Leaflet: information for the user

Olazax 5 mg EFG tablets

Olazax 7.5 mg EFG tablets

Olazax 10 mg EFG tablets

Olazax 15 mg EFG tablets

Olazax 20 mg EFG 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, consult your doctor or pharmacist.
• This medicine has been prescribed for you and should not be given 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.

Contents of the leaflet:

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

Olazax contains the active ingredient olanzapine. Olazax belongs to a group of medicines called antipsychotics and is indicated for the treatment of the following diseases:

Olazax has demonstrated the ability to prevent the recurrence of these symptoms in patients with bipolar disorder whose manic episodes have responded to treatment with olanzapine.

Do not take Olazax

• If you are allergic to olanzapine or any of the other components of this medication (listed in section 6). An allergic reaction may manifest as 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 pressure in the eye).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Olazax

• Olazax is not recommended for use in elderly patients with dementia as it may have severe adverse effects.

• Medications of this type may cause unusual movements, especially in the face or tongue. If this happens after taking Olazax, tell your doctor.
• In rare cases, medications of this type produce a combination of fever, rapid breathing, sweating, muscle rigidity, and a state of confusion or drowsiness. If this occurs, contact your doctor immediately.
• Weight gain has been observed in patients taking Olazax. You and your doctor should check your weight regularly. If necessary, your doctor may help you plan a diet or refer 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 monitor your blood sugar and fat levels before starting Olazax 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:

If you have dementia, you or your caregiver or family member should inform your doctor if you have ever had a stroke or transient ischemic attack.

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 old should not take Olazax.

Use of Olazax with other medications

Only use other medications at the same time as Olazax if your doctor authorizes it. You may feel drowsy if you combine Olazax with antidepressants or medications for anxiety or sleep (tranquilizers).

Inform your doctor or pharmacist if you are using, have used recently

or may need to use any other medication.

Specifically, 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 adjust your Olazax dosage.

Use of Olazax with alcohol

You should not drink alcohol if you have been given Olazax as it 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. Do not take this medication while 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, rigidity, and/or muscle weakness, drowsiness, agitation, breathing difficulties, and feeding problems. If your baby develops any of these symptoms, contact your doctor.

Driving and operating machinery

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

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

Follow exactly the administration instructions for this medication as indicated by your doctor. If in 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 to 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. Olazax coated tablets are for oral administration. You should swallow the Olazax tablets whole with water.

If you take more Olazax than you should

Patients 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 reduced consciousness level. 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. Contact your doctor or go to the hospital immediately if you notice any of the mentioned symptoms. Show the packaging with the tablets to the doctor.

If you forgot to take Olazax

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

If you interrupt treatment with Olazax

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

If you stop taking Olazax suddenly, you may experience symptoms such as sweating, inability to sleep, tremors, anxiety, 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 medication, ask your doctor or pharmacist.

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

Immediately contact your doctor if you have:

?unusual movements (a frequent side effect that can affect up to 1 in 10 people), especially of the face or tongue.

Frequent side effects (which can 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 lying down or sitting. This feeling usually disappears on its own, but if it does not, consult your doctor.

Frequent side effects (which can affect up to 1 in 10 people) include:

• Changes in levels of some circulating blood cells and lipids at the beginning of treatment, temporary increases in liver enzymes.
• Increased levels of blood sugar and urine.
• Increased levels of uric acid and creatine phosphokinase in the blood.
• Increased appetite.
• Dizziness.
• Agitation.
• Tremor.
• Strange movements (dyskinesia).
• Language alterations.
• Constipation.
• Dry mouth.
• Skin rash.
• Loss of strength.
• Excessive fatigue.
• Fever
• Joint pain
• Fluid retention causing inflammation of the hands, ankles, or feet,
• Sexual dysfunction such as decreased libido in men and women or erectile dysfunction in men.

Rare side effects (which can affect up to 1 in 100 people) include:

• Hyper sensitivity (e.g.inflammation of the mouth andthroat, itching, skin rash)
• Diabetes or worsening of diabetes, occasionally related to ketoacidosis (acetone in the 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
• Stammering
• Slow pulse.
• Sensitivity to sunlight.
• Nasal bleeding
• Abdominal distension
• Excessive salivation
• Memory loss or forgetfulness
• Urinary incontinence, loss of ability to urinate.
• Loss of hair.
• Absence or decrease of menstrual periods.
• Changes in the breast gland in men and women such as abnormal milk production or abnormal growth.

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

• Decreased normal body temperature.
• Abnormal heart rhythm.
• Sudden death without apparent explanation.
• Pancreatitis, which causes severe stomach pain, fever, and discomfort.
• Liver disease, with yellowing of the skin and white parts of the eye.
• Muscular disorder that presents as unexplained pain.
• Prolonged and/or painful erection.

Very rare side effects (which can affect up to 1 in 10,000 people) include:

• Severe allergic reactions, such as Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) DRESS initially presents with symptoms similar to the flu, with skin rash on the face that then 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).

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

Olanzax may worsen symptoms in patients with Parkinson's disease.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the national notification system included in theAnnex V.By reporting side effects, you can contribute to providing more information about the safety of this medicine.

Keep out of sight and reach of children.

Do not use this medication after the expiration date shown on the packaging and blister. The expiration date refers to the last day of the month indicated.

Store below 30 °C.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and medication that you no longer need. This will help protect the environment.

Composition of Olazax

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

Appearance of Olazax and contents of the packaging

Olazax 5 mg:

Round tablets with a flat, bisected edge and a yellow color with a "B" inscribed on one face.

Olazax 7.5 mg:

Round tablets with a flat, bisected edge and a yellow color with a "C" inscribed on one face.

Olazax 10 mg:

Round tablets with a flat, bisected edge and a yellow color with "OL" inscribed on one face and a "D" inscribed on the other face.

Olazax 15 mg:

Round tablets with a flat, bisected edge and a yellow color with "OL" inscribed on one face and an "E" inscribed on the other face.

Olazax 20 mg:

Round tablets with a flat, bisected edge and a yellow color with "OL" inscribed on one face and an "F" inscribed on the other face.

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

Only some packaging sizes may be commercially marketed.

Holder of the marketing authorization and responsible for manufacturing

Responsible for marketing

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

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

Date of the last review of this leaflet:May 2020

The detailed information of this medication is available on the website of the European Medicines Agency (EMA)http://www.emea.europa.eu