Package Leaflet: Information for the User

Olanzapine Teva-ratio 2.5 mg Film-Coated Tablets

Olanzapine

Read this 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. Do not pass it on to others even if they have the same symptoms as you, as it may harm them.

• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4

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

2. What you need to know before you start taking 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 additional information.

Olanzapina Teva-ratio contains the active ingredient Olanzapina. Olanzapina Teva-ratio belongs to a group of medicines called antipsychotics.

Olanzapina Teva-ratio is used for:

?Treating a condition with symptoms such as hearing, seeing or feeling things that are not real, false beliefs

incorrect, unusual suspicion and a tendency to withdraw. People who suffer from these

conditions may also be depressed, anxious or tense.

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

Do not take Olanzapina Teva-ratio

?If you are allergic to the active ingredient or any of the other components of

this medication (listed in section 6). An allergic reaction may manifest itself

in the form of a rash, itching, swelling of the face or lips, or difficulty breathing. If

this happens, tell your doctor.

?If you have previously been diagnosed with eye problems such as certain types of

glaucoma (increased eye pressure).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Olanzapina Teva-ratio .

?Olanzapina is not recommended for elderly patients with dementia, as it may have

severe side effects.

?Medications of this type may cause unusual movements, especially in the face or

tongue. If this happens after taking Olanzapina, tell your doctor.

?In rare cases, medications of this type can cause a combination of fever, rapid

breathing, sweating, muscle stiffness, and a state of confusion or drowsiness. If

this happens, contact your doctor immediately.

?Weight gain has been observed in patients taking Olanzapina. You and your doctor

should regularly check your weight. If necessary, your doctor can help you plan a

diet or refer you to a nutritionist.

?Elevated levels of sugar and fats (triglycerides and cholesterol) in the blood have

been observed in patients taking Olanzapina. Your doctor should perform blood tests

to monitor your blood sugar and fat levels before starting Olanzapina and regularly

during treatment.

?If you or a family member 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:

• Diaabetes

• Heart disease

• Liver or kidney disease

• Parkinson's disease

• Epilepsy

• Prostate problems

• Intestinal blockage (Paralytic ileus)

• Blood disorders

• Cerebral infarction or transient cerebral ischemia (temporary lack of blood flow to the

brain).

If you have dementia, you or your caregiver should inform your doctor if you have ever had a

cerebral infarction or transient cerebral ischemia.

As a routine precaution, if you are over 65 years old, your doctor should check your blood pressure.

Children and adolescents

Patients under 18 years old should not take Olanzapina Teva-ratio .

Other medications and Olanzapina Teva-ratio

Only use other medications at the same time as Olanzapina Teva-ratio , if your doctor authorizes it.

You may feel drowsy if you combine Olanzapina Teva-ratio with antidepressants or medications for anxiety or sleep (tranquilizers).

Inform your doctor if you are taking fluvoxamine (antidepressant) or ciprofloxacin (antibiotic), as

your Olanzapina Teva-ratio dose may need to be adjusted.

Inform your doctor or pharmacist if you are taking or have recently taken other medications or may need to take another medication.

Inform 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). You may need to change your Olanzapina Teva-ratio dose.

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

Olanzapina Teva-ratio can be taken with or without food. Do not drink alcohol if you have been given Olanzapina Teva-ratio , as the combination of Olanzapina Teva-ratio and alcohol may cause drowsiness.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor before using this medication.

Pregnancy

Newborn babies of mothers who have taken Olanzapina Teva-ratio in the last trimester of pregnancy may experience the following symptoms: tremors, muscle stiffness, and/or weakness, drowsiness, agitation, breathing difficulties, and feeding problems. If your newborn baby experiences any of these symptoms, contact your doctor.

Breastfeeding

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

Driving and operating machinery

Olanzapina Teva-ratio may cause symptoms such as drowsiness, dizziness, or visual disturbances, and may impair your ability to react. These effects, as well as the underlying condition, may make it difficult for you to drive vehicles or operate machinery. Therefore, do not drive, operate machinery, or engage in other activities that require special attention, until your doctor assesses your response to this medication.

Olanzapina Teva-ratio contains lactose and sodium

This medication contains lactose. If your doctor has told you that you have a certain sugar intolerance, consult with them before taking this medication.

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

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist.

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

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

You should take your Olanzapina Teva-ratio tablets once a day, following your doctor's instructions. 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 Olanzapina Teva-ratio than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

Patients who have taken more Olanzapina Teva-ratio than they should have experienced the following symptoms:

rapid heartbeats, agitation/aggressiveness, 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 rigidity, drowsiness or lethargy, slowed respiratory frequency, aspiration, increased or decreased blood pressure, abnormal heart rhythms.

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 interrupt treatment with Olanzapina Teva-ratio

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

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

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

Patients under 18 years old should not take Olanzapina Teva-ratio.

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

Contact your doctor immediately if you have:

?Unusual movements (a common 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, see your doctor immediately

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

Side effects very common: (can 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 experience dizziness or fainting (with slower heart rate), especially when getting up from lying or sitting. This feeling usually disappears spontaneously, but if it did not, report it to your doctor

Side effects common: (can affect up to 1 in 10 patients)

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

?Increased levels of sugar in the blood and urine

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

?Increased appetite

?Dizziness

?Restlessness

?Tremor

?Strange movements (dyskinesia)

?Constipation

?Dry mouth

?Skin rash

?Joint pain

?Loss of strength

?Excessive fatigue

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

?Fever

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

Side effects rare: (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 the blood and urine) or coma

?Convulsions, in most cases related to a history of convulsions (epilepsy)

?Muscle stiffness or spasms (including eye movements)

?Restless legs syndrome

?Speech problems

?Slow pulse

?Abnormal heart rhythm

?Sensitivity to sunlight

?Nasal bleeding

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

?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

Side effects rare (can affect up to 1 in 1000 patients)

?Decreased platelets

?Decreased normal body temperature

?Withdrawal syndrome when stopping treatment

?Sudden death without apparent explanation

?Rapid pulse

?Pancreatitis, which causes severe stomach pain, fever, and discomfort

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

?Muscle disorder that presents as unexplained pain

?Prolonged and/or painful erection

Side 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 fatigue, visual hallucinations, increased body temperature, skin redness, and walking difficulties.

A small increase in the number of deaths in elderly patients with dementia treated with antipsychotics has been reported, 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 taking this type of medication for a long period may experience milk production by the breast gland, stop menstruating, or have irregular periods. If this situation persists, consult your doctor. In very rare cases, babies born to mothers who have taken Olanzapine Teva-ratio in the last stage of pregnancy (third trimester) may experience tremor, drowsiness, or lethargy.

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

Reporting of side effects:

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Vigilance of Medicines for Human Use:https://www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

This medication does not require special storage conditions.

Do not use this medication after the expiration date that appears on the carton and blister packaging after "CAD". The expiration date is the last day of the month indicated.

Do not dispose of medications through drains or trash. Dispose of packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and unused medications. By doing so, you will help protect the environment.

Composition of Olanzapina Teva-ratio

- The active ingredient is olanzapine. Each tablet contains 2.5 mg of active ingredient.

- The other components are: Core excipients: Lactose monohydrate, croscarmellose sodium, pregelatinized cornstarch, hydroxypropylcellulose, magnesium stearate, anhydrous colloidal silica, cornstarch, and microcrystalline cellulose. Coating excipients:

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

Appearance of the product and content of the packaging

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

Olanzapina Teva-ratio 2.5 mg is presented in tablet form. It is presented in packs of 28 tablets.

Other presentations

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

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

Olanzapina Teva-ratio 10 mg: Pack of 28 or 56 tablets.

Holder of the marketing authorization and responsible for manufacturing:

Holder of the marketing authorization

Teva Pharma, S.L.U.

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

Alcobendas, 28108, Madrid

Responsible for manufacturing

Teva Pharma, S.L.U.

Malpica Industrial Estate c/C 4.

50016 Zaragoza

Date of the last review of this leaflet:April 2020

The detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/

You can access detailed and updated information on this medicine by scanning with your smartphone the QR code included in the carton. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/73461/P_73461.html