Olanzapine Mabo 10 mg orodispersible tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Olanzapina MABO 10 mg orodispersible 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 only and must not be given to other people, even if they have the same symptoms, as it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet contents

1. What Olanzapina MABO is and what it is used for
2. What you need to know before taking Olanzapina MABO
3. How to take Olanzapina MABO
4. Possible adverse effects
5. How to store Olanzapina MABO
6. Contents of the pack and other information

1. What is Olanzapina MABO 10 mg and what is it used for?

Olanzapina MABO tablets belong to a group of medicines known as antipsychotics.

Olanzapina MABO is used to treat:

• Schizophrenia, a condition characterized by symptoms such as hearing, seeing, or sensing things that are not real, false beliefs, unusual suspiciousness, and social withdrawal. People with this illness may also experience depression, anxiety, or tension.

• Moderate to severe manic episodes, characterized by symptoms such as excitement or euphoria, excessive energy, a reduced need for sleep, rapid speech with racing thoughts, and sometimes marked irritability. It is also a mood stabilizer that helps prevent extreme fluctuations in mood associated with this disorder.

• This medicine has been shown to prevent the recurrence of these symptoms in patients with bipolar disorder whose manic episodes have responded to treatment with olanzapine.

2. What you need to know before starting to take Olanzapine MABO

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 (increased pressure in the eye).

Warnings and precautions

Consult your doctor or pharmacist before starting to take this medicine:

• use of this medicine is not recommended in elderly patients with dementia, as it may cause serious adverse effects.
• medicines of this type may 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 cause a combination of fever, rapid breathing, sweating, muscle stiffness, and mental confusion or drowsiness. If this occurs, contact your doctor immediately.
• weight gain has been observed in patients taking this medicine. You and your doctor should monitor your weight regularly. If necessary, your doctor may help you plan a diet or consider referring you to a nutritionist.
• elevated levels of sugar and fats (triglycerides and cholesterol) in the blood have been observed in patients taking this medicine. Your doctor should perform blood tests to monitor your blood sugar and fat levels before you start taking olanzapine and regularly during treatment.
• if you or someone in your family has a history of blood clots, consult your doctor, as medicines of this type have been associated with blood clot formation.

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

• stroke or transient ischaemic attack (temporary stroke-like symptoms)
• Parkinson’s disease
• prostate problems
• intestinal blockage (paralytic ileus)
• liver or kidney disease
• blood disorders
• heart disease
• diabetes
• seizures
• if you think you may have loss of body salts due to prolonged severe diarrhoea and vomiting, or due to taking diuretic medicines (water tablets)

If you have dementia, you or your caregiver or family member should inform your doctor, as you may experience serious adverse effects.

If you have ever had a stroke or reduced blood flow to the brain.

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

Children and adolescents

Patients under 18 years of age must not take olanzapine.

Other medicines and Olanzapine MABO

Only use other medicines together with this medicine if your doctor authorises it. You may feel increased drowsiness if you combine this medicine with antidepressants or medicines for anxiety or sleep (tranquilisers).

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:

• medicines for Parkinson’s disease.
• carbamazepine (an antiepileptic and mood stabiliser), fluvoxamine (an antidepressant), or ciprofloxacin (an antibiotic). Your dose of this medicine 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 orodispersible tablets. The combination of olanzapine and alcohol may cause drowsiness.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor before using this medicine. You must not take this medicine while breastfeeding, as small amounts of olanzapine can pass into breast milk.

The following symptoms may occur in newborn babies of mothers who have been treated with olanzapine during the third trimester of pregnancy (last three months of pregnancy):

tremor, muscle stiffness and/or weakness, drowsiness, agitation, breathing difficulties, and feeding problems. If your baby develops any of these symptoms, contact your doctor.

Driving and using machines

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

Olanzapine MABO contains aspartame

This medicine contains 5.6 mg of aspartame per tablet.

Aspartame is a source of phenylalanine, which may be harmful if you have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body cannot eliminate it properly.

3. How to take Olanzapine MABO

Follow exactly the instructions for administering Olanzapine MABO as given by your doctor. If you have any doubts, consult your doctor or pharmacist.

Your doctor will tell you how many tablets of this medicine you should take and for how long.

The daily dose of Olanzapine ranges between 5 and 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. Olanzapine tablets are for oral administration.

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.

Olanzapine MABO tablets disintegrate easily and therefore must be handled with care. Do not handle the tablets with wet hands, as they may disintegrate.

1. Hold the blister pack by the edges and separate one of the blisters, gently breaking it along the perforations surrounding it.

2. Gently peel back the back of the blister.

3. Carefully remove the tablet.

4. Place the tablet in your mouth. It will dissolve directly in the mouth, making it very easy to swallow.

Alternatively, the tablet can be placed in a cup or glass filled with water, orange juice, apple juice, milk, or coffee, and stirred. With some beverages, the mixture may change color and become cloudy. It should be drunk immediately.

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 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 prescribed have experienced the following symptoms: rapid heartbeat, agitation/aggression, speech difficulties, unusual movements (especially of the face and tongue), and reduced level of consciousness. Other possible symptoms 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 medicine's packaging and remaining 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. It is very important that you continue taking this medicine for as long as your doctor tells you to. Discontinuation of treatment should be done gradually and always under your doctor's instructions.

If you stop taking this medicine suddenly, symptoms such as sweating, difficulty sleeping, tremor, anxiety, nausea, and vomiting may occur. Your doctor may advise you to gradually reduce 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.

Contact your doctor immediately if you experience:

• unusual movements (a common adverse effect which may affect up to 1 in 10 people), especially of the face or tongue, tremors;

• blood clots in the veins (an uncommon adverse effect which may affect up to 1 in 100 people), particularly in the legs (symptoms include swelling, pain, and redness in the leg), which may travel through the bloodstream to the lungs, causing chest pain and difficulty breathing. If you experience any of these symptoms, seek medical attention immediately;

• a combination of fever, rapid breathing, sweating, muscle stiffness, and mental confusion or drowsiness (frequency cannot be estimated from available data).

Very common adverse effects (may affect more than 1 in 10 people) include weight gain; drowsiness; and increased levels of prolactin in the blood. In the early stages of treatment, some people may feel dizzy or faint (with slower heartbeat), especially when getting up from lying down or sitting. This sensation usually resolves spontaneously, but if it does not, consult your doctor.

Common adverse effects (may affect up to 1 in 10 people) include changes in levels of certain blood cells and circulating lipids, and temporary increases in liver enzymes at the beginning of treatment; increased blood and urine sugar levels; increased levels of uric acid and creatine phosphokinase in the blood; increased appetite; dizziness; restlessness; tremor; unusual movements (dyskinesia); constipation; dry mouth; skin rash; loss of strength; excessive tiredness; fluid retention causing swelling of the hands, ankles, or feet; fever; joint pain; and sexual dysfunction such as decreased libido in men and women or erectile dysfunction in men.

Uncommon adverse 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 associated with ketoacidosis (ketones in blood and urine) or coma; seizures, which in most cases are related to a history of seizures (epilepsy); muscle stiffness or spasms (including eye movements); restless legs syndrome; speech problems; stuttering; 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 growth, excessive salivation.

Rare adverse effects (may affect up to 1 in 1,000 people) include decreased body temperature; abnormal heart rhythm; sudden unexplained death; inflammation of the pancreas, causing severe stomach pain, fever, and malaise; liver disease, with yellowing of the skin and whites of the eyes; a muscular disorder presenting as unexplained muscle pain and prolonged and/or painful erection.

Very rare adverse effects include severe allergic reactions such as drug reaction with eosinophilia and systemic symptoms (DRESS). DRESS initially presents with flu-like symptoms and a rash on the face, followed by widespread rash, fever, swollen lymph nodes, elevated liver enzymes observed in blood tests, and increased levels of a type of white blood cell (eosinophilia).

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.

Reporting of adverse effects:

If you experience any adverse effect, talk to your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You can 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 Olanzapina MABO

Keep this medicine out of the sight and reach of children.

Storage conditions:

Blister: No special storage conditions required.

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

Medicines should not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE Point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Olanzapine MABO

• The active substance is Olanzapine. Each orodispersible tablet contains 10 mg of Olanzapine.

• The other components (excipients) are: heavy magnesium carbonate, microcrystalline cellulose, crospovidone, microcrystalline cellulose and guar gum, aspartame E951, low-substituted hydroxypropyl cellulose, orange flavour, colloidal anhydrous silica, magnesium stearate, L-methionine.

Appearance of the product and contents of the pack

Olanzapine MABO 10 mg is presented as orodispersible tablets. The tablets are yellow, round and biconvex, marked with an 'O1' on one side.

Pack sizes:

Al/Al non-divisible blister packs in single doses containing 28 and 56 tablets.

Al/Al perforated blister packs divisible into single doses 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

Date of the most recent revision of this leaflet: September 2024

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