OLANZAPINE SUN 10 mg TABLETS

Introduction

Package Leaflet: Information for the User

OlanzapineSUN 10mg tabletsEFG

olanzapine

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 and other information:

1. What Olanzapine SUN tablets are and what they are used for
2. What you need to know before you take Olanzapine SUN tablets
3. How to take Olanzapine SUN tablets
4. Possible side effects
5. Storing Olanzapine SUN tablets
6. Contents of the pack and other information

1. What Olanzapine SUN tablets are and what they are used for

Olanzapine SUN contains the active substance olanzapine. Olanzapine belongs to a group of medicines called antipsychotics that are used to treat the following diseases:

• Schizophrenia, a disease with symptoms such as hearing, seeing or feeling unreal things, mistaken beliefs, unusual suspicion, and a tendency to withdraw. People suffering from this disease may also feel depressed, anxious or tense.

• Moderate to severe manic disorder, characterized by symptoms such as excitement or euphoria.

Olanzapine 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 SUN tablets

Do not take OlanzapineSUNtablets

• If you are allergic (hypersensitive) to olanzapine or any of the other ingredients of this medicine (listed in section 6). The allergic reaction can 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 eye pressure).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Olanzapine SUN tablets

• Olanzapine is not recommended for use 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.
• Very rarely, 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. 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. Elevated 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 control your blood sugar and fat levels before you start taking Olanzapine SUN tablets 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 lack of blood flow to the brain (transient stroke 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 salt loss due to prolonged and intense diarrhea and vomiting or due to the use of diuretic medications (urination 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 a transient 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

Patient under 18 years should not take Olanzapine SUN tablets.

Using OlanzapineSUNtablets with other medicines

Only use other medicines at the same time as Olanzapine SUN tablets if your doctor authorizes it. You may feel a certain sensation of sleepiness if you combine Olanzapine SUN tablets with antidepressants or medications 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 medication.

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). You may need to change your dose of Olanzapine SUN tablets.

Taking Olanzapine SUN tablets with alcohol

You should not drink alcohol if you have been given Olanzapine SUN tablets because the combination with alcohol can cause sleepiness.

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 should not take this medicine during pregnancy unless your doctor recommends it.

You should not take this medicine while breastfeeding as small amounts of Olanzapine may pass into breast milk.

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

Driving and using machines

There is a risk of feeling sleepy when you are taking Olanzapine SUN tablets. If this happens to you, do not drive vehicles or use machinery. Consult your doctor.

OlanzapineSUNtablets contain lactose

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

3. How to take Olanzapine SUN tablets

Follow exactly the administration instructions of this medicine indicated by your doctor. In case of 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 tablets ranges from 5 to 20 mg. Consult your doctor if you suffer from symptoms again, but do not stop taking Olanzapine SUN tablets unless your doctor tells you to.

You should take your Olanzapine 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 tablets are for oral administration. You should swallow the Olanzapine tablets whole with water.

If you take more Olanzapine SUNtabletsthan you should

Patient who have taken more Olanzapine tablets 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 be: 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, abnormal heart rhythms. Contact your doctor or go to the hospital immediately if you notice any of the above symptoms. It is recommended to show the medicine package to the doctor.

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

If you forget to take Olanzapine SUN tablets

Take your tablet as soon as you remember. Do not take two doses in one day.

If you stop taking Olanzapine SUN tablets

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

If you suddenly stop taking Olanzapine tablets, you may have symptoms such as sweating, insomnia, tremors, anxiety, nausea, or vomiting. Your doctor may suggest reducing the dose gradually 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, 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 (may affect more than 1 in 10 people):

• 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 getting up from a sitting or lying position. This sensation usually disappears on its own, but if it does not, consult your doctor.

Common side effects (may affect up to 1 in 10 people):

• Changes in the levels of some circulating blood cells and fats, and temporary increases in liver enzymes at the start of treatment
• Increased levels of sugar and uric acid in the blood
• Increased levels of creatine phosphokinase in the blood
• Increased appetite
• Dizziness
• Fatigue
• Tremors
• Unusual movements (dyskinesia)
• Constipation
• Dry mouth
• Hives
• Loss of strength
• Extreme fatigue
• Fluid retention that can lead to swelling of the hands, ankles, or feet.
• Fever
• Pain in the joints
• Sexual dysfunction such as decreased libido in men and women or erectile dysfunction in men.

Rare side effects (may affect up to 1 in 1000 people) include:

• Decrease in normal body temperature
• Abnormal heart rhythm
• Sudden and unexplained death
• Pancreatitis, which can cause stomach pain, fever, and dizziness.
• Liver disease, which manifests as yellowing of the skin and the white part of the eyes.
• Muscle disease, manifested as unexplained pains and aches.
• Prolonged and/or painful erections

Very serious side effects include severe allergic reactions, such as Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS). DRESS is initially manifested 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 levels of liver enzymes in blood tests, and an increase in a type of white blood cell (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, redness of the skin, and walking problems. Deaths have been reported in this particular group of patients.

Olanzapine SUN tablets may worsen the symptoms of patients with Parkinson's disease.

Reporting of side effects:

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Olanzapine SUN tablets

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

Do not use this medicine after the expiration date that appears on the packaging. The expiration date is the last day of the month indicated.

This medicine does not require special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and medicines you no longer need in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Contents of the pack and other information

Composition of Olanzapine SUN tablets

• The active substance is olanzapine. Each coated tablet contains 10 mg of active substance.
• The other ingredients are: anhydrous lactose, microcrystalline cellulose, low-substituted hydroxypropyl cellulose, and magnesium stearate.

Appearance of Olanzapine SUN tablets and pack contents

Olanzapine SUN 10 mg tablets EFG are presented in the form of tablets, light yellow to yellow in color, slightly speckled, round, biconvex, with the inscription "O7" in low relief on one of their faces and smooth on the other face.

This medicine is available in packs of 7, 10, 14, 28, 30, 35, 56, and 70 mg tablets. Not all pack sizes may be marketed.

T

Marketing Authorization Holder:

Sun Pharmaceutical Industries Europe B.V.

Polarisavenue 87

2132 JH Hoofddorp

Netherlands

Manufacturer:

Sun Pharmaceutical Industries Europe B.V.

Polarisavenue 87

2132 JH Hoofddorp

Netherlands

or

Terapia SA,

Str. Fabricii Nr. 124,

Cluj Napoca, Romania

You can request more information about this medicine by contacting the local representative of the Marketing Authorization Holder:

Sun Pharma Laboratorios, S.L.

Rambla de Catalunya 53-55

08007 Barcelona.

Spain

Phone: +34 93 342 78 90

This medicine is authorized in the Member States of the EEA under the following names:

Austria- Olanzapine Ranbaxy 10mg Tabletter

France- Olanzapine SUN, 10mg Comprime

Germany- Olanzapine Basics 10mg tabletten

Netherlands- Olanzapine SUN 10mg tablet

Spain-Olanzapina SUN 10mg comprimidos EFG

Sweden- Olanzapina Ranbaxy 10mg Tablett

Date of last revision of this leaflet: July 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/