Patient Information Leaflet: Information for the User

Olazax 5 mg tablets, 7.5 mg tablets, 10 mg tablets, 15 mg tablets, 20 mg tablets

Olanzapine
Please read this leaflet carefully before taking this medicine, as it contains
important information for you.

Keep this leaflet. 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 other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:
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 E is and what it is used for

Olazax contains the active substance olanzapine. Olazax belongs to a group of medicines called antipsychotics and is used to treat the following conditions:

Schizophrenia, a disorder characterized by symptoms such as hearing, seeing, or experiencing things that do not exist, false beliefs, unjustified suspicion, and social withdrawal. People with this disorder may also feel depressed, anxious, or tense.
Moderate to severe manic episode, a condition characterized by symptoms of excitement or euphoria.

OLAZAX has been shown to prevent the recurrence of these symptoms in patients with bipolar disorder whose manic episode has responded to treatment with olanzapine.

2. What you need to know before taking Olanzapine Glenmark

Do not take Olazax

if you are allergic (hypersensitive) to olanzapine or to any of the other ingredients of this medicine (listed in section 6). An allergic reaction may include rash, itching, facial swelling, lip swelling, or shortness of breath. If you have experienced any of these, inform your doctor.
if you have previously been diagnosed with an eye problem such as certain types of glaucoma (increased pressure inside the eye).

Warnings and precautions
Talk to your doctor or pharmacist before taking Olazax

The use of Olazax in elderly patients with dementia is not recommended, as it may cause serious side effects.
Medicines of this type may cause unusual movements, especially of the face and tongue. If this occurs after starting Olazax, inform your doctor.
Very rarely, medicines of this type may cause a combination of symptoms including fever, rapid breathing, sweating, muscle stiffness, confusion or drowsiness. If this occurs, contact your doctor immediately.
Weight gain has been observed in patients taking Olazax. You and your doctor should monitor your weight regularly. If necessary, consider consulting a dietitian or following a dietary program.
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 check your blood sugar and certain fat levels before you start taking Olazax and regularly during treatment.
Inform your doctor if you or someone in your family has a history of blood clots, as medicines like this 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 ischaemic attack (TIA) (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 know you may lose excessive amounts of salt due to severe and prolonged diarrhoea or vomiting (due to illness) or from using diuretics (water tablets)

If you have dementia, you or your caregiver should inform your doctor if you have previously had a stroke or transient ischaemic attack.
As a routine precaution, if you are over 65 years old, have your blood pressure checked regularly by your doctor.
Children and adolescents
Olazax is not indicated for patients under 18 years of age.
Other medicines and Olazax
During treatment with Olazax, take other medicines only after consulting your doctor. You may feel drowsy if Olazax is taken together with antidepressants or medicines used for anxiety or to help you sleep (tranquillisers).
Inform your doctor if you are taking, have recently taken, or might take any other medicines.
In particular, inform your doctor if you are taking:

medicines for Parkinson's disease.
carbamazepine (an antiepileptic and mood stabiliser), fluvoxamine (an antidepressant), or ciprofloxacin (an antibiotic) – your dose of Olazax may need to be adjusted.

Olazax and alcohol
Do not drink any alcoholic beverages during treatment with Olazax, as taking Olazax together with alcohol may cause drowsiness.
Pregnancy and breastfeeding
If you are pregnant, breastfeeding, think you might be pregnant, or are planning to become pregnant, ask your doctor for advice before taking 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 newborns whose mothers have used Olazax during the third trimester (last three months of pregnancy): tremor, muscle stiffness and/or weakness, drowsiness, agitation, breathing difficulties, and feeding problems. If your baby shows any of these symptoms, you may need to contact your doctor.
Driving and using machines
When taking Olazax, there is a risk that you may become drowsy. If this occurs, do not drive or operate tools or machinery. Inform your doctor.
Olanzapine Glenmark contains aspartame
Olanzapine Glenmark contains aspartame, which is a source of phenylalanine. This may be harmful to people with phenylketonuria.

3. How to take Olanzapine Glenmark

Take this medicine exactly as your doctor has told you. If you are not sure, consult your doctor or pharmacist.
Your doctor will tell you how many Olazax tablets to take and for how long you should continue taking them. The usual dose of Olazax ranges from 5 mg to 20 mg daily. If your symptoms return, speak to your doctor, but do not stop taking Olazax unless your doctor tells you to do so.
You should take Olazax tablets once daily, as directed by your doctor. Try to take the tablets at the same time each day. It does not matter whether you take them with or without food. Olazax coated tablets are for oral use. Swallow the tablets whole with water.

If you take more Olazax than you should
Patients who have taken more Olazax than prescribed have experienced the following symptoms: rapid heartbeat, agitation/aggression, speech problems, unusual movements (especially of the face or tongue), and reduced level of consciousness. Other possible symptoms include: acute confusion, seizures (epilepsy), coma, or a combination of fever, rapid breathing, sweating, muscle stiffness, drowsiness or lethargy, slowed breathing, reduced cough reflex, high or low blood pressure, and changes in heart rhythm. Contact your doctor or go to hospital immediately if any of these symptoms occur. Show your doctor the pack of tablets.

If you forget to take Olazax
Take the missed dose as soon as you remember. Do not take a double dose on the same day.

If you stop taking Olazax
Do not stop taking the tablets just because you start to feel better. It is important that you continue treatment with Olazax for as long as your doctor considers necessary.
If you suddenly stop taking Olazax, you may experience symptoms such as sweating, difficulty sleeping, tremor, anxiety, nausea, or vomiting. Your doctor may advise you to gradually reduce the dose before stopping treatment completely.

If you have any 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.
Tell your doctor immediately if you experience:

unusual movements (a common side effect that may affect up to 1 in 10 patients), especially of the face or tongue;
blood clots in the veins (an uncommon side effect that may affect up to 1 in 100 patients), particularly in the lower limbs (symptoms include swelling, pain and redness of the leg), which may travel through the blood vessels to the lungs causing chest pain and breathing difficulties. If you notice any of these symptoms, consult a doctor immediately;
a combination of fever, rapid breathing, sweating, muscle stiffness and confusion or drowsiness (the frequency of this side effect 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 initial stages of treatment, some people may feel dizzy or faint (with a slowing of the heartbeat), especially when standing up from a lying or sitting position. These effects usually resolve spontaneously, but if they do not, inform your doctor.
Common side effects (may affect up to 1 in 10 people) include changes in levels of certain blood cells, circulating fats, and temporary increases in liver enzymes during the initial stages of treatment; increased blood and urine sugar levels; increased levels of uric acid and creatine phosphokinase in the blood; increased appetite; dizziness; restlessness; tremor; unusual movements (dyskinesias); constipation; dry mouth; skin rash; loss of strength; extreme tiredness; water retention leading to swelling of the hands, ankles or feet; fever; joint pain; and sexual dysfunction, such as decreased libido in males and females or erectile dysfunction in males.
Uncommon side effects (may affect up to 1 in 100 people) include hypersensitivity (e.g. swelling of the mouth and throat, itching, skin rash); diabetes or worsening of diabetes, occasionally associated with ketoacidosis (presence of ketone bodies in blood and urine) or coma; epileptic seizures, usually in patients with a history of seizures (epilepsy); muscle stiffness or spasms (including eye movements); restless legs syndrome; speech problems; stuttering; slowed heartbeat; sensitivity to sunlight; nosebleeds; abdominal swelling; drooling; memory loss or forgetfulness; urinary incontinence; inability to urinate; hair loss; absence or reduction of menstrual cycles; and breast changes in males and females, such as abnormal growth or abnormal milk secretion.
Rare side effects (may affect up to 1 in 1,000 people) include decreased body temperature; changes in heart rhythm; unexplained sudden death; inflammation of the pancreas causing severe stomach pain, fever and malaise; liver disease manifesting as yellowing of the skin and whites of the eyes; muscle disease presenting as tenderness and unexplained muscle pain; and prolonged and/or painful erection.
Very rare side effects include severe allergic reactions such as Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS syndrome). DRESS initially presents with influenza-like symptoms, a skin rash starting on the face which then spreads, high body temperature, swollen lymph nodes, increased liver enzyme levels observed in blood tests, and an increase in a type of white blood cell (eosinophilia).
In elderly patients with dementia treated with olanzapine, stroke, pneumonia, urinary incontinence, falls, extreme tiredness, visual hallucinations, increased body temperature, skin redness, and walking disturbances may occur. Fatal cases have been reported in this particular patient group.
In patients with Parkinson's disease, Olazax may worsen symptoms.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or nurse. You can also report side effects directly via 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. How to store Olanzapina Glenmark

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after the word "Exp". The expiry date refers to the last day of the month indicated.
Store below 30°C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer used. This will help protect the environment.

6. Package contents and other information

What Olazax contains

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 ingredients are: mannitol (E 421), microcrystalline cellulose, aspartame (E 951), crospovidone, magnesium stearate.

Description of the appearance of Olazax and pack contents
Olazax is available as yellow, round-shaped tablets with bevelled edges, imprinted with the letter “B” on one side.
Olazax 7.5 mg:
yellow, round-shaped tablets with bevelled edges, imprinted with the letter “C” on one side.
Olazax 10 mg:
yellow, round-shaped tablets with bevelled edges, imprinted with “OL” on one side and the letter “D” on the other side.
Olazax 15 mg:
yellow, round-shaped tablets with bevelled edges, imprinted with “OL” on one side and the letter “E” on the other side.
Olazax 20 mg:
yellow, round-shaped tablets with bevelled edges, imprinted with “OL” on one side and the letter “F” on the other side.
Olazax 5 mg, 7.5 mg, 10 mg, 15 mg, 20 mg is available in aluminum blisters containing 28 and 56 tablets.

Marketing Authorisation Holder and Manufacturer
Glenmark Pharmaceuticals s.r.o.
Hvězdova 1716/2b, 140 78 Praha 4
Czech Republic

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

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