Olanzapine Teva-Ratio 10 mg orodispersible tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Olanzapina Teva-ratio 10 mg orodispersible tablets EFG

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• 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 you, because it could harm them.

• If you experience any adverse effects, consult your doctor or pharmacist, even if they

are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet:

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

1. What Olanzapina Teva-ratio is and what it is used for

Olanzapina Teva-ratio contains the active substance olanzapine. Olanzapine belongs to the therapeutic group of antipsychotics and is indicated for the treatment of the following conditions:

• Schizophrenia, a disorder whose symptoms include hearing, seeing, or sensing things that are not real, false beliefs, unusual suspiciousness, and social withdrawal. People with this condition may also experience depression, anxiety, or feelings of tension.
• Moderate to severe manic disorder, a condition whose symptoms include excitement or euphoria.

Olanzapine 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 Teva-ratio

Do not take Olanzapine Teva-ratio:

? If you are allergic to olanzapine or to any of the other ingredients of this medicine (listed in section 6). 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 eye problems such as certain types of

glaucoma (increased pressure in the eye).

Warnings and precautions

• Consult your doctor or pharmacist before starting to take olanzapine.
• The use of olanzapine is not recommended in elderly patients with dementia, as it may cause serious adverse effects.
• Medications of this type may cause unusual movements, especially in the face or tongue. If this occurs after taking olanzapine, inform your doctor.
• Very rarely, medications of this type may cause a combination of fever, rapid breathing, sweating, muscle rigidity, and mental confusion or drowsiness. If this happens to you, contact your doctor immediately.
• Weight gain has been observed in patients taking olanzapine. 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 dietitian.
• Elevated levels of blood sugar and fats (triglycerides and cholesterol) have been observed in patients taking olanzapine. 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 medications of this type have been associated with blood clot formation.

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

• Stroke or transient ischemic 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 salts due to prolonged severe diarrhea and vomiting, or due to taking diuretic medicines (water tablets)

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.

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 Teva-ratio

Only use other medicines together with olanzapine if authorized by your doctor. You may feel increased drowsiness if olanzapine is taken together with antidepressants or medicines for anxiety or sleep (tranquilizers).

Inform your doctor if you are taking, have recently taken, or might need to take any other medicine.

Specifically, tell your doctor if you are taking:

• Medication for Parkinson's disease.
• Carbamazepine (an antiepileptic and mood stabilizer), fluvoxamine (an antidepressant), or ciprofloxacin (an antibiotic). Your olanzapine dose may need to be adjusted.

Taking Olanzapine Teva-ratio with food, drinks, and alcohol

Olanzapine may be taken with or without food.

You should not drink alcohol while taking olanzapine, as combining it with 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 should not take this medicine 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 during the third trimester of pregnancy (last three months of pregnancy): tremors, 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 while taking olanzapine. If this occurs, do not drive or operate machinery. Discuss this with your doctor.

Olanzapine Teva-ratio contains lactose and aspartame

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

This medicine contains 4.5 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 properly eliminate it.

3. How to take Olanzapina Teva-ratio

Follow exactly the instructions for use of this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Your doctor will tell you how many olanzapine tablets you should take and for how long.

The daily dose of olanzapine ranges between 5 mg and 20 mg. Consult your doctor if your symptoms return, but do not stop taking this medicine unless instructed by your doctor.

Olanzapine tablets should be taken once daily, as directed by your doctor. Try to take the tablets at the same time every day. They may be taken with or without food. Oromucosal dispersible tablets are for oral administration. Suck the tablets until completely dissolved in the mouth.

Olanzapine tablets crumble easily and therefore must be handled with care. Do not handle the tablets with wet hands, as they may disintegrate. Since the oromucosal dispersible tablet is fragile, it should be taken immediately after opening the blister pack.

If you take more Olanzapina Teva-ratio than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, stating the medicine and the amount ingested.

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 or decreased blood pressure, or abnormal heart rhythms.

Contact your doctor or go immediately to hospital if you experience any of the symptoms listed above. Show the doctor the medicine package and remaining tablets.

If you forget to take Olanzapina Teva-ratio

Take your tablet as soon as you remember. Do not take a double dose to make up for the missed dose.

If you stop taking Olanzapina Teva-ratio

Do not stop treatment just because you feel better. It is very important that you continue taking olanzapine for as long as your doctor advises.

If you stop taking olanzapine suddenly, symptoms such as sweating, inability to sleep, tremor, anxiety, or nausea and vomiting may occur. Your doctor may recommend that you gradually reduce the dose before stopping treatment.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Contact your doctor immediately if you have:

• Unusual movements (a common adverse effect that may affect up to 1 in 10 people), especially of the face or tongue

• Blood clots in the veins (an uncommon adverse effect that 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 help 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)

• Weight gain

• Drowsiness

• Increased levels of prolactin in the blood

• In the early stages of treatment, some people may feel dizzy or faint (with slowed heartbeat), especially when standing up from lying or sitting positions. This sensation usually resolves spontaneously, but if it does not, consult your doctor

Common adverse effects: (may affect up to 1 in 10 people)

• Changes in levels of certain blood cells, circulating lipids, and temporary increases in liver enzymes at the beginning of treatment

• Increased cholesterol levels

• Increased levels of blood and urine sugar

• Increased levels of uric acid, creatine phosphokinase in blood, increased alkaline phosphatase, and increased gamma-glutamyltransferase

• Increased appetite

• Dizziness

• Agitation

• 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

• 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)

• Hypersensitivity (e.g. mouth and throat swelling, itching, skin rash)

• Diabetes or worsening of diabetes, occasionally associated with ketoacidosis (acetone in blood and urine) or coma

• Seizures; in most cases, these 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, urinary retention, loss of ability to urinate

• Hair loss

• Absence or reduction of menstrual periods and changes in the mammary gland in men and women such as abnormal milk production or abnormal growth

• Abnormal heart rhythm

• Increased total bilirubin

Rare adverse effects (may affect up to 1 in 1,000 people)

• Decrease in normal body temperature

• 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

• Muscle disorder presenting as unexplained muscle pains

• Prolonged and/or painful erection

• Abnormal heart rhythm

• Decrease in platelet count

• Withdrawal syndrome upon discontinuation of treatment

• Rapid pulse

Very rare adverse effects include severe allergic reactions such as Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS). Initially, DRESS presents with flu-like symptoms, facial rash, followed by widespread rash, fever, enlarged lymph nodes, elevated liver enzymes in blood tests, and increased levels of a type of white blood cell (eosinophilia).

Adverse effects with unknown frequency (cannot be estimated from available data)

• Withdrawal syndrome in newborns

During treatment with olanzapine, elderly patients with dementia may experience stroke, pneumonia, urinary incontinence, 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 kind of adverse effect, consult 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: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Olanzapine Teva-ratio

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

This medicine does not require any special storage conditions.

Do not use this medicine after the expiry date stated on the packaging and blister after "EXP". The expiry date refers to the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If in doubt, 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 Teva-ratio:

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

• The other components are: mannitol (E421), aspartame (E951), magnesium stearate (E470B), crospovidone, lactose monohydrate, hydroxypropylcellulose (E463), and lemon flavour (contains sucrose).

Appearance of the product and contents of the pack.

Olanzapine Teva-ratio 10 mg tablets are yellow, round, 10 mm in diameter.

Olanzapine Teva-ratio 10 mg is presented as tablets. It is available in packs of 28 and 56 tablets.

Marketing Authorization Holder and Manufacturer:

Marketing Authorization Holder

Teva Pharma, S.L.U.

Calle Anabel Segura 11, Edificio Albatros B, 1st floor,

Alcobendas, 28108 Madrid

Spain

Manufacturer:

Teva Pharma, S.L.U.

Polígono Malpica, Calle C 4,

50016 Zaragoza

Spain

Date of the most recent review of this leaflet: November 2025

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

You can access detailed information about this medicine by scanning with your mobile phone (smartphone) the QR code included on the outer packaging. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/73478/P_73478.html