OLAZAX 10 mg TABLETS

1. What is Olazax and what is it used for

Olazax contains the active substance olanzapine. Olazax belongs to a group of medicines called antipsychotics and is indicated for the treatment of 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disease whose symptoms are hearing, seeing, or feeling unreal things, mistaken beliefs, unusual suspicion, and becoming withdrawn.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.

OLAZAX 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 OLAZAX

Do not take Olazax

• 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

Talk to your doctor or pharmacist before starting to take Olazax

• Olazax 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 Olazax, 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 Olazax. 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 Olazax. Your doctor should perform blood tests to control your blood sugar and fat levels before you start taking Olazax 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 temporary 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 suffer from dementia, you or your caregiver or relative should inform your doctor if you have ever had a stroke or a lack of blood flow to the brain.

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 Olazax.

Using Olazax with other medicines

Only use other medicines at the same time as Olazax if your doctor authorizes it. You may feel drowsy if you combine Olazax with antidepressants or medicines for anxiety or to 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 Olazax may need to be changed.

Using Olazax with alcohol

You should not drink alcohol if you have been given Olazax because it 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 when you are breastfeeding, as small amounts of Olazax may pass into breast milk.

The following symptoms may occur in newborn babies of mothers who have been treated with Olazax in the last trimester of pregnancy (last three months of pregnancy): tremors, stiffness and/or muscle weakness, drowsiness, agitation, breathing problems, and difficulty feeding. If your baby develops any of these symptoms, you should contact your doctor.

Driving and using machines

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

The Olazax tablets contain aspartame, which is a source of phenylalanine.The Olanzapine Glenmark tablets contain aspartame, which is a source of phenylalanine. Therefore, this medicine may be harmful to people with phenylketonuria.

3. How to take Olazax

Follow exactly the instructions of administration of this medicine indicated by your doctor. In case of doubt, consult your doctor or pharmacist again. Consult your doctor or pharmacist if you have any doubts.

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

You should take your Olazax 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. The Olazax film-coated tablets are for oral administration. You should swallow the Olazax tablets whole with water.

If you take more Olazax than you should

Patient who have taken more Olazax than they should have experienced the following symptoms: rapid heartbeat, 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 stiffness, drowsiness or lethargy, 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 Olazax

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

If you stop taking Olazax

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

If you stop taking Olazax suddenly, you may experience symptoms such as sweating, insomnia, tremors, anxiety, or nausea and vomiting. 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:

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• Blood clots in the veins (a rare side effect that may 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) include:

• 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 lying or sitting position. This feeling usually goes away 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, lipids, and liver enzymes.
• Increased levels of sugar in the blood and urine.
• Increased levels of uric acid and creatine phosphokinase in the blood.
• Increased appetite.
• Dizziness.
• Agitation.
• Tremors.
• Unusual movements (dyskinesia).
• Speech disorders.
• Constipation.
• Dry mouth.
• Rash.
• Loss of strength.
• Excessive fatigue.
• Fever
• Pain in the joints
• Fluid retention that causes swelling of the hands, ankles, or feet,
• Sexual dysfunctions such as decreased libido in men and women or erectile dysfunction in men.

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

• Hypersensitivity (e.g., inflammation of the mouth and throat, itching, rash)
• Diabetes or worsening of diabetes, occasionally related to ketoacidosis (acetone in blood and urine) or coma
• Seizures, most often related to a history of seizures (epilepsy)
• Muscle stiffness or spasms (including eye movements)
• Restless legs syndrome
• Speech problems
• Stuttering
• Slow pulse.
• Sensitivity to sunlight.
• Nosebleeds
• Abdominal distension
• Excessive salivation
• Memory loss or forgetfulness
• Urinary incontinence, loss of ability to urinate.
• Hair loss.
• Absence or decrease of menstrual periods.
• Changes in the mammary gland in men and women, such as abnormal milk production or abnormal growth.

Rare side effects (may affect up to 1 in 1,000 people) include:

• Decrease 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 muscle pain.
• Prolonged and/or painful erection.

Very rare side effects (may affect up to 1 in 10,000 people) 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 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 experience stroke, pneumonia, urinary incontinence, falls, extreme fatigue, visual hallucinations, a rise in body temperature, redness of the skin, and walking problems. Some deaths have been reported in this particular group of patients.

Olazax may worsen symptoms in 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 national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of OLAZAX

Keep out of the sight and reach of children.

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

Store below 30 ºC.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

Composition of Olazax

• The active substance is olanzapine.
• Each Olazax tablet contains 5 mg, 7.5 mg, 10 mg, 15 mg, 20 mg of olanzapine.
• The other ingredients are mannitol (E 421), microcrystalline cellulose, aspartame (E 951), crospovidone, and magnesium stearate.

Appearance of Olazax and contents of the pack

Olazax 5 mg:

round, flat, beveled-edge tablets, yellow in color with a "B" engraved on one face.

Olazax 7.5 mg:

round, flat, beveled-edge tablets, yellow in color with a "C" engraved on one face.

Olazax 10 mg:

round, flat, beveled-edge tablets, yellow in color with "OL" engraved on one face and a "D" engraved on the other face.

Olazax 15 mg:

round, flat, beveled-edge tablets, yellow in color with "OL" engraved on one face and an "E" engraved on the other face.

Olazax 20 mg:

round, flat, beveled-edge tablets, yellow in color with "OL" engraved on one face and an "F" engraved on the other face.

Olazax, 5 mg, 7.5 mg, 10 mg, 15 mg, 20 mg is presented in aluminum foil blisters of 28 & 56 tablets

Some pack sizes may only be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Glenmark Pharmaceuticals s.r.o. Hvezdova 1716/2b, 140 78 Praha 4, Czech Republic

Manufacturer Glenmark Pharmaceuticals s.r.o. Hvezdova 1716/2b, 140 78 Praha 4, Czech Republic

Date of last revision of this leaflet:May 2020

Detailed information on this medicine is available on the European Medicines Agency (EMA) website http://www.emea.europa.eu