Olanzapine Mabo 10 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Olanzapine MABO 10 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 other people, even if they have the same symptoms as you, because it could 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, please inform your doctor or pharmacist.

Leaflet contents:

1. What Olanzapine MABO 10 mg tablets are and what they are used for
2. Before taking Olanzapine MABO 10 mg tablets
3. How to take Olanzapine MABO 10 mg tablets
4. Possible side effects
5. How to store Olanzapine MABO 10 mg tablets
6. Further information

1. What OLANZAPINE MABO 10 mg TABLETS is and what it is used for

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

Olanzapine MABO is used to treat:

• a condition with symptoms such as hearing, seeing, or feeling things that are not real, false beliefs, unusual suspiciousness, and a tendency to withdraw socially. 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 marked irritability. It is also a mood stabilizer that prevents the occurrence of extreme mood changes associated with this illness.

2. BEFORE TAKING OLANZAPINE MABO 10 mg TABLETS

Do not take Olanzapine MABO

• if you are allergic to olanzapine or to any of the other ingredients. The allergic reaction may manifest 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.

Take special care with Olanzapine MABO

• medicines of this type may cause unusual movements, especially in the face or tongue. If this occurs after taking Olanzapine, inform your doctor,
• very rarely, medicines of this type cause a combination of fever, rapid breathing, sweating, muscle stiffness, and mental confusion or drowsiness. If this occurs, stop taking the medication and contact your doctor immediately.

If you suffer from any of the following conditions, 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 have 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 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 authorizes it. You may experience drowsiness if Olanzapine is combined with antidepressants or medications for anxiety or sleep (tranquilizers).

You must inform your doctor if you are taking fluvoxamine (an antidepressant) or ciprofloxacin (an antibiotic), as your dose of Olanzapine may need to be adjusted.

Taking Olanzapine with food and drinks

Olanzapine MABO tablets can be taken with or without food.

You must not drink alcohol during treatment with Olanzapine MABO tablets. The combination of Olanzapine and alcohol may cause drowsiness.

Pregnancy and Breast-feeding

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 must not take this medicine during pregnancy unless your doctor advises you to do so.

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

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

Driving and using machines

There is a risk of drowsiness while taking Olanzapine. If this occurs, do not drive or operate machinery. Discuss this with your doctor.

Important information about some of the components of Olanzapine MABO

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

This medicine contains soya oil. It must not be used if you are allergic to peanuts or soya.

3. HOW TO TAKE OLANZAPINE MABO 10 mg TABLETS

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

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 must swallow the tablets whole with water.

Take your Olanzapine tablets once daily, as directed by your doctor. Try to take the tablets at the same time every day. Olanzapine tablets are for oral use.

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

If you take more Olanzapine MABO than you should

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

Patients who have taken more Olanzapine than recommended 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 or decreased blood pressure, and abnormal heart rhythms. Contact your doctor or go immediately to the hospital. Show the doctor the medicine’s packaging and tablets.

If you forget to take Olanzapine MABO

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

If you stop taking Olanzapine MABO

Do not stop treatment without first consulting your doctor, even if you feel better. Discontinuation of treatment should be done gradually and always according to your doctor’s instructions.

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.

Uncommon adverse effects (may affect up to 1 in 100 people) include hypersensitivity (e.g. swelling of the mouth and throat, itching, skin rash); diabetes or worsening of diabetes, occasionally associated with ketoacidosis (ketones in blood and urine) or coma; seizures, which in most cases are related to a history of seizures (epilepsy); muscle rigidity or spasms (including abnormal 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 reduction of menstrual periods; and changes in the mammary gland in both men and women, such as abnormal production of breast milk or abnormal breast enlargement, and excessive salivation.

In this leaflet, when an adverse effect is described 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 an adverse effect is described 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 fatigue, weight gain, dizziness, increased appetite, fluid retention, constipation, dry mouth, restlessness, unusual movements (especially of the face or tongue), tremors, and changes in levels of certain blood cells and circulating fats. In some patients, inflammation of the pancreas has developed very rarely, causing severe stomach pain, fever, and malaise.

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 rare 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, falls, extreme fatigue, visual hallucinations, increased 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.

Liver disorders have also been reported rarely. Very rarely, prolonged and/or painful erection (priapism), decreased body temperature, blood clots (e.g. deep vein thrombosis in the legs), and unexplained muscle disorders presenting as muscle pain have been reported.

Very rarely, babies born to mothers who have taken Olanzapine during 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), may travel through the bloodstream to the lungs, causing chest pain and difficulty breathing. If you experience any of these symptoms, seek immediate medical attention.

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 that spreads to other areas, fever, swollen lymph nodes, elevated liver enzymes in blood tests, and an increase in a type of white blood cell (eosinophilia).

Reporting of adverse effects:

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines (Website: www.notificaram.es). By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of OLANZAPINE MABO 10 mg TABLETS

Keep out of the reach and sight of children.

Storage conditions:

No special storage conditions required.

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

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. ADDITIONAL INFORMATION

Composition of Olanzapine MABO 10 mg tablets

• The active substance is Olanzapine. Each film-coated tablet contains 10 mg of Olanzapine.

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

Appearance of the product and contents of the container

Olanzapine MABO 10 mg is presented as film-coated tablets. The tablets are white, round and biconvex, with an imprint 'O3' on one side.

Pack sizes:

Al/Al blister packs containing 28 and 56 tablets.

Marketing Authorization Holder

MABO-FARMA S.A.

Calle 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 reviewed in May 2021

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