PATIENT INFORMATION LEAFLET

OLANZAPINE KERN PHARMA 10 MG FILM-COATED TABLETS

OLANZAPINE

Read this leaflet carefully before you start to take 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 only. Do not pass it on to others even if their symptoms are the same as yours. It may harm them.
• If you experience any side effects, talk to your doctor or pharmacist. This includes very rare side effects. See section 4.

Contents of the pack and additional information

This medication belongs to a group of medications called antipsychotics.

Olanzapina Kern Pharma is used for:

• To treat a disease with symptoms such as hearing, seeing or feeling things that are not real, false beliefs, unusual suspicion and a tendency to withdraw. People who suffer from these diseases may also be depressed, anxious or tense.
• To treat a disorder characterized by symptoms such as feeling euphoric, having excessive energy, needing to sleep much less than usual, speaking very quickly with a flight of ideas, and sometimes considerable irritability. It is also a mood stabilizer that prevents the onset of extreme variations in mood.

Do not take Olanzapina Kern Pharma

• If you are allergic (hypersensitive) to olanzapina or to any of the other components of this medication (listed in section 6). An allergic reaction may manifest as a rash, itching, swelling of the face or lips, or difficulty breathing. If this happens, tell your doctor.
• If you have previously been diagnosed with narrow-angle glaucoma.

• If you are under 18 years old.

Warnings and precautions

• This type of medication may cause unusual movements, especially in the face or tongue. If this happens after taking Olanzapina Kern Pharma, tell your doctor.

Very rarely, this type of medication produces a combination of fever, rapid breathing, sweating, muscle stiffness, and a state of confusion or drowsiness. If this happens, discontinue the medication and immediately contact your doctor.

• The use of Olanzapina Kern Pharma in elderly patients with dementia is not recommended as it may have severe adverse effects.

If you have any of the following diseases, 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 transient cerebral ischemia

If you have dementia, you or your caregiver or family member should inform your doctor if you have ever had a stroke or transient cerebral ischemia.

As a routine precaution, if you are over 65 years old, your doctor should monitor your blood pressure.

If you or a family member has a history of blood clots, these medications may be associated with the formation of blood clots.

Consult your doctor or pharmacist before starting this medication.

Use of Olanzapina Kern Pharma with other medications

Only use other medications at the same time as Olanzapina Kern Pharma if your doctor authorizes it. You may feel drowsy if you combine Olanzapina Kern Pharma with antidepressants or medications for anxiety or sleep (tranquilizers). Inform your doctor especially if you are taking medication for Parkinson's disease.

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

Inform your doctor or pharmacist that you are using or have recently used or may need to use any other medication.

Use of Olanzapina Kern Pharma with food, drinks, and alcohol

The tablets can be taken with or without food and should be swallowed whole with water.

You should not drink alcohol while taking Olanzapina Kern Pharma as the combination with alcohol may cause drowsiness.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or think you may be pregnant or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy:

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

Breastfeeding:

You should not take this medication while breastfeeding as small amounts of Olanzapina Kern Pharma may pass into breast milk.

Driving and operating machinery

Olanzapina may cause symptoms such as drowsiness, dizziness, or visual disturbances, and may impair your reaction time. These effects, as well as the underlying disease, may make it difficult for you to drive vehicles or operate machinery. Therefore, do not drive, operate machinery, or engage in other activities that require special attention until your doctor assesses your response to this medication.

Olanzapina Kern Pharma contains lactose

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

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

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

You should take your Olanzapina Kern Pharma tablets once a day, following your doctor's instructions.

Try to take the tablets at the same time every day. You can take them with or without food. Olanzapina Kern Pharma tablets are for oral administration. You should swallow the tablets whole with water.

Do not interrupt treatment when you think you are feeling better. It is essential that you continue taking it as long as your doctor tells you to.

Patients under 18 years old should not take Olanzapina Kern Pharma.

If you take more Olanzapina Kern Pharma than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

Patients who have taken more Olanzapina Kern Pharma than they should have experienced the following symptoms: rapid heart rate, agitation/aggression, speech problems, unusual movements (especially of the face and tongue) and reduced consciousness level. Other symptoms may include: acute confusion, seizures (epilepsy), coma, a combination of fever, rapid breathing, sweating, muscle rigidity, drowsiness or lethargy, slowed respiratory frequency, aspiration, increased or decreased blood pressure, abnormal heart rhythms.

If you forgot to take Olanzapina Kern Pharma

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

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

If you interrupt treatment with Olanzapina Kern Pharma

If you stop taking Olanzapina Kern Pharma suddenly, you may experience symptoms such as sweating, inability to sleep, tremors, anxiety, nausea, or vomiting. Your doctor may suggest reducing the dose gradually before stopping treatment.

Do not interrupt treatment when you think you are feeling better. It is very important that you continue taking Olanzapina Kern Pharma as long as your doctor tells you to.

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

Like all medications, Olanzapina Kern Pharma may cause side effects, although not everyone will experience them.

The observed side effects are classified according to their frequency of presentation:

Very frequent (may affect more than 1 in 10 people):

• Weight gain
• Drowsiness
• Increased plasma levels of prolactin (hormone that stimulates milk production)

Frequent (may affect up to 1 in 10 people):

• Increased levels of a type of white blood cell (eosinophils)
• Increased appetite
• High blood sugar, elevated triglyceride levels
• Agitation, parkinsonism, dyskinesia, unusual movements (especially of the face or tongue)
• Decreased blood pressure
• Mild gastrointestinal disorders such as constipation and dry mouth
• Asymptomatic and transient increases in liver enzymes (ALT, AST) especially at the beginning of treatment
• Fatigue, fluid retention inflammation

Occasional (may affect up to 1 in 100 people):

• Elevated levels of the enzyme creatine phosphokinase
• Sensitivity to sunlight
• Abnormal heart rhythms, such as slowing of the heartbeat
• Restless legs syndrome
• Excessive salivation

Rare (may affect up to 1 in 1,000 people):

• Decreased white blood cells
• Seizures
• Skin eruptions

Very rare (may affect up to 1 in 10,000 people):

• Decreased platelets
• Decreased levels of certain white blood cells (neutrophils)
• High blood sugar and/or initial symptoms of worsening diabetes, with acetone in the blood and urine or coma
• Elevated triglycerides in the blood, decreased normal body temperature
• Neuroleptic Malignant Syndrome (NMS) cases have been reported in association with olanzapina
• Parkinsonism, abnormal repetitive movement disorders such as contortions, tremors, and rigidity
• Sweating, inability to sleep, tremors, anxiety, nausea, or vomiting upon discontinuing treatment
• Blood clot formation
• Pancreatitis
• Liver disease
• Allergic reaction (e.g. anaphylactoid reaction, angioedema, pruritus, or urticaria)
• Rhabdomyolysis (increase in creatine kinase enzyme concentration and myoglobinuria)
• Difficulty initiating urination
• Prolonged and/or painful erection or difficulty urinating

Severe allergic reactions, such as Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), have been reported. DRESS initially presents with symptoms similar to the flu, with skin rash on the face that spreads to other areas, fever, lymph node swelling, elevated liver enzymes in blood tests, and increased levels of a type of white blood cell (eosinophilia).

During treatment with olanzapina, elderly patients with dementia may experience cerebrovascular side effects. In this group of patients, very frequent (affecting more than 1 in 10 people) problems walking and falls have been observed. Frequent (affecting up to 1 in 10 people) pneumonia, urinary incontinence, extreme fatigue, visual hallucinations, elevated body temperature, and skin redness have also been observed. Fatalities have been reported in this particular group of patients.

Other observed side effects include blood clots in the veins, especially in the legs (symptoms include swelling, pain, and redness in the leg), which can migrate through the blood vessels to the lungs, causing chest pain and difficulty breathing. If you experience any of these symptoms, seek immediate medical attention.

Reporting side effects

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

Keep this medication out of the sight and reach of children.

No special storage conditions are required.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at your pharmacy.If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need.By doing so, you will help protect the environment.

Composition of Olanzapina Kern Pharma

The active ingredient is olanzapine. Each tablet contains 10 mg of olanzapine.

The other components are: microcrystalline cellulose, lactose monohydrate, crospovidone, and magnesium stearate.

Appearance of the product and content of the packaging

Olanzapina is presented in the form of round, biconvex tablets, yellow in color, and marked with “Y10” on one of its faces. Each package contains 28 and 56 tablets.

Other presentations

Olanzapina KERN PHARMA 2.5 mg tablets: package of 28 tablets

Olanzapina KERN PHARMA 5 mg tablets: package of 28 tablets

Olanzapina KERN PHARMA 7.5 mg tablets: packages of 56 tablets

Holder of the marketing authorization and Responsible for manufacturing

KERN PHARMA, S.L.

Vernus, 72 – Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

Last review date of this prospectus: April 2020.

The detailed and updated information on this medication is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/.