OlaX 5 mg tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

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, as 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 only. Do not give it to others, even if they have the same symptoms as you, because it may 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. How to store 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whose symptoms include hearing, seeing, or sensing unreal things, false beliefs, unusual suspiciousness, and becoming withdrawn. People with this disorder may also feel depressed, anxious, or tense.
• Moderate to severe manic episode, 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 use in 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 promptly.

• Very rarely, medications of this type may cause a combination of symptoms including fever, rapid breathing, sweating, muscle stiffness, 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 taking Olazax and regularly during treatment.

• 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, it is advisable for your doctor to 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 at the same time as Olazax if your doctor has instructed you to do so. You may feel drowsy if Olazax is combined with antidepressants or medicines for anxiety or sleep (tranquilisers).

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Specifically, tell your doctor if you are taking:

• medication for Parkinson's disease

• carbamazepine (an antiepileptic and mood stabiliser), 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 are planning to become pregnant, consult your doctor before using this medicine. You should not take this medicine while breastfeeding, as small amounts of Olazax may pass into breast milk.

The following symptoms may occur in newborn babies whose mothers have been treated with Olazax during the third trimester of pregnancy (last three months of pregnancy): tremor, muscle stiffness and/or weakness, drowsiness, 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 somnolence 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. Olanzapina 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 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 or decreased blood pressure, and abnormal heart rhythms. Contact your doctor or go immediately to the hospital if you experience 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 advises.

If you stop taking Olazax suddenly, symptoms such as sweating, inability to sleep, tremor, anxiety, or nausea and vomiting may occur. Your doctor may recommend that you 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 may 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 every 10 people), especially of the face or tongue.

• Blood clots in the veins (an uncommon adverse effect which may affect up to 1 in every 100 people), particularly in the legs (symptoms include sweating, leg pain, and redness), 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.
• A 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 experience dizziness or fainting (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 levels of blood sugar and sugar in urine.
• Increased levels of uric acid and creatine phosphokinase in the blood.
• Increased appetite.
• Dizziness.
• Agitation.
• Tremor.
• Strange 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, which in most cases are 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 reduction of menstrual periods
• Changes in the breast gland in men and women, such as abnormal production of breast milk or abnormal 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 general discomfort.
• 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 treatment with olanzapine, 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 group of patients.

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 listed 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 must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of any unused medicine and its packaging. This 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, or 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, bevel-edged, yellow tablets with a "B" engraved on one side.

Olazax 7.5 mg:
Round, bevel-edged, yellow tablets with a "C" engraved on one side.

Olazax 10 mg:
Round, bevel-edged, yellow tablets with "OL" engraved on one side and a "D" on the other side.

Olazax 15 mg:
Round, bevel-edged, yellow tablets with "OL" engraved on one side and an "E" on the other side.

Olazax 20 mg:
Round, bevel-edged, yellow tablets with "OL" engraved 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 review of this leaflet: May 2020

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