Olanzapine Flas Kern Pharma 15 mg orodispersible tablets EFG

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Olanzapina Flas Kern Pharma 15 mg orodispersible 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 and should not be given to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are side effects not listed in this leaflet. See Section 4.

Leaflet contents:

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

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

Olanzapina Flas Kern Pharma belongs to the therapeutic group of antipsychotics.

Olanzapina Flas is indicated for the treatment of a condition whose symptoms include hearing, seeing, or sensing things that are not real, false beliefs, unusual suspiciousness, and social withdrawal. People affected by this condition may also feel depressed, tense, or anxious.

Olanzapina Flas is used to treat a disorder characterized by symptoms such as feeling euphoric, having excessive energy, needing much less sleep than usual, speaking rapidly with racing thoughts, and sometimes marked irritability. It is also a mood stabilizer that helps prevent extreme fluctuations in mood.

2. What you need to know before starting to take Olanzapina Flas Kern Pharma

Do not take Olanzapina Flas Kern Pharma

• if you are allergic to olanzapine or to any of the other components of Olanzapina Flas Kern Pharma. The allergic reaction may manifest as rash, itching, swelling of the face or lips, or difficulty breathing. If this happens to you, inform 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

• Medicines of this type may cause unusual movements, especially in the face or tongue. If this occurs after taking Olanzapina Flas Kern Pharma, inform your doctor.
• Very rarely, medicines of this type may cause a combination of fever, rapid breathing, sweating, muscle rigidity, and mental confusion or drowsiness. If this occurs, stop taking the medication and contact your doctor immediately.
• The use of Olanzapina Flas in elderly patients with dementia is not recommended, as it may lead to serious adverse effects.

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

• Diabetes
• Heart disease
• Liver or kidney disease
• Parkinson's disease
• Epilepsy
• Prostate problems
• Intestinal obstruction (paralytic ileus)
• Blood disorders
• Stroke or reduced blood flow to the brain (transient ischemic attacks).

If you have dementia, you or your caregiver or family member should inform your doctor if you have ever had a stroke or reduced blood flow to the brain.

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 Flas Kern Pharma.

Interaction of Olanzapina Flas Kern Pharma with other medicines

Only use other medicines together with Olanzapina Flas Kern Pharma if authorized by your doctor. You may experience drowsiness if Olanzapina Flas Kern Pharma is combined with antidepressants or medications used for anxiety or to help sleep (tranquilizers).

You must inform your doctor if you are taking fluvoxamine (an antidepressant) or ciprofloxacin (an antibiotic), as your dose of Olanzapina Flas Kern Pharma may need to be adjusted.

Please inform your doctor or pharmacist if you are taking or have recently taken any other medicines, including those obtained without a prescription. Especially inform your doctor if you are taking medicines for Parkinson's disease.

Interaction of Olanzapina Flas Kern Pharma with food and drink

You must not drink alcohol while taking Olanzapina Flas, as the combination of Olanzapina Flas and alcohol may cause drowsiness.

Pregnancy and breastfeeding

Inform your doctor as soon as possible if you are pregnant or think you might be pregnant. You should not take this medicine during pregnancy unless your doctor advises you to do so. You should not take this medicine while breastfeeding, as small amounts of Olanzapina Flas may pass into breast milk.

Newborns of mothers who have used olanzapine during the third trimester of pregnancy may experience the following symptoms: tremors, muscle stiffness and/or weakness, drowsiness, agitation, breathing difficulties, and feeding problems. If your newborn shows any of these symptoms, contact your doctor.

Driving and using machines

Olanzapina Flas may cause symptoms such as drowsiness, dizziness, or vision disturbances, and may reduce reaction ability. These effects, as well as the underlying illness itself, may impair your ability to drive or operate machinery. Therefore, do not drive, operate machinery, or engage in any other activities requiring special attention until your doctor has assessed your response to this medicine.

Olanzapina Flas Kern Pharma contains lactose

If your doctor has diagnosed you with an intolerance to certain sugars, consult him before taking this medicine.

Olanzapina Flas Kern Pharma contains aspartame

Aspartame is a source of phenylalanine. It may be harmful for people with phenylketonuria.

3. How to take Olanzapina Flas Kern Pharma

Follow exactly the administration instructions for Olanzapina Flas Kern Pharma provided by your doctor.

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

Olanzapina Flas tablets should be taken once daily, as directed by your doctor. Try to take the tablets at the same time every day. You may take them with or without food. The orodispersible tablets of Olanzapina Flas are intended for oral administration.

Olanzapina Flas Kern Pharma tablets crumble easily and therefore must be handled with care. Do not handle the tablets with wet hands, as they may disintegrate.

1. Hold the blister pack by the edges and separate one of the compartments by gently breaking it along the perforations surrounding it.
2. Gently peel back the backing of the compartment.
3. Carefully remove the tablet.
4. Place the tablet in your mouth. It will dissolve directly in the mouth, making it very easy to swallow.

Alternatively, the tablet may be placed into a cup or glass filled with water, orange juice, apple juice, milk, or coffee, and stirred. With some beverages, the mixture may change color and appear cloudy. It should be drunk immediately.

If you take more Olanzapina Flas Kern Pharma than you should

Patients who have taken more Olanzapina Flas than prescribed have experienced the following symptoms: rapid heartbeat, agitation/aggression, speech difficulties, 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 immediately or go to the hospital. Show the doctor the packaging of the tablets.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at: 91 562 04 20, stating the name of the medication and the amount ingested.

If you forget to take Olanzapina 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 Olanzapina Flas Kern Pharma

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

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

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

4. Possible adverse effects

Like all medicines, Olanzapina Flas Kern Pharma may have adverse effects, although not everyone will experience them.

Very common adverse effects: May affect more than 1 in 10 people

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

Common adverse effects: May affect up to 1 in 10 people

• Changes in levels of certain blood cells and circulating lipids.
• Increased blood and urine sugar levels.
• Increased appetite.
• Dizziness.
• Agitation.
• Tremor.
• Muscle rigidity or spasms (including eye movements).
• Speech disturbances.
• Unusual movements (especially of the face or tongue).
• Constipation.
• Dry mouth.
• Skin rash.
• Loss of strength.
• Excessive tiredness.
• Fluid retention causing swelling of the hands, ankles, or feet.
• In the early stages of treatment, some people may experience dizziness or fainting (with slower heartbeat), especially when standing up from a lying or sitting position.
• This sensation usually disappears spontaneously, but if it does not, inform your doctor.
• 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

• Slow pulse.
• Sensitivity to sunlight.
• Urinary incontinence.
• Hair loss.
• Absence or reduction of menstrual periods.
• Changes in the breast gland in men and women such as abnormal production of breast milk or abnormal growth.
• Restless legs syndrome.
• Allergic reaction (e.g., mouth and throat swelling, itching, skin rash).
• Diabetes or worsening of diabetes, occasionally associated with ketoacidosis (acetone in blood and urine) or coma.
• Seizures; in most cases, these are related to a history of seizures (epilepsy).
• Muscle spasms in the eyes causing circular eye movements.
• Excessive salivation.

Other possible adverse 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 mental confusion or drowsiness.
• Abnormal heart rhythm.
• Sudden unexplained death.
• Blood clots such as deep vein thrombosis in the legs and blood clots in the lungs.
• Inflammation of the pancreas, causing severe stomach pain, fever, and malaise.
• Liver disease, with yellowing of the skin and whites of the eyes.
• Muscle disorder presenting as unexplained muscle pain.
• Difficulty urinating.
• 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 later 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 Flas may worsen symptoms in patients with Parkinson's disease.

Rarely, women who take this type of medication for a long time may experience milk secretion from the breast, absence of menstrual periods, or irregular menstruation. If this situation persists, consult your doctor. Very rarely, babies born to mothers who took Olanzapina Flas during the last stage of pregnancy (third trimester) may experience tremor, drowsiness, or lethargy.

Reporting of adverse effects

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

5. Storage of Olanzapina Flas Kern Pharma

Keep this medicine out of sight and reach of children.

Do not use Olanzapina Flas Kern Pharma after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

No special storage conditions are required.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Olanzapina Flas Kern Pharma 15 mg tablets

• The active substance is olanzapine. Each Olanzapina Flas Kern Pharma orodispersible tablet contains 15 mg of olanzapine.
• The other components are monohydrate lactose, calcium silicate (E552), low-substituted hydroxypropyl cellulose (E463), crospovidone, aspartame (E951), orange flavor, banana flavor, anhydrous colloidal silica, and magnesium stearate.

Nature of the product and pack contents

Olanzapina Flas Kern Pharma are round, flat, bevelled yellow tablets. The tablets are packaged in aluminum/aluminum blisters that open by separating one foil, in cartons containing 28 tablets.

Olanzapina Flas Kern Pharma is also available as orodispersible tablets of 5 mg in cartons of 28 tablets, of 10 mg in cartons of 28 and 56 tablets, and of 20 mg in cartons of 28 tablets.

Only certain pack sizes may be marketed.

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

The last revision of this leaflet was in April 2020

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) www.aemps.gob.es