OLANZAPINE SUN 2.5 mg TABLETS

2. What you need to know before you take Olanzapine SUN tablets

Do not take Olanzapine SUN tablets

• 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

Talk to 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.
• High levels of sugar and fats (triglycerides and cholesterol) in the blood have been observed in patients taking olanzapine. Your doctor should perform blood tests to check 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 symptoms of stroke)
• 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 loss of salts 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

Patients under 18 years of age should not take Olanzapine SUN tablets.

Using Olanzapine SUN tablets 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 drowsiness 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 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). 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 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. You should not take this medicine during pregnancy unless your doctor recommends it.

You should not take this medicine when you are breastfeeding because 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, 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 you are taking Olanzapine SUN tablets. If this happens to you, do not drive vehicles or use machinery. Consult your doctor.

Olanzapine SUN tablets 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 SUN 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 SUN tablets than you should

Patients 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, and 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 gradually reducing 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 (an uncommon 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 sitting or lying down. This feeling usually disappears on its own, but if it doesn't, 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 in the blood and urine
• Increased levels of uric acid and 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

Uncommon side effects (may affect up to 1 in 100 people):

• 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
• Stuttering
• Slow heartbeat
• Sensitivity to sunlight
• Nosebleeds
• Abdominal distension
• Excessive salivation
• Memory loss or forgetfulness
• Urinary incontinence
• Loss of ability to urinate
• Hair loss
• Absence or increase of menstrual periods
• Changes in the breasts in men and women, such as abnormal milk production or abnormal growth.

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

• 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 erection

Very rare side effects include severe allergic reactions, such as Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS). 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 enzyme levels in blood tests, and an increase in a type of white blood cell (eosinophilia).

If you experience side effects, talk to your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet.

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 type of side effect, talk to your doctor or pharmacist, even if it is a possible side effect not listed in the 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 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 at the SIGRE collection point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and further information

Composition of Olanzapine SUN tablets

• The active substance is olanzapine. Each coated tablet contains 2.5 mg of active substance.
• The other ingredients are: anhydrous lactose, microcrystalline cellulose, low-substitution hydroxypropyl cellulose, and magnesium stearate.

Appearance of Olanzapine SUN tablets and pack contents

Olanzapine SUN 2.5 mg tablets EFG are presented in the form of tablets, light yellow to yellow in color, slightly speckled, round, biconvex, with the inscription in low relief "O4" 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 with the following names:

Austria - Olanzapine Ranbaxy 2.5mg Tabletter

France - Olanzapine SUN, 2.5mg Comprimé

Germany - Olanzapine Basics 2.5mg tabletten

Netherlands - Olanzapine SUN 2.5mg tablet

Spain - Olanzapina SUN 2.5mg comprimidos EFG

Sweden - Olanzapina Ranbaxy 2.5mg Tablett

Date of the 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/