OLANZAPINA 2.5 mg Tablet

Зміст інструкції

1. Olanzapina Glenmark 2.5 mg tablets, 5 mg tablets, 7.5 mg tablets, 10 mg tablets, 15 mg tablets, 20 mg tablets
   1. What is Olanzapina Glenmark and what it is used for
   2. What you need to know before taking Olanzapine Glenmark
   3. How to take Olanzapina Glenmark
   4. Possible side effects
   5. How to store Olanzapina Glenmark
   6. Package contents and other information

Olanzapina Glenmark 2.5 mg tablets, 5 mg tablets, 7.5 mg tablets, 10 mg tablets, 15 mg tablets, 20 mg tablets

olanzapina

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 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 Olanzapina Glenmark is and what it is used for
2 What you need to know before you take Olanzapina Glenmark
3 How to take Olanzapina Glenmark
4 Possible side effects
5 How to store Olanzapina Glenmark
6 Contents of the pack and other information

1. What is Olanzapina Glenmark and what it is used for

Olanzapina Glenmark contains the active ingredient olanzapine. Olanzapina Glenmark 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.
• moderate to severe manic episode, a condition characterized by symptoms of excitement or euphoria

Olanzapina Glenmark 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 Olanzapine Glenmark

• 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 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 Olanzapine Glenmark

• The use of Olanzapine Glenmark 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 Olanzapine Glenmark, 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 Olanzapine Glenmark. You and your doctor should check 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 Olanzapine Glenmark. Your doctor should request blood tests to check sugar and certain fat levels in the blood before you start taking Olanzapine Glenmark and, regularly, during treatment.
• Report to your doctor if you or someone in your family has had a history of blood clot formation, 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 sick) 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
Olanzapine Glenmark is not indicated in patients under the age of 18 years.

Other medicines and Olanzapine Glenmark
During treatment with Olanzapine Glenmark, take other medicines only after your doctor's authorization.
You may feel sleepy if Olanzapine Glenmark 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 Olanzapine Glenmark.

Olanzapine Glenmark and alcohol
Do not drink any type of alcohol during treatment with Olanzapine Glenmark as the simultaneous
administration of Olanzapine Glenmark 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 Olanzapine Glenmark
can pass into breast milk.
The following symptoms may occur in newborns of mothers who have used Olanzapine Glenmark
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 using machines
When you take Olanzapine Glenmark there is a risk that you may experience drowsiness. 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. It may be harmful
to people who suffer from phenylketonuria.

3. How to take Olanzapina Glenmark

Take this medicine following exactly the instructions of your doctor. If you have any doubts, ask your
doctor or pharmacist.
Your doctor will tell you how many Olanzapine Glenmark tablets you need to take and for how long you need to
continue taking them. The dose of Olanzapine Glenmark 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 Olanzapine Glenmark unless your
doctor tells you to.
You should take Olanzapine Glenmark 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. Olanzapine Glenmark
film-coated tablets are for oral use. Swallow Olanzapine Glenmark tablets whole, with water.

If you take more Olanzapine Glenmark than you should
Patients who have taken more Olanzapine Glenmark than they should have, have
manifested 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 rigidity, 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 Olanzapine Glenmark
Take the tablets as soon as you remember. Do not take a double dose in one day.

If you stop taking Olanzapine Glenmark
Do not stop taking the tablets just because you start to feel better. It is important that you continue
treatment with Olanzapine Glenmark for as long as your doctor deems necessary.
If you suddenly stop taking Olanzapine Glenmark, 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 on 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.
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 certain 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; 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 men and women or erectile dysfunction in men.
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 heartbeat; 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 men and women, 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; and 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 flushing, gait disturbances. Some fatal cases have been reported in this particular group of patients.
In patients with Parkinson's disease Olanzapine Glenmark may worsen symptoms.

Reporting of side effects
If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through 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 sight and reach of children.
Do not use this medicine after the expiry date which is stated on the package and on the 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 Olanzapina Glenmark contains

• The active ingredient is olanzapine.
• Each tablet of Olanzapina Glenmark contains 2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg, 20 mg of olanzapine.
• The excipients are: mannitol (E 421), microcrystalline cellulose, aspartame (E 951), crospovidone, magnesium stearate

Description of the appearance of Olanzapina Glenmark and package contents
Olanzapina Glenmark 2.5 mg is available in:
yellow tablets, circular in shape, with beveled edges and with the number “A” imprinted on one side.
Olanzapina Glenmark 5 mg:
yellow tablets, circular in shape, with beveled edges and with the number “B” imprinted on one side.
Olanzapina Glenmark 7.5 mg:
yellow tablets, circular in shape, with beveled edges and with the number “C” imprinted on one side.
Olanzapina Glenmark 10 mg:
yellow tablets, circular in shape, with beveled edges and with the abbreviation “OL” imprinted on one side and the
number “D” on the other side.
Olanzapina Glenmark 15 mg:
yellow tablets, circular in shape, with beveled edges and with the abbreviation “OL” imprinted on one side and the
number “E” on the other side.
Olanzapina Glenmark 20 mg:
yellow tablets, circular in shape, with beveled edges and with the abbreviation “OL” imprinted on one side and the
number “F” on the other side.
Olanzapina Glenmark 2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg is available in aluminum blisters of 28,
56, 70 and 98 tablets
Olanzapina Glenmark 20 mg is available in aluminum blisters of 28, 35, 56, 70 and 98 tablets
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Glenmark Arzneimittel GmbH
Industriestr. 31, D – 82194,
Gröbenzell, Germany

Manufacturer
Glenmark Pharmaceuticals s.r.o.
City Tower, Hvězdova 1716/2b, 140 78 Praha 4,
Czech Republic
For further information on this medicine, contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien
Glenmark Arzneimittel GmbH, Germany
Tel: + 49 (8142) 44392 0

Lietuva
Glenmark Arzneimittel GmbH, Germany
Tel: + 49 (8142) 44392 0

България
Glenmark Arzneimittel GmbH, Germany
Tel: + 49 (8142) 44392 0

Luxembourg/Luxemburg
Glenmark Arzneimittel GmbH, Germany
Tel: + 49 (8142) 44392 0

Česká republika
Glenmark Arzneimittel GmbH, Germany
Tel: + 49 (8142) 44392 0

Magyarország
Glenmark Arzneimittel GmbH, Germany
Tel: + 49 (8142) 44392 0

Danmark
Glenmark Pharmaceuticals Nordic AB
Tel/Tel: + 46 (0) 40 35 48 10

Malta
Glenmark Arzneimittel GmbH, Germany
Tel: + 49 (8142) 44392 0

Deutschland
Glenmark Arzneimittel GmbH
Tel: + 49 (8142) 44392 0

Nederland
Glenmark Pharmaceuticals B.V.
Tel/Tel: + 31 800 33 555 33

Eesti
Glenmark Arzneimittel GmbH, Germany
Tel: + 49 (8142) 44392 0

Norge
Glenmark Pharmaceuticals Nordic AB
Tel/Tel: + 46 (0)40 35 48 10

Ελλάδα
Glenmark Arzneimittel GmbH, Germany
Tel: + 49 (8142) 44392 0

Österreich
Glenmark Arzneimittel GmbH, Germany
Tel: + 49 (8142) 44392 0

España
Viso Farmacéutica S.L.U
Tel/Tel: + 34 911 593 944

Polska
Glenmark Arzneimittel GmbH, Germany
Tel: + 49 (8142) 44392 0

France
Glenmark Arzneimittel GmbH, Germany
Tel: + 49 (8142) 44392 0

Portugal
Glenmark Arzneimittel GmbH
Tel: + 49 (8142) 44392 0

Hrvatska
Glenmark Arzneimittel GmbH, Germany
Tel: + 49 (8142) 44392 0

România
Glenmark Arzneimittel GmbH, Germany
Tel: + 49 (8142) 44392 0

Ireland
Glenmark Arzneimittel GmbH, Germany
Tel: + 49 (8142) 44392 0

Slovenija
Glenmark Arzneimittel GmbH, Germany
Tel: + 49 (8142) 44392 0

Ísland
Glenmark Pharmaceuticals Nordic AB
Tel/Tel: + 46 (0) 40 35 48 10

Slovenská republika
Glenmark Arzneimittel GmbH, Germany
Tel: + 49 (8142) 44392 0

Italia
Glenmark Arzneimittel GmbH, Germany
Tel: + 49 (8142) 44392 0

Suomi/Finland
Glenmark Pharmaceuticals Nordic AB
Tel/Tel: + 46 (0)40 35 48 10

Κύπρος
Glenmark Arzneimittel GmbH, Germany
Tel: + 49 (8142) 44392 0

Sverige
Glenmark Pharmaceuticals Nordic AB
Tel/Tel: + 46 (0)40 35 48 10

Latvija
Glenmark Arzneimittel GmbH, Germany
Tel: + 49 (8142) 44392 0

United Kingdom (Northern Ireland)
Glenmark Arzneimittel GmbH, Germany
Tel: + 49 (8142) 44392 0
More detailed information on this medicine is available on the website of the European Medicines Agency http://www.ema.europa.eu