Olezan  5

Olezan 5

- Olanzapine it is a drug belongs to a group of medicines called atypical 
  antipsychotics. This drug’s efficacy in schizophrenia is mediated through a
  combination of dopamine and serotonin type 2 (5HT2) antagonism.
- Olanzapine binds with high affinity to the following receptors:  
  serotonin 5HT2A/2C, 5HT6 , dopamine D1 - 4 , histamine H1 and adrenergic α1 
- Olanzapine is an antagonist with moderate affinity binding for serotonin 
  5HT3 and muscarinic M1-5 .
- Olanzapine binds weakly to GABAA, BZD, and β-adrenergic receptors.
- Olanzapine is well absorbed and reaches peak concentrations in approxima-
  tely 6 hours following an oral dose. Food does not affect the rate or extent of
  Olanzapine absorption. 
- It is eliminated extensively by first pass metabolism, with approximately 
  40% of the dose metabolized before reaching the systemic circulation. Its 
  half-life ranges from 21 to 54 hours and apparent plasma clearance ranges 
  from 12 to 47 L/hr. It is 93% bound to plasma proteins over the concentra-
  tion range of 7 to 1100ng / mL, binding primarily to albumin and α1-acid 
  glycoprotein. Approximately 57% and 30% of the dose was recovered in the 
  urine and feces, respectively.
- Direct glucuronidation and cytochrome P450 (CYP) mediated oxidation are 
  the primary metabolic pathways for Olanzapine.
- Clearance of Olanzapine may vary between individuals on the basis of 
   smoking status, gender and age. 

- Each film coated tablet of OLEZAN® 10 contains:
    Olanzapine                              10 mg   
- Each film coated tablet of OLEZAN®  5 contains:
    Olanzapine                                5 mg 

  Before starting OLEZAN®, tell your doctor if you have or had:
- heart problems.
- seizures.
- diabetes or high blood sugar levels (hyperglycemia).
- high cholesterol or triglyceride levels in your blood.
- liver problems.
- low or high blood pressure.
- strokes or “mini-strokes” also called transient ischemic attacks (TIAs).
- Alzheimer’s disease.
- narrow-angle glaucoma.
- enlarged prostate in men.
- bowel obstruction.
- breast cancer.
- thoughts of suicide or hurting yourself.
- any other medical condition.
- allergic reaction to OLEZAN® or the product ingrediants.

- Tell your doctor if you are taking any other medicines, including any that you buy without a prescription from your pharmacy, supermarket or health food shop. Some medicines may be affected by OLEZAN® or may affect how it    
  works. These include:
• medicines used to treat a fast or irregular heart beat (arrhythmia).
• medicines taken for anxiety or to help you sleep.
• medicines taken for depression.
• carbamazepine, a medicine used for mood stabilisation and to treat epilepsy.
• other centrally acting medicines (eg. tranquillisers).
• ciprofloxacin, a medicine used to treat bacterial infections.
• medicines that lower blood pressure.
• medicines used for Parkinson's disease.
• medicines that can change the heart's electrical activity or make it more likely to change.
- Your doctor or pharmacist has more information on medicines to be careful with or avoid while taking OLEZAN®.
- Tell your doctor about these things before you take OLEZAN®.

- Like most antipsychotic medicinens OLEZAN® is not recommended for use
  during pregnancy. If there is need to consider OLEZAN® during pregnancy,
  your doctor will discuss with you the benefits and risks of using it. 
- It is not recommended to the OLEZAN® if you are breastfeeding. 

- Tell your doctor if you notice any of the following side effects and 
  they worry you.
- Common side effects: 
- lack of energy, dry mouth, increased appetite, sleepiness, tremor (shakes), 
  having hard or infrequent stools, dizziness, changes in behavior, or   
- Other common side effects in teenagers (13-17 years old) include: headache,
  stomach-area (abdominal) pain, pain in arms or legs, or tiredness. Teenagers 
  experienced greater increases in prolactin, liver enzymes, and sleepiness, as
  compared with adults.
- Drowsiness, unusual tiredness or weakness, fever, bloating, swelling of your 
  hands, feet and ankles, aching joints, nose bleeds, confusion, forgetfulness.
- Some people may feel dizzy in the early stages of treatment, especially when 
   getting up from a lying or sitting position. This side effect usually passes after
   taking Olanzapine for a few days.
- Uncommon side effects:
  Symptoms of sunburn (such as redness, itching, swelling or blistering of the 
  skin) which occur more quickly than normal, rash or allergic reaction, slow 
  heart beat, changes in sexual functioning or sex drive in men or women, 
  prolonged and/or painful erection, unusual secretion of breast milk, breast
  enlargement in men or women, symptoms of high sugar levels in the blood, 
  reaction following abrupt discontinuation (profuse sweating, nausea or 
  vomiting), absence of menstrual periods and changes in the regularity of 
  menstrual periods, involuntary passing of urine or, difficulty in initiating 
  urination, unusual hair loss or thinning.
- Drug reaction with Eosinophilia and Systemic Symptoms (DRESS): (DRESS
  may include rash, fever, swollen glands and other internal organ involvement 
  such as liver, kidney, lung and heart.)
- Tardive Dyskinesia: This condition causes body movements that keep
   happening and that you can not control. These movements usually affect the 
  face and tongue. Tardive dyskinesia may not go away, even if you stop taking 
  OLEZAN®. It may also start after you stop taking OLEZAN®. Tell your
   doctor if you get any body movements that you can not control.
- Decreased blood pressure when you change positions, with symptoms of 
  dizziness, fast or slow heartbeat, or fainting.
- Difficulty swallowing
- Seizures.
- If you or anyone take too much OLEZAN® tablets, you should contact you 
  doctor directly or go to the nearest hospital even if there are no signs of
  discomfort, the most common signs are fast heart beat, agitation 
  /aggression, difficulty speaking and uncontrollable movements and 

- OLEZAN® can cause sleepiness and may affect your ability to make decisions,
  think clearly, or react quickly. You should not drive, operate heavy machinery, or 
  do other dangerous activities until you know how OLEZAN® affects you.
- Avoid drinking alcohol while taking OLEZAN®. Drinking alcohol while you
   take OLEZAN® may make you sleepier than if you take OLEZAN® alone.

- OLEZAN® 5  Tablet : Blister of 10 tablets, pack of 3 blisters. 
- OLEZAN® 10 Tablet : Blister of 10 tablets, pack of 3 blisters.  

- Store in a dry place, in temperature below  25º C.