OLANZAPINE KERN PHARMA 10 mg TABLETS

2. What you need to know before taking Olanzapine Kern Pharma

Do not take Olanzapine Kern Pharma

• If you are allergic (hypersensitive) to olanzapine or any of the other components of this medication (listed in section 6). The 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 been previously diagnosed with narrow-angle glaucoma.

• If you are under 18 years old.

Warnings and precautions

• Medications of this type can cause unusual movements, especially in the face or tongue. If this happens to you after taking Olanzapine Kern Pharma, tell your doctor.

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

• The use of Olanzapine Kern Pharma in elderly patients with dementia is not recommended, as it may have serious side 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 suffer from 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, it would be advisable for your doctor to check your blood pressure.

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

Consult your doctor or pharmacist before starting to take this medication.

Using Olanzapine Kern Pharma with other medications

Only use other medications at the same time as Olanzapine Kern Pharma if your doctor authorizes it. You may feel drowsy if you combine Olanzapine Kern Pharma with antidepressants or medications for anxiety or sleep aids (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 Olanzapine Kern Pharma.

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

Using Olanzapine 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 Olanzapine 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 olanzapine in the last trimester of pregnancy may experience the following symptoms: tremors, muscle stiffness and/or weakness, drowsiness, agitation, breathing problems, 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 Olanzapine Kern Pharma may pass into breast milk.

Driving and using machines

Olanzapine may cause symptoms such as drowsiness, dizziness, or changes in vision, and may reduce your reaction ability. These effects, as well as the disease itself, may make it difficult for you to drive vehicles or operate machines. Therefore, do not drive, operate machines, or engage in other activities that require special attention until your doctor assesses your response to this medication.

Olanzapine 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.

3. How to take Olanzapine Kern Pharma

Follow your doctor's instructions for taking this medication exactly. If you are unsure, consult your doctor or pharmacist again.

Your doctor will tell you how many Olanzapine Kern Pharma tablets to 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 Olanzapine Kern Pharma unless your doctor tells you to.

You should take your Olanzapine 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. Olanzapine Kern Pharma tablets are for oral administration. You should swallow the tablets whole with water.

Do not interrupt treatment when you feel better. It is important that you continue taking it while your doctor tells you to.

Patient under 18 years old should not take Olanzapine Kern Pharma.

If you take more Olanzapine 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.

Patient who have taken more Olanzapine Kern Pharma than they should 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 symptoms may include: acute confusion, seizures (epilepsy), coma, a combination of fever, rapid breathing, sweating, muscle stiffness, drowsiness or lethargy, slowing of respiratory rate, aspiration, increased or decreased blood pressure, and abnormal heart rhythms.

If you forget to take Olanzapine Kern Pharma

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

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

If you stop taking Olanzapine Kern Pharma

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

Do not interrupt treatment when you feel better. It is very important that you continue taking Olanzapine Kern Pharma while your doctor tells you to.

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

4. Possible side effects

Like all medications, Olanzapine Kern Pharma can cause side effects, although not everyone experiences them.

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

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

• Weight gain
• Drowsiness
• Increased levels of prolactin (hormone that stimulates milk production in the breast)

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

• Increased levels of a type of white blood cell (eosinophils)
• Increased appetite
• High levels of sugar, high levels of triglycerides
• 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 start of treatment
• Fatigue, swelling due to fluid retention

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

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

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

• Decreased white blood cells
• Seizures
• Skin rashes

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

• Decreased platelets
• Decreased levels of certain white blood cells (neutrophils)
• High levels of sugar and/or initial symptoms of worsening diabetes, with acetone in blood and urine or coma
• High levels of triglycerides in the blood, decreased body temperature
• There have been reports of Neuroleptic Malignant Syndrome (NMS) associated with olanzapine
• Parkinsonism, problems with abnormal repetitive movements such as contortions, jerks, and stiffness
• Sweating, insomnia, tremors, anxiety, nausea, or vomiting when stopping treatment
• Blood clots
• Pancreatitis
• Liver disease
• Allergic reaction (e.g., anaphylactoid reaction, angioedema, pruritus, or urticaria)
• Rhabdomyolysis (increased concentration of the enzyme creatine kinase and myoglobinuria)
• Difficulty starting urination
• Prolonged and/or painful erections or difficulty urinating

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

In elderly patients with dementia, olanzapine may cause cerebrovascular side effects. In this group of patients, very common (affecting more than 1 in 10 people) problems with walking and falls have been observed. Additionally, common (affecting up to 1 in 10 people) pneumonia, urinary incontinence, extreme fatigue, visual hallucinations, increased body temperature, and skin redness have been observed. Deaths have been reported in this particular group of patients.

Other side effects observed include blood clots in the veins, especially in the legs (symptoms include swelling, pain, and redness in the leg), which can move through the blood vessels to the lungs, causing chest pain and difficulty breathing. If you experience any of these symptoms, go to your doctor immediately.

Reporting side effects

If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: http//www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Olanzapine Kern Pharma

Keep this medication out of sight and reach of children.

No special storage conditions are required.

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

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and any unused medication in the pharmacy's SIGRE collection point. If you have any questions, ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Package contents and additional information

Composition of Olanzapine Kern Pharma

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

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

Appearance of the product and package contents

Olanzapine is presented in the form of round, biconvex tablets, yellow in color, and marked with "Y10" on one side. 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

Marketing authorization holder and manufacturer

KERN PHARMA, S.L.

Vernus, 72 – Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

Date of last revision of this leaflet: April 2020.

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.