Prospect: Information for the User

Olanzapine Viatris 2.5 mg Film-Coated Tablets

Olanzapine Viatris 5 mg Film-Coated Tablets

Olanzapine Viatris 7.5 mg Film-Coated Tablets

Olanzapine Viatris 10 mg Film-Coated Tablets

Olanzapine Viatris 15 mg Film-Coated Tablets

Olanzapine Viatris 20 mg Film-Coated Tablets

olanzapine

Read this prospect carefully before starting to take this medicine, as it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed to you alone and should not be given to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

Olanzapina Viatris contains the active ingredient olanzapina. Olanzapina belongs to a group of medicines called antipsychotics and is indicated for the treatment of the following diseases:

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

Do not take Olanzapina Viatris

• If you are allergic to olanzapina, peanuts, soy, or any of the other components of this medication (listed in section 6). An allergic reaction may manifest as a rash, itching, swelling of the face or lips, or difficulty breathing. If this happens, 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

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

• Olanzapina Viatris is not recommended for use in elderly patients with dementia as it may have severe adverse effects.
• Medications of this type may cause unusual movements, especially in the face or tongue. If this happens after taking Olanzapina Viatris, tell your doctor.
• In rare cases, medications of this type produce a combination of fever, rapid breathing, sweating, muscle stiffness, and a state of drowsiness or somnolence. If this occurs, contact your doctor immediately.
• Weight gain has been observed in patients taking Olanzapina Viatris.
• You and your doctor should regularly check your weight. Consider consulting a dietitian or adopting a dietary plan if necessary.
• High 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 Olanzapina Viatris and regularly during treatment.
• If you or a family member has a history of blood clots, consult your doctor, as medications 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:

• Cerebral infarction or transient cerebral ischemia (temporary symptoms of cerebral infarction).
• Parkinson's disease.
• Prostate problems.
• Intestinal blockage (paralytic ileus).
• Liver or kidney disease.
• Blood disorders.
• Heart disease.
• Diabetes.
• Seizures.
• If you think you may have electrolyte loss due to prolonged diarrhea and vomiting or the use of diuretic medications (urine tablets).

If you have dementia, you or your caregiver or family member should inform your doctor if you have ever had a cerebral infarction or cerebral ischemia.

As a routine precaution, if you are over 65 years old, it would be advisable for your doctor to monitor your blood pressure.

Children and adolescents

Patients under 18 years old should not take Olanzapina Viatris.

Use of Olanzapina Viatris with other medications

Only use other medications at the same time as Olanzapina Viatris if your doctor authorizes it. You may feel drowsy if you combine Olanzapina Viatris with antidepressants or medications for anxiety or sleep (tranquilizers).

Inform your doctor or pharmacist if you are using or have recently used or may need to use any other medication.

Specifically, tell your doctor if you are taking:

Use of Olanzapina Viatris with alcohol

You should not drink alcohol if you have been administered Olanzapina Viatris as it may cause drowsiness.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor before using this medication. Do not take this medication while breastfeeding as small amounts of Olanzapina Viatris may pass into breast milk.

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

Driving and operating machinery

There is a risk of drowsiness when taking Olanzapina Viatris. If this happens, do not drive vehicles or operate machinery. Consult your doctor.

Olanzapina Viatris contains lactose and soy lecithin

If your doctor has told you that you have a certain sugar intolerance, consult with them before taking this medication. This medication contains soy lecithin. Do not use it if you are allergic to peanuts or soy.

Follow exactly the administration instructions for this medication as indicated by your doctor. If in doubt, consult your doctor or pharmacist again. Consult your doctor or pharmacist if you have any doubts.

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

You should take your Olanzapina Viatris tablets once a day, following your doctor's instructions. Try to take the tablets at the same time every day. You can take them with or without food. The coated tablets of Olanzapina Viatris are for oral administration. You should 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 heart rate, agitation/aggressiveness, speech problems, unusual movements (especially of the face and tongue) and a reduced level of consciousness. Other symptoms may include: acute confusion, seizures (epilepsy), coma, a combination of fever, rapid breathing, sweating, muscle rigidity, drowsiness or lethargy, slowed respiratory frequency, aspiration, increased blood pressure or decreased blood pressure, abnormal heart rhythms. Contact your doctor or go to the hospital immediately if you notice any of the mentioned symptoms. Show the doctor the packaging with 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 the missed dose.

If you interrupt treatment with Olanzapina Viatris

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

If you stop taking Olanzapina Viatris suddenly, you may experience symptoms such as sweating, inability to sleep, tremors, anxiety, nausea, and vomiting. Your doctor may suggest that you gradually reduce the dose before stopping treatment.

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

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

Get in touch with your doctor immediately if you have:

Frequent side effects (which can 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 lying down or sitting. This feeling usually goes away on its own, but if it doesn't, consult your doctor.

Common side effects (which can affect up to 1 in 10 people) include: changes in levels of some blood cells, circulating lipids, and at the beginning of treatment temporary increases in liver enzymes; increased levels of sugar in the blood and urine; increased levels of uric acid and creatine phosphokinase in the blood; increased appetite; dizziness; agitation; tremor; strange movements (dyskinesia); constipation; dry mouth; skin rash; loss of strength; 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.

Rare side effects (which can affect up to 1 in 100 people) include: hypersensitivity (e.g., inflammation of the mouth and throat, itching, skin rash); diabetes or worsening of diabetes, occasionally related to ketoacidosis (acetone in the blood and urine) or coma; seizures, in most cases 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 decrease of menstrual periods; and changes in the breast gland in men and women such as abnormal milk production or abnormal growth.

Very rare side effects (which can affect up to 1 in 1,000 people), include: decrease in normal body temperature; abnormal heart rhythm; sudden death without apparent explanation; pancreatitis, which causes severe stomach pain, fever, and discomfort; liver disease, with yellowing of the skin and white parts of the eye; muscle disorder that presents as unexplained pain; and prolonged and/or painful erection.

Severe allergic reactions, such as drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported. DRESS initially presents with symptoms similar to the flu, with skin rash on the face that spreads to other areas, fever, lymph node swelling, 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.

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

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is

possible side effects that do not appear in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the box and label after CAD. The expiration date is the last day of the month indicated.

Do not store above 25 °C.

Bottles: After opening the packaging for the first time, use the product within 90 days.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the containers and medications that you no longer need.

By doing so, you will help protect the environment.

Composition of Olanzapina Viatris

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

Appearance of the medicinal product and contents of the pack

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

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

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

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

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

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

Blister packs:

Olanzapina 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 multipack of 35) and 70 film-coated tablets.

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

Pre-cut single-dose blister pack

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

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

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

Bottles:

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

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

Olanzapina Viatris 10 mg is available in bottles of 100 and 500 film-coated tablets.

Marketing authorisation holder:

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

Manufacturer:

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

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

For further information about this medicinal product, please contact the local representative of the marketing authorisation holder:

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Other sources of information

The detailed information about this medicinal product is available on the website of the European Medicines Agency:http://www.ema.europa.eu.