Olanzacon 10 mg. 28 tablets

1. What OLANZACON is and what it is used for

Olanzacon contains the active substance olanzapine. Olanzacon belongs to the group of medicines called antipsychotics and is used to treat the following diseases:

Schizophrenia - a disease with symptoms such as hearing, seeing or feeling non-existent objects, delusional thoughts, unusual suspiciousness and withdrawal. People with this condition may also feel depressed, anxious or tense.

Moderate to severe manic episodes - states with symptoms of excitement or euphoria.

OLANZACON has been shown to prevent the recurrence of these symptoms in patients with bipolar disorder whose manic episode was affected by treatment with olanzapine.

2. What you need to know before you take Olanzacon

Do not accept Olanzakon

If you are allergic (hypersensitive) to olanzapine or any of the other ingredients of this medicine (listed in section 6). An allergic reaction can be recognized by the presence of a rash, itching, swelling of the face, swelling of the 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 types of glaucoma (increased pressure in the eye).

Warnings and precautions

Talk to your doctor or pharmacist before taking Olanzacon.

The use of Olanzapine in elderly patients with dementia is not recommended, as this medicine may have serious side effects in them.

Medicines of this type can cause abnormal movements mainly in the area of ​​the face and tongue. If this happens after taking Olanzacon, tell your doctor.

Very rarely, drugs of this type can cause a combination of fever, rapid breathing, sweating, muscle stiffness and drowsiness or insomnia. If this happens, see your doctor immediately.

Weight gain has been observed in patients taking Olanzapine. You and your doctor should check your weight regularly. Consider a referral to a nutritionist or help with a diet plan if needed.

High levels of blood sugar and blood fats (triglycerides and cholesterol) have been observed in patients taking Olanzapine. Your doctor should do blood tests to check blood sugar and levels of certain fats before you start taking Olanzapine and regularly during treatment.

Tell the doctor if you or anyone in your family has ever had blood clots, as medicines like this are associated with blood clots.

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

Stroke or "mini" stroke (temporary signs of a stroke);

Parkinson's disease;

Prostate problems;

Intestinal obstruction (paralytic ileus);

Liver or kidney disease;

Blood diseases;

Heart disease;

Diabetes;

Convulsions;

If you know that you may be losing salt as a result of prolonged severe diarrhea and vomiting or the use of diuretics (water tablets).

If you suffer from dementia, you or your carer/relative should tell your doctor if you have ever had a stroke or "mini" stroke. As a routine precaution, if you are over the age of 65, your blood pressure should be monitored by your doctor.

Children and adolescents

Olanzacon is not intended for patients under 18 years of age.

Other medicines and Olanzacon

Take other medicines during treatment with Olanzacon only if your doctor has told you that this is possible. You may feel drowsy if you take Olanzapine in combination with antidepressants or medicines to treat anxiety or sleep aids (tranquilizers).

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:

drugs for Parkinson's disease.

carbamazepine (an anti-epileptic and mood-stabilising medicine), fluvoxamine (an antidepressant), or ciprofloxacin (an antibiotic), as this may require a change in your Olanzapine dose.

Food, drink and alcohol regulations

Do not drink alcohol during treatment with Olanzacon, as it can cause drowsiness at the same time.

Pregnancy, lactation and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, consult your doctor before using this medicine. You should not take this medicine if you are pregnant unless you have discussed it with your doctor. You should not take this medicine if you are breast-feeding, as a small amount of Olanzacon may pass into breast milk.

The following symptoms may occur in newborns whose mothers used Olanzacon during the last trimester (the last three months of pregnancy): tremors, stiffness and/or muscle weakness, drowsiness, agitation, breathing problems and feeding difficulties. If p

Pregnancy, lactation and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, consult your doctor before using this medicine. You should not take this medicine if you are pregnant, unless you have discussed it with your doctor. You should not take this medicine if you are breast-feeding, as a small amount of Olanzacon may pass into breast milk.

The following symptoms may occur in newborns whose mothers used Olanzacon during the last trimester (the last three months of pregnancy): tremors, stiffness and/or muscle weakness, drowsiness, agitation, breathing problems and feeding difficulties. If your baby shows any of these symptoms, see your doctor.

Driving and using machines

There is a risk of drowsiness while taking Olanzacon. If this happens, do not drive or work with any equipment or machinery. Notify your doctor.

Olanzacon contains lactose

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

3. How to take Olanzacon

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.

Your doctor will tell you how many Olanzacon tablets to take and how long to take them. The daily dose of Olanzacon is between 5 mg and 20 mg. Consult your doctor if your symptoms return, but do not stop taking Olanzacon until your doctor advises you to do so.

You should take Olanzacon once a day, following your doctor's recommendations. Try to take the tablets at the same time every day. Tablet intake does not depend on food intake. Olanzacon tablets should be taken whole with water.

If you have taken more Olanzacon than you should

In patients who have taken more than the required amount of Olanzacon, the following symptoms have been observed: increased heart rate, agitation/aggression, speech problems, unusual movements (especially of the face or tongue) and varying degrees of impaired consciousness. Other symptoms may be: sudden confusion, seizure (epilepsy), coma, a combination of fever, rapid breathing, sweating, muscle stiffness and dizziness or drowsiness, slow heart rate, aspiration, increased or decreased blood pressure, abnormal heart rhythm. Contact your doctor immediately or go straight to the nearest hospital if you have any of the above symptoms. Show the doctor the package of your tablets.

If you forget to take Olanzacon

Take the tablets as soon as you remember. Do not take two doses in one day. If you have stopped taking Olanzacon

Do not stop taking the tablets just because you feel better. It is important to continue taking Olanzacon for as long as your doctor has recommended.

If you suddenly stop taking Olanzapine, you may experience symptoms such as sweating, inability to sleep, tremors, anxiety or nausea and vomiting. Your doctor may suggest that you reduce the dose gradually before stopping treatment.

If you have any further questions 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 right away if you have:

unusual movements (a common side effect that may affect up to 1 in 10 people) mainly of the face or tongue;

blood clots in the veins (an uncommon side effect that may affect up to 1 in 100 people), especially in the legs (symptoms include swelling, pain and redness in the leg), which may travel through the blood vessels to the lung, causing pain in chest area and difficulty breathing. If you notice any of these signs, seek medical advice immediately;

a combination of fever, rapid breathing, sweating, muscle stiffness 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 people) include:

weight gain; drowsiness and increases in blood prolactin levels. At the beginning of treatment, some people may feel dizzy or weak (with a slow heart rate), especially when standing up from a lying or sitting position. This usually goes away on its own, but if it doesn't, tell your doctor.

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

changes in the levels of some blood cells, fats in the circulation and, at the beginning of treatment, a temporary increase in liver enzymes; increases in blood and urine sugar levels; increases in blood levels of uric acid and creatine phosphokinase; increased feeling of hunger; dizziness; anxiety; tremor; unusual moving

Uncommon side effects (may affect up to 1 in 100 people) include:

hypersensitivity (eg, swelling of the mouth and throat, itching, rash); diabetes or worsening of diabetes, sometimes associated with ketoacidosis (ketones in the blood and urine) or coma; seizures, usually associated with seizures in the past (epilepsy); muscle stiffness or spasms (including eye movements); speech problems; slow heart rate; sensitivity to sunlight; nosebleeds; bloating; memory loss or forgetfulness; urinary incontinence; difficulty urinating; hair loss; absence or reduction of menstrual cycles and breast changes in men and women, such as abnormal milk production or abnormal enlargement.

Rare side effects (may affect up to 1 in 1,000 people) include:

lowering of normal body temperature; heart rhythm disorders; sudden unexplained death; inflammation of the pancreas causing severe abdominal pain, fever and malaise; liver disease manifested as yellowing of the skin and the whites of the eyes; muscle disease manifesting as unexplained pains and suffering; prolonged and/or painful erection.

While taking olanzapine, elderly patients with dementia may experience stroke, pneumonia, urinary incontinence, seizures, extreme tiredness, visual hallucinations, fever, flushing of the skin, and trouble walking. A few fatal cases have also been reported in this specific group of patients.

In patients with Parkinson's disease, Olanzacon may cause symptoms to worsen.

5. How to store Olanzacon

Keep out of the reach of children.

Do not use this medicine after the expiry date which is stated on the cartridge pack.

To be stored below 25°C.

Do not dispose of medicines down the drain or in the household waste container.

Ask your pharmacist how to dispose of medicines you no longer use. These measures will help protect the environment.

6. Contents of the package and additional information

What OLANZACON contains

The active substance is olanzapine. Each Olanzacon tablet contains S mg or 10 mg of the active substance. The exact amount is shown on your Olanzakon packaging,

Excipients are: lactose monohydrate, crospovidone, hydroxypropyl cellulose, magnesium stearate.

What Olanzacon looks like and contents of the pack

Olanzacon 10 mg tablets are available in cartons containing 28 or 30 tablets. Not all packages may be marketed.