Olanzapine Viatris 10 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Olanzapina Viatris 2.5 mg film-coated tablets EFG

Olanzapina Viatris 5 mg film-coated tablets EFG

Olanzapina Viatris 7.5 mg film-coated tablets EFG

Olanzapina Viatris 10 mg film-coated tablets EFG

Olanzapina Viatris 15 mg film-coated tablets EFG

Olanzapina Viatris 20 mg film-coated tablets EFG

olanzapine

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents:

1. What Olanzapina Viatris is and what it is used for
2. What you need to know before taking Olanzapina Viatris
3. How to take Olanzapina Viatris
4. Possible side effects
5. How to store Olanzapina Viatris
6. Contents of the pack and other information

1. What Olanzapina Viatris is and what it is used for

Olanzapina Viatris contains the active substance olanzapine. Olanzapine belongs to a group of medicines called antipsychotics and is indicated for the treatment of the following conditions:

• Schizophrenia, a disorder whose symptoms include hearing, seeing, or sensing things that are not real, false beliefs, unusual suspiciousness, and social withdrawal. People with this disorder may also experience depression, anxiety, or tension.
• Moderate to severe manic disorder, characterized by symptoms such as excitement or euphoria.

Olanzapina Viatris has been shown to prevent the recurrence of these symptoms in patients with bipolar disorder whose manic episodes have responded to treatment with olanzapine.

2. What you need to know before taking Olanzapina Viatris

Do not take Olanzapina Viatris

• If you are allergic to olanzapine, peanuts, soy, or any of the other ingredients of this medicine (listed in section 6). The allergic reaction may manifest as rash, itching, swelling of the face or lips, or difficulty breathing. If this happens to you, tell your doctor.
• If you have previously been diagnosed with eye problems such as certain types of glaucoma (increased pressure in the eye).

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Olanzapina Viatris.

• Use of Olanzapina Viatris is not recommended in elderly patients with dementia, as it may cause serious adverse effects.
• Medicines of this type may cause unusual movements, especially in the face or tongue. If this occurs after taking Olanzapina Viatris, inform your doctor.
• Very rarely, medicines of this type can cause a combination of fever, rapid breathing, sweating, muscle stiffness, and a state of mental confusion or drowsiness. If this occurs, contact your doctor immediately.
• Weight gain has been observed in patients taking Olanzapina Viatris.
• You and your doctor should monitor your weight regularly. Consider consulting a dietitian or adopting a dietary plan if necessary.
• Elevated levels of sugar and fats (triglycerides and cholesterol) in the blood have been observed in patients taking Olanzapina Viatris. Your doctor should perform blood tests to monitor your blood sugar and fat levels before starting treatment and regularly during treatment.
• If you or someone in your family has a history of blood clots, consult your doctor, as medicines of this type have been associated with blood clot formation.

If you have any of the following conditions, inform your doctor as soon as possible:

• Stroke or transient ischemic attack (temporary stroke-like symptoms).
• Parkinson's disease.
• Prostate problems.
• Intestinal obstruction (paralytic ileus).
• Liver or kidney disease.
• Blood disorders.
• Heart disease.
• Diabetes.
• Seizures.
• If you think you may have loss of salts due to prolonged severe diarrhea and vomiting, or due to use of diuretic medicines (water tablets).

If you suffer from dementia, you or your caregiver or family member should inform your doctor if you have ever had a stroke or transient ischemic attack.

As a routine precaution, if you are over 65 years old, your doctor should monitor your blood pressure.

Children and adolescents

Patients under 18 years of age must not take Olanzapina Viatris.

Taking Olanzapina Viatris with other medicines

Only use other medicines together with Olanzapina Viatris if authorized by your doctor. You may feel increased drowsiness if Olanzapina Viatris is combined with antidepressants or medicines for anxiety or sleep (tranquilizers).

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Specifically, tell your doctor if you are taking:

• Medication for Parkinson's disease.
• Carbamazepine (an antiepileptic and mood stabilizer), fluvoxamine (an antidepressant), or ciprofloxacin (an antibiotic). Your dose of Olanzapina Viatris may need to be adjusted.

Taking Olanzapina Viatris with alcohol

You should not drink alcohol while taking Olanzapina Viatris, as it may cause drowsiness.

Pregnancy and breastfeeding

If you are pregnant, breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor before using this medicine. You should not take this medicine while breastfeeding, as small amounts of Olanzapina Viatris may pass into breast milk.

The following symptoms may occur in newborns of mothers who have taken Olanzapina Viatris during the third trimester (last three months of pregnancy): tremors, muscle stiffness and/or weakness, drowsiness, agitation, difficulty breathing, and feeding difficulties. If your baby shows any of these symptoms, contact your doctor.

Driving and using machines

There is a risk of drowsiness when taking Olanzapina Viatris. If this occurs, do not drive or operate machinery. Discuss this with your doctor.

Olanzapina Viatris contains lactose and soy lecithin

If your doctor has informed you of an intolerance to certain sugars, consult him before taking this medicine. This medicine contains soy lecithin. It must not be used in case of allergy to peanuts or soy.

3. How to take Olanzapina Viatris

Follow exactly the instructions for using this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again. Consult your doctor or pharmacist if you have any questions.

Your doctor will tell you how many Olanzapina Viatris tablets to take and for how long. The daily dose of Olanzapina Viatris ranges from 5 to 20 mg. Speak to your doctor if your symptoms return, but do not stop taking Olanzapina Viatris unless your doctor tells you to.

You should take your Olanzapina Viatris tablets once daily, as directed by your doctor. Try to take the tablets at the same time each day. You may take them with or without food. Olanzapina Viatris coated tablets are for oral administration. You must swallow the Olanzapina Viatris tablets whole with water.

If you take more Olanzapina Viatris than you should

Patients who have taken more Olanzapina Viatris than they should have experienced the following symptoms: rapid heartbeat, agitation/aggression, speech problems, unusual movements (especially of the face and tongue), and reduced level of consciousness. Other possible symptoms include: acute confusion, seizures (epilepsy), coma, a combination of fever, rapid breathing, sweating, muscle rigidity, drowsiness or lethargy, slowed breathing rate, aspiration, increased blood pressure or decreased blood pressure, and abnormal heart rhythms. Contact your doctor or go immediately to a hospital if you experience any of the symptoms listed above. Show the doctor the package and the tablets.

If you forget to take Olanzapina Viatris

Take your tablets as soon as you remember. Do not take a double dose to make up for forgotten doses.

If you stop taking Olanzapina Viatris

Do not stop treatment just because you feel better. It is very important that you continue taking Olanzapina Viatris for as long as your doctor tells you to.

If you stop taking Olanzapina Viatris suddenly, symptoms such as sweating, inability to sleep, tremor, anxiety, or nausea and vomiting may occur. Your doctor may advise you to gradually reduce the dose before stopping treatment.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Contact your doctor immediately if you have:

• unusual movements (a common adverse effect that may affect up to 1 in 10 people), especially of the face or tongue.
• blood clots in the veins (an uncommon adverse effect that may affect up to 1 in 100 people), particularly in the legs (symptoms include sweating, pain, and redness in the leg), which may travel through the bloodstream to the lungs, causing chest pain and difficulty breathing. If you experience any of these symptoms, seek medical help immediately.
• a combination of fever, rapid breathing, sweating, muscle stiffness, and mental confusion or drowsiness (frequency cannot be estimated from the available data).

Very common adverse effects (may affect more than 1 in 10 people) include: weight gain; drowsiness; and increased levels of prolactin in the blood. In the early stages of treatment, some people may feel dizzy or faint (with slower heartbeats), especially when getting up from a lying or sitting position. This sensation usually resolves spontaneously, but if it does not, consult your doctor.

Common adverse effects (may affect up to 1 in 10 people) include: changes in levels of certain blood cells and circulating lipids, and temporary increases in liver enzymes at the beginning of treatment; increased levels of blood sugar and sugar in urine; increased levels of uric acid and creatine phosphokinase in the blood; increased appetite; dizziness; restlessness; tremor; unusual movements (dyskinesia); constipation; dry mouth; skin rash; weakness; excessive fatigue; fluid retention causing swelling of the hands, ankles, or feet; fever; joint pain; and sexual dysfunction such as decreased libido in men and women or erectile dysfunction in men.

Uncommon adverse effects (may affect up to 1 in 100 people) include: hypersensitivity (e.g., swelling of the mouth and throat, itching, skin rash); diabetes or worsening of diabetes, occasionally associated with ketoacidosis (acetone in blood and urine) or coma; seizures, which in most cases are related to a history of seizures (epilepsy); muscle stiffness or spasms (including eye movements); restless legs syndrome; speech problems; stuttering; slow pulse; sensitivity to sunlight; nosebleeds; abdominal distension; excessive salivation; memory loss or forgetfulness; urinary incontinence, loss of ability to urinate; hair loss; absence or reduction of menstrual periods; and changes in the breast gland in both men and women, such as abnormal production of breast milk or abnormal breast enlargement.

Rare adverse effects (may affect up to 1 in 1,000 people) include: decrease in normal body temperature; abnormal heart rhythm; sudden unexplained death; inflammation of the pancreas, causing severe stomach pain, fever, and malaise; liver disease, with yellowing of the skin and whites of the eyes; a muscle disorder presenting as unexplained muscle pains; and prolonged and/or painful erection.

Serious allergic reactions have been reported, such as drug reaction with eosinophilia and systemic symptoms (DRESS). DRESS initially presents with flu-like symptoms, facial skin rash that spreads to other areas, fever, swollen lymph nodes, elevated liver enzymes in blood tests, and increased levels of a type of white blood cell (eosinophilia).

During treatment with olanzapine, elderly patients with dementia may experience:

stroke, pneumonia, urinary incontinence, falls, extreme fatigue, visual hallucinations, increased body temperature, skin redness, and difficulty walking. Some deaths have been reported in this particular group of patients.

Olanzapina Viatris may worsen symptoms in patients with Parkinson's disease.

Reporting of adverse effects

If you experience any type of adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish System for Pharmacovigilance of Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Olanzapine Viatris

Keep out of the sight and reach of children.

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

Do not store above 25 °C.

Vials: After first opening of the container, use the product within 90 days.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and containers you no longer need.

This will help protect the environment.

6. Storage of the container and additional information

Composition of Olanzapine Viatris

• The active substance is olanzapine. Each Olanzapine Viatris tablet contains
• 2.5 mg; 5 mg; 7.5 mg; 10 mg; 15 mg or 20 mg of active substance. The exact amount is indicated on the packaging of your Olanzapine Viatris.
• The other components are:
• Tablet core: lactose monohydrate (see section 2 “Olanzapine Viatris contains lactose”), maize starch, pregelatinized maize starch, crospovidone type A, magnesium stearate,
• Coating: polyvinyl alcohol, titanium dioxide (E171), talc (E553b), lecithin (soy) (E322) (see section 2 “Olanzapine Viatris contains soy lecithin”) and xanthan gum (E415).

Appearance of the medicine and contents of the pack

Olanzapine Viatris 2.5 mg are white, round, biconvex, film-coated tablets marked with “OZ over 2.5” on one side and “G” on the other.

Olanzapine Viatris 5 mg are white, round, biconvex, film-coated tablets marked with “OZ over 5” on one side and “G” on the other.

Olanzapine Viatris 7.5 mg are white, round, biconvex, film-coated tablets marked with “OZ over 7.5” on one side and “G” on the other.

Olanzapine Viatris 10 mg are white, round, biconvex, film-coated tablets marked with “OZ over 10” on one side and “G” on the other.

Olanzapine Viatris 15 mg are white, oval, biconvex, film-coated tablets marked with “OZ15” on one side and “G” on the other.

Olanzapine Viatris 20 mg are white, oval, biconvex, film-coated tablets marked with “OZ20” on one side and “G” on the other.

Blister packs:

Olanzapine Viatris 2.5 mg, 5 mg, 7.5 mg, 15 mg and 20 mg are available in packs of 10, 28, 30, 35, 56, 70 (2 multipacks of 35) and 70 film-coated tablets.

Olanzapine Viatris 10 mg is available in packs of 7, 10, 28, 30, 35, 56, 70 (2 x 35) (multipack) and 70 film-coated tablets.

Single-dose perforated blister packs:

Olanzapine Viatris 2.5 mg, 15 mg and 20 mg are available in packs of 28 film-coated tablets.

Olanzapine Viatris 5 mg and 10 mg are available in single-dose perforated packs of 28 and 98 film-coated tablets.

Olanzapine Viatris 7.5 mg is available in packs of 28, 56, 98 x 1 and 100 film-coated tablets.

Bottles:

Olanzapine Viatris 2.5 mg and 5 mg are available in bottles containing 250 and 500 film-coated tablets.

Olanzapine Viatris 7.5 mg, 15 mg and 20 mg are available in bottles containing 100 film-coated tablets.

Olanzapine Viatris 10 mg is available in bottles containing 100 and 500 film-coated tablets.

Marketing Authorization Holder:

Viatris Limited, Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN, Ireland

Manufacturer responsible for manufacturing:

Gerard Laboratories, 35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13, Ireland.

Mylan Hungary Kft., Mylan utca 1., Komárom, 2900, Hungary.

More information about this medicine can be requested by contacting the local representative of the Marketing Authorization Holder:

Date of most recent review of this leaflet: {MM/YYYY}

Other sources of information

Detailed information on this medicine is available on the website of the European Medicines Agency: http://www.ema.europa.eu.