OLANZAPINA 2.5 mg Tabletka powlekana

Treść ulotki

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

Olanzapine Aurobindo 2.5 mg tablets, 5 mg tablets, 7.5 mg tablets, 10 mg tablets

Generic medicine

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

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

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

• Schizophrenia, a disease whose symptoms include hearing, seeing or perceiving unreal things, believing false things, unusual suspiciousness, becoming withdrawn. People with this disease may also feel depressed, anxious or tense.
• Episodes of mania, from moderate to severe; a condition with symptoms such as feeling euphoric. Olanzapina Aurobindo has been shown to prevent the recurrence of these symptoms in patients with bipolar disorder whose episode of mania has responded to treatment with olanzapine.

2. What you need to know before you take Olanzapina Aurobindo

Do not take Olanzapina Aurobindo

• 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 be recognised by symptoms such as skin rash, itching, swelling of the face or lips, or shortness of breath. If this applies to you, tell your doctor.
• If you have previously been diagnosed with certain types of eye problems, such as some types of glaucoma (increased pressure inside the eye).

Warnings and precautions
Talk to your doctor or pharmacist before taking Olanzapina Aurobindo.

• The use of Olanzapina Aurobindo in elderly patients with dementia is not recommended as it may have serious undesirable effects.
• Medicines of this type can cause unusual movements, mainly of the face or tongue. If this happens to you after taking Olanzapina Aurobindo, tell your doctor.
• Very rarely, medicines of this type cause a combination of fever, fast breathing, sweating, muscle stiffness and drowsiness or sleepiness. If this applies to you, contact your doctor immediately.
• Weight gain has been observed in patients taking Olanzapina Aurobindo. You and your doctor should check your weight regularly. Seek advice from a dietitian or get help with your diet if necessary.
• High levels of sugars and fats (triglycerides and cholesterol) in the blood have been observed in patients taking Olanzapina Aurobindo. Your doctor should have your blood tested and check the levels of sugars and some fats before you start taking Olanzapina Aurobindo and regularly during treatment.
• Tell your doctor if you or someone in your family has a history of blood clots, as medicines like this may be associated with the formation of blood clots.

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

• Diabetes
• Heart disease
• Liver or kidney disease
• Parkinson’s disease
• Epilepsy
• Problems with the prostate
• Bowel obstruction (paralytic ileus)
• Blood disorders
• Stroke or “mini” stroke (transient stroke symptoms)
• If you know you may have a salt deficiency as a result of severe and prolonged diarrhoea and vomiting or use of diuretics.

If you suffer from dementia, you or your healthcare provider or a relative must inform the doctor if you have had
a stroke or a “mini” stroke.
If you are over 65 years of age, your blood pressure may need to be monitored as a routine
precaution.

Children and adolescents
Olanzapina Aurobindo is not indicated for patients under the age of 18 years.

Other medicines and Olanzapina Aurobindo
Only take other medicines with Olanzapina Aurobindo after consulting your doctor. You may feel
sleepy if you take Olanzapina Aurobindo in combination with antidepressants or medicines for anxiety
or to help you sleep (sedatives).
Tell your doctor if you are taking, have recently taken or might take any other
medicines.
In particular, tell your doctor if you are taking:

• medicines for Parkinson’s disease
• carbamazepine (an anti-epileptic and mood-stabilising drug), fluvoxamine (an antidepressant) or ciprofloxacin (an antibiotic) - it may be necessary to adjust the dose of Olanzapina Aurobindo.

Olanzapina Aurobindo and alcohol
You should not drink alcohol while taking Olanzapina Aurobindo as taken together they can cause
sleepiness.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant or are planning a pregnancy, or if you are breastfeeding,
ask your doctor for advice before taking this medicine. You should not take this
medicine if you are pregnant unless your doctor has told you to. You should not take
this medicine while you are breastfeeding, as small amounts of Olanzapina Aurobindo can
pass into breast milk.
The following symptoms may occur in newborns whose mothers used olanzapine during the last
trimester (last three months of pregnancy): tremors, 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
There is a risk that you may feel sleepy while taking Olanzapina Aurobindo. If this happens
do not drive vehicles or use tools or machines. Tell your doctor.
Olanzapina Aurobindo contains lactose. If you have been diagnosed with an intolerance to some
sugars, contact your doctor before taking this medicine.

3. How to take Olanzapina Aurobindo

Take this medicine following exactly the instructions of your doctor. If you have any doubts, consult
your doctor or pharmacist.
Your doctor will tell you how many Olanzapina Aurobindo tablets to take and for how long you should
continue to take them. The daily dose of Olanzapina Aurobindo is between 5 mg and 20 mg. Consult your
doctor if your symptoms reappear but do not stop taking Olanzapina Aurobindo unless
your doctor tells you to do so.
You should take Olanzapina Aurobindo tablets once a day following your doctor's instructions. Try to take the tablets every day at the same time. You can take them with or without food.
Olanzapina Aurobindo tablets are for oral use. You must swallow Olanzapina
Aurobindo tablets whole with a little water.

If you take more Olanzapina Aurobindo than you should
Patients who have taken more Olanzapina Aurobindo than they should have experienced the
following symptoms: rapid heartbeat, agitation/aggressiveness, problems speaking, unusual movements
(especially of the face or tongue) and reduced level of consciousness. Other symptoms may
be: acute confusion, seizures (epilepsy), coma, a combination of fever, rapid breathing, sweating, muscle rigidity and drowsiness or sleepiness, slower breathing,
aspiration, low or high blood pressure, irregular heartbeat. Contact your doctor or go
immediately to hospital if you experience any of the symptoms described above. Show the doctor the
pack of tablets.

If you forget to take Olanzapina Aurobindo
Take the tablets as soon as you remember. Do not take a double dose in one day.

If you stop taking Olanzapina Aurobindo
Do not stop taking the tablets just because you think you feel better. It is important that you continue to
take Olanzapina Aurobindo for the entire time indicated by your doctor.
If you suddenly stop taking Olanzapina Aurobindo, symptoms such as sweating, inability to sleep, tremor, anxiety or nausea and vomiting may occur. Your doctor may suggest you
reduce the dose gradually before stopping treatment.
If you have any doubts 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 have:

• unusual movements, especially of the face or tongue (a common side effect that can affect 1 in 10 people)
• blood clots in the veins (an uncommon side effect that can affect 1 in 100 people), especially in the legs (symptoms include swelling, pain and redness of the leg), which can travel to the lungs causing chest pain and difficulty breathing. If you notice any of these symptoms, consult a doctor immediately
• a combination of fever, fast breathing, sweating, muscle stiffness, numbness and drowsiness or sleepiness (the frequency of this side effect cannot be estimated from the available data).

Very common side effects:(may affect more than 1 in 10 patients) include weight gain, drowsiness and increased levels of prolactin in the blood.
In the early stages of treatment, some people may experience dizziness or fainting (with a slow
heart rate), especially when getting up from a lying or sitting position. Usually these
symptoms pass on their own, but if this does not happen, tell your doctor.

Common side effects:(may affect up to 1 in 10 patients) include:

• changes in the levels of some blood cells, blood fats and temporary increases in liver enzymes at the beginning of treatment
• increases in blood sugar and urine sugar levels
• increases in uric acid and creatine phosphokinase levels in the blood
• feeling of increased appetite
• dizziness
• restlessness
• tremor
• unusual movements (dyskinesia)
• constipation
• dry mouth
• skin rash
• loss of strength
• extreme fatigue
• water retention leading to swelling of the hands, ankles and 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 patients) 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
• convulsions, usually associated with a history of seizures (epilepsy)
• muscle rigidity or spasm (including eye movements)
• restless legs syndrome
• problems with speech
• slow heartbeat
• sensitivity to sunlight
• nosebleeds
• abdominal distension
• loss of memory 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 milk production from the breasts or abnormal growth. Rare side effects:(may affect up to 1 in 1000 patients) include
• reduction of normal body temperature
• abnormal heart rhythm
• sudden unexplained death
• inflammation of the pancreas causing severe stomach pain, fever and malaise
• liver disease manifesting with yellowing of the skin and whites of the eyes
• muscle disease presenting 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 is initially characterized by flu-like symptoms,
such as a rash on the face and then spreading, high temperature, enlarged lymph nodes,
elevated liver enzyme levels in blood tests and an increase in a type of white blood cells (eosinophilia).
While taking olanzapine, elderly patients with dementia may suffer from stroke, pneumonia,
urinary incontinence, falls, extreme fatigue, visual hallucinations, increased body
temperature, skin flushing and problems with walking. Some fatal outcomes have been
reported in this particular group of patients.
In patients with Parkinson's disease, Olanzapina Aurobindo may worsen their symptoms.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through
the national reporting system at http://www.agenziafarmaco.gov.it/content/come-
segnalare-una-sospetta-reazione-avversa.
By reporting side effects you can help provide more information on the safety of
this medicine.

5. How to store Olanzapina Aurobindo

Keep this medicine out of the sight and reach of children.
Store at a temperature below 25 °C.
Do not use this medicine after the expiry date which is stated on the package, blister and
the label of the bottle.
Do not dispose of any medicine in waste water 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 Aurobindo contains

• The active ingredient is olanzapine. Each Olanzapina Aurobindo tablet contains 2.5 mg, 5 mg, 7.5 mg or 10 mg of the active ingredient. The exact quantity is indicated on the packaging of Olanzapina Aurobindo.
• The excipients are: lactose monohydrate, crospovidone (type B), hydroxypropylcellulose and magnesium stearate.

Description of the appearance of Olanzapina Aurobindo and package contents
Olanzapina 2.5 mg tablets:
Yellow, circular (5.2 mm diameter) biconvex, uncoated tablets, imprinted
“C” on one side and “45” on the other side.
Olanzapina 5 mg tablets:
Yellow, circular (6.5 mm diameter) biconvex, uncoated tablets, imprinted
“C” on one side and “46” on the other side.
Olanzapina 7.5 mg tablets:
Yellow, circular (7.5 mm diameter) biconvex, uncoated tablets, imprinted
“C” on one side and “47” on the other side.
Olanzapina 10 mg tablets:
Yellow, circular (8.0 mm diameter) biconvex, uncoated tablets, imprinted
“C” on one side and “48” on the other side.
Olanzapina Aurobindo tablets are available in:
blister packs in PVC/ polyamide/aluminium/PVC/aluminium:
7, 14, 28, 30, 35, 50, 56, 70, 96, 98 and 100 tablets.
Bottle packs in HDPE and polypropylene closure with silica gel desiccant:
30 and 1000 tablets.

Marketing authorisation holder and manufacturer
Aurobindo Pharma (Italia) s.r.l.
via San Giuseppe, 102

• 21047 - Saronno (VA) Italy

Manufacturer
APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate, Hal Far,
Birzebbugia, BBG 3000.
Malta
Orion Corporation, Orion Pharma
Orionintie 1,
FI-02200 Espoo,
Finland

This medicinal product is authorised in the Member States of the European Economic Area with the
following denominations:
Belgium Olanzapine AB 2.5mg/ 5mg/ 7.5mg/ 10mg/ 15mg/ 20mg tablets
Cyprus Olanzapine Aurobindo 5 mg/ 10 mg tablets
Denmark Olanzapin "Orion"
Finland Olanzapin Orion 2.5mg/ 5mg/ 7.5mg/ 10mg/ 15mg/ 20mg tablets
France OLANZAPINE ARROW 5mg/ 7.5mg/ 10mg tablet
Germany Olanzapin Aurobindo 2.5mg/ 5mg/ 7.5mg/ 10mg/ 15mg/ 20 mg Tablets
Italy Olanzapina Aurobindo
Malta Olanzapine Aurobindo 2.5mg/ 5mg/ 7.5mg/ 10mg/ 15mg/ 20mg tablets
Netherlands Olanzapine Aurobindo 2.5mg/ 5mg/ 7.5mg/ 10mg/ 15mg/ 20mg, tablets
Norway Olanzapin Orion 2.5mg/ 5mg/ 7.5mg/ 10mg/ 15mg/ 20mg tablets
Poland Sizin/Olanzapina Aurobindo
Portugal Olanzapina Aurobindo
Romania Olanzapina Aurobindo 5mg/ 10mg/ 15mg/ 20 mg tablets
Spain OLANZAPINA AUROBINDO 2.5mg/ 5mg/ 7.5mg/ 10mg, EFG tablets
Sweden Olanzapin Orion 2.5mg/ 5mg/ 7.5mg/ 10mg/ 15mg/ 20mg tablets
United Kingdom Olanzapine 2.5mg/ 5mg/ 7.5mg/ 10mg/ 15mg/ 20mg tablets