Olanzapine 5 mg. 28 tablets

What is Olanzapine tablets Accord and what it is used?
Olanzapine Accord belongs to a group of medicines called antipsychotics and is used to treat:
- Schizophrenia, a disease with symptoms such as hearing, seeing or sensing things, mistaken beliefs, unusual suspiciousness, and becoming withdrawn. People with this disease may also feel depressed, anxious or tense.
- Moderate to severe manic episodes, states with symptoms of excitement or euphoria.
Accord olanzapine tablets are indicated for the prevention of recurrence of manic episodes in patients who responded to treatment with olanzapine.

2. What you need to know before taking Olanzapine tablets Accord?
Do not take Olanzapine tablets Accord
• If you are allergic to olanzapine or any of the other ingredients of this medicine (listed in section 6). An allergic reaction may be recognized as a rash, itching, swollen face, swollen lips or shortness of breath. If this happens to you, talk to your doctor.
• If you have been diagnosed with eye problems such as certain kinds of glaucoma (increased pressure in the eye).

Warnings and Precautions
Talk to your doctor or pharmacist before taking Olanzapine tablets Accord.
• Using Accord Olanzapine tablets in elderly patients is not recommended as it can have serious side effects.
• Medicines of this type may cause unusual movements mainly of the face and tongue. If this happens after you take Olanzapine Accord tablets, tell your doctor.
• Very rarely, medicines of this type cause a combination of fever, faster breathing, sweating, muscle stiffness and drowsiness or sleepiness. If this happens, contact your doctor immediately.
• There was weight gain in patients taking olanzapine tablets. You and your doctor should regularly check your weight.
• In patients taking olanzapine tablets were seen high levels of blood sugar and blood fats (triglycerides and cholesterol). Your doctor should do blood tests to check blood sugar levels and some fat before you start taking Olanzapine tablets and regular intake during treatment.
• Tell your doctor if you or someone in your family has a history of blood clots, as the drug is associated with formation of blood clots.

If you suffer from any of the following illnesses tell your doctor as soon as possible:
• Stroke or "mini" stroke (temporary symptoms of stroke)
• Parkinson's disease
• Prostate problems
• Bowel obstruction (paralytic ileus)
• Liver disease or kidney
• Blood
• Heart disease
• Diabetes
• Seizures
If you suffer from dementia, you or the person who takes care of you / your relative should tell your doctor if you have ever had a stroke or "mini" stroke.
As a routine precaution, if you are over 65 years your blood pressure should be monitored by your doctor.

Children and adolescents
Accord olanzapine tablets for patients under 18 years of age. Other medicines and tablets Olanzapine Accord:
You should tell your doctor if you are taking Olanzapine Accord in combination with antidepressants or medicines taken for anxiety or to help you sleep (tranquillizers). You may feel drowsy
Tell your doctor if you are taking, have recently taken or may take any other medicines. In particular, tell your doctor if you take:
- Drugs for Parkinson's disease
- Carbamazepine (antiepileptic and mood stabilizer), fluvoxamine (an antidepressant), or ciprofloxacin (an antibiotic / - may need a change in the dose of olanzapine tablets Accord.

Accord olanzapine tablets with alcohol:
Do not drink alcohol during treatment with Olanzapine tablets Accord as concomitant use of alcohol can cause drowsiness.

Pregnancy and lactation:
If you are pregnant or breast feeding, or think you may be pregnant, you should not take this medicine. If you are pregnant or planning to become pregnant, ask your doctor. You should not take this medicine while breast-feeding, as small amounts of Olanzapine Accord can pass into breast milk.
The following symptoms may occur in newborn infants of mothers who had used olanzapine during the last trimester (last three months of pregnancy): shaking, muscle stiffness and / or weakness, drowsiness, agitation, breathing problems and difficulty eating. If your child develops any of these symptoms, you may need to contact your doctor.

Driving and using machines:
There is a risk of feeling drowsy while taking Olanzapine tablets Accord. If this happens, do not drive or operate any tools or machines. Tell your doctor.

Olanzapine Accord contains lactose
If your doctor has told you that you have an intolerance to some sugars, consult him before taking this medicine.

3. How to take Olanzapine tablets Accord?
Always take the medicine exactly as prescribed by your doctor. If you are not sure, check with your doctor or pharmacist.
Your doctor will tell you how many tablets Olanzapine Accord tablets to take and how long to take them. The daily dose of Olanzapine Accord tablets is between 5 and 20 mg. Consult your doctor if your symptoms return but do not stop taking Olanzapine Accord tablets until your doctor tells you to do so.
You should take your Olanzapine Accord tablets once a day following the advice of your doctor. Try to take your tablets at the same time each day. It does not matter whether you take it with or without food. Accord olanzapine tablets are for oral use. You should swallow the tablets Olanzapine Accord tablets whole with water.

If you take more than the amount of Olanzapine tablets Accord
Patients who received more than the required amount Olanzapine Accord have the following symptoms: fast heart rate, agitation / aggressiveness, problems with speech, unusual movements (especially of the face or tongue) and reduced level of consciousness. Other symptoms may include sudden confusion, seizures (epilepsy), coma, a combination of fever, faster breathing, sweating, muscle stiffness and drowsiness or sleepiness, slowing of the breathing rate, aspiration, high or low blood pressure, irregular heart rhythm. Contact your doctor
or just go to the nearest hospital if you experience any of the above symptoms. Show the doctor your pack of tablets.

If you forget to take Olanzapine tablets Accord
Take your tablets as soon as you remember. Do not take two doses in one day.

If you stop taking Olanzapine tablets Accord
Do not stop taking your tablets just because you feel better. It is important to continue taking Olanzapine tablets Accord as long as you have been advised by your doctor. If you suddenly stop taking Olanzapine tablets Accord may be symptoms such as sweating, unable to sleep, tremor, anxiety or nausea and vomiting. Your doctor may suggest you to reduce the dose gradually before stopping treatment.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Like all medicines, this medicine can cause side effects, although not everybody gets them.

Tell your doctor immediately if you have:
• unusual movement (a common side effect that can affect 1 in 10 patients), mainly of the face or tongue,
• blood clots in the veins (unusual side effect that can affect 1 in 100 patients), especially in the legs (symptoms include swelling, pain and redness in the leg), which may travel through blood vessels to the lungs and cause chest pain and difficulty breathing. If you notice any of these symptoms, seek medical attention immediately.
• a combination of fever, faster breathing, sweating, muscle stiffness and drowsiness (incidence of this side effect can not be estimated from available data).

Very common side effects may affect more than 1 in 10 patients include:
• Weight gain
• Drowsiness and elevated levels of prolactin in the blood.

Common side effects may affect up to 1 in 10 patients include:
• Changes in the levels of some blood cells and circulating fats
• Increases in the level of sugars in the blood and urine
• Increased hunger, dizziness, restlessness, tremor, muscle stiffness or spasm (including eye movements)
• Problems with speech
• Constipation, dry mouth
• Rash, loss of strength
• Excessive tiredness
• Water retention leading to swelling of the hands, ankles or feet, sexual dysfunction such as decreased libido in males and females or erectile dysfunction in men
In the early stages of treatment, some people may feel dizzy or faint (with a slow heart rate), especially when getting up from a lying or sitting position. This will usually pass on its own, but if not, tell your doctor.

Uncommon side effects: affect 1 in 100 include:
• Slow heartbeat, sensitivity to sunlight
• Urinary retention
• Lack of ability to urinate, loss of hair
• Absence or decrease in menstrual periods
• Change in breast men and women, abnormal formation of breast milk or abnormal growth.

Other possible side effects whose frequency can not be estimated from available data (frequency not known) include:
• Allergic reaction (eg. Swelling of the mouth and throat, itching, rash).
• Diabetes or exacerbation of diabetes occasionally associated with ketoacidosis (ketones in the blood and urine) or coma.
• Lowering of normal body temperature.
• Seizures, usually associated with a history of previous seizures (epilepsy); spasms of eye muscles, causing a rotational movement of the eyes.
• Heart rhythm abnormalities.
• Sudden unexplained death.
• Inflammation of the pancreas causing severe stomach pain, fever and malaise.
• Liver disease appearing as yellowing of the skin and whites of the eyes.
• Muscle disease presenting as unexplained aches and pains and prolonged and / or painful erection.
While taking olanzapine, elderly patients with dementia may suffer from stroke, pneumonia, urinary incontinence, falls, extreme tiredness, visual hallucinations, a rise in body temperature, redness of the skin and problems with walking. In this particular group of patients has been reported several cases fatal.
Olanzapine Accord may worsen symptoms of patients with Parkinson's disease.
If you have other side effects, talk with your doctor or pharmacist. This includes any side effects not listed in this leaflet.

5. How to store Olanzapine tablets Accord?
Keep this medicine out of the reach of children.
Do not use this medicine after the expiry date printed on the blister and carton after "EXP". The expiry date refers to the last day of that month.
Do not store above 30 ° C.
Do not dispose of medications in wastewater or household waste. Ask your pharmacist how to dispose of medicines no use. These measures will help to protect the environment.

6. Contents of the pack and other information
What Olanzapine tablets Accord:
The active ingredient is olanzapine.
Each tablet contains: 2,5 mg; 5 mg; 7,5 mg; 10 mg; 15 mg or 20 mg of olanzapine. The tablet also contains lactose monohydrate, microcrystalline cellulose, crospovidone, hydroxypropylcellulose, magnesium stearate
The film coating contains: hypromellose (E464), titanium dioxide (E 171), macrogol 400, polysorbate 80 (E433). In addition, the film coating of the tablets of 15 mg and containing indigo carmine aluminum lake (E 132) and tablets containing 20 mg of red iron oxide (E 172).