Olanzapine Viatris (previously Olanzapine Mylan)

Не приемайте, ако

От листовката в продуктовата информация на EMA, стр. 97.

Как да се приема

Тези указания са за точно тази концентрация и форма. За друга те са различни.

• Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
• Your doctor will tell you how many Olanzapine Viatris tablets to take and how long you should continue to take them. The daily dose of olanzapine is between 5 mg and 20 mg. Consult your doctor if your symptoms return but do not stop taking Olanzapine Viatris unless your doctor tells you to.
• You should take your Olanzapine Viatris tablets once a day following the advice of your doctor. Try to take your tablets at the same time each day. It does not matter whether you take them with or without food. Olanzapine Viatris tablets are for oral use. You should swallow the Olanzapine Viatris tablets whole with water.
• If you take more Olanzapine Viatris than you should Patients who have taken more olanzapine than they should have experienced the following symptoms:
• rapid beating of the heart, agitation/aggressiveness, problems with speech, unusual movements (especially of the face or tongue) and reduced level of consciousness. Other symptoms may be: acute confusion, seizures (epilepsy), coma, a combination of fever, faster breathing, sweating, muscle stiffness and drowsiness or sleepiness, slowing of the breathing rate, aspiration, high blood pressure or low blood pressure, abnormal rhythms of the heart. Contact your doctor or hospital straight away if you experience any of the above symptoms. Show the doctor your pack of tablets.
• If you forget to take Olanzapine Viatris Take your tablets as soon as you remember. Do not take a double dose to make up for the forgotten tablet.
• If you stop taking Olanzapine Viatris Do not stop taking your tablets just because you feel better. It is important that you carry on taking Olanzapine Viatris for as long as your doctor tells you.
• If you suddenly stop taking Olanzapine Viatris, symptoms such as sweating, unable to sleep, tremor, anxiety or nausea and vomiting might occur. Your doctor may suggest you to reduce the dose gradually before stopping treatment.
• If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

От листовката в продуктовата информация на EMA, стр. 99.

Предупреждения и предпазни мерки

От листовката в продуктовата информация на EMA, стр. 97–98.

Бременност и кърмене

От листовката в продуктовата информация на EMA, стр. 98–99.

Други лекарства

От листовката в продуктовата информация на EMA, стр. 98.

Шофиране и работа с машини

• There is a risk of feeling drowsy when you are given Olanzapine Viatris. If this happens do not drive or operate any tools or machines. Tell your doctor.
• Olanzapine Viatris contains lactose and soya lecithin If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product. The tablet film-coating contains soya lecithin. If you are allergic to peanut or soya do not take these tablets.

От листовката в продуктовата информация на EMA, стр. 99.

Нежелани реакции

• Like all medicines, this medicine can cause side effects, although not everybody gets them.
• Tell your doctor immediately if you have:
• unusual movement (a common side effect that may affect up to 1 in 10 people) mainly of the face or tongue;
• blood clots in the veins (an uncommon side effect that may affect up to 1 in 100 people)
• 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 in breathing. If you notice any
• of these symptoms seek medical advice immediately;
• a combination of fever, faster breathing, sweating, muscle stiffness and drowsiness or sleepiness
• (the frequency of this side effect cannot be estimated from the available data)
• Very common side effects (may affect more than 1 in 10 people) include weight gain; sleepiness; and increases in levels of prolactin in the blood. In the early stages of treatment, some people may feel dizzy or faint (with a slow heart rate), especially when getting up from a lying or sitting position. This will usually pass on its own but if it does not, tell your doctor.
• Common side effects (may affect up to 1 in 10 people) include changes in the levels of some blood cells, circulating fats and early in treatment, temporary increases in liver enzymes; increases in the level of sugars in the blood and urine; increases in levels of uric acid and creatine phosphokinase in the blood; feeling more hungry; dizziness; restlessness; tremor; unusual movements (dyskinesias);
• constipation; dry mouth; rash; loss of strength; extreme tiredness; water retention leading to swelling of the hands, ankles or feet; fever; joint pain; and sexual dysfunctions such as decreased libido in males and females or erectile dysfunction in males.
• Uncommon side effects (may affect up to 1 in 100 people) include hypersensitivity (e.g. swelling in the mouth and throat, itching, rash); diabetes or the worsening of diabetes, occasionally associated with ketoacidosis (ketones in the blood and urine) or coma; seizures, usually associated with a history of seizures (epilepsy); muscle stiffness or spasms (including eye movements); restless legs syndrome;
• problems with speech; stuttering; slow heart rate; sensitivity to sunlight; bleeding from the nose;
• abdominal distension; drooling; memory loss or forgetfulness; urinary incontinence; lack of ability to urinate; hair loss; absence or decrease in menstrual periods; and changes in breasts in males and females such as an abnormal production of breast milk or abnormal growth.
• Rare side effects (may affect up to 1 in 1 000 people) include lowering of normal body temperature;
• abnormal rhythms of the heart; sudden unexplained death; inflammation of the pancreas causing severe stomach pain, fever and sickness; liver disease appearing as yellowing of the skin and white parts of the eyes; muscle disease presenting as unexplained aches and pains; and prolonged and/or painful erection.
• Very rare side effects include serious allergic reactions such as Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS). DRESS appears initially as flu-like symptoms with a rash on the face and then with an extended rash, high temperature, enlarged lymph nodes, increased levels of liver enzymes seen in blood tests and an increase in a type of white blood cells (eosinophilia).
• While taking olanzapine, elderly patients with dementia may suffer from stroke, pneumonia, urinary incontinence, falls, extreme tiredness, visual hallucinations, a rise in body temperature, redness of the skin and have trouble walking. Some fatal cases have been reported in this particular group of patients.
• In patients with Parkinson's disease Olanzapine Viatris may worsen the symptoms.
• Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

От листовката в продуктовата информация на EMA, стр. 99–100.

Как да се съхранява

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date, which is stated on the carton or label after EXP. The expiry date refers to the last day of that month.
• Do not store above 25°C.
• Bottles: After first opening use within 90 days.
• Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

От листовката в продуктовата информация на EMA, стр. 101.

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Подробности

Източник: European Medicines Agency — medicine data · 2026-09-30 · не е прегледано от лекар

Source: European Medicines Agency (EMA). Product information as published by EMA. Условия за повторно използване: EMA legal notice (reproduction authorised).

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