OLANZAPINE- olanzapine tablet, film coated
REMEDYREPACK INC.
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Medication Guide
Olanzapine Tablets, USP
(oh lan′ za peen)
Read the Medication Guide that comes with olanzapine tablets before you start taking it and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking to your doctor about your medical condition or treatment. Talk with your doctor or pharmacist if there is something you do not understand or you want to learn more about olanzapine tablets.
What is the most important information I should know about olanzapine tablets?
Olanzapine tablets may cause serious side effects, including:
These serious side effects are described below.
What are olanzapine tablets?
Olanzapine tablets are a prescription medicine used to treat:
Olanzapine tablets have not been approved for use in children under 13 years of age. Olanzapine in combination with fluoxetine has not been approved for use in children under 10 years of age.
The symptoms of schizophrenia include hearing voices, seeing things that are not there, having beliefs that are not true, and being suspicious or withdrawn.
The symptoms of bipolar I disorder include alternating periods of depression and high or irritable mood, increased activity and restlessness, racing thoughts, talking fast, impulsive behavior, and a decreased need for sleep.
The symptoms of treatment resistant depression include decreased mood, decreased interest, increased guilty feelings, decreased energy, decreased concentration, changes in appetite, and suicidal thoughts or behavior.
Some of your symptoms may improve with treatment. If you do not think you are getting better, call your doctor.
What should I tell my doctor before taking olanzapine tablets?
Olanzapine tablets may not be right for you. Before starting olanzapine tablets, tell your doctor if you have or had:
If you become pregnant while receiving olanzapine tablets, talk to your healthcare provider about registering with the National Pregnancy Registry for Atypical Antipsychotics. You can register by calling 1-866-961-2388 or go to http://womensmentalhealth.org/clinical-andresearch-programs/pregnancyregistry/.
are breast-feeding or plan to breast-feed. Olanzapine passes into your breast milk. Talk to your doctor about the best way to feed your baby if you take olanzapine tablets.
Tell your doctor if you exercise a lot or are in hot places often.
The symptoms of bipolar I disorder, treatment resistant depression, or schizophrenia may include thoughts of suicide or of hurting yourself or others. If you have these thoughts at any time, tell your doctor or go to an emergency room right away.
Tell your doctor about all the medicines that you take, including prescription and nonprescription medicines, vitamins, and herbal supplements. Olanzapine tablets and some medicines may interact with each other and may not work as well, or cause possible serious side effects. Your doctor can tell you if it is safe to take olanzapine tablets with your other medicines. Do not start or stop any medicine while taking olanzapine tablets without talking to your doctor first.
How should I take olanzapine tablets?
What should I avoid while taking olanzapine tablets?
What are the possible side effects of olanzapine tablets?
Serious side effects may happen when you take olanzapine tablets, including:
Common side effects of olanzapine tablets include: lack of energy, dry mouth, increased appetite, sleepiness, tremor (shakes), having hard or infrequent stools, dizziness, changes in behavior, or restlessness.
Other common side effects in teenagers (13 to 17 years old) include: headache, stomach-area (abdominal) pain, pain in your arms or legs, or tiredness. Teenagers experienced greater increases in prolactin, liver enzymes, and sleepiness, as compared with adults.
Tell your doctor about any side effect that bothers you or that does not go away.
These are not all the possible side effects with olanzapine tablets. For more information, ask your doctor or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store olanzapine tablets?
Keep olanzapine tablets and all medicines out of the reach of children.
General information about olanzapine tablets
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use olanzapine tablets for a condition for which it was not prescribed. Do not give olanzapine tablets to other people, even if they have the same condition. It may harm them.
This Medication Guide summarizes the most important information about olanzapine tablets. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about olanzapine tablets that was written for healthcare professionals. For more information about olanzapine tablets call Apotex Corp. at 1-800-706-5575 or visit www.apotexcorp.com/products.
What are the ingredients in olanzapine tablets?
Active ingredient: olanzapine
Inactive ingredients: lactose, magnesium stearate, microcrystalline cellulose, starch. The color coating contains FD&C blue No.2 aluminum lake (15 mg), ferric oxide red (20 mg), hydroxypropyl cellulose, hypromellose, iron oxide yellow (20 mg), polyethylene glycol and titanium dioxide (all strengths).
This Medication Guide has been approved by the U.S. Food and Drug Administration.
All registered trademarks in this document are the property of their respective owners.
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