Olanzapine Flas Kern Pharma 10 mg orodispersible tablets EFG

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Olanzapina Flas Kern Pharma 10 mg orodispersible tablets EFG

Olanzapine

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

• 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 you should not give it to others, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are 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 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 disease whose symptoms include hearing, seeing, or feeling unreal things, false beliefs, unusual suspiciousness, and social withdrawal. Individuals suffering from 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 flight of ideas, and sometimes marked irritability. It is also a mood stabilizer that prevents 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 to you after taking Olanzapina Flas Kern Pharma, tell your doctor.
• Very rarely, medicines of this type cause a combination of fever, rapid breathing, sweating, muscle rigidity, 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 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 blockage (paralytic ileus)
• Blood disorders
• Stroke or reduced blood flow to the brain (transient ischemic attack 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.

Olanzapina Flas Kern Pharma must not be taken by patients under 18 years of age.

Use of other medicines

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

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.

Taking Olanzapina Flas Kern Pharmawith food and drink

Do 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 may 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 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 of an intolerance to certain sugars, consult with him before taking this medicine.

This medicine may be harmful to people with phenylketonuria because 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 given 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 your doctor tells you to.

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 administration.

The orodispersible tablets of Olanzapina Flas Kern Pharma 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 cavity and carefully remove the orodispersible tablet of Olanzapina Flas Kern Pharma.

Place the tablet in your mouth. It will dissolve rapidly 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 problems, 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 or decreased blood pressure, and abnormal heart rhythms. Contact your doctor immediately or go to the nearest hospital. Show the doctor the packaging 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 forgotten doses.

If you stop taking Olanzapina Flas Kern Pharma

Do not stop treatment just because you feel better. It is very important that you continue taking Olanzapina Flas Kern Pharma for as long as your doctor advises.

If you stop taking Olanzapina Flas Kern Pharma suddenly, symptoms such as sweating, inability to sleep, tremor, anxiety, or nausea and vomiting may occur. Your doctor may recommend that you 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 can produce adverse effects, although not everyone will experience them.

Very common adverse effects: affecting 1 in every 10 patients

• Weight gain.
• Drowsiness.
• 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 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 initial stages of treatment, some people may experience dizziness or fainting (with slower heartbeats), 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., inflammation 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, this is 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 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, skin rash on the face spreading 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 Kern Pharma may worsen symptoms in patients with Parkinson's disease.

Rarely, women who take this type of medicine for a long period of time may secrete milk from the mammary glands, stop having regular menstrual periods, or have 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 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 Pharmacovigilance System for Human Medicinal Products: 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 collection 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 pack and other information

Composition of Olanzapina Flas Kern Pharma 10 mg

The active substance is olanzapine. Each orodispersible tablet of Olanzapina Flas Kern Pharma contains 10 mg of active substance.

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

Appearance of Olanzapina Flas Kern Pharma 10 mg and contents of the pack

Olanzapina Flas Kern Pharma 10 mg orodispersible tablets are yellow.

Olanzapina Flas Kern Pharma 10 mg orodispersible tablets are available in packs of 28 and 56 tablets.

Other presentations:

Olanzapina Flas Kern Pharma 5 mg orodispersible tablets: packs 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 last reviewed 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) http://www.aemps.gob.es/