Olanzapine Flas Kern Pharma 20 mg orodispersible tablets EFG

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Olanzapina Flas Kern Pharma 20 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; 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 could harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if such effects are not listed in this leaflet. See Section 4.

Contents of the leaflet:

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 disorder whose symptoms include hearing, seeing, or sensing things that are not real, false beliefs, unusual suspiciousness, and social withdrawal. People suffering from this disorder may also experience depression, tension, or anxiety.

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, 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

• 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 cause a combination of fever, rapid breathing, sweating, muscle stiffness, and mental confusion or drowsiness. If this happens to you, stop taking the medicine 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 attack).

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 feel drowsiness if Olanzapina Flas Kern Pharma is combined with antidepressants or medications for anxiety or sleep (tranquilizers).

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

Please inform your doctor or pharmacist if you are using or have recently used 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 drinks

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

Pregnancy and breastfeeding

Tell 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: tremor, 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 illness itself, may impair your ability to drive or operate machinery. Therefore, do not drive, operate machinery, or perform 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 informed you that you have an intolerance to certain sugars, consult with 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 your doctor's instructions for taking Olanzapina Flas Kern Pharma.

Your doctor will tell you how many tablets of Olanzapina Flas 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 your doctor tells you to.

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 at the edges and separate one of the pockets by gently breaking it along the perforations surrounding it.
2. Carefully peel back the backing of the pocket.
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 glass or cup containing water, orange juice, apple juice, milk, or coffee, and stirred. With some beverages, the mixture may change color and become cloudy. The mixture should be drunk immediately.

If you take more Olanzapina Flas Kern Pharma than you should

Patients who have taken more Olanzapina Flas than recommended 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, aspiration, increased blood pressure or decreased blood pressure, and abnormal heart rhythms. Contact your doctor or go to the hospital immediately. Show the doctor the packaging and remaining 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, indicating 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, you may experience symptoms such as sweating, difficulty sleeping, tremor, anxiety, or nausea and vomiting. Your doctor may recommend gradually reducing the dose before stopping treatment completely.

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

4. Possible adverse effects

Like all medicines, Olanzapine Flas Kern Pharma may have adverse effects, although not everyone experiences 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 fatigue.
• 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 resolves 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 mammary gland in men and women such as abnormal production of breast milk or abnormal growth.
• Restless legs syndrome.
• Allergic reaction (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; in most cases, these are related to a history of seizures (epilepsy).
• Muscle spasms in the eyes causing rolling 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 rigidity, 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 pains.
• 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 manifests 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, elevated body temperature, skin redness, and difficulty walking. Some deaths have been reported in this particular group of patients.

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

Rarely, women who take this type of medication for a long period of time may produce milk from the mammary gland, stop having regular menstrual periods, or have irregular periods. If this persists, consult your doctor. Very rarely, babies born to mothers who have taken Olanzapine Flas during the last stage of pregnancy (third trimester) may experience tremors, 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 may also report them directly via the Spanish System of Pharmacovigilance of 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 the 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 point in your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused medicines and their containers. This will help protect the environment.

6. Contents of the package and other information

Composition of Olanzapine Flas Kern Pharma 20 mg tablets

• The active substance is olanzapine. Each orodispersible tablet of Olanzapine Flas Kern Pharma contains 20 mg of olanzapine.
• The other components are monohydrate lactose, calcium silicate (E552), low-substituted hydroxypropyl cellulose, crospovidone, aspartame (E951), orange flavor, banana flavor, colloidal anhydrous silica, and magnesium stearate.

Appearance of the product and contents of the pack

Olanzapine Flas Kern Pharma are round, flat, bevelled, yellow tablets. The tablets are packaged in aluminum/aluminum blisters that open by peeling off a foil, in cartons containing 28 tablets.

Olanzapine Flas Kern Pharma is also available as orodispersible tablets of 5 mg in cartons of 28 tablets, 10 mg in cartons of 28 and 56 tablets, and 15 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