OLANZAPINE MABO 5 mg FILM-COATED TABLETS

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Olanzapine MABO 5 mg film-coated tablets EFG

Read all of this leaflet carefully before you start taking this medicine.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others, as it may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

Contents of the pack:

1. What Olanzapine MABO 5 mg film-coated tablets are and what they are used for
2. Before taking Olanzapine MABO 5 mg film-coated tablets
3. How to take Olanzapine MABO 5 mg film-coated tablets
4. Possible side effects
5. Storage of Olanzapine MABO 5 mg film-coated tablets
6. Further information

1. What OLANZAPINE MABO 5 mg film-coated tablets are and what they are used for

Olanzapine MABO tablets belong to a group of medicines called antipsychotics.

Olanzapine MABO is used to treat:

• a disease with symptoms such as hearing, seeing, or feeling unreal things, mistaken beliefs, unusual suspicion, and a tendency to withdraw. People suffering from these diseases may also be depressed, anxious, or tense.

• a disorder characterized by symptoms such as feeling euphoric, having excessive energy, a need to sleep much less than usual, talking very quickly with a 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 OLANZAPINE MABO 5 mg film-coated tablets

Do not take Olanzapine MABO

• if you are allergic to Olanzapine or any of the other ingredients. 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 especially careful with Olanzapine MABO

• medicines of this type can cause unusual movements, especially in the face or tongue. If this happens to you after taking Olanzapine, tell your doctor.
• very rarely, medicines of this type produce a combination of fever, rapid breathing, sweating, muscle stiffness, and a state of confusion or drowsiness. If this happens to you, stop taking the medication and contact your doctor immediately.

If you have 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.

If you or a family member have a history of blood clots, these medicines may be associated with the formation of clots.

Children and adolescents under 18 years

Patients under 18 years should not take Olanzapine.

Elderly

The use of Olanzapine 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 monitor your blood pressure.

Use of other medicines

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

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

Only take other medicines at the same time as Olanzapine 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 Olanzapine.

Taking Olanzapine with food and drinks

Olanzapine MABO film-coated tablets can be taken with or without food.

You should not drink alcoholic beverages during treatment with Olanzapine MABO film-coated tablets. The combination of Olanzapine and alcohol may cause sleepiness.

Pregnancy and Breastfeeding

Consult your doctor or pharmacist before taking this medicine.

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

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

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

Driving and using machines

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

Important information about some of the ingredients of Olanzapine MABO

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.

This medicine contains soybean oil. It should not be used in case of peanut or soy allergy.

3. How to take OLANZAPINE MABO 5 mg film-coated tablets

Follow the administration instructions of Olanzapine MABO indicated by your doctor. Consult your doctor or pharmacist if you have doubts.

The daily dose of Olanzapine ranges from 5 to 20 mg. Consult your doctor if you experience symptoms again, but do not stop taking Olanzapine unless your doctor tells you to.

Swallow the tablets whole with water.

You should take your Olanzapine tablets once a day, following your doctor's instructions. Try to take the tablets at the same time every day. Olanzapine tablets are for oral administration.

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

If you take more Olanzapine MABO 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 medicine and the amount ingested. It is recommended to take the package and the package leaflet of the medicine 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 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. Contact your doctor or go to the hospital immediately. Show the doctor the package with the tablets.

If you forget to take Olanzapine MABO

If you forget to take a dose of Olanzapine, continue treatment with the normal dose. Do not take a double dose to make up for the forgotten doses.

If you stop taking Olanzapine MABO

Do not stop treatment without consulting your doctor first, even if you feel better. Stopping treatment should be done gradually and always following the doctor's instructions.

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 can cause side effects, although not everybody gets them.

The uncommon side effects (may affect up to 1 in 100 people) include hypersensitivity (e.g., inflammation of the mouth and throat, itching, skin rash); diabetes or worsening of diabetes, occasionally related to ketoacidosis (acetone in blood and urine) or coma; convulsions, in most cases related to a history of convulsions (epilepsy); muscle stiffness or spasms (including eye movements); restless legs syndrome; speech problems; slow pulse; sensitivity to sunlight; nosebleeds; abdominal distension; memory loss or forgetfulness; urinary incontinence; inability to urinate; hair loss; absence or decrease of menstrual periods and changes in the mammary gland in men and women, such as abnormal milk production or abnormal growth.

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

The side effects of Olanzapine may be sleepiness or excessive fatigue, weight gain, dizziness, increased appetite, fluid retention, constipation, dry mouth, agitation, unusual movements (especially of the face or tongue), tremors, and changes in the levels of some blood cells and circulating fats. In some patients, pancreatitis has very rarely developed, causing severe stomach pain, fever, and discomfort.

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, tell your doctor.

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

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

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

Liver disease has also been rarely reported. Very rare cases of prolonged and/or painful erections, decreased body temperature, and blood clots have been reported, which can manifest as deep vein thrombosis in the legs or muscle disorder, which can manifest as unexplained pain.

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

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, go to your 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).

Reporting of side effects:

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency (AEMPS) website (www.notificaram.es). By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of OLANZAPINE MABO 5 mg film-coated tablets

Keep out of the reach and sight of children.

Storage conditions:

No special storage conditions are required.

Do not use Olanzapine MABO after the expiration date stated on the package. The expiration date is the last day of the month indicated.

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

6. FURTHER INFORMATION

Composition of Olanzapine MABO 5 mg film-coated tablets

• The active ingredient is Olanzapine. Each film-coated tablet contains 5 mg of Olanzapine.

• The other ingredients (excipients) are: lactose, microcrystalline cellulose, crospovidone, magnesium stearate, polyvinyl alcohol, titanium dioxide E171, talc, soy lecithin E322, xanthan gum E415.

Appearance of the product and package contents

Olanzapine MABO 5 mg is presented in the form of film-coated tablets. The tablets are white, round, and biconvex, with a marking 'O1' on one face.

Package sizes:

Al/Al blister pack with 28 tablets.

Marketing authorization holder

MABO-FARMA S.A.

Vía de los Poblados, 3,

Edificio 6, 28033 Madrid,

Spain.

Manufacturer

Actavis Ltd.

BLB016 Bulebel Industrial Estate

Zejtun ZTN 3000

Malta

This leaflet was last revised in May 2021

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