OLANZAPINE STADA 5 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Olanzapine Stada 5 mg film-coated tablets EFG

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this 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 signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

1. What is Olanzapine Stada and what is it used for

Olanzapine Stada contains the active substance olanzapine. Olanzapine belongs to a group of medicines called antipsychotics and is used to treat the following diseases:

• Schizophrenia, a disease whose symptoms are hearing, seeing, or feeling unreal things, mistaken beliefs, unusual suspicion, and becoming withdrawn. People suffering from these diseases may also be depressed, anxious, or tense.
• Moderate to severe manic disorder, characterized by symptoms such as excitement or euphoria.

Olanzapine Stada 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 you take Olanzapine Stada

Do not take Olanzapine Stada:

• If you are allergic to olanzapine or 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

Consult your doctor or pharmacist before starting to take Olanzapine Stada.

• Olanzapine Stada is not recommended for use in elderly patients with dementia, as it may have serious side effects.
• Medicines of this type may cause unusual movements, especially in the face or tongue. If this happens to you after taking Olanzapine Stada, 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.

A weight gain has been observed in patients taking Olanzapine Stada. 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 fat (triglycerides and cholesterol) have been observed in the blood of patients taking Olanzapine Stada. Your doctor should perform blood tests to check your blood sugar and fat levels before you start taking Olanzapine Stada 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 the formation of blood clots.

If you suffer from any of the following diseases, tell your doctor as soon as possible:

• Stroke or transient cerebral ischemia (transient stroke symptoms).
• Parkinson's disease
• Prostate problems
• Intestinal obstruction (paralytic ileus)
• Liver or kidney disease
• Blood disorders
• Heart disease
• Diabetes
• Seizures

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 Stada.

Use of Olanzapine Stada with other medicines

Only use other medicines at the same time as Olanzapine Stada if your doctor authorizes it. You may feel a certain sensation of drowsiness if you combine Olanzapine Stada with antidepressants or medicines for anxiety or that help you sleep (tranquilizers).

Tell your doctor or pharmacist if you are using, have recently used, or may need to use any other medicine.

In particular, 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 dose of Olanzapine Stada may need to be changed.

Use of Olanzapine Stada with alcohol

You should not drink alcohol if you have been given Olanzapine Stada, as it may cause drowsiness.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medicine.

You should not take this medicine when you are breastfeeding, as small amounts of Olanzapine Stada may pass into breast milk.

The following symptoms may occur in newborns of mothers who have used Olanzapine Stada in the last trimester (last three months of pregnancy): tremors, muscle stiffness, and/or weakness, drowsiness, agitation, respiratory problems, and difficulty eating. If your baby has any of these symptoms, contact your doctor.

Driving and using machines

There is a risk of drowsiness when taking Olanzapine Stada. If this happens to you, do not drive vehicles or use machinery. Consult your doctor.

Olanzapine Stada contains lactose and soy lecithin

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 soybean oil. It should not be used in case of peanut or soy allergy.

3. How to take Olanzapine Stada

Follow exactly the administration instructions of this medicine indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Your doctor will tell you how many Olanzapine Stada tablets you should take and for how long. The daily dose of Olanzapine Stada ranges from 5 mg to 20 mg. Consult your doctor if you suffer from symptoms again, but do not stop taking Olanzapine Stada unless your doctor tells you to.

You should take your Olanzapine Stada tablets once a day, following your doctor's instructions. Try to take the tablets at the same time every day. You can take them with or without food. Olanzapine Stada film-coated tablets are for oral administration. You should swallow the Olanzapine Stada tablets whole with water.

If you take more Olanzapine Stada than you should

Consult your doctor, pharmacist, or call the Toxicology Information Service immediately, telephone 91 562 04 20, indicating the medicine and the amount used.

Patients who have taken more Olanzapine Stada 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. Contact your doctor or go to the hospital immediately if you notice any of the above symptoms. Show the doctor the package with the tablets.

If you forget to take Olanzapine Stada

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

If you stop taking Olanzapine Stada

Do not stop treatment just because you feel better. It is very important that you continue taking Olanzapine Stada while your doctor tells you to.

If you stop taking Olanzapine Stada suddenly, symptoms such as sweating, insomnia, tremors, anxiety, or nausea and vomiting may appear. Your doctor may suggest that you gradually reduce the dose before stopping treatment.

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

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 people), especially of the face or tongue.
• blood clots in the veins (a rare side effect that can affect up to 1 in 100 people), 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 a 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 (may affect more than 1 in 10 people) include weight gain, drowsiness, and increased prolactin levels in the blood. In the early stages of treatment, some people may feel dizzy or faint (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, consult your doctor.

Common side effects (may affect up to 1 in 10 people) include changes in the levels of some blood cells and circulating lipids, and at the beginning of treatment, temporary increases in liver enzymes, increased blood sugar and urine levels, increased uric acid and creatine phosphokinase levels in the blood, increased appetite, dizziness, agitation, tremors, unusual movements (dyskinesia), constipation, dry mouth, skin rash, loss of strength, excessive fatigue, fluid retention that causes swelling of the hands, ankles, or feet, fever, joint pain, and sexual dysfunctions such as decreased libido in men and women or erectile dysfunction in men.

Rare side effects (may affect up to 1 in 1,000 people) include 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, sensitivity to sunlight, nosebleeds, abdominal distension, excessive salivation, memory loss or forgetfulness, urinary incontinence, loss of urination ability, hair loss, absence or decrease of menstrual periods, and changes in the mammary gland in men and women, such as abnormal milk production or abnormal growth.

Very rare side effects (may affect up to 1 in 10,000 people) include a drop in normal body temperature, abnormal heart rhythm, sudden unexplained death, pancreatitis, which causes severe stomach pain, fever, and discomfort, liver disease, with yellowing of the skin and the white parts of the eyes, muscle disorder that presents as unexplained pain and weakness, and prolonged and/or painful erections.

Very rare side effects include severe allergic reactions such as drug reaction with eosinophilia and systemic symptoms (DRESS). Initially, DRESS manifests with symptoms similar to the flu, with a rash on the face, and later with an extensive rash, fever, swollen lymph nodes, elevated liver enzymes observed in blood tests, and an increase in a type of white blood cell in the blood (eosinophilia).

During treatment with olanzapine, elderly patients with dementia may suffer from stroke, pneumonia, urinary incontinence, falls, extreme fatigue, visual hallucinations, a rise in body temperature, skin redness, and walking problems. Some deaths have been reported in this particular group of patients.

Olanzapine Stada may worsen symptoms in patients with Parkinson's disease.

Reporting of side effects

If you experience any side effect, consult your doctor 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 Pharmacovigilance System for Human Use Medicines: http://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

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5. Storage of Olanzapine Stada

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

Do not use this medicine after the expiry date which is stated on the carton, after EXP. The expiry date refers to the last day of the month stated.

No special storage conditions are required. Store in the original package.

Medicines should not be disposed of via wastewater or household waste. Place the package and any unused medicine in the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of the package and any unused medicine. This will help protect the environment.

6. Contents of the pack and other information

Composition of Olanzapine STADA

• The active substance is olanzapine. Each tablet contains 5 mg of active substance.

• The other ingredients (excipients) are: lactose monohydrate, microcrystalline cellulose, low-substituted hydroxypropylcellulose, crospovidone, anhydrous colloidal silica, magnesium stearate, polyvinyl alcohol, titanium dioxide, talc, soy lecithin (E322), xanthan gum, and purified water.

Appearance of the product and pack contents

Olanzapine STADA 5 mg is presented in the form of film-coated tablets. The tablets are round, white, with the inscription "5" on one face.

It is presented in packs of 28 tablets.

Marketing authorization holder and manufacturer:

Marketing authorization holder:

Laboratory STADA, S.L. Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Manufacturer:

Neuraxpharm Pharmaceuticals, S.L.

Avda. Barcelona, 69

08970 Sant Joan Despí (Barcelona)

Spain

Date of the last revision of this leaflet:April 2020

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