Olanzapine Flas Kern Pharma 5 mg orodispersible tablets EFG

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Olanzapina Flas Kern Pharma 5 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 personally and must not be given to other people, even if they have the same symptoms, as it may harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions 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 adverse 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 Kern Pharma is indicated for the treatment of a disorder whose symptoms include hearing, seeing, or feeling unreal things, false beliefs, unusual suspiciousness, and social withdrawal. Individuals affected by these conditions may also experience depression, tension, or anxiety.

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

2. Before taking Olanzapina Flas Kern Pharma

Do not take Olanzapina Flas Kern Pharma

• if you are allergic (hypersensitive) 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).

Take special care with Olanzapina Flas Kern Pharma

• Medicines of this type may cause unusual movements, especially in the face or tongue. If this happens after taking Olanzapina Flas Kern Pharma, tell 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 occurs, contact your doctor immediately.
• The use of Olanzapina Flas Kern Pharma in elderly patients with dementia is not recommended, as it may cause serious adverse effects.

If you have 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 blockage (paralytic ileus)
• Blood disorders
• Stroke or reduced blood flow to the brain (transient stroke symptoms)

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.

Patients under 18 years of age must not take Olanzapina Flas Kern Pharma.

Use of other medicines

Only use other medicines at the same time as Olanzapina Flas Kern Pharma if authorized by your doctor. You may feel drowsy if Olanzapina Flas Kern Pharma is combined with antidepressants or medicines for anxiety or 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 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.

Taking Olanzapina Flas Kern Pharmawith food and drinks

You must not drink alcohol while taking Olanzapina Flas Kern Pharma, as the combination of Olanzapina Flas Kern Pharma 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 must not take this medicine during pregnancy unless your doctor recommends it. You must not take this medicine while breastfeeding, as small amounts of Olanzapina Flas Kern Pharma 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

There is a risk of drowsiness while taking Olanzapina Flas Kern Pharma. If this occurs, do not drive or operate machinery. Discuss this with your doctor.

Important information about some of the components of Olanzapina Flas Kern Pharma

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

This medicine may be harmful for people with phenylketonuria, as it contains aspartame, a source of phenylalanine.

3. How to take Olanzapina Flas Kern Pharma

Follow exactly the administration instructions for Olanzapina Flas Kern Pharma provided by your doctor. Consult your doctor or pharmacist if you have any doubts.

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

Olanzapina Flas Kern Pharma 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. Olanzapina Flas Kern Pharma tablets are for oral use.

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

Peel back the upper aluminum foil from a blister and carefully remove the orodispersible tablet of Olanzapina Flas Kern Pharma.

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

If you take more Olanzapina Flas Kern Pharma than you should

Patients who have taken more Olanzapina Flas Kern Pharma 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 straight away. Show the doctor the package with the tablets.

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 missed 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 Kern Pharma for as long as your doctor instructs.

If you stop taking Olanzapina Flas Kern Pharma suddenly, symptoms such as sweating, inability to sleep, tremor, anxiety, 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 product, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, Olanzapina Flas Kern Pharma may produce adverse effects, although not everyone experiences them.

Very common adverse effects: affecting 1 in every 10 patients

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

Common adverse effects: affecting between 1 and 10 in every 100 patients

• Changes in levels of certain blood cells and circulating lipids.
• Increased levels of blood and urine sugar.
• 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: affecting between 1 and 10 in every 1,000 patients

• 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).
• Spasms in the eye muscles 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 rigidity, and a state of mental confusion or somnolence.
• Abnormal heart rhythm.
• Sudden unexplained death.
• Blood clots such as deep vein thrombosis in the legs and blood clots in the lung.
• 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 presents with flu-like symptoms, skin rash starting on the face and spreading to other areas, fever, swollen lymph nodes, elevated liver enzymes in blood tests, and an increase in a type of white blood cells (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 Kern Pharma may worsen symptoms in patients with Parkinson's disease.

Rarely, women who take this type of medication for a prolonged period may experience milk secretion from the mammary glands, absence of menstruation, or irregular periods. If this condition persists, consult your doctor. Very rarely, babies born to mothers who took Olanzapina Flas Kern Pharma during the last stage of pregnancy (third trimester) may experience tremor, somnolence, 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 through 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 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 refers to the last day of the month indicated.

No special storage conditions are required.

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

6. Contents of the package and other information

Composition of Olanzapina Flas Kern Pharma 5 mg

The active substance is olanzapine. Each orodispersible tablet of Olanzapina Flas Kern Pharma contains 5 mg of active substance.

The other components are lactose monohydrate, calcium silicate, low-substituted hydroxypropyl cellulose, crospovidone, aspartame, orange flavour, banana flavour, colloidal anhydrous silica, and magnesium stearate.

Appearance of Olanzapina Flas Kern Pharma 5 mg and contents of the pack

Olanzapina Flas Kern Pharma 5 mg orodispersible tablets are yellow.

Olanzapina Flas Kern Pharma 5 mg orodispersible tablets are available in packs of 28 tablets.

Other presentations:

Olanzapina Flas Kern Pharma 10 mg orodispersible tablets: packs of 28 and 56 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 last reviewed in April 2020

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