Olanzapine ACCORD 10 mg. 28 tablets

What is Olanzapine Accord tablets and what is it 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disease with symptoms such as hearing, seeing or sensing things, mistaken beliefs, unusual suspiciousness, and becoming withdrawn.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, a condition with symptoms of excitement or euphoria.
Olanzapine Accord 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, contact your doctor.
• If you have ever 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 Accord tablets.
• The use of Olanzapine Accord 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, drugs of this type cause a combination of fever, rapid breathing, sweating, muscle stiffness and drowsiness or sleepiness. If this happens, contact your doctor immediately.
• There was a weight gain in patients taking Olanzapine tablets. You and your doctor should regularly check your weight.
• In patients taking Olanzapine tablets are observed high levels of blood sugar and blood fats (triglycerides and cholesterol). Your doctor should do blood tests to check blood sugar and certain fat levels before you start taking Olanzapine tablets and regular intake during treatment.
• Inform 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)
• A disease of the liver or kidneys
• Blood
• Heart disease
• Diabetes
• Seizures
If you suffer from dementia, you or the person who cares for 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
Olanzapine Accord tablets is not intended for patients under 18 years of age. Other medicines and Accord Olanzapine tablets:
You should tell your doctor if you are taking Olanzapine Accord in combination with antidepressants or medications to treat anxiety or help you sleep (tranquillizers). You might feel drowsy
Tell your doctor if you are taking, have recently taken or might take any other medicines. In particular, tell your doctor if you take:
- Medicines for Parkinson's disease
- Carbamazepine (an antiepileptic and mood stabilizer), fluvoxamine (an antidepressant) or ciprofloxacin (an antibiotic / - may be necessary to change the dose of Olanzapine Accord tablets.

Olanzapine Accord tablets with alcohol:
Do not drink alcohol during treatment with Olanzapine Accord tablets as the 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, sleepiness, agitation, breathing problems, and difficulty in feeding. If your baby 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 Accord tablets. If this happens, do not drive or operate any tools or machinery. 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 Accord tablets?
Always take the medicine exactly as your doctor tells you. If you're 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.
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. Olanzapine Accord tablets are for oral use. You should swallow the tablets Olanzapine Accord tablets whole with water.

If you take more dose Olanzapine tablets Accord
Patients who have taken 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 get any of the above symptoms. Show your 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 Accord tablets as long as you recommend your doctor. If you suddenly stop taking Olanzapine Accord tablets may occur symptoms such as sweating, unable to sleep, tremor, anxiety or nausea and vomiting. Your doctor may suggest that you 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 experience:
• unusual movement (a common side effect that may affect 1 in 10 people) 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 help 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 people include:
• Weight Gain
• Sleepiness and elevated prolactin in the blood.

Common side effects may affect up to 1 in 10 people include:
• Changes in the levels of some blood cells and circulating fats
• Increases in the levels of sugar in 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 usually resolves by itself, but if not, tell your doctor.

Uncommon side effects: affects 1 in 100, include:
• slow heartbeat, sensitivity to sunlight
• Urinary retention
• Lack of ability to pass urine, hair loss
• Absence or decrease in menstrual periods
• Changes in breasts of men and women, abnormal formation of breast milk or abnormal growth.

Other possible side effects whose frequency can not be estimated from available data (not known) include:
• Allergic reaction (eg. Swelling of the mouth and throat, itching, rash).
• diabetes or worsening 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 past seizures (epilepsy) spasms of eye muscles, causing a rotational movement of the eyes.
• Abnormal heart rhythm.
• Sudden unexplained death.
• Inflammation of the pancreas causing severe stomach pain, fever and malaise.
• Liver disease appearing as yellowing of 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 can worsen symptoms in patients with Parkinson's disease.
If you have other side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet.

5. How to store Olanzapine Accord tablets?
Keep this medicine out of the reach of children.
Do not use this medicine after the expiry date stated 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 Accord tablets:
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). Furthermore, 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).

How does Olanzapine Accord tablets and contents of the pack:
Olanzapine Accord 2,5 mg; White to off-white, round biconvex tablets, plain on both sides.
Accord olanzapine 5 mg: White to almost white, round biconvex film-coated tablets debossed with indication 'O1 on one side and plain on the other.
Olanzapine Accord 7,5 mg: White to almost white, round biconvex film-coated tablets debossed with designation 402 "on one side and plain on the other.
Accord olanzapine 10 mg: white to off-white round biconvex film-coated tablets debossed with 4 mark 03 'on one side and plain on the other. Olanzapine Accord 15 mg tablets: Coloured light blue round biconvex tablets, plain on both sides.
Olanzapine Accord 20 mg tablets: Coloured in pale pink round biconvex tablets, plain on both sides.