Olanzapine Tecnigen 5 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the

Olanzapina TecniGen 5 mg film-coated 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 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 serious, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.

Contents of the leaflet

1. What Olanzapina TecniGen 5 mg film-coated tablets are and what they are used for
2. Before you take TecniGen 5 mg film-coated tablets
3. How to take Olanzapina TecniGen 5 mg film-coated tablets
4. Possible side effects
5. How to store Olanzapina TecniGen 5 mg film-coated tablets

Additional information

1. What Olanzapina TecniGen 5 mg tablets is and what it is used for

Olanzapine belongs to a group of medicines called antipsychotics.

Olanzapina TecniGen is used to treat

• a condition with symptoms such as hearing, seeing, or sensing things that are not real, false beliefs, unusual suspiciousness, and a tendency to withdraw. People with this condition may also feel depressed, anxious, or tense.
• 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 associated with this illness.

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 ingredients of Olanzapina. The allergic reaction may appear 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.

Take special care with Olanzapine TecniGen:

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

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

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 of age

Patients under 18 years of age must not take Olanzapine.

Elderly

The use of Olanzapine in elderly patients with dementia is not recommended, as it may cause serious adverse effects.

As a routine precaution, if you are over 65 years old, your doctor should monitor your blood pressure.

Use of other medicines

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

Especially inform your doctor if you are taking medication for Parkinson's disease.

Only take other medicines together with Olanzapine if your doctor has instructed you to do so. You may feel drowsy if olanzapine is combined with antidepressants or medicines used for anxiety or to help you sleep (tranquilizers).

Inform your doctor if you are taking fluvoxamine (an antidepressant) or ciprofloxacin (an antibiotic), as it may be necessary to adjust your dose of Olanzapine.

Taking Olanzapine with food and drinks

Olanzapine may be taken with or without food.

You should not drink alcohol while taking Olanzapine, as the combination of Olanzapine and alcohol may cause drowsiness.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before taking any medicine.

If you are pregnant or think you might be pregnant, consult your doctor before taking this medicine. You should not take this medicine during pregnancy unless your doctor specifically advises you to do so.

Newborns of mothers who have taken Olanzapine TecniGen during the last trimester of pregnancy may experience the following symptoms: tremor, muscle stiffness and/or weakness, drowsiness, agitation, breathing difficulties, and feeding problems. If your newborn shows any of these symptoms, contact your doctor immediately.

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

Driving and operating machinery

There is a risk of experiencing drowsiness when taking Olanzapine. If this occurs, do not drive vehicles or operate machinery. Consult your doctor.

Important information about some of the components of Olanzapine

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

3. How to take Olanzapina TecniGen 5 mg film-coated tablets

Follow exactly the administration instructions for Olanzapine given by your doctor. Consult your doctor or pharmacist if you have any doubts.

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

You should take your Olanzapine tablets once daily, as directed by your doctor. Try to take the tablets at the same time every day. You may take them with or without food. Olanzapine tablets are for oral administration.

Swallow the tablets whole with water.

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

If you take more Olanzapine than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone: 91 562 04 20, indicating the medication and the amount ingested. It is recommended to bring the medicine's packaging and leaflet to the healthcare professional.

Patients who have taken more Olanzapine 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 rigidity, drowsiness or lethargy, slowed breathing rate, aspiration, increased blood pressure or decreased blood pressure, and abnormal heart rhythms. Contact your doctor or go immediately to the hospital. Show the doctor the container with the tablets.

If you forget to take Olanzapine

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

If you stop taking Olanzapine

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

If you suddenly stop taking Olanzapine, you may experience symptoms such as sweating, inability to sleep, tremor, anxiety, nausea, or vomiting. Your doctor may recommend gradually reducing the dose before stopping treatment.

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

4. Possible adverse effects

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

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

Adverse effects of Olanzapine may include drowsiness or excessive tiredness, weight gain, dizziness, increased appetite, fluid retention, constipation, dry mouth, agitation, unusual movements (especially of the face or tongue), tremors, muscle rigidity or spasms, speech disturbances, and changes in levels of certain blood cells and circulating fats. In some patients, very rarely, inflammation of the pancreas has developed, causing severe stomach pain, fever, and malaise.

Uncommon adverse effects include "restless legs syndrome" and excessive salivation.

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

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

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

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

Rarely, Olanzapine may cause an allergic reaction (e.g., mouth and throat swelling, itching, rash), slow heart rate, or increased sensitivity to sunlight. Liver disorders have also been reported rarely. Very rarely, cases of prolonged and/or painful erection, difficulty urinating, decreased normal body temperature, blood clots (such as deep vein thrombosis in the legs), or muscle disorders presenting as unexplained muscle pain have been reported. Some patients, very rarely, have experienced high blood sugar levels or early signs of worsening diabetes, with ketoacidosis (ketones in blood and urine) or coma.

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

Serious allergic reactions have been reported, such as Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS). DRESS initially presents with flu-like symptoms, skin rash starting on the face and spreading to other areas, fever, swollen lymph nodes, elevated liver enzymes in blood tests, and increased levels of a type of white blood cells (eosinophilia).

Rarely, women who have taken this type of medicine for a long period may experience milk secretion from the mammary glands, absence of monthly periods, or irregular menstruation. If this condition persists, consult your doctor.

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

Seizures may occur rarely. In most cases, there was a history of seizures (epilepsy).

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

5. Storage of Olanzapine TecniGen 5 mg Film-coated Tablets

Keep out of the reach and sight of children.

Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month indicated.

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

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE point located at your pharmacy. If you are unsure, please ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Additional information

Composition of Olanzapina TecniGen 5 mg

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

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

Appearance of Olanzapina TecniGen 5 mg and contents of the pack

Olanzapina TecniGen 5 mg is available as round, film-coated tablets without a breakline, with a yellow core and white coating.

It is available in blister packs containing 28 tablets. Only certain pack sizes may be marketed.

Other presentations:

Olanzapina TecniGen 10 mg tablets EFG, 28 tablets

Olanzapina TecniGen 10 mg 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: [email protected]

Manufacturer

West Pharma - Pharmaceutical Specialties Production, S.A.

Rua João de Deus, nº 11, Venda Nova. 2700 Amadora.

PORTUGAL

Atlantic Pharma – Pharmaceutical Productions SA

Rua da Tapada Grande nº 2, Abrunheira. 2710 – 089 Sintra (Portugal).

This patient information leaflet was reviewed in January 2020

Detailed and up-to-date information about this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/