Olanzapine Teva-Ratio 2.5 mg film-coated tablets EFG: detailed information

Brand name Olanzapine Teva-Ratio 2.5 mg film-coated tablets EFG

Form tablets, film-coated

Active substance / Dosage

OLANZAPINE · 2,5 mg

Prescription type Prescription Only Medicine

ATC code

N05A N05AH N05AH03

Registration number 73461

Manufacturer Teva Pharma S.L.U.

Table of Contents

Package leaflet: Information for the user
Introduction
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 Olanzapine Teva-ratio
4. Possible adverse effects
5. Storage of Olanzapine Teva-ratio Tablets
6. Contents of the container and other information

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Olanzapina Teva-ratio 2.5 mg film-coated tablets EFG

Olanzapine

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.

Leaflet contents:

What Olanzapina Teva-ratio is and what it is used for.
What you need to know before taking Olanzapina Teva-ratio.
How to take Olanzapina Teva-ratio.
Possible adverse effects.
How to store Olanzapina Teva-ratio.
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. Olanzapina Teva-ratio belongs to a group of medicines called antipsychotics.

Olanzapina Teva-ratio is used to:

• treat a condition with symptoms such as hearing, seeing, or sensing 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.

• treat a disorder characterized by symptoms such as feeling excessively elated, having abnormally high energy levels, needing much less sleep than usual, speaking very rapidly with racing thoughts, and sometimes having marked irritability. It is also a mood stabilizer that helps prevent extreme mood swings.

2. What you need to know before taking Olanzapina Teva-ratio

Do not take Olanzapina Teva-ratio

? If you are allergic to the active substance 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, inform your doctor immediately.

? 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 Olanzapina Teva-ratio.

? The use of olanzapine is not recommended in elderly patients with dementia, as it may cause serious adverse effects.

? Medicines of this type may cause unusual movements, especially of the face or tongue. If this occurs after taking Olanzapina, inform 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 you experience these symptoms, contact your doctor immediately.

? Weight gain has been observed in patients taking Olanzapina. 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 blood sugar and fats (triglycerides and cholesterol) have been observed in patients taking Olanzapina. Your doctor should perform blood tests to monitor your blood sugar and fat levels before you start treatment 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:

Diabetes
Heart disease
Liver or kidney disease
Parkinson's disease
Epilepsy
Prostate problems
Intestinal blockage (paralytic ileus)
Blood disorders
Stroke or transient ischemic attack (temporary stroke-like symptoms)

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 Olanzapina Teva-ratio.

Other medicines and Olanzapina Teva-ratio

Only take other medicines together with Olanzapina Teva-ratio if authorized by your doctor. You may experience increased drowsiness if Olanzapina Teva-ratio is taken together with antidepressants or medicines 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 Olanzapina Teva-ratio may need to be adjusted.

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

Especially inform 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 dose of Olanzapina Teva-ratio may need to be changed.

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

Olanzapina Teva-ratio can be taken with or without food. You must not drink alcohol while taking Olanzapina Teva-ratio, as the combination of Olanzapina Teva-ratio 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.

Pregnancy

Newborns whose mothers have taken Olanzapina Teva-ratio during the last trimester of pregnancy may present with 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.

Breastfeeding

You must not take this medicine while breastfeeding, as small amounts of Olanzapina Teva-ratio may pass into breast milk.

Driving and using machines

Olanzapina Teva-ratio may cause symptoms such as drowsiness, dizziness, or vision disturbances, and may reduce reaction ability. These effects, as well as the underlying illness itself, may impair your ability to drive vehicles or operate machinery. Therefore, do not drive, operate machinery, or perform other activities requiring full attention until your doctor has assessed your response to this medicine.

Olanzapina Teva-ratio contains lactose and sodium

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

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; i.e., it is essentially "sodium-free".

3. How to take Olanzapine Teva-ratio

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

Your doctor will tell you how many Olanzapine Teva-ratio tablets you should take and for how long.

The daily dose of Olanzapine Teva-ratio ranges from 5 mg to 20 mg. Consult your doctor if your symptoms return, but do not stop taking Olanzapine Teva-ratio unless your doctor tells you to do so.

You should take your Olanzapine Teva-ratio tablets once daily, as directed by your doctor. Try to take the tablets at the same time every day. The tablets are for oral use. Swallow the tablets whole with water.

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 telephone number 91 562 04 20, indicating the medicine and the amount ingested.

Patients who have taken more Olanzapine Teva-ratio than they should 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 stiffness, drowsiness or lethargy, slowed breathing rate, aspiration, increased blood pressure or decreased blood pressure, and abnormal heart rhythms.

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 the forgotten dose.

If you stop taking Olanzapine Teva-ratio

If you suddenly stop taking Olanzapine Teva-ratio, you may experience symptoms such as sweating, inability to sleep, tremor, anxiety, nausea, or vomiting. Your doctor may recommend gradually reducing the dose before stopping treatment.

Do not stop treatment when you feel better. It is very important that you continue taking Olanzapine Teva-ratio for as long as your doctor tells you to.

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

Olanzapine Teva-ratio must not be taken by patients under 18 years of age.

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 affecting up to 1 in 10 patients), especially of the face or tongue

? Blood clots in the veins (an uncommon adverse effect affecting up to 1 in 100 patients), particularly in the legs (symptoms include sweating, 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 patients)

? Weight gain

? Drowsiness

? Increased levels of prolactin in the blood

? In the early stages of treatment, some people may experience dizziness or fainting (with slower heartbeats), especially when standing up from lying or sitting positions. This sensation usually resolves spontaneously, but if it does not, inform your doctor

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

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

? Increased levels of blood and urine sugar

? Increased levels of uric acid, creatine phosphokinase in blood, and increased alkaline phosphatase

? Increased appetite

? Dizziness

? Agitation

? Tremor

? Unusual movements (dyskinesia)

? Constipation

? Dry mouth

? Skin rash

? Joint pain

? 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 patients)

? 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, mostly related to a history of seizures (epilepsy)

? Muscle stiffness or spasms (including eye movements)

? Restless legs syndrome

? Speech problems

? Slow pulse

? Abnormal heart rhythm

? Sensitivity to sunlight

? Nosebleeds

? Blood clots such as deep vein thrombosis in the legs and blood clots in the lung

? Abdominal distension

? Memory loss or forgetfulness

? Urinary incontinence

? Urinary retention

? Difficulty urinating

? Hair loss

? Absence or reduction of menstrual periods

? Breast gland changes in men and women such as abnormal production of breast milk or abnormal growth

? Increased total bilirubin

? Excessive salivation

Rare adverse effects (may affect up to 1 in 1000 patients)

? Decreased platelet count

? Decrease in normal body temperature

? Withdrawal syndrome upon discontinuation of treatment

? Sudden unexplained death

? Rapid pulse

? Inflammation of the pancreas, causing severe stomach pain, fever, and discomfort

? 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

Adverse effects of 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 tiredness, visual hallucinations, increased body temperature, skin redness, and difficulty walking.

A slightly increased number of deaths has been reported in elderly patients with dementia treated with antipsychotics compared to those not receiving such treatment.

Olanzapina Teva-ratio may worsen symptoms in patients with Parkinson's disease.

Rarely, women who take this type of medicine for a long time may experience milk secretion from the breast gland, absence of menstrual periods, or irregular menstruation. If this condition persists, consult your doctor. Very rarely, babies born to mothers who took Olanzapina Teva-ratio during the last stage of pregnancy (third trimester) may experience tremors, drowsiness, or lethargy.

Severe allergic reactions have been reported, such as Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS). DRESS initially presents with flu-like symptoms, a facial skin 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 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 Tablets

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 carton and blister after "EXP". 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. Contents of the container and other information

Composition of Olanzapine Teva-ratio

The active substance is olanzapine. Each tablet contains 2.5 mg of active substance.
The other components are: Core excipients: Lactose monohydrate, sodium croscarmellose, pregelatinized corn starch, hydroxypropylcellulose, magnesium stearate, colloidal anhydrous silica, corn starch and microcrystalline cellulose. Coating excipients: Hypromellose, polyethylene glycol 6000 and titanium dioxide (E171).

Appearance of the product and contents of the container

Olanzapine Teva-ratio 2.5 mg tablets are white, round, concave, 6 mm in diameter and film-coated.

Olanzapine Teva-ratio 2.5 mg is presented in tablet form. It is available in packs containing 28 tablets.