OLANZAPINE FLAS KERN PHARMA 10 mg ORALLY DISINTEGRATING TABLETS

Introduction

PATIENT INFORMATION LEAFLET

Olanzapine Flas Kern Pharma 10 mg orodispersible tablets EFG

Olanzapine

Read all of this leaflet carefully before you start taking this medicine.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack:

1. What Olanzapine Flas Kern Pharma is and what it is used for
2. What you need to know before you take Olanzapine Flas Kern Pharma
3. How to take Olanzapine Flas Kern Pharma
4. Possible side effects
5. Storage of Olanzapine Flas Kern Pharma
6. Contents of the pack and other information

1. What Olanzapine Flas Kern Pharma is and what it is used for

Olanzapine Flas Kern Pharma belongs to a group of medicines called antipsychotics.

Olanzapine Flas Kern Pharma is used to treat a disease with symptoms such as hearing, seeing or feeling things that are not real, mistaken beliefs, unusual suspiciousness, and becoming withdrawn. People with these diseases may also feel depressed, tense, or anxious.

Olanzapine Flas Kern Pharma is used to treat a disorder characterized by symptoms such as feeling euphoric, having excessive energy, a decreased need for sleep, talking very quickly with flight of ideas, and sometimes considerable irritability. It is also a mood stabilizer that prevents the appearance of extreme variations in mood.

2. Before taking Olanzapine Flas Kern Pharma

Do not take Olanzapine Flas Kern Pharma

• if you are allergic (hypersensitive) to olanzapine or any of the other ingredients of Olanzapine Flas Kern Pharma. 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 pressure in the eye).

Be careful withOlanzapine Flas Kern Pharma

• Medicines of this type can cause unusual movements, especially in the face or tongue. If this happens to you after taking Olanzapine Flas Kern Pharma, tell your doctor.
• Very rarely, medicines of this type produce a combination of fever, rapid breathing, sweating, muscle stiffness, and a state of obnubilation or somnolence. If this happens to you, contact your doctor immediately.
• The use of Olanzapine Flas Kern Pharma in elderly patients with dementia is not recommended as it may have serious side effects.

If you have any of the following diseases, tell your doctor as soon as possible:

• Diabetes
• Heart disease
• Liver or kidney disease
• Parkinson's disease
• Epilepsy
• Prostate problems
• Intestinal blockage (paralytic ileus)
• Blood disorders
• Stroke or lack of blood flow to the brain (transient stroke symptoms).

If you suffer from dementia, you or your caregiver or relative should inform your doctor if you have ever had a stroke or a lack of blood flow to the brain.

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

Patients under 18 years old should not take Olanzapine Flas Kern Pharma.

Use of other medicines

Only use other medicines at the same time as Olanzapine Flas Kern Pharma if your doctor authorizes it. You may feel a certain sensation of drowsiness if you combine Olanzapine Flas Kern Pharma with antidepressants or medicines for anxiety or that help you sleep (tranquilizers).

You should inform your doctor if you are taking fluvoxamine (antidepressant) or ciprofloxacin (antibiotic), as it may be necessary to modify your dose of Olanzapine Flas Kern Pharma.

Please inform your doctor or pharmacist if you are using or have recently used other medicines, even those purchased without a prescription. Especially inform your doctor if you are using medicines to treat Parkinson's disease.

TakingOlanzapine Flas Kern Pharmawith food and drinks

You should not drink alcohol while taking Olanzapine Flas Kern Pharma as the combination of Olanzapine Flas Kern Pharma and alcohol can cause drowsiness.

Pregnancy and breastfeeding

Tell your doctor as soon as possible if you are pregnant or think you may be. You should not take this medicine during pregnancy unless your doctor recommends it. You should not take this medicine while breastfeeding as small amounts of Olanzapine Flas Kern Pharma may pass into breast milk.

Newborns of mothers who have used (olanzapine) in the last trimester of pregnancy may present with the following symptoms: tremors, muscle stiffness and/or weakness, drowsiness, agitation, breathing problems, and feeding problems. If your newborn presents with any of these symptoms, contact your doctor.

Driving and using machines

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

Important information about some of the ingredients ofOlanzapine Flas Kern Pharma

This medicine contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medicine.

This medicine may be harmful to people with phenylketonuria because it contains aspartame, which is a source of phenylalanine.

3. How to take Olanzapine Flas Kern Pharma

Follow the administration instructions of Olanzapine Flas Kern Pharma indicated by your doctor. Consult your doctor or pharmacist if you have doubts.

Your doctor will indicate how many tablets of Olanzapine Flas Kern Pharma you should take and for how long. The daily dose of Olanzapine Flas Kern Pharma ranges from 5 to 20 mg. Consult with your doctor if you suffer from symptoms again, but do not stop taking Olanzapine Flas Kern Pharma unless your doctor tells you to.

The tablets of Olanzapine Flas Kern Pharma should be taken once a day, following the instructions of your doctor. Try to take the tablets at the same time every day. You can take them with or without food. The tablets of Olanzapine Flas Kern Pharma are for oral administration.

The orodispersible tablets of Olanzapine Flas Kern Pharma dissolve easily, so they should be handled with care. Do not handle the tablets with wet hands as they may disintegrate.

Separate the top aluminum foil from a blister and carefully remove the orodispersible tablet of Olanzapine Flas Kern Pharma.

Place the tablet in your mouth. It will dissolve directly in your mouth, making it very easy to swallow.

If you take moreOlanzapine Flas Kern Pharmathan you should

Patients who have taken more Olanzapine Flas Kern Pharma 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, somnolence or lethargy, slowing of respiratory rate, aspiration, increased or decreased blood pressure, and abnormal heart rhythms. Contact your doctor or go to the hospital immediately. Show the doctor the package with the tablets.

If you forget to takeOlanzapine Flas Kern Pharma

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

If you stop taking Olanzapine Flas Kern Pharma

Do not stop treatment just because you feel better. It is very important that you continue taking Olanzapine Flas Kern Pharma while your doctor tells you to.

If you stop taking Olanzapine Flas Kern Pharma suddenly, symptoms such as sweating, insomnia, tremors, anxiety, or nausea and vomiting may appear. Your doctor may suggest that you gradually reduce the dose before stopping treatment.

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

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4. Possible side effects

Like all medicines, Olanzapine Flas Kern Pharma can cause side effects, although not everybody gets them.

Very common side effects: affecting 1 in 10 patients

• Weight gain.
• Drowsiness.
• Increased prolactin levels in blood.

Common side effects: affecting 1 to 10 in 100 patients

• Changes in levels of certain blood cells and circulating lipids.
• Increased blood and urine sugar levels.
• Increased appetite.
• Dizziness.
• Agitation.
• Tremors.
• Muscle stiffness or spasms (including eye movements).
• Language disorders.
• Unusual movements (especially of the face or tongue).
• Constipation.
• Dry mouth.
• Skin rash.
• Loss of strength.
• Excessive fatigue.
• Fluid retention that causes swelling of the hands, ankles, or feet.
• In the early stages of treatment, some people experience dizziness or fainting (with slower heartbeats), especially when getting up from lying down or sitting. This sensation usually disappears on its own, but if it does not, inform your doctor.
• Sexual dysfunctions such as decreased libido in men and women or erectile dysfunction in men.

Uncommon side effects: affecting 1 to 10 in 1,000 patients

• Slow pulse.
• Sensitivity to sunlight.
• Urinary incontinence.
• Hair loss.
• Absence or decrease of menstrual periods.
• Changes in the mammary gland in men and women, such as abnormal milk production or abnormal growth.
• Restless legs syndrome.
• Allergic reaction (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, in most cases related to a history of seizures (epilepsy).
• Muscle spasms in the eye muscles causing circular movements of the eyes.
• Excessive salivation.

Other possible side effects: frequency cannot be estimated from available data

• Decrease in normal body temperature.
• Combination of fever, rapid breathing, sweating, muscle stiffness, and a state of obnubilation or somnolence.
• Abnormal heart rhythm.
• Sudden unexplained death.
• Blood clots such as deep vein thrombosis of the legs and blood clots in the lungs.
• 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.
• Difficulty urinating.
• Prolonged and/or painful erection.

Severe allergic reactions, such as Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) have been reported. DRESS appears initially 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 suffer from stroke, pneumonia, urinary incontinence, falls, extreme fatigue, visual hallucinations, a rise in body temperature, redness of the skin, and walking problems. Some deaths have been reported in this particular group of patients.

Olanzapine Flas Kern Pharma may worsen symptoms in patients with Parkinson's disease.

Rarely, women who take medicines of this type for a long time may secrete milk from the mammary gland, stop having their menstrual period, or have it irregularly. If this situation persists, consult your doctor. Very rarely, babies of mothers who have taken Olanzapine Flas Kern Pharma in the last stage of pregnancy (third trimester) may present with tremors, drowsiness, or lethargy.

Reporting of side effects

If you experience any side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: http//www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Olanzapine Flas Kern Pharma

Keep out of sight and reach of children.

Do not use Olanzapine Flas Kern Pharma after the expiration date that appears on the package after CAD. The expiration date is the last day of the month indicated.

No special storage conditions are required.

Medicines should not be disposed of through wastewater or household waste. Place the packages and medicines you no longer need in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packages and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Olanzapine Flas Kern Pharma 10 mg

The active ingredient is olanzapine. Each orodispersible tablet of Olanzapine Flas Kern Pharma contains 10 mg of active ingredient.

The other ingredients are lactose monohydrate, calcium silicate, low-substitution hydroxypropyl cellulose, crospovidone, aspartame, orange flavor, banana flavor, anhydrous colloidal silica, and magnesium stearate.

Appearance of Olanzapine Flas Kern Pharma 10 mg and package contents

Olanzapine Flas Kern Pharma 10 mg orodispersible tablets are yellow.

Olanzapine Flas Kern Pharma 10 mg orodispersible tablets are available in packages of 28 and 56 tablets.

Other presentations:

Olanzapine Flas Kern Pharma 5 mg orodispersible tablets: packages of 28 tablets.

Marketing authorization holder

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

Manufacturer

Neuraxpharm Pharmaceuticals, S.L.

Avda. Barcelona 69

08970 Sant Joan Despí

Barcelona - Spain

This leaflet was revised in April 2020

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/