Olanzapine Pensa 5 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Olanzapina pensa 5 mg tablets EFG

Read the entire 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 personally and you should not give it to others, even if they have the same symptoms, as it may harm them.
• If you consider any of the side effects you experience to be severe, or if you notice any side effect not listed in this leaflet, inform your doctor or pharmacist.

In this leaflet:

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

2. Before you take Olanzapina pensa.

3. How to take Olanzapina pensa.

4. Possible side effects.

5. How to store Olanzapina pensa.

6. Further information.

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

Pharmacotherapeutic group: antipsychotic.

Olanzapina pensa is used for:

• Treating an illness with symptoms such as hearing, seeing, or feeling unreal things, false beliefs, unusual suspiciousness, and a tendency to withdraw socially. People with these conditions may also feel depressed, anxious, or tense.
• Treating a disorder characterized by symptoms such as feeling euphoric, having excessive energy, needing much less sleep than usual, speaking very rapidly with racing thoughts, and sometimes having considerable irritability. It is also a mood stabilizer that prevents the occurrence of extreme mood swings.

2. Before taking Olanzapina pensa

Do not take Olanzapina pensa:

If you are allergic (hypersensitive) to olanzapine or to any of the other ingredients of Olanzapina pensa. The allergic reaction may appear 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 narrow-angle glaucoma.

If you are under 18 years of age.

Exercise special caution with Olanzapina pensa:

• Medications of this type may cause unusual movements, especially in the face or tongue. If this occurs after taking Olanzapina pensa, inform your doctor. Very rarely, medications of this type may cause a combination of fever, rapid breathing, sweating, muscle rigidity, and mental confusion or drowsiness. If you experience this, stop taking the medication immediately and contact your doctor without delay.
• The use of Olanzapina pensa in elderly patients with dementia is not recommended, as it may lead to serious adverse effects.

If you have 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 transient ischemic attack (TIA)

If you or a family member has a history of blood clots, these medications may be associated with an increased risk of clot 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 ischemic attack.

As a routine precaution, if you are over 65 years of age, it is advisable for your doctor to monitor your blood pressure.

Use of other medicines:

Only use other medicines together with Olanzapina pensa if your doctor has authorized you to do so. You may feel drowsy if Olanzapina pensa is combined with antidepressants or medicines for anxiety or sleep (tranquilizers). Inform your doctor especially if you are taking medication for Parkinson's disease.

Tell your doctor if you are taking fluvoxamine (an antidepressant) or ciprofloxacin (an antibiotic), as your dose of Olanzapina pensa may need to be adjusted.

Inform your doctor or pharmacist if you are currently using or have recently used any other medicines, including those obtained without a prescription.

Taking Olanzapine pensa with food and drinks:

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

You should not drink alcohol while taking Olanzapine pensa, as combining it with alcohol may cause drowsiness.

Pregnancy and lactation:

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 are planning to become pregnant. You must not take this medicine during pregnancy unless your doctor advises you to do so.

Newborn babies 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 baby shows any of these symptoms, contact your doctor.

Breast-feeding

You should not take this medication while breast-feeding, as small amounts of Olanzapine Pensa may pass into breast milk.

Driving and use of machines:

Olanzapina pensa may cause symptoms such as drowsiness, dizziness, visual disturbances, and reduced reaction capacity. These effects, as well as the underlying illness itself, may impair your ability to drive or operate machinery. Therefore, do not drive, operate machinery, or engage in other activities requiring special attention until your doctor has assessed your response to this medication.

Important information about some components of Olanzapina pensa:

This medicinal product contains lactose. If your doctor has informed you of an intolerance to certain sugars, consult him before taking this medication.

3. How to take Olanzapina pensa

Follow your doctor's instructions exactly. 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. Speak to your doctor if your symptoms return, but do not stop taking Olanzapina pensa unless your doctor tells you to.

You should take your Olanzapina pensa tablets once daily, as directed by your doctor.

Try to take the tablets at the same time each day. You may take them with or without food. Olanzapina pensa tablets are for oral use. Swallow the tablets whole with water.

Do not stop treatment when you feel better. It is very important to continue taking it for as long as your doctor tells you to.

Olanzapina pensa must not be used in patients under 18 years of age.

If you take more Olanzapina pensa than you should:

Contact your doctor, pharmacist, or call the Toxicology Information Service at 91 562 04 20 immediately, stating the name of the medicine and the amount taken. It is recommended to bring the medicine package and the leaflet to the healthcare professional.

Patients who have taken more Olanzapina pensa 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, aspiration, increased or decreased blood pressure, and abnormal heart rhythms.

If you forget to take Olanzapina pensa:

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 further questions about using this medicine, ask your doctor or pharmacist.

If you stop treatment with Olanzapina pensa

If you suddenly stop taking Olanzapina pensa, you may experience symptoms such as sweating, difficulty sleeping, tremor, anxiety, nausea, or vomiting. Your doctor may recommend gradually reducing the dose before stopping treatment.

Do not stop treatment when you feel better. It is very important to continue taking Olanzapina pensa for as long as your doctor tells you to.

If you have any further questions about using this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, Olanzapine Pensa may have adverse effects, although not everyone experiences them.

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

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

• Weight gain
• Somnolence
• Increased plasma levels of prolactin (a hormone that stimulates milk production in the mammary glands)

Common (affects at least 1 in 100 patients):

• Increase in a type of white blood cells (eosinophils)
• Increased appetite
• High blood sugar levels, 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 with swelling

Uncommon (affects at least 1 in 1,000 patients):

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

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

• Decrease in white blood cells
• Seizures
• Skin rashes

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

• Decreased platelet count
• Decrease in certain white blood cells (neutrophils)
• High blood sugar and/or initial symptoms of worsening diabetes, with acetone in blood and urine or coma
• Increased blood triglycerides, decreased normal body temperature
• Cases have been reported identified as Neuroleptic Malignant Syndrome (NMS), associated with olanzapine:
  • Parkinsonism, problems with abnormal repetitive movements such as twisting, jerking, and rigidity
  • Sweating, inability to sleep, tremor, anxiety, nausea or vomiting, upon discontinuation of treatment
• Pancreatitis
• Liver disease
• Allergic reaction (e.g. anaphylactic 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
• Blood clots in the veins, especially in the legs (symptoms include swelling, pain and redness in the leg); these clots may travel through blood vessels to the lungs, causing chest pain and difficulty breathing. If you experience any of these symptoms, contact your doctor immediately.

During treatment with olanzapine, elderly patients with dementia may experience cerebrovascular adverse effects. In this group of patients, very common (affects at least 1 in 10 patients) adverse effects include walking difficulties and falls. Pneumonia, urinary incontinence, extreme fatigue, visual hallucinations, increased body temperature, and skin redness have also been observed frequently (affects at least 1 in 100 patients). 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 not receiving this medication.

Serious allergic reactions have been reported, such as Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS). DRESS initially presents with flu-like symptoms, facial rash 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).

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.

Reporting of adverse effects:

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the national reporting system included in the Spanish System of Pharmacovigilance of Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide 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 refers to the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Return unused containers and medicines to the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of unused containers and medicines. This will help protect the environment.

6. Information for the user

Composition of Olanzapina pensa

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

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

Description of the product and contents of the pack:

Olanzapina pensa 5 mg is presented as yellow, cylindrical, biconvex tablets marked with the code “Y5”.

Each pack contains 28 tablets.

Other pack sizes available:

Olanzapina pensa 2.5 mg tablets: Pack of 28 tablets
Olanzapina pensa 7.5 mg tablets: Pack of 56 tablets
Olanzapina pensa 10 mg tablets: Packs 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 last approved in: February 2020

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