NYKOB 10 mg 28 tablets

What NYKOB and what it is used
NYKOB belongs to the group of medicines called antipsychotics and is used to treat the following diseases:
Schizophrenia, a disease in which there are symptoms such as hearing, seeing or sensing things, mistaken beliefs, unusual suspiciousness, becoming withdrawn. People with this disease may also feel depressed, anxious or tense;
Moderate to severe episodes of mania, a condition with symptoms of excitement or euphoria.
NYKOB is indicated for the prevention of recurrence of these symptoms in patients with bipolar disorder whose manic episode was influenced by treatment with olanzapine.

2. What you need to know before taking NYKOB
Do not take NYKOB:
if you are allergic (hypersensitive) 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, tell your doctor;
if it has 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 NYKOB:
Drugs of this type may cause unusual movements mainly of the face or tongue. If this happens after you have NYKOB, you tell your doctor;
Very rarely, drugs of this type cause a combination of fever, faster breathing, sweating, muscle stiffness and drowsiness or insomnia. If this happens, immediately contact your doctor;
It is recommended to use NIKOB in elderly patients with dementia, as this can lead to serious side effects;
There was weight gain in patients taking NIKOB. You and your doctor should regularly check your weight;
There have high blood glucose and high values of fat (triglycerides and cholesterol) in patients receiving NYKOB. Your doctor should do blood tests to check blood sugar levels and some fat before you start taking NYKOB and regularly during treatment;
Tell your doctor if you or any of your family has a history of blood clots, as medicines like it have been associated with formation of blood clots.
If you suffer from any of the following illnesses tell your doctor as soon as possible:
Diabetes;
Heart disease;
Liver or kidney disease;
Parkinson's disease;
Seizures;
Prostate problems;
Bowel obstruction (paralytic ileus);
Blood disorders;
Stroke or "mini" stroke (temporary symptoms of stroke).
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
NIKOB is not intended for patients under 18 years of age.

Other medicines and NYKOB
Take other medicines during treatment with NYKOB only if your doctor has told you that this is possible. You might feel drowsy if NYKOB in combination with antidepressants or medications to treat anxiety or supporting your sleep (tranquillizers).
Tell your doctor or pharmacist if you are taking, you have recently taken or might take any other medicines.

In particular, tell your doctor if you take:
carbamazepine (an antiepileptic and mood stabilizing drug), fluvoxamine (an antidepressant) or ciprofloxacin (an antibiotic), as it may be necessary to change your dose NYKOB;
drugs for the treatment of Parkinson's disease.
Taking NYKOB alcohol
Do not drink alcohol if you are taking NYKOB as concomitant use of NIKOB and alcohol can cause drowsiness.

Pregnancy and lactation
If you are pregnant or breast-feeding, you think you may be pregnant or planning to become pregnant, ask your doctor or pharmacist before taking this medicine. You should not take this medicine during breast-feeding, as small amounts of NIKOB can pass into breast milk.
In newborn infants of mothers in the last trimester (last three months of pregnancy) have applied NYKOB may experience the following symptoms: shaking, muscle stiffness and / or weakness, sleepiness, agitation, breathing problems, and difficulty in feeding. If your baby develops any of these symptoms it may need to contact your doctor.

Driving and using machines
There is a risk of feeling drowsy while taking NYKOB. If this happens do not drive or operate any tools or machinery. Tell your doctor.

NYKOB contains lactose and soya oil
NYKOB contains lactose. If your doctor has told you that you have an intolerance to some sugars, contact your doctor before taking this medicine.
NIKOB contains soya oil. If you are allergic to peanuts or soya, do not take this medicine.

3. How to take NYKOB
Always take this medicine exactly as you have been told your doctor or pharmacist. If you're not sure, ask your doctor or pharmacist.
Your doctor will tell you how many tablets NIKOB to take and how long to take them. The daily dose of NYKOB is between 5 and 20 mg. Consult your doctor if your symptoms return but do not stop taking NIKOB until your doctor tells you to do.
You should take your tablets NYKOB once a day following the advice of your doctor. Try to take your tablets at the same time every day. The tablets independent of food intake.
NYKOB tablets are taken orally. You should swallow the tablets whole with water NYKOB.

If you take more dose NYKOB
In patients take more than the required amount NIKOB experienced 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 be: acute 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 go to the nearest hospital. Show your doctor your pack of tablets.

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

If you stop taking NYKOB
Do not stop taking your tablets just because you feel better. It is important to continue taking NYKOB as long as you recommend your doctor.
If you suddenly stop taking NIKOB may be signs 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 medicine, ask your doctor or pharmacist.

4. Possible side effects
Like all medicines, NYKOB 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 up to 1 in 10 people), especially of the face or tongue;
blood clots in the veins (an uncommon side effect which 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 blood vessels to the lungs, causing pain chest and difficulty breathing. If you notice any of these symptoms, seek medical advice immediately;
a combination of fever, faster breathing, sweating, muscle stiffness and drowsiness or sleepiness (the frequency of this side effect can not be estimated from available data).
Very common side effects may affect more than 1 in 10 people:
Weight gain;
Drowsiness;
Increases in the levels of prolactin in the blood.
Common side effects may affect up to 1 in 10 people:
Changes in the levels of certain blood cells and circulating fats;
Increases in the levels of sugar in the blood and urine;
Feeling more hungry;
Dizziness;
Restlessness;
Tremor;
Muscle stiffness or spasm (including eye movements);
Problems with speech;
Constipation;
Dry mouth;
Rash;
Loss of strength;
Extreme tiredness;
Water retention leading to swelling of the hands, ankles or feet;
Sexual dysfunctions such as decreased libido in males and females or erectile dysfunction in men;
In the initial 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 on its own, but if it does not, tell your doctor.
Uncommon side effects may affect up to 1 in 100 people:
Slow heartbeat;
Sensitivity to sunlight;
Hair loss;
Urinary incontinence;
Inability to urinate;
Dilution or absence of menstrual cycles;
Changes in breasts in men and women, unusual formation or abnormal breast enlargement.
Other additional side effects: frequency can not be estimated from available data (not known):
Allergic reaction (eg swelling in 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 seizures (epilepsy)
Spasms of the eye muscles, causing rolling movement of the eyes;
Heart rhythm disorders;
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;
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 have trouble walking. In this particular group of patients has been reported several cases fatal.
In patients with Parkinson's disease NYKOB can lead to worsening of symptoms.

If any of the side effects gets serious, or you notice other effects not listed in this leaflet, please tell your doctor.

5. How to store NYKOB
Keep out of reach of children.
Do not use NYKOB after the expiry date stated on the carton and blister after "EXP". The expiry date refers to the last day of that month.
This medicinal product does not require any special storage conditions.
Do not dispose of medications in wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help to protect the environment.

6. Contents of the pack and further information
What NYKOB?
The active substance is olanzapine. Each tablet contains 10 mg NIKOB of the active substance.

Other ingredients are:
Tablet core: lactose monohydrate, microcrystalline cellulose, crospovidone (type A), hydroxypropylcellulose, talc and magnesium stearate;
Tablet coating: soy lecithin (E322), polyvinyl alcohol, talc, titanium dioxide (E 171), xanthan gum (E415).
NYKOB looks like and contents of the pack
NYKOB 10 mg film-coated tablets are white.
NYKOB 10 mg film-coated tablets are available in packs containing 7, 28, 30, 35, 56 or 70 tablets.
Not all pack sizes may be marketed.