Package leaflet: Information for the user

Olazax Disperzi 5 mg orodispersible tablets, 10 mg orodispersible tablets, 15 mg orodispersible tablets, 20 mg orodispersible tablets

Olanzapine
Please read all of this leaflet carefully before taking this medicine because 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, because it may be harmful, even if their symptoms are identical to yours.
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Olazax Disperzi is and what it is used for
What you need to know before taking Olazax Disperzi
How to take Olazax Disperzi
Possible side effects
How to store Olazax Disperzi
Contents of the pack and other information

1. What Olazax Disperzi is and what it is used for

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

schizophrenia, a disorder with symptoms such as hearing, seeing, or sensing things that do not exist, false beliefs, unjustified suspiciousness, 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 Disperzi 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 Olazax Disperzi

Do not take Olazax Disperzi

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 skin rash, itching, facial swelling, swelling of the lips, or shortness of breath. If you have experienced this, 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 Disperzi

The use of Olazax Disperzi in elderly patients with dementia is not recommended, as it may cause serious adverse effects.
Medicines of this type may cause unusual movements, particularly of the face and tongue. If this occurs after starting Olazax Disperzi, inform your doctor.
Very rarely, medicines of this type may cause a combination of symptoms including fever, rapid breathing, sweating, muscle stiffness, and confusion or drowsiness. If this occurs, contact your doctor immediately.
Weight gain has been observed in patients taking Olazax Disperzi. You and your doctor should monitor your weight regularly. If necessary, consider consulting a dietitian or starting a dietary management program.
High levels of blood sugar and fats (triglycerides and cholesterol) have been observed in patients taking Olazax Disperzi. Your doctor should perform blood tests to monitor your blood sugar and certain blood fat levels before you start taking Olazax Disperzi and regularly during treatment.

If you have any of the following conditions, inform your doctor as soon as possible:

Stroke or transient ischemic attack (TIA) (transient 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 should inform your doctor if you have previously had a stroke or transient ischemic 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 Disperzi is not indicated for patients under 18 years of age.

Other medicines and Olazax Disperzi
During treatment with Olazax Disperzi, take other medicines only after obtaining approval from your doctor. You may feel drowsy if Olazax Disperzi is taken together with antidepressants or medicines used for anxiety or to help you sleep (tranquilizers).
Inform your doctor if you are currently 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 stabilizer), fluvoxamine (an antidepressant), or ciprofloxacin (an antibiotic) – your dose of Olazax Disperzi may need to be adjusted.

Olazax Disperzi and alcohol
Do not drink any alcoholic beverages during treatment with Olazax Disperzi, as taking Olazax Disperzi together with alcohol may cause drowsiness.

Pregnancy and breastfeeding
If you are pregnant, breastfeeding, suspect you may be pregnant, or are planning to become pregnant, consult your doctor before taking this medicine. You must not take this medicine during breastfeeding, as small amounts of Olazax Disperzi may pass into breast milk.
The following symptoms may occur in newborns of mothers who have taken Olazax Disperzi during the third trimester (last three months of pregnancy): tremors, 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 Disperzi, there is a risk of drowsiness. If this occurs, do not drive or operate tools or machinery. Inform your doctor.

Olazax Disperzi contains aspartame
Olazax Disperzi contains a source of phenylalanine, which can be harmful to people with phenylketonuria.

3. How to take Olazax Disperzi

Take this medicine exactly as prescribed by your doctor. If you have any doubts, consult your doctor or pharmacist.
Your doctor will tell you how many Olazax Disperzi orodispersible tablets to take and for how long you should continue taking them. The dose of Olazax Disperzi ranges from 5 mg to 20 mg per day. If your symptoms return, discuss this with your doctor, but do not stop taking Olazax Disperzi unless your doctor tells you to do so.
You should take Olazax Disperzi orodispersible 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 Disperzi orodispersible tablets are for oral use. Place the tablet in your mouth, where it will dissolve quickly and can be easily swallowed.
Alternatively, the tablet may be placed in a glass or cup containing water, orange juice, apple juice, milk, or coffee, and stirred. Drink the mixture immediately.

If you take more Olazax Disperzi than you should
Patients who have taken more Olazax Disperzi than prescribed have experienced the following symptoms: increased heart rate, agitation/aggression, speech difficulties, unusual movements (especially of the face or 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 somnolence, 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 medicine packaging.

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

If you stop taking Olazax Disperzi
Do not stop taking the tablets as soon as you start feeling better. It is important that you continue treatment with Olazax Disperzi for as long as your doctor considers necessary.
If you stop taking Olazax Disperzi suddenly, you may experience symptoms such as sweating, difficulty sleeping, tremor, anxiety, or nausea and 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 which may affect up to 1 in 10 patients), especially of the face or tongue;
blood clots in the veins (an uncommon side effect which 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 difficulty in breathing. 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 early 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 and circulating fats, and temporary increases in liver enzymes during the early stages of treatment; increased levels of sugar in the blood and urine; increased levels of uric acid and creatine phosphokinase in the blood; increased feeling of hunger; 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 occurring in patients with a history of seizures (epilepsy); muscle stiffness or spasms (including eye movements); restless legs syndrome; problems with speech; stuttering; slowing of the heartbeat; sensitivity to sunlight; nosebleeds; abdominal swelling; memory loss or forgetfulness; urinary incontinence; inability to urinate; hair loss; absence or reduction of menstrual cycles; and breast-related 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 flu-like symptoms, a skin rash starting on the face which subsequently becomes widespread, high body temperature, swollen lymph nodes, increased levels of liver enzymes observed in blood tests, and an increase in a type of white blood cells (eosinophilia).
In elderly patients with dementia treated with olanzapine, stroke, pneumonia, urinary incontinence, falls, extreme tiredness, visual hallucinations, increased body temperature, skin redness, and gait disturbances may occur. In this particular patient group, some fatal cases have been reported.
In patients with Parkinson's disease, Olazax Disperzi may worsen symptoms.
Reporting of side effects
If you experience any side effect, 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 detailed in Annex V.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Olazax Disperzi

Keep this medicine out of 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 required. This will help protect the environment.

6. Package contents and other information

What Olazax Disperzi contains

The active substance is olanzapine.
Each Olazax Disperzi tablet contains 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 Disperzi and package contents
Olazax Disperzi is available as:
yellow, round orodispersible tablets with bevelled edges, marked with the letter “B”
on one side.
Olazax Disperzi 10 mg:
yellow, round orodispersible tablets with bevelled edges, marked with “OL” on
one side and the letter “D” on the other side.
Olazax Disperzi 15 mg:
yellow, round orodispersible tablets with bevelled edges, marked with “OL” on
one side and the letter “E” on the other side.
Olazax Disperzi 20 mg:
yellow, round orodispersible tablets with bevelled edges, marked with “OL” on
one side and the letter “F” on the other side.
Olazax Disperzi 5 mg, 10 mg, 15 mg, and 20 mg are available in aluminium blisters containing 28 orodispersible 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

This patient information leaflet was last updated on {MM/YYYY}.
Detailed information about this medicinal product is available on the website of the European Medicines Agency (EMA): http://www.ema.europa.eu