OlaX 10 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Olazax 5 mg tablets EFG

Olazax 7.5 mg tablets EFG

Olazax 10 mg tablets EFG

Olazax 15 mg tablets EFG

Olazax 20 mg tablets EFG

Olanzapine

Read the entire 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, ask your doctor or pharmacist.
• This medicine has been prescribed for you and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Package leaflet contents:

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

1. What Olazax is and what it is 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 conditions:

• Schizophrenia, a disorder whose symptoms include hearing, seeing, or sensing things that are not real, false beliefs, unusual suspiciousness, and social withdrawal. People with this condition may also feel 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 starting to 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 appear 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 Olazax

• Olazax is not recommended for elderly patients with dementia, as it may cause serious adverse effects.

• Medications of this type may cause unusual movements, particularly of the face or tongue. If this occurs after taking Olazax, inform your doctor immediately.

• Very rarely, medicines of this type may cause a combination of fever, rapid breathing, sweating, muscle rigidity, and mental status changes such as confusion or drowsiness. If you experience these symptoms, contact your doctor immediately.

• Weight gain has been observed in patients taking Olazax. You and your doctor should monitor your weight regularly. If necessary, your doctor may help you plan a diet or consider referring you to a nutritionist.

• Elevated levels of blood sugar and fats (triglycerides and cholesterol) have been observed in patients taking Olazax. Your doctor should perform blood tests to monitor your blood sugar and lipid levels before you start treatment and regularly during therapy.

• If you or someone in your family 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:

• Stroke or transient ischemic attack (temporary stroke-like symptoms)
• Parkinson's disease
• Prostate problems
• Intestinal blockage (paralytic ileus)
• Liver or kidney disease
• Blood disorders
• Heart disease
• Diabetes
• Seizures

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 of age, your doctor should monitor your blood pressure.

Children and adolescents

Patients under 18 years of age must not take Olazax.

Use of Olazax with other medicines

Only use other medicines together with Olazax if your doctor has authorized it. You may experience drowsiness if Olazax is combined with antidepressants or medicines for anxiety or sleep (tranquilizers).

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

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). Your Olazax dose may need to be adjusted.

Use of Olazax with alcohol

You should not drink alcohol if you have been administered Olazax, as it may 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 must not take this medicine 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 during the third trimester of pregnancy (last three months of pregnancy): tremors, muscle rigidity and/or weakness, somnolence, agitation, breathing difficulties, and feeding problems. If your baby develops any of these symptoms, you should contact your doctor.

Driving and operating machinery

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

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

3. How to take Olazax

Follow exactly the instructions for use of this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again. Consult your doctor or pharmacist if you have any questions.

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 your symptoms return, but do not stop taking Olazax unless your doctor tells you to.

You should take your Olazax tablets once daily, as directed by your doctor. Try to take the tablets at the same time each day. You may take them with or without food. Olazax coated tablets are for oral administration. 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 level of consciousness. Other possible symptoms include: acute confusion, seizures (epilepsy), coma, a combination of fever, rapid breathing, sweating, muscle rigidity, drowsiness or lethargy, slowed breathing rate, aspiration, increased blood pressure, or decreased blood pressure, and abnormal heart rhythms. Contact your doctor or go to the hospital immediately if you notice any of the symptoms listed above. Show the doctor the pack 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 missed doses.

If you interrupt treatment with Olazax

Do not stop treatment just because you feel better. It is very important to continue taking Olazax for as long as your doctor recommends.

If you stop taking Olazax suddenly, symptoms such as sweating, inability to sleep, tremor, anxiety, or nausea and vomiting may occur. Your doctor may advise you to gradually reduce the dose before stopping treatment.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

Contact your doctor immediately if you have:

? Unusual movements (a common adverse effect which may affect up to 1 in 10 people), especially of the face or tongue.

• Blood clots in veins (an uncommon adverse effect which may affect up to 1 in 100 people), particularly in the legs (symptoms include sweating, pain, and redness in the leg), which may travel through the bloodstream to the lungs, causing chest pain and difficulty breathing. If you experience any of these symptoms, seek medical attention immediately.
• Combination of fever, rapid breathing, sweating, muscle stiffness, and mental confusion or drowsiness (frequency cannot be estimated from available data).

Very common adverse 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 sensation usually resolves spontaneously, but if it does not, consult your doctor.

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

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

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

• Hypersensitivity (e.g., mouth and throat swelling, itching, skin rash)
• Diabetes or worsening of diabetes, occasionally associated with ketoacidosis (ketones in blood and urine) or coma
• Seizures, mostly occurring in patients with 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 reduction of menstrual periods
• Changes in breast glands in men and women, such as abnormal milk production or abnormal breast growth

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

• Decrease in normal body temperature
• Abnormal heart rhythm
• Sudden unexplained death
• Inflammation of the pancreas, causing severe stomach pain, fever, and malaise
• Liver disease, with yellowing of the skin and whites of the eyes (jaundice)
• Muscle disorder presenting as unexplained muscle pains
• Prolonged and/or painful erection

Very rare adverse 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 initially presents with flu-like symptoms, skin rash starting on the face and spreading to other areas, fever, swollen lymph nodes, elevated liver enzymes in blood tests, and increased levels of a type of white blood cell (eosinophilia).

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

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

Reporting of adverse reactions

If you experience any type of adverse reaction, consult your doctor or pharmacist, even if it is a possible adverse reaction not listed in this leaflet. You may also report them directly through the national reporting system detailed in Annex V. By reporting adverse reactions, 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 stated on the packaging and blister. The expiry date refers to the last day of the month indicated.

Store below 30 °C.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging you no longer need. This way, you will help protect the environment.

6. Contents of the container and additional 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 components 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, biconvex, yellow tablets with a bevelled edge, marked with a "B" on one side.

Olazax 7.5 mg:
Round, biconvex, yellow tablets with a bevelled edge, marked with a "C" on one side.

Olazax 10 mg:
Round, biconvex, yellow tablets with a bevelled edge, marked with "OL" on one side and a "D" on the other side.

Olazax 15 mg:
Round, biconvex, yellow tablets with a bevelled edge, marked with "OL" on one side and an "E" on the other side.

Olazax 20 mg:
Round, biconvex, yellow tablets with a bevelled edge, marked with "OL" on one side and an "F" on the other side.

Olazax 5 mg, 7.5 mg, 10 mg, 15 mg, 20 mg is available in aluminum foil blisters containing 28 and 56 tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturing Responsible Party

Marketing Authorization Holder

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

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

Date of the most recent 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