PATIENT INFORMATION LEAFLET

Olanzapine MABO 5 mg Film-Coated Tablets

Read this 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. Do not pass it on to others even if their symptoms are the same. It may harm them.
• If you think any of the side effects get serious or if you notice any side effects not listed in this leaflet, tell your doctor or pharmacist.

1. What is Olanzapine MABO 5 mg tablets and what is it used for

2. Before taking Olanzapine MABO 5 mg tablets

3. How to take Olanzapine MABO 5 mg tablets

4. Possible side effects

5. Storage of Olanzapine MABO 5 mg tablets

6. Additional information

Olanzapina MABOtabletsbelongs to a group of medicines called antipsychotics.

OlanzapinaMABOis used to treat:

- a condition with 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 conditions 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 occurrence of extreme variations in mood associated with this condition.

Do not take OlanzapinaMABO

• If you are allergic to Olanzapina or any of the other components. 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.

Be especially careful withOlanzapina MABO

• Medicines of this type may cause unusual movements, especially in the face or tongue. If this happens after taking Olanzapina, tell your doctor
• 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, discontinue the medication and immediately contact your doctor.

If you have any of the following conditions, tell your doctor as soon as possible:

• Diabetes
• Heart disease
• Liver or kidney diseases
• 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 has a history of blood clots, these medications may be associated with their formation.

Children and adolescents under 18 years

Patients under 18 years should not take Olanzapina.

Seniors

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

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

Use of other medications

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

Inform 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 drowsy if you combine Olanzapina with antidepressants or medications for anxiety or to help sleep (tranquilizers).

You should inform your doctor if you are taking fluvoxamine (antidepressant) or ciprofloxacin (antibiotic), as it may be necessary to modify your Olanzapina dose.

Taking Olanzapina with food and drinks

OlanzapinaMABO tabletscan be taken with or without food.

You should not take alcoholic beverages during treatment with Olanzapina MABO tablets. The combination of Olanzapina and alcohol may cause drowsiness.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before taking this medication.

If you are pregnant or think you may be, 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 MABO in the last trimester of pregnancy may exhibit the following symptoms: tremors, muscle stiffness, and/or weakness, drowsiness, agitation, breathing difficulties, and feeding problems. If your newborn exhibits any of these symptoms, contact your doctor.

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

Driving and operating machinery

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

Important information about some of the components of OlanzapinaMABO

This medication contains lactose. If your doctor has indicated that you have an intolerance to certain sugars, consult with them before taking this medication.

This medication contains soy oil. It should not be used in cases of allergy to peanuts or soy.

Follow exactly the administration instructions for Olanzapina as indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

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.

Swallow the tablets whole with water.

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

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

If you take more Olanzapina 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 medication and the amount ingested. It is recommended to bring the packaging and the medication leaflet to the healthcare professional.

Patients who have taken more Olanzapina than they should have experienced the following symptoms: rapid heartbeats, agitation/aggressiveness, 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, slowing of respiratory frequency, aspiration, increased blood pressure or decreased blood pressure, abnormal heart rhythms. Contact your doctor or go to the hospital immediately. Show the doctor the packaging with the tablets.

If you forgot to takeOlanzapina MABO

If you forgot to take a dose of Olanzapina, continue treatment with the normal dose. Do not take a double dose to compensate for the missed dose.

If you interrupt treatment withOlanzapina MABO

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

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

Like all medicines, Olanzapine may cause side effects, although not everyone will experience them.

Rare 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 the blood and urine) or coma; seizures, in most cases related to a history of seizures (epilepsy); muscle stiffness or spasms (including eye movements); restless legs syndrome; speech problems; slow pulse; sensitivity to sunlight; nasal bleeding; abdominal distension; memory loss or forgetfulness; urinary incontinence; loss of ability to urinate; hair loss; absence or decrease of menstrual periods and changes in the breast gland in men and women such as abnormal milk production or abnormal growth, excessive salivation.

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 less than 1 in 1,000. When a side effect is defined as “very rare”, this means that it has been reported in less than 1 in 10,000 patients.

Olanzapine side effects may include excessive drowsiness or fatigue, weight gain, dizziness, increased appetite, fluid retention, constipation, dry mouth, agitation, unusual movements (especially of the face or tongue), tremors, and changes in some blood cells and circulating fats. In some patients, pancreatitis has developed in very rare cases, 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 lying down or sitting. This sensation usually disappears on its own, but if it does not, inform your doctor.

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

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 difficulty walking. Some deaths have been reported in this particular group of patients.

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

There have also been reports of liver disease in rare cases. In very rare cases, prolonged and/or painful erections, decreased normal body temperature, blood clots that present, for example, as deep vein thrombosis of the legs or muscle disorders that present as unexplained pain have been reported.

Very rarely, babies born to mothers who have taken Olanzapine in the last stage of pregnancy (third trimester) may experience tremors, drowsiness, 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 immediately to your doctor.

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 levels of a type of white blood cell (eosinophilia).

Reporting of side effects:

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through theSpanish System of Pharmacovigilance of Medicines for Human Use (Website:www.notificaram.es)By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep out of reach and sight of children.

Storage conditions:

No special storage conditions are required.

Do not use Olanzapina MABO after the expiration date shown on the packaging.The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and unused medicines at the SIGRE point of the pharmacy.Ask your pharmacist if you are unsure how to dispose of the packaging and unused medicines. This will help protect the environment.

Composition ofOlanzapina MABO5mg tablets

• The active ingredient is Olanzapina. Each film-coated tablet contains5mg of Olanzapina.

-The other components (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 contents of the package

OlanzapinaMABO5mg is presented in the form of film-coated tablets. The tablets arewhite, round, and biconvex, with a marked ‘O1’ on one face.

Package sizes:

Aluminum/Aluminum blister with28tablets.

Marketing authorization holder

MABO-FARMA S.A.

Calle Rejas 2, 1st floor

28821 CosladaMadrid

Spain

Responsible for manufacturing

Actavis Ltd.

BLB016 Bulebel Industrial Estate

Zejtun ZTN 3000

Malta

This leaflet has been reviewed in May 2021

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/