OLANZAPINE MABO 5 mg ORALLY DISINTEGRATING TABLETS

Introduction

Package Leaflet: Information for the User

Olanzapine MABO 5 mg Orodispersible Tablets EFG

Read the entire package leaflet carefully before starting to take the medication.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What is Olanzapine MABO and what is it used for
2. What you need to know before taking Olanzapine MABO
3. How to take Olanzapine MABO
4. Possible side effects
5. Storage of Olanzapine MABO
6. Package Contents and Additional Information

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

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

Olanzapine MABO is used to treat:

• Schizophrenia, 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 feel depressed, anxious, or tense.

• Moderate to severe manic disorder, characterized by symptoms such as excitement or euphoria, a disorder characterized by symptoms such as feeling euphoric, having excessive energy, a decreased need for sleep, talking very quickly with flight of ideas, and sometimes considerable irritability. It is also a mood stabilizer that prevents extreme mood swings associated with this disease.

• This medication 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 taking Olanzapine MABO

Do not take Olanzapine MABO

• if you are allergic to Olanzapine or any of the other components. 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 (increased pressure in the eye).

Warnings and Precautions

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

• the use of this medication is not recommended in elderly patients with dementia, as it may have serious side effects.
• medications 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, medications 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, contact your doctor immediately.
• a weight gain has been observed in patients taking this medication. You and your doctor should check your weight regularly. If necessary, your doctor can help you plan a diet or consider referring you to a nutritionist.
• high levels of sugar and fat (triglycerides and cholesterol) have been observed in the blood of patients taking this medication. Your doctor should perform blood tests to control your blood sugar and fat levels before starting olanzapine and regularly during treatment.

If you suffer from any of the following diseases, tell your doctor as soon as possible:

• stroke or transient cerebral ischemia (temporary stroke symptoms)
• Parkinson's disease
• prostate problems
• paralytic ileus (intestinal blockage)
• liver or kidney disease
• blood disorders
• heart disease
• diabetes
• seizures

If you suffer from dementia, you or your caregiver or family member should inform your doctor if you have ever had a stroke or cerebral ischemia.

As a routine precaution, if you are over 65 years old, it is advisable for your doctor to check your blood pressure.

Children and Adolescents

Patient under 18 years old should not take Olanzapine.

Other Medications and Olanzapine MABO

Only use other medications at the same time as this medication if your doctor authorizes it. It is possible that you may feel drowsy if you combine this medication with antidepressants or medications for anxiety or to help you sleep (tranquilizers).

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

Tell your doctor especially if you are taking

• medication for Parkinson's disease.
• carbamazepine (an antiepileptic and mood stabilizer), fluvoxamine (an antidepressant), or ciprofloxacin (an antibiotic). Your dose of this medication may need to be changed.

Taking Olanzapine with Food and Drinks

Olanzapine MABO tablets can be taken with or without food.

You should not drink alcoholic beverages 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 plan to become pregnant, consult your doctor before using this medication. You should not take this medication while breastfeeding, as small amounts of olanzapine may pass into breast milk.

The following symptoms may occur in newborn babies of mothers who have been treated with olanzapine in the last trimester of pregnancy (last three months of pregnancy): trembling, stiffness and/or muscle weakness, drowsiness, agitation, breathing problems, and difficulty feeding. 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 happens to you, do not drive vehicles or use machinery. Consult your doctor.

Olanzapine MABO contains Aspartame

This medication contains 2.8 mg of aspartame in each tablet.

Aspartame contains a source of phenylalanine, which may be harmful in case of phenylketonuria (PKU), a rare genetic disease in which phenylalanine accumulates because the body is unable to eliminate it properly.

3. How to take Olanzapine MABO

Follow your doctor's instructions for taking Olanzapine MABO exactly. Consult your doctor or pharmacist if you have any questions.

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

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.

Olanzapine MABO tablets dissolve easily, so they should be handled with care. Do not handle the tablets with wet hands, as they may break.

1. Hold the blister pack by the ends and separate one of the cells, breaking it gently along the perforations that surround it.

1. Gently remove the back of the cell.

1. Carefully remove the tablet.

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

You can also put the tablet in a cup or glass filled with water, orange juice, apple juice, milk, or coffee, stirring. With some beverages, the mixture may change color and appear cloudy. You should drink it immediately.

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 medication and the amount ingested. It is recommended to take the package and package leaflet of the medication to the healthcare professional.

Patient 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, seizures (epilepsy), coma, a combination of fever, rapid breathing, sweating, muscle stiffness, and a state of confusion or drowsiness, slowing of respiratory rate, aspiration, increased or decreased blood pressure, and 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 forgotten doses.

If you interrupt treatment with Olanzapine MABO

Do not interrupt treatment without consulting your doctor first, even if you feel better. It is very important that you continue taking this medication while your doctor tells you to. Treatment interruption should be done gradually and always following the doctor's instructions.

If you stop taking this medication suddenly, you may experience symptoms such as sweating, insomnia, trembling, anxiety, or nausea and vomiting. Your doctor may suggest that you gradually reduce the dose before stopping treatment.

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

4. Possible Side Effects

Like all medications, Olanzapine can cause side effects, although not everyone experiences them.

Contact your doctor immediately if you experience:

-unusual movements (a frequent side effect that may affect up to 1 in 10 people), especially of the face or tongue, tremors.

-blood clots in the veins (a rare side effect that may affect up to 1 in 100 people), especially in the legs (symptoms include swelling, pain, and redness in the leg), which can travel through the blood to the lungs, causing chest pain and difficulty breathing. If you experience any of these symptoms, see a doctor immediately.

-a combination of fever, rapid breathing, sweating, muscle stiffness, and a state of confusion or drowsiness (the frequency cannot be estimated from the available data)

Very common side effects (affecting more than 1 in 10 people) include weight gain; drowsiness; and increased prolactin levels in the blood. In the early stages of treatment, some people may feel dizzy or faint (with slower heartbeats), especially when getting up from a lying or sitting position. This feeling usually disappears on its own, but if it does not, consult your doctor.

Common side effects (affecting up to 1 in 10 people) include changes in the levels of certain blood cells, circulating lipids, and temporary increases in liver enzymes at the start of treatment; increased blood sugar and urine levels; increased uric acid and creatine phosphokinase levels in the blood; increased appetite; dizziness; agitation; tremors; unusual movements (dyskinesia); constipation; dry mouth; skin rash; loss of strength; excessive fatigue; fluid retention that causes 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.

Rare side effects (affecting 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; seizures, most often 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; loss of urination ability; 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.

Very rare side effects (affecting up to 1 in 1000 people) include a drop in normal body temperature; abnormal heart rhythm; sudden unexplained death; pancreatitis, which causes severe stomach pain, fever, and discomfort; liver disease, with yellowing of the skin and the white areas of the eyes; muscle disorder that presents as unexplained pain and prolonged and/or painful erections.

Very rare side effects include severe allergic reactions such as drug reaction with eosinophilia and systemic symptoms (DRESS). Initially, DRESS manifests with symptoms similar to the flu, with a rash on the face, and later with an extensive rash, fever, swollen lymph nodes, elevated liver enzymes observed in blood tests, and an increase in a type of white blood cell (eosinophilia).

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

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

Reporting Side Effects:

If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use (Website: www.notificaram.es) By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Olanzapine MABO

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

Storage Conditions:

Blister: No special storage conditions are required.

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

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

6. Package Contents and Additional Information

Composition of Olanzapine MABO

• The active ingredient is Olanzapine. Each orodispersible tablet contains 5 mg of Olanzapine.

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

Appearance of the Product and Package Contents

Olanzapine MABO 5 mg is presented in the form of orodispersible tablets. The tablets are yellow, round, and biconvex, marked with an 'O' on one face.

Package sizes:

Non-divisible blister pack of Al/Al with 28 tablets.

Perforable blister pack divisible into individual doses of Al/Al with 28 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 Last Revision of this Package Leaflet: September 2024

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