treatment.
Most patients feel better with a daily dose of 4 to 6 mg.
This total daily dose can be given at once or divided into two doses
Your doctor will tell you what is best for you.
Elderly people
Your starting dose will usually be 0.5 mg twice a day.
Your dose will be gradually increased by your doctor until it reaches 1 to 2 mg twice. Your doctor will tell you what is best for you.

For the treatment of mania
Adults
Your starting dose 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 people
Your starting dose will usually be 0.5 mg twice a day.
Your dose will be gradually adjusted by your doctor to 1 mg or 2 mg twice a day, depending on how you respond to treatment.
For the treatment of long-term aggression in people with Alzheimer's dementia
Adults (including the elderly)
The starting dose 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 need 1 mg twice a day.
The duration of treatment in patients with Alzheimer's dementia should not exceed 6 weeks.
Use in children and adolescents
Children and adolescents under 18 years of age should not be treated with Medorisper for schizophrenia and mania.

For the treatment of a behavioral disorder
The dose depends on your child's weight:

For children weighing less than 50 kg

The starting dose is usually 0.25 mg daily.
The dose may be increased gradually by 0.25 mg daily.
The usual maintenance dose is 0.25 mg to 0.75 mg once a day.
For children weighing 50 kg and more
The starting dose is usually 0.5 mg per day.
The dose may be increased gradually by 0.5 mg daily.
The usual maintenance dose is 0.5 mg to 1 mg once a day.
The duration of treatment in patients with a behavioral disorder should not exceed 6 weeks.

Children under 5 years of age should not be treated with Medorisper for a behavioral disorder.

Patients with kidney or liver problems
Although the disease is treatable, all starting doses and subsequent doses of risperidone should be divided. Dose escalation should be slow in this group of patients. Risperidone should be used with caution in this patient group.

You must take the tablet with water.

If you take more Medorisper than you should
A doctor should see you immediately. Take the medicine pack with you.
In the event of an overdose, you may feel drowsy or tired, or have abnormal body movements, may have problems standing or walking, may feel dizzy due to low blood pressure, or may have abnormal heartbeats or seizures.

If you forget to take Medorisper
If you forget to take a dose, take it as soon as you
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.

Tell your doctor immediately if:
You have blood clots in your veins, especially in your legs (symptoms include swelling, pain and redness in your legs), which can travel through your blood vessels to your lungs, causing chest pain and difficulty breathing. If you notice any of these symptoms, seek medical attention immediately.
You have dementia and feel a sudden change in your mental state or a sudden weakness or stiffness in your face, arms or legs, especially on one side, or slurred speech, even for a short time. These may be signs of a stroke.
You have a fever, muscle stiffness, sweating or a low level of consciousness (a disorder called 'Neuroleptic Malignant Syndrome'). Immediate medical treatment may be needed.
You are a man and you have a prolonged or painful erection. It is called priapism. Immediate medical treatment may be required. If you feel involuntary rhythmic movements of the tongue, mouth and face. Discontinuation of risperidone may be required.
You experience a severe allergic reaction characterized by fever, swelling of the mouth, face, lips or tongue, difficulty breathing, itching, skin rash or a drop in blood pressure.
The following side effects may occur:

Very common (may affect more than 1 in 10 people):
Difficulty falling asleep or shallow sleep
Parkinsonism. This condition can include: slow or impaired movement, a feeling of stiffness or tightness in the muscles (which makes your movements abrupt) and sometimes even a feeling of "freezing" and then resumption of movement. at rest, increased salivation and / or drooling, musculoskeletal stiffness, drooling, spasms of the limbs and loss of facial expression.
Drowsiness or decreased alertness
Headache.
Common (may affect up to 1 in 10 people):
Pneumonia, chest infection (bronchitis), common cold symptoms, sinus infection, urinary tract infection, ear infection, feeling sick with the flu
Medorisper may increase levels of a hormone called 'prolactin', which is found in blood tests (which may or may not cause symptoms). When symptoms of elevated prolactin occur, they may include breast swelling, difficulty getting or maintenance of an erection or other sexual dysfunction In women, these may include breast discomfort, leakage of breast milk, missed menstrual cycles, or other menstrual problems.
Weight gain, increased appetite, decreased appetite
Sleep disorders, irritability, depression, anxiety, inability to sit still
Dystonia: This is a condition that involves delayed or prolonged involuntary muscle contractions. Although it can affect any part of the body (and can lead to unusual posture), dystonia often affects the muscles of the face, including abnormal movements of the eyes, mouth, tongue, or jaw.
Dizziness
Dyskinesia: This is a condition that involves involuntary muscle movements and may include repetitive, spastic or torsional movements or twitching.
Tremor (shaking)
Blurred vision, eye infection or "pink eye"
Accelerated pulse, high blood pressure, difficulty breathing. Blood clots in the legs, blood clots in the lungs
Sore throat, cough, nosebleeds, stuffy nose
Abdominal pain, abdominal discomfort, vomiting, nausea, constipation, diarrhea, indigestion, dry mouth, toothache
Rash, redness of the skin
Muscle spasms, bone or muscle pain, back pain, joint pain
Urinary incontinence (lack of control), wetting
Swelling of the body, arms or legs, fever, chest pain, weakness, tiredness, pain
Fall.
Uncommon (may affect up to 1 in 100 people):
Respiratory tract infection, bladder infection, eye infection, tonsillitis, fungal nail infection, skin infection, infection limited to a specific part of the skin or body, viral infection, skin inflammation caused by ticks.
Decreased number of certain types of white blood cells that help prevent infections. Decreased number of white blood cells, decreased number of platelets (blood cells that help stop bleeding), anemia, decreased number of red blood cells, increased number of eosinophils (a type of white blood cell) in the blood.
Alergic reaction. Serious allergic reaction with swelling that may involve the throat and lead to difficulty breathing
Diabetes or worsening of diabetes, high blood sugar, drinking too much water
Weight loss, loss of appetite, leading to malnutrition and low body weight
Elevated blood cholesterol
Excited mood (mania), confusion, decreased sexual desire, nervousness, 
5. How to store Medorisper
Keep out of reach of children.

Do not use this medicine after the expiry date which is stated on the carton after EXP and on the blister after EXP. The expiry date refers to the last day of that month.

This medicinal product does not contain any special storage conditions.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the package and additional information
What Medorisper contains
The active substance in Medorisper is risperidone.
Medorisper 1 mg: Each film-coated tablet contains 1 mg risperidone.
Medorisper 2 mg: Each film-coated tablet contains 2 mg risperidone
Medorisper 3 mg: Each film-coated tablet contains 3 mg risperidone
Medorisper 4 mg: Each film-coated tablet contains 4 mg risperidone

The other ingredients are:

Tablet core: lactose monohydrate, maize starch, sodium lauryl sulphate, microcrystalline cellulose, hypromellose, silica, colloidal, anhydrous, magnesium stearate. Film coating: hypromellose, titanium dioxide (E171), propylene glycol, talc. In addition, the tablets contain the following colorants:
Medorisper 2 mg: orange yellow (E110)
Medorisper 3 mg: quinoline yellow (E 104)
Medorisper 4 mg: indigotine (E 132), quinoline yellow (E 104).

What Medorisper looks like and contents of the pack
Number in package:
Medorisper 1 mg: 6,20,30 tablets in a carton.
Medorisper 2 mg: 20, 30 tablets placed in a cardboard box.
Medorisper 3 mg: 20, 30 tablets placed in a cardboard box.
Medorisper 4 mg: 6.20 tablets placed in a cardboard box.

Not all pack sizes may be marketed.

Film-coated tablets.

Medorisper 1 mg: White, oval film-coated tablet measuring 11 χ 5.5 mm and scored on both sides. The tablets can be divided into equal doses.
Medorisper 2 mg: Orange, oval film-coated tablet, size 11x5.5 mm, scored on both sides. The tablets can be divided into equal doses.

 

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