OLANZAPINE TECNIGEN 5 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the patient/user

Olanzapine TecniGen 5 mg coated tablets EFG

Read the package leaflet carefully before starting to take the medication.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you 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 side effects you are suffering from is serious or if you notice any side effect not mentioned in this package leaflet, inform your doctor or pharmacist.

Contents of the package leaflet

1. What Olanzapina TecniGen 5 mg coated tablets are and what they are used for
2. Before taking TecniGen 5 mg coated tablets
3. How to take Olanzapina TecniGen 5 mg coated tablets
4. Possible side effects
5. Storage of Olanzapina TecniGen 5 mg coated tablets

Additional information

1. What Olanzapina TecniGen 5 mg tablets are and what they are used for

Olanzapine belongs to a group of medications called antipsychotics.

Olanzapina TecniGen is used to treat

• a disease with symptoms such as hearing, seeing, or feeling unreal things, mistaken beliefs, unusual suspicion, and tendency to withdraw. People suffering from this disease may also be depressed, anxious, or tense.
• a disorder characterized by symptoms such as feeling euphoric, having excessive energy, needing to sleep much less than usual, talking very quickly with flight of ideas, and sometimes considerable irritability. It is also a mood stabilizer that prevents the appearance of extreme mood swings associated with this disease.

2. Before taking TecniGen 5 mg coated tablets

Do not take Olanzapina TecniGen:

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

Be careful with Olanzapina TecniGen:

• Medications of this type can cause unusual movements, especially in the face or tongue. If this happens to you after taking Olanzapina, tell your doctor.
• Very rarely, medications of this type produce a combination of fever, rapid breathing, sweating, muscle stiffness, and drowsiness. If this happens to you, contact your doctor immediately.
• If you or someone in your family has a history of blood clots, these medications may be associated with the formation of clots.

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 ischemic attack

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.

Children and adolescents under 18 years

Patients under 18 years should not take Olanzapina

Elderly

The use of Olanzapina in elderly patients with dementia is not recommended as it may have serious side effects.

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

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

Tell your doctor especially if you are taking medication for Parkinson's disease.

Only take other medications at the same time as Olanzapina if your doctor authorizes it. You may feel a certain sensation of sleepiness if you combine olanzapine with antidepressants or medications for anxiety or that help you sleep (tranquilizers).

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.

Taking Olanzapina with food and drinks

Olanzapina can be taken with or without food.

You should not drink alcohol if you have been given Olanzapina because the combination of Olanzapina and alcohol can cause drowsiness.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medication.

If you are pregnant or think you may be pregnant, consult your doctor before taking this medication. You should not take this medication during pregnancy unless your doctor recommends it.

Newborns of mothers who have used Olanzapina TecniGen 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.

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

Driving and using machines

There is a risk of drowsiness when taking Olanzapina. If this happens to you, do not drive vehicles or use machinery. Consult your doctor.

Important information about some of the components of Olanzapina

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.

3. How to take Olanzapina TecniGen 5 mg coated tablets

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

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

You should take your Olanzapina 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 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 Olanzapina while your doctor tells you to.

If you take more Olanzapina 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. It is recommended to take the package and package leaflet of the medication to the healthcare professional.

Patient who have taken more Olanzapina 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, 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. Contact your doctor or go to the hospital immediately. Show the doctor the package with the tablets.

If you forget to take Olanzapina

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

If you stop taking Olanzapina

Do not stop taking Olanzapina unless your doctor tells you to.

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

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

4. Possible side effects

Like all medications, Olanzapina can cause side effects, although not everyone experiences them.

In this package leaflet, when a side effect is defined as "uncommon", it means that it has been reported in more than 1 in 1,000 patients. When a side effect is defined as "rare", it means that it has been reported in more than 1 in 10,000 patients, but less than 1 in 1,000. When a side effect is defined as "very rare", it means that it has been reported in less than 1 in 10,000 patients.

Olanzapina's side effects may include drowsiness or excessive fatigue, weight gain, dizziness, increased appetite, fluid retention, constipation, dry mouth, agitation, unusual movements (especially of the face or tongue), tremors, muscle stiffness or spasms, language alterations, and changes in the levels of some blood cells and circulating fats. In some patients, pancreatitis has developed very rarely, causing severe stomach pain, fever, and malaise.

Uncommon side effects reported include "restless legs syndrome" and excessive salivation.

Some people experience dizziness or fainting (with slower heartbeats) in the early stages of treatment, especially when getting up from a lying or sitting position. This sensation usually disappears spontaneously, but if it does not, inform your doctor.

Very rare cases of patients with abnormal heart rhythms have been reported, which can be serious.

During treatment with olanzapine, elderly patients with dementia may experience stroke, pneumonia, urinary incontinence, falls, extreme fatigue, visual hallucinations, elevated body temperature, skin redness, and walking problems. Some deaths have been reported in this particular group of patients.

Olanzapina may worsen symptoms in patients with Parkinson's disease.

Rarely, Olanzapina could cause an allergic reaction (e.g., inflammation of the mouth and throat, itching, rash), slow heart rate, or sensitivity to sunlight. Liver disease has also been reported rarely. Very rarely, cases of prolonged and/or painful erections or difficulty urinating, decreased body temperature, blood clots (e.g., deep vein thrombosis in the legs or muscle disorder presenting as unexplained pain) have been reported. Some patients have experienced high blood sugar levels or initial symptoms of diabetes worsening, with ketoacidosis (acetone in blood and urine) or coma.

Blood clots in the veins, especially in the legs (symptoms include swelling, pain, and redness in the leg), can move through the blood vessels to the lungs, causing chest pain and difficulty breathing. If you notice any of these symptoms, consult a doctor immediately.

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).

Rarely, women taking medications of this type for a long time may experience milk secretion from the mammary gland, stop having their menstrual period, or have it irregularly. If this situation persists, consult your doctor.

Very rarely, babies of mothers who have taken Olanzapina in the last stage of pregnancy (third trimester) may experience tremors, drowsiness, or lethargy.

Seizures can occur rarely. In most cases, there were previous episodes of seizures (epilepsy).

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 package leaflet, inform your doctor or pharmacist.

5. Storage of Olanzapina TecniGen 5 mg coated tablets

Keep out of the reach and sight of children.

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

Do not store above 25°C. Store in the original packaging to protect from light and moisture.

Medications should not be disposed of through wastewater or household waste. Deposit the packages and medications you no longer need at the SIGRE collection point in the pharmacy. If in doubt, ask your pharmacist how to dispose of packages and medications you no longer need. This will help protect the environment.

6. Additional information

Composition of Olanzapina TecniGen 5 mg

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

The other components are: Core: lactose monohydrate, hydroxypropylcellulose, crospovidone, microcrystalline cellulose, and magnesium stearate. Coating: Hydroxypropylmethylcellulose 6cP, titanium dioxide, and polyethylene glycol 400.

Appearance of Olanzapina TecniGen 5 mg and package contents

Olanzapina TecniGen 5 mg is presented in the form of round, uncoated, white-coated tablets with a yellow core.

It is presented in blisters of 28 tablets. Some package sizes may only be marketed.

Other presentations:

Olanzapina TecniGen 10 mg coated tablets EFG, 28 tablets

Olanzapina TecniGen 10 mg coated tablets EFG, 56 tablets

Marketing authorization holder

Tecnimede España Industria Farmacéutica S.A. Avda. de Bruselas, 13, 3º D. Edificio América. Polígono Arroyo de la Vega, 28108 Alcobendas (Madrid) SPAIN Tel: 91 383 51 66 Fax: 91 383 51 67 E-mail: registros@tecnimede.es

Manufacturer

West Pharma - Producções de Especialidades Farmacêuticas, S.A. Rua João de Deus, nº 11, Venda Nova. 2700 Amadora. PORTUGAL

Atlantic Pharma – Produções Farmacêuticas SA Rua da Tapada Grande nº 2, Abrunheira. 2710 – 089 Sintra (Portugal).

This package leaflet was revised in January 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/