OLANZAPINE PENSA 5 mg TABLETS

2. Before taking Olanzapine Pensa

Do not takeOlanzapine Pensa:

If you are allergic (hypersensitive) to olanzapine or to any of the other components of Olanzapine Pensa. The allergic reaction may manifest as a 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 narrow-angle glaucoma.

If you are under 18 years old.

Be especially careful withOlanzapine Pensa:

• Medicines of this type can cause unusual movements, especially in the face or tongue. If this happens to you after taking Olanzapine Pensa, tell your doctor. Very rarely, medicines of this type produce a combination of fever, rapid breathing, sweating, muscle stiffness and a state of stupor or drowsiness. If this happens to you, stop the medication and contact your doctor immediately.
• The use of Olanzapine Pensa in elderly patients with dementia is not recommended as it may have serious adverse effects.

If you suffer from any of the following diseases, tell 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 or a family member have a history of blood clots, these medicines may be associated with the formation of clots.

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.

Use of other medicines:

Only use other medicines at the same time as Olanzapine Pensa if your doctor authorizes it. You may feel a certain sensation of drowsiness if you combine Olanzapine Pensa with antidepressants or medicines for anxiety or that help you sleep (tranquilizers). Tell your doctor especially if you are taking medication for Parkinson's disease

You must tell your doctor if you are taking fluvoxamine (antidepressant) or ciprofloxacin (antibiotic), as it may be necessary to modify your dose of Olanzapine Pensa.

Tell your doctor or pharmacist if you are using or have recently used other medicines, even those purchased without a prescription.

Taking Olanzapine Pensa with food and drinks:

The tablets can be taken with or without food, and you should swallow them whole with water.

You should not drink alcohol while taking Olanzapine Pensa as the combination with alcohol may cause drowsiness.

Pregnancy and breastfeeding:

Consult your doctor or pharmacist before using any medicine.

Pregnancy

Tell your doctor as soon as possible if you are pregnant, think you may be pregnant or plan to become pregnant. You should not take this medicine during pregnancy unless your doctor recommends it.

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

Breastfeeding

You should not take this medicine while breastfeeding as small amounts of Olanzapine Pensa may pass into breast milk.

Driving and using machines:

Olanzapine Pensa may cause symptoms such as drowsiness, dizziness, vision changes, and decreased 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 medicine.

Important information about some components of Olanzapine Pensa:

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

3. How to take Olanzapine Pensa

Follow your doctor's instructions exactly. Consult your doctor or pharmacist if you have any doubts.

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

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

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

Patient under 18 years old should not take Olanzapine Pensa

If you take moreOlanzapine Pensathan you should:

Consult your doctor, pharmacist, or call the Toxicology Information Service phone 91 562 04 20 indicating the medicine and the amount used. It is recommended to take the package and the package leaflet of the medicine to the healthcare professional.

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

If you forget to takeOlanzapine Pensa:

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

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

If you stop taking Olanzapine Pensa

If you suddenly stop taking Olanzapine Pensa, you may have 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 Pensa while your doctor tells you to.

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

4. Possible side effects

Like all medicines, Olanzapine Pensa can have side effects, although not everybody gets them.

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

Very common (at least 1 in 10 patients):

• Weight gain

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

Common (at least 1 in 100 patients):

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

Uncommon (at least 1 in 1,000 patients)

• High levels of the enzyme creatine phosphokinase
• Sensitivity to sunlight

• Abnormal heart rhythms, such as slowed heartbeat.
• Restless legs syndrome.
• Excessive salivation

Rare (at least 1 in 10,000 patients)

• Decreased white blood cells
• Convulsions
• Skin rashes

Very rare (less than 1 in 10,000 patients)

• Decreased platelets

• Decreased levels of certain white blood cells (neutrophils)
• High sugar levels and/or initial symptoms of worsening diabetes, with acetone in blood and urine or coma.
• Increased triglycerides in the blood, decreased body temperature.
• Cases of Neuroleptic Malignant Syndrome (NMS) have been reported in association with olanzapine.
  • Parkinsonism, movement problems such as contortions, jerks, and stiffness
  • Sweating, insomnia, tremors, anxiety, nausea, or vomiting when stopping treatment.

• Pancreatitis
• Liver disease
• Allergic reaction (e.g. anaphylactic reaction, angioedema, pruritus or urticaria.)
• Rhabdomyolysis (increased concentration of the enzyme creatine kinase and myoglobinuria)
• Difficulty starting urination.
• Prolonged and/or painful erection or difficulty urinating.
• Blood clots in the veins, especially in the legs (symptoms include swelling, pain, and redness in the leg), these clots can move through the blood vessels to the lungs, causing chest pain and difficulty breathing. If you experience any of these symptoms, see your doctor immediately.

During treatment with olanzapine, elderly patients with dementia may experience cerebrovascular adverse effects. In this group of patients, very common (at least 1 in 10 patients) problems walking and falls have been observed. Also, common (at least 1 in 100 patients) 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

A small increase in the number of deaths has been reported in elderly patients with dementia treated with antipsychotics, compared to those who do not receive this medicine.

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 enzyme levels in blood tests, and an increase in a type of white blood cell (eosinophilia).

If you consider that any of the side effects you are suffering from is serious or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

Reporting of side effects:

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

5. Storage of Olanzapine Pensa

Keep out of the sight and reach of children.

No special storage conditions are required.

Do not use this medicine after the expiry date stated on the carton.

After "EXP", the expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicines in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Further information

Composition ofOlanzapine Pensa

The active ingredient is olanzapine. Each tablet contains 5 mg of olanzapine

The other ingredients are:microcrystalline cellulose (E-460), lactose monohydrate, crospovidone, magnesium stearate.

Appearance of the product and package contents:

Olanzapine Pensa 5 mg is presented in the form of cylindrical, biconvex tablets, yellow in color and marked with the code "Y5".

Each package contains 28 tablets.

Other presentations:

Olanzapine Pensa 2.5 mg tablets: Package of 28 tablets

Olanzapine Pensa 7.5 mg tablets: Package of 56 tablets

Olanzapine Pensa 10 mg tablets: Packages of 28 and 56 tablets

Marketing authorization holder:

Towa Pharmaceutical, S.A.

C/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

Manufacturer:

Laboratorios Cinfa, S.A.

c/Olaz-Chipi, 10

31620 Huarte- Pamplona

Spain

This leaflet was approved in: February 2020

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