OLANZAPINE VIATRIS 15 mg FILM-COATED TABLETS

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 package leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

Contents of the package leaflet:

1. What is Olanzapina Viatris and what is it used for
2. What you need to know before taking Olanzapina Viatris
3. How to take Olanzapina Viatris
4. Possible side effects
5. Storage of Olanzapina Viatris
6. Package contents and additional information

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

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

• Schizophrenia, a disease whose symptoms are: hearing, seeing, or feeling unreal things, mistaken beliefs, unusual suspicion, and becoming withdrawn. People suffering from these diseases may also be depressed, anxious, or tense.
• 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 components of this medication (listed in section 6). The allergic reaction may manifest as a 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 eye pressure).

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 serious side effects.
• Medications of this type may cause unusual movements, especially in the face or tongue. If this happens to you after taking Olanzapina Viatris, tell your doctor.
• In very rare cases, medications of this type produce a combination of fever, rapid breathing, sweating, muscle stiffness, and a state of confusion or drowsiness. If this happens to you, contact your doctor immediately.
• A weight gain has been observed in patients taking Olanzapina Viatris.
• You and your doctor should check your weight regularly. Consider consulting a dietitian or adopting a diet plan if necessary.
• High levels of sugar and fat (triglycerides and cholesterol) have been observed in the blood of patients taking Olanzapina Viatris. Your doctor should perform blood tests to check your blood sugar and fat levels before you start taking 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 the formation of blood clots.

If you suffer from any of the following diseases, inform your doctor as soon as possible:

• Stroke or transient cerebral ischemia (temporary stroke symptoms).
• 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 loss of salts due to prolonged and intense diarrhea and vomiting or the use of diuretic medications (water pills).

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

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

Children and adolescents

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

Using 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 aids (tranquilizers).

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

In particular, 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 changed.

Using Olanzapina Viatris with alcohol

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medication. You should 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 using machines

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

Olanzapina Viatris contains lactose and soy lecithin

If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication. This medication contains soy lecithin. It should not be used in case of peanut or soy allergy.

3. How to take Olanzapina Viatris

Follow the administration instructions of this medication indicated by your doctor exactly. In case of 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 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. Olanzapina Viatris film-coated tablets 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 heartbeat, agitation/aggression, 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 stiffness, and a state of confusion or drowsiness, slowing of respiratory rate, aspiration, increased or decreased blood pressure, and abnormal heart rhythms. Contact your doctor or go to the hospital immediately if you notice any of the above symptoms. Show the doctor the package 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 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 while your doctor tells you to.

If you stop taking Olanzapina Viatris suddenly, you may experience symptoms such as sweating, insomnia, tremors, anxiety, or 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.

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone experiences them.

Contact your doctor immediately if you experience:

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

Very common side effects (affecting more than 1 in 10 people) include: weight gain; drowsiness; and increased prolactin levels 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 disappears on its own, but if it does not, consult your doctor.

Common side effects (affecting up to 1 in 10 people) include: changes in the levels of some blood cells, circulating lipids, and temporary increases in liver enzymes at the start of treatment; increased blood sugar and urine levels; increased uric acid and creatine phosphokinase levels in the blood; increased appetite; dizziness; agitation; tremors; unusual movements (dyskinesia); constipation; dry mouth; skin rash; loss of strength; excessive fatigue; fluid retention that causes 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 side effects (affecting 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 blood and urine) or coma; seizures, most often 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 mammary gland in men and women, such as abnormal milk production or abnormal growth.

Rare side effects (affecting up to 1 in 1,000 people) include: decreased body temperature; abnormal heart rhythm; sudden unexplained death; pancreatitis, which causes severe stomach pain, fever, and discomfort; liver disease, with yellowing of the skin and the white areas of the eyes; muscle disorder that presents as unexplained pain; and prolonged and/or painful erections.

Severe allergic reactions, such as drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported. DRESS initially manifests with symptoms similar to those of the flu, with a skin rash on the face that then spreads to other areas, fever, swelling of the lymph nodes, elevated liver enzyme levels in blood tests, and an increase in 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 walking problems. Some deaths have been reported in this particular group of patients.

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

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Medicines Agency's online platform: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Olanzapina Viatris

Keep out of sight and reach of children.

Do not use this medication after the expiration date stated on the carton and label after EXP. The expiration date is the last day of the month indicated.

Do not store above 25°C.

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

Medications should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of the package and any unused medications.

By doing so, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Olanzapina Viatris

• The active ingredient is olanzapine. 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:
• Core of the tablet: lactose monohydrate (see section 2 "Olanzapina Viatris contains lactose"), corn starch, pregelatinized corn starch, crospovidone type A, magnesium stearate,
• Coating: 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 Package Contents

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

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

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

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

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

Olanzapina Viatris 20 mg are film-coated white, 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.

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 are 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.

You can request more information about this medicinal product by contacting the local representative of the marketing authorisation holder:

Date of Last Revision of this Leaflet:{MM/AAAA}

Other sources of information

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