Package Insert: Information for the Patient

Olanzapine pensa 10 mg Tablets EFG

Read this package insert carefully before starting to take the medication.

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed for you personally and should not be given to others, even if they have the same symptoms, as it may harm them.
• If you consider that any of the adverse effects you are experiencing are severe or if you notice any adverse effect not mentioned in this package insert, inform your doctor or pharmacist.

In this package insert:

1. What Olanzapine pensa is and for what it is used.

2.Before taking Olanzapine pensa .

1. How to take Olanzapine pensa .
2. Possible adverse effects.
3. Storage of Olanzapine pensa .
4. Additional information.

Pharmacotherapeutic group: antipsychotic.

Olanzapina is used to treat:

• A disease characterized by 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.
• A disorder characterized by symptoms such as feeling euphoric, having excessive energy, needing less sleep 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 mood variations.

Do not takeOlanzapina pensa:

If you are allergic (hypersensitive) to olanzapina or to any of the other components of Olanzapina pensa. 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.

Be especially careful withOlanzapina pensa:

• Medicines of this type may cause unusual movements, especially in the face or tongue. If this happens after taking Olanzapina pensa, tell your doctor. Rarely, medicines of this type produce a combination of fever, rapid breathing, sweating, muscle rigidity, and a state of confusion or drowsiness. If this happens, stop taking the medication and immediately contact your doctor.
• The use of Olanzapina pensa 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
• Cerebral infarction or transient cerebral ischemia

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

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 medications:

Only use other medicines at the same time as Olanzapina pensa, if your doctor authorizes it. You may feel a certain sense of drowsiness if you combine Olanzapina pensa with antidepressants or medications for anxiety or that help you 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 Olanzapina pensa dose.

Inform your doctor or pharmacist if you are using or have recently used other medications, including those purchased without a prescription.

Taking Olanzapina 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 Olanzapina pensa, as the combination with alcohol may cause drowsiness.

Pregnancy and breastfeeding:

Consult your doctor or pharmacist before using any medication.

Pregnancy

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

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 problems, and feeding difficulties. If your newborn experiences any of these symptoms, contact your doctor.

Breastfeeding

Do not take this medication while breastfeeding, as small amounts of Olanzapina pensa may pass into breast milk.

Driving and operating machinery:

Olanzapina pensa may cause symptoms such as drowsiness, dizziness, visual disturbances, and decreased reaction time. These effects, as well as the underlying disease, may impair your ability 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.

Important information about some components of Olanzapina pensa:

This medication 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 provided by your doctor. Consult your doctor or pharmacist if you have any doubts.

Your doctor will tell you how many Olanzapina pensa 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 Olanzapina pensa unless your doctor tells you to.

You should take your Olanzapina 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. Olanzapina 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 to continue taking it as long as your doctor tells you to.

Patients under 18 years old should not take Olanzapina pensa

If you take moreOlanzapina pensathan you should:

Consult your doctor, pharmacist, or callthe Toxicology Information Service at telephone 91 562 04 20indicating the medication and the amount used.It is recommended to bring the packaging and the medication leaflet to the healthcare professional.

Patients who have taken more Olanzapina pensa than they should have experienced the following symptoms: rapid heartbeats, agitation/aggression, speech problems, unusual movements (especially of the face and tongue) and a reduced level of consciousness. 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 forget to takeOlanzapina pensa:

Take your tablet as soon as you remember. Do not take a double dose to compensate 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 pensa

If you suddenly stop taking Olanzapina pensa, you may experience symptoms such as sweating, inability to sleep, 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 to continue taking Olanzapina pensa as long as your doctor tells you to.

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

Like all medicines, Olanzapina pensa may have side effects, although not everyone will experience them.

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

Very common (in at least 1 in 10 patients):

• Weight gain

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

Common (in at least 1 in 100 patients):

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

Rare (in at least 1 in 1,000 patients)

• High levels of creatine phosphokinase enzyme
• Sensitivity to sunlight

- Abnormal heart rhythms, such as slowed heart rate.

-Restless legs syndrome.

- Excessive salivation

Rare (in at least 1 in 10,000 patients)

• Decreased white blood cells
• Seizures
• Skin eruptions

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

• Decreased platelets

- Decreased certain white blood cells (neutrophils)

- High blood sugar and/or initial symptoms of worsening diabetes, with acetone in blood and urine or coma.

-High triglycerides in blood, decreased normal body temperature.

-There have been reported cases, identified as Neuroleptic Malignant Syndrome (NMS), associated with olanzapina.

• Parkinsonism, abnormal repetitive movement disorders such as contortions, tremors, and rigidity
• Sweating, inability to sleep, tremors, anxiety, nausea, or vomiting, upon interrupting treatment.

-Pancreatitis

-Liver disease

-Severe allergic reaction (e.g. anaphylactoid reaction, angioedema, pruritus, or urticaria)

-Rhabdomyolysis (increased concentration of creatine kinase enzyme and myoglobinuria)

-Difficulty initiating urination.

-Prolonged and/or painful erection or difficulty urinating.

-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, seek immediate medical attention.

During treatment with olanzapina, elderly patients with dementia may experience cerebrovascular side effects. In this group of patients, very common (in at least 1 in 10 patients) problems walking and falls have been observed. Also, frequent (in at least 1 in 100 patients) pneumonia, urinary incontinence, extreme fatigue, visual hallucinations, elevated 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 in elderly patients with dementia treated with antipsychotics, compared to those who do not receive this medication, has been reported.

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 eosinophils.

If you consider that any of the side effects you are experiencing are severe or if you notice any side effect not mentioned in this prospectus, inform your doctor or pharmacist.

Reporting side effects:

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

Keep 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.

Do not dispose of medications through drains or trash. Dispose of packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and unused medications. By doing so, you will help protect the environment.

Composition ofOlanzapina pensa

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

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

Appearance of the product and contents of the package:

Olanzapina pensa 10 mg is presented in the form of cylindrical, biconvex tablets, yellow in color, and marked with the code “Y10”.

Each package contains 28 and 56 tablets.

Other presentations:

Olanzapina pensa 2.5 mg tablets: Package of 28 tablets

Olanzapina pensa 5 mg tablets: Package of 28 tablets.

Olanzapina pensa 7.5 mg tablets: Package of 56 tablets

Holder of the marketing authorization:

Towa Pharmaceutical, S.A.

C/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

Responsible for manufacturing:

Laboratorios Cinfa, S.A. c/Olaz-Chipi, 10

31620 Huarte- PamplonaSpain

This prospectus was approved in: February 2020

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