OLANZAPINE TEVA-RATIO 10 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Olanzapine Teva-ratio 10 mg film-coated tablets EFG

Olanzapine

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

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. See section 4.

Contents of the package leaflet:

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

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

Olanzapine Teva-ratio contains the active substance olanzapine. Olanzapine Teva-ratio belongs to a group of medicines called antipsychotics.

Olanzapine Teva-ratio is used to:

? treat a disease with symptoms such as hearing, seeing or feeling unreal things, mistaken beliefs, unusual suspiciousness and a tendency to withdraw. People suffering from these diseases may also be depressed, anxious or tense.

? treat a disorder characterized by symptoms such as feeling elated, having excessive energy, a need to sleep much less than usual, talking very quickly with flight of ideas and, sometimes, considerable irritability. It is also a mood stabilizer that prevents the appearance of extreme variations in mood.

2. What you need to know before you take Olanzapine Teva-ratio

Do not take Olanzapine 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 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 Teva-ratio.

? The use of olanzapine is not recommended in elderly patients with dementia as it may have serious side effects.

? Medicines of this type can cause unusual movements, especially in the face or tongue. If this happens to you after taking Olanzapine, tell your doctor.

? In very rare cases, medicines 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.

? Weight gain has been observed in patients taking Olanzapine. 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 fats (triglycerides and cholesterol) have been observed in the blood of patients taking Olanzapine. Your doctor should perform blood tests to check your blood sugar and fat levels before you start taking Olanzapine and regularly during treatment.

? If you or a family member have a history of blood clots, consult your doctor, as medicines of this type have been associated with the formation of blood clots.

If you suffer from any of the following diseases, tell 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 cerebral ischemia (temporary stroke 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 cerebral ischemia.

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

Children and adolescents

Patients under 18 years of age should not take Olanzapine Teva-ratio.

Other medicines and Olanzapine Teva-ratio

Only use other medicines at the same time as Olanzapine Teva-ratio if your doctor authorizes it. You may feel drowsy if you combine Olanzapine Teva-ratio with antidepressants or medicines for anxiety or sleep aids (tranquilizers).

You should inform your doctor if you are taking fluvoxamine (antidepressant) or ciprofloxacin (antibiotic), as it may be necessary to modify your dose of Olanzapine Teva-ratio.

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

Tell your doctor especially if you are using:

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

Taking Olanzapine Teva-ratio with food, drinks and alcohol

Olanzapine Teva-ratio can be taken with or without food. You should not drink alcohol if you have been given Olanzapine Teva-ratio because the combination of Olanzapine Teva-ratio and alcohol can 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.

Pregnancy

Newborns of mothers who have used Olanzapine Teva-ratio in the last trimester of pregnancy may present with the following symptoms: tremors, muscle stiffness and/or weakness, drowsiness, agitation, breathing problems, and feeding problems. If your child is born with any of these symptoms, contact your doctor.

Breastfeeding

You should not take this medicine when you are breastfeeding because small amounts of Olanzapine Teva-ratio can pass into breast milk.

Driving and using machines

Olanzapine Teva-ratio can cause symptoms such as drowsiness, dizziness or changes in vision, and reduce your reaction ability. These effects, as well as the disease itself, can make it difficult for you to drive vehicles or operate machines. Therefore, do not drive, operate machines, or engage in other activities that require special attention until your doctor assesses your response to this medicine.

Olanzapine Teva-ratio contains lactose and sodium

This medicine contains lactose. If your doctor has told 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; this is essentially "sodium-free".

3. How to take Olanzapine Teva-ratio

Follow the instructions for administration of this medicine exactly as indicated by your doctor or pharmacist. In case of 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 you experience symptoms again, but do not stop taking Olanzapine Teva-ratio unless your doctor tells you to.

You should take your Olanzapine Teva-ratio tablets once a day, following the instructions of your doctor. Try to take the tablets at the same time every day. The tablets are for oral administration. You should swallow the tablets whole with water.

If you take more Olanzapine Teva-ratio 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 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 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.

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, insomnia, tremors, anxiety, nausea, or vomiting. Your doctor may suggest gradually reducing the dose before stopping treatment.

Do not interrupt treatment when you feel better. It is very important that you continue taking Olanzapine Teva-ratio while your doctor tells you to.

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

Patients under 18 years of age should not take Olanzapine Teva-ratio.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Contact your doctor immediately if you have:

? Unusual movements (a frequent side effect that can affect up to 1 in 10 patients), especially of the face or tongue.

? Blood clots in the veins (a rare side effect that can affect up to 1 in 100 patients), especially in the legs (symptoms include sweating, 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, go to the 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: (can affect more than 1 in 10 patients)

? Weight gain.

? Drowsiness.

? Increased prolactin levels in the blood.

? In the early stages of treatment, some people experience dizziness or fainting (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, tell your doctor.

Common side effects: (can affect up to 1 in 10 patients)

? Changes in the levels of some blood cells, circulating lipids, and temporary increases in liver enzymes at the start of treatment.

? Increased blood sugar and urine levels.

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

? Increased appetite.

? Dizziness.

? Agitation.

? Tremors.

? Unusual movements (dyskinesia).

? Constipation.

? Dry mouth.

? Skin rash.

? Joint pain.

? Loss of strength.

? Excessive fatigue.

? Fluid retention that causes swelling of the hands, ankles, or feet.

? Fever.

? Sexual dysfunctions such as decreased libido in men and women or erectile dysfunction in men.

Uncommon side effects: (can affect up to 1 in 100 patients)

? 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, in most cases 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 of the legs and blood clots in the lungs.

? Abdominal distension.

? Memory loss or forgetfulness.

? Urinary incontinence.

? Urinary retention.

? Difficulty urinating.

? Hair loss.

? Absence or decrease of menstrual periods.

? Changes in the breast gland in men and women, such as abnormal milk production or abnormal growth.

? Increased total bilirubin.

• Excessive salivation.

Rare side effects: (can affect up to 1 in 1,000 patients)

? Decreased platelets.

? Decrease in normal body temperature.

? Withdrawal syndrome when stopping treatment.

? Sudden unexplained death.

? Rapid heartbeat.

? Pancreatitis, which causes severe stomach pain, fever, and malaise.

? Liver disease, with yellowing of the skin and the white areas of the eyes.

? Muscle disorder that presents as unexplained pain.

? Prolonged and/or painful erections.

Side effects of unknown frequency (cannot be estimated from the 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, a rise in body temperature, redness of the skin, and walking problems.

A small increase in the number of deaths has been reported in elderly patients with dementia treated with antipsychotics, compared to those who do not receive this treatment.

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

In rare cases, women who have been taking medicines of this type for a long time may secrete milk from the breast gland, stop having their menstrual period, or have it irregularly. If this situation persists, consult your doctor. In very rare cases, babies of mothers who have taken Olanzapine Teva-ratio in the last stage of pregnancy (third trimester) may experience tremors, drowsiness, or lethargy.

Severe allergic reactions, such as Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), have been reported. DRESS initially manifests with symptoms similar to those of the flu, with a skin rash on the face that then spreads to other areas, fever, swelling of the lymph nodes, elevated liver enzymes in blood tests, and an increase in a type of white blood cell (eosinophilia).

Reporting of side effects:

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if it is a possible side effect not listed in this package leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side 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 special storage conditions.

Do not use this medicine after the expiry date which is stated on the carton and blister after "EXP". The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Return the containers and any unused medicines to the pharmacy. If you have any doubts, ask your pharmacist how to dispose of the containers and any unused medicines. This will help protect the environment.

6. Container Content and Additional Information

Composition of Olanzapina Teva-ratio

• The active ingredient is olanzapine. Each tablet contains 10 mg of active ingredient.
• The other components are: Core excipients: Lactose monohydrate, croscarmellose

sodium, pregelatinized corn starch, hydroxypropylcellulose, magnesium stearate, anhydrous colloidal silica, corn starch and microcrystalline cellulose. Coating excipients:

Hydroxypropylmethylcellulose, polyethylene glycol 6000 and titanium dioxide (E171).

Product Appearance and Container Content

Olanzapina Teva-ratio 10 mg tablets are white, round, concave, 10 mm in diameter and coated.

Olanzapina Teva-ratio 10 mg is presented in tablet form. It is presented in packs of 28 and

56 tablets.

Other presentations

Olanzapina Teva-ratio 2.5 mg: Pack of 28 tablets.

Olanzapina Teva-ratio 5 mg: Pack of 28 tablets.

Olanzapina Teva-ratio 7.5 mg: Pack of 56 tablets.

Marketing Authorization Holder and Manufacturer:

Marketing Authorization Holder

Teva Pharma, S.L.U.

Anabel Segura street, 11, Albatros B building, 1st floor,

Alcobendas, 28108, Madrid

Manufacturer

Teva Pharma, S.L.U.

Malpica industrial estate, C/ 4.

50016 Zaragoza

Date of the Last Revision of this Prospectus:April 2020

Detailed and updated 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/

You can access detailed and updated information about this medicinal product by scanning the QR code included in the packaging with your mobile phone (smartphone). You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/73459/P_73459.html