Olanzapine Teva-Ratio 5 mg orodispersible tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Olanzapina Teva-ratio 5 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 be harmful to 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.

Leaflet contents:

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

Olanzapine has demonstrated effectiveness in preventing 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 Olanzapina Teva-ratio

Do not take Olanzapina 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 appear 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 eye problems such as certain types of

glaucoma (increased pressure in the eye).

Warnings and precautions

Talk to 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.
• Medicines of this type can cause unusual movements, especially in the face or tongue. If this happens after taking olanzapine, tell your doctor.
• Very rarely, medicines of this type may 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 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 sugar and fats (triglycerides and cholesterol) in the blood 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 medicines 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 lost salts due to prolonged severe diarrhea or 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 Olanzapina Teva-ratio

Only use other medicines together with olanzapine if your doctor authorizes it. You may feel drowsiness if olanzapine is combined with antidepressants or medicines for anxiety or sleep (tranquilizers).

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

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 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 plan to become pregnant, consult your doctor before using this medicine. You must not take this medicine while breastfeeding, as small amounts of olanzapine may pass into breast milk.

The following symptoms may occur in newborn babies whose mothers have been treated with olanzapine during the last 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 when taking olanzapine. If this occurs, do not drive or operate machinery. Discuss this with your doctor.

Olanzapina Teva-ratio contains lactose and aspartame

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 2.25 mg of aspartame per tablet.

Aspartame is a source of phenylalanine, which can 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 Teva-ratio

Follow exactly the instructions for use of this medicine given by your doctor. 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 your doctor tells you to.

Olanzapine tablets should be taken once daily, as directed by your doctor. Try to take the tablets at the same time every day. You may take them with or without food. Olanzapine orodispersible tablets are for oral use. Suck the tablets until they are 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.

As the orodispersible tablet is fragile, it should be taken immediately after opening the blister pack.

If you take more Olanzapine 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 91 562 04 20, indicating the medicine and the amount ingested.

Patients who have taken more olanzapine than prescribed 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 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 the hospital if you experience any of the symptoms listed above. Show the doctor the package with the tablets.

If you forget to take Olanzapine Teva-ratio

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

If you stop taking Olanzapine 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 tells you to.

If you stop taking olanzapine suddenly, symptoms such as sweating, inability to sleep, tremor, anxiety, or 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 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 patients), 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) include:

? Weight gain

? Drowsiness

? Increased levels of prolactin in the blood

? In the early stages of treatment, some people may feel dizzy or faint (with slower heartbeats), especially when standing up from a lying or sitting position. 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, alkaline phosphatase, and gamma-glutamyl transferase

? 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

? 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 (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
• Excessive salivation
• 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 both men and women such as abnormal production of breast milk or abnormal growth
• Abnormal heart rhythm
• Blood clots such as deep vein thrombosis in the legs and blood clots in the lung
• 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 (jaundice)
• Muscle disorder presenting as unexplained muscle pain
• Prolonged and/or painful erection
• Abnormal heart rhythm
• Decreased platelet count
• Withdrawal syndrome upon discontinuation of treatment
• Fast pulse

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, 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 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: 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 outer 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 unused medicines and their packaging at the SIGRE collection point at your pharmacy. If you are unsure, please ask your pharmacist how to dispose of unused medicines and their packaging. 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 5 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 5 mg tablets are yellow, round, 8 mm in diameter.

Olanzapine Teva-ratio 5 mg is presented as tablets. It is available in packs of 28 tablets.

Marketing Authorization Holder and Manufacturer:

Marketing Authorization Holder

Teva Pharma, S.L.U.

C/ Anabel Segura 11, Edificio Albatros B, 1st floor,

Alcobendas, 28108 Madrid (Spain)

Manufacturer:

Teva Pharma, S.L.U.

Polígono Malpica, C/ C 4,

50016 Zaragoza,

Spain

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

Detailed information about this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/).

You can access detailed and up-to-date information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the packaging. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/73482/P_73482.html