OLAZAX 5 mg Tabletka

Treść ulotki

1. Olazax 5 mg tablets, 7.5 mg tablets, 10 mg tablets, 15 mg tablets, 20 mg tablets
   1. What OLAZAX E is and what it is used for
   2. What you need to know before taking Olanzapina Glenmark
   3. How to take Olanzapina Glenmark
   4. Possible side effects
   5. How to store Olanzapina Glenmark
   6. Package contents and other information

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

Olanzapine

Read this leaflet carefully before you start 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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell 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 you take 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 ingredient olanzapine. Olazax belongs to a group of medicines called
antipsychotics and is used to treat the following conditions:

• schizophrenia, an illness with symptoms such as hearing, seeing or feeling things that are not there, false beliefs, unjustified suspicion and social withdrawal. People with this illness may also feel depressed, anxious or tense.
• an episode of moderate to severe mania, 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 responded to treatment with olanzapine.

2. What you need to know before taking Olanzapina 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 can manifest with skin rash, itching, swelling of the face, swelling of the lips, shortness of breath. If this has happened to you, report it to 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
Consult 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 can cause unusual movements, especially of the face and tongue. If this happens after you have been given Olazax, report it to your doctor.
• Very rarely, medicines of this type cause a combination of fever, rapid breathing, sweating, muscle stiffness and confusion or drowsiness. If this happens, consult 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 getting help with a diet program.
• High levels of sugar and fat (triglycerides and cholesterol) in the blood have been observed in patients taking Olazax. The doctor must request blood tests to check sugar and certain fat values in the blood before you start taking Olazax and, regularly, during treatment.
• Report to your doctor if you or someone in your family has had a history of blood clots, as medicines like these have been associated with the formation of blood clots.

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

• Stroke or transient ischemic attack (TIA) (temporary symptoms of stroke).
• Parkinson's disease
• Prostate problems
• Bowel obstruction (paralytic ileus)
• Liver or kidney disease
• Blood diseases
• Heart disease
• Diabetes
• Convulsions
• If you know that you may have excessive salt loss due to severe and prolonged diarrhea and vomiting (being ill) or the use of diuretics (water pills)

If you suffer from dementia, you or your caregiver must inform the doctor if you have
had a stroke or transient ischemic attack in the past.
As a routine precaution, if you are over 65 years of age, have your
blood pressure checked periodically by your doctor.

Children and adolescents
Olazax is not indicated in patients under the age of 18 years.

Other medicines and Olazax
During treatment with Olazax, take other medicines only after your doctor's authorization. You
may feel sleepy if Olazax is taken in combination with antidepressants or medicines
taken for anxiety or to help you sleep (tranquilizers).
Tell your doctor if you are taking, have recently taken or may take any other
medicine.
In particular, tell your doctor if you are taking:

• medicines for Parkinson's disease.
• carbamazepine (an anti-epileptic and mood stabilizer), fluvoxamine (an antidepressant), or ciprofloxacin (an antibiotic) - it may be necessary to adjust your dose of Olazax.

Olazax and alcohol
Do not drink any type of alcohol during treatment with Olazax as the simultaneous
administration of Olazax and alcohol can cause drowsiness.

Pregnancy and breastfeeding
If you are pregnant or breastfeeding, if you suspect or are planning a
pregnancy, ask your doctor for advice before taking this medicine. You should not take
this medicine while breastfeeding, as small amounts of Olazax can pass
into breast milk.
The following symptoms may occur in newborns of mothers who have used Olazax in the last
trimester (last three months of pregnancy): tremor, stiffness and/or muscle weakness, drowsiness,
agitation, breathing problems and difficulty feeding. If your baby presents any of these
symptoms, you may need to contact your doctor.

Driving and operating machinery
When you take Olazax there is a risk that you may experience drowsiness. If this occurs, do not
drive or operate tools or machinery. Inform your doctor.

Olanzapina Glenmark contains aspartame
Olanzapina Glenmark contains aspartame which is a source of phenylalanine. They may be harmful
to people suffering from phenylketonuria.

3. How to take Olanzapina Glenmark

Take this medicine exactly as your doctor has told you. If you have any doubts, ask your doctor or
pharmacist.
Your doctor will tell you how many Olazax tablets you need to take and for how long you should
continue to take them. The dose of Olazax to be taken varies from 5 mg to 20 mg per day. If your
symptoms reappear, talk to your doctor, but do not stop taking Olazax unless your doctor tells you to.
You should take Olazax tablets once a day, following your doctor's instructions. Try to take the tablets
every day at the same time. It does not matter if you take them on a full or empty stomach. Olazax
coated tablets are for oral use. Swallow Olazax tablets whole with water.

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

If you forget to take Olazax
Take the tablets as soon as you remember. Do not take a double dose in one 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 deems necessary.
If you suddenly stop taking Olazax, 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 questions about using this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
Report to your doctor immediately if you experience:

• unusual movements (a common side effect that can affect up to 1 in 10 patients), especially of the face or tongue;
• blood clots in the veins (an uncommon side effect that can affect up to 1 in 100 patients), especially in the lower legs (symptoms include swelling, pain and redness of the leg), which can travel through blood vessels to the lungs causing chest pain and difficulty breathing. If you experience 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 based on 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 experience a feeling of dizziness or fainting (with a slowing of the heart rate), especially when getting up from a lying or sitting position. These effects usually subside spontaneously, but if this does not happen, inform your doctor.
Common side effects (may affect up to 1 in 10 people) include changes in the levels of some blood cells, circulating fats and in the early stages of treatment temporary increases in liver enzymes; increases in blood sugar and urine sugar levels; increases in uric acid and creatine phosphokinase levels in the blood; a feeling of increased hunger; dizziness; restlessness; tremor, unusual movements (dyskinesias); constipation; dry mouth; skin rash; loss of strength; extreme fatigue; 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 the blood and urine) or coma; seizures, usually associated with a history of seizures (epilepsy); muscle stiffness or spasms (including eye movements); restless legs syndrome; speech problems; stuttering; slowing of the heart rate; sensitivity to sunlight; nosebleeds; abdominal bloating; drooling; memory loss or forgetfulness; urinary incontinence; inability to urinate; hair loss; absence or reduction of menstrual cycles, and changes in the breasts 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 a decrease in body temperature; changes in heart rhythm; sudden unexplained death; inflammation of the pancreas causing severe stomach pain, fever and malaise; liver disease that manifests as yellowing of the skin and whites of the eyes; muscle disease that presents as tenderness and unexplained pain; prolonged and/or painful erection.
Very rare side effects include severe allergic reactions such as Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS). DRESS initially manifests with flu-like symptoms, with a rash on the face that subsequently becomes widespread, high body temperature, enlarged lymph nodes, increased levels of liver enzymes observed in blood tests and an increase in a type of white blood cells (increased eosinophils).
During treatment with olanzapine, elderly patients with dementia may be subject to stroke, pneumonia, urinary incontinence, falls, extreme fatigue, visual hallucinations, a rise in body temperature, skin redness, gait disturbances. Some fatal cases have been reported in this particular group of patients.
In patients with Parkinson's disease Olazax may cause a worsening of symptoms.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please inform your doctor or nurse. You can also report side effects directly through 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 Olanzapina Glenmark

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date which is stated on the package and blister after the
wording Exp. The expiry date refers to the last day of the month indicated.
Store at temperatures below 30°C
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Olazax contains

• The active ingredient is olanzapine.
• Each Olazax tablet contains 5 mg, 7.5 mg, 10 mg, 15 mg, 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 package contents
Olazax is available in yellow, circular-shaped tablets, with beveled edges and imprinted with the
number “B” on one side.
Olazax 7.5 mg:
yellow, circular-shaped tablets, with beveled edges and imprinted with the number “C” on one side.
Olazax 10 mg:
yellow, circular-shaped tablets, with beveled edges and imprinted with the abbreviation “OL” on one side and the
number “D” on the other side.
Olazax 15 mg:
yellow, circular-shaped tablets, with beveled edges and imprinted with the abbreviation “OL” on one side and the
number “E” on the other side.
Olazax 20 mg:
yellow, circular-shaped tablets, with beveled edges and imprinted with the abbreviation “OL” on one side and the
number “F” on the other side.
Olazax 5 mg, 7.5 mg, 10 mg, 15 mg, 20 mg is available in aluminum blisters containing 28 & 56 tablets

Marketing authorization 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 relating to the product is available on the website of the European
Medicines Agency (EMA): http://www.ema.europa.eu