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Olanzapine (Olanzapine Tablets USP 10 mg) 8Olanzapine (Olanzapine Tablets USP 10 mg)

Olanzapine 10 MG USP Tablet

Olanzapine tablets are prescription medicine used to treat:
Schizophrenia in people 13 or older,Bipolar disorder.


UK Generic Name

Olanzapine


Packing

30


Therapeutic Category

Anti Psychotic


Storage

Store at room temperature, between 68°F to 77°F (20°C to 25°C).


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adobe-pdf-logoPrescribing Information(SPC)


Product Description

Product Overview


What Olanzapine is and what it is used for

Olanzapine tablets are prescription medicine used to treat:
• Schizophrenia in people 13 or older.
• Bipolar disorder, including:
• Manic or mixed episodes that happen with bipolar I disorder in people age 13 or older.
• Manic or mixed episodes that happen with bipolar I disorder, when used with the medicine lithium or valproate, in adults.
• Long-term treatment of bipolar I disorder in adults.
• Episodes of depression that happen with bipolar I disorder, when used with the medicine fluoxetine (Prozac®), in adults.
Olanzapine tablets have not been approved for use in children less than 13 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include hearing voices, seeing things that are not there, having beliefs that are not true, and being suspicious or withdrawn.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 behaviour, and a decreased need for sleep.
Some of your symptoms may improve with treatment. If you do not think you are getting better, call your doctor.

What you need to know before you take Olanzapine tablets

Olanzapine tablets may cause serious side effects, including:
1. Increased risk of death in elderly people who are confused, have memory loss and have lost touch with reality (dementia-related psychosis).
2. High blood sugar (hyperglycemia).
3. High fat levels in your blood (increased cholesterol and triglycerides), especially in teenagers age 13 to 17.
4. Weight gain, especially in teenagers age 13 to 17.

These serious side effects are described below.
1.Increased risk of death in elderly people who are confused, have memory loss and have lost touch with reality (dementia-related psychosis). Olanzapine tablets are not approved for treating psychosis in elderly people with dementia.
2. High blood sugar (hyperglycemia). High blood sugar can happen if you have diabetes already or if you have never had diabetes.
High blood sugar could lead to:
• A build up of acid in your blood due to ketones (ketoacidosis)
• Coma
• Death
Your doctor should do tests to check your blood sugar before you start taking olanzapine tablets and during treatment.
In people who do not have diabetes, sometimes high blood sugar goes away when olanzapine tablets are stopped. People with diabetes and some people who did not have diabetes before taking olanzapine tablets need to take medicine for high blood sugar even after they stop taking olanzapine tablets.
If you have diabetes, follow your doctor’s instructions about how often to check your blood sugar while taking olanzapine tablets.
Call your doctor if you have any of these symptoms of high blood sugar (hyperglycemia) while taking olanzapine tablets:
• feel very thirsty
• need to urinate more than usual
• feel very hungry
• feel weak or tired
• feel sick to your stomach
• feel confused or your breath smells fruity
3.High fat levels in your blood (cholesterol and triglycerides).
High fat levels may happen in people treated with olanzapine tablets, especially in teenagers (13 to 17 years old). You may not have any symptoms, so your doctor should do blood tests to check your cholesterol and triglyceride levels before you start taking olanzapine tablets and during treatment.
4. Weight gain. Weight gain is very common in people who take olanzapine tablets. Teenagers (13 to 17 years old) are more likely to gain weight and to gain more weight than adults. Some people may gain a lot of weight while taking olanzapine tablets, so you and your doctor should check your weight regularly. Talk to your doctor about ways to control weight gain, such as eating a healthy, balanced diet, and exercising.
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:
• 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
• Are pregnant or plan to become pregnant. It is not known if olanzapine tablets will harm your unborn baby.
• Are breast-feeding or plan to breast-feed? Olanzapine tablets can pass into your breast milk and may harm your baby. You should not breast-feed while taking olanzapine tablets. 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 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 non-prescription 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 to take Olanzapine

• Take Olanzapine tablets exactly as prescribed. Your doctor may need to change (adjust) the dose of olanzapine tablets until it is right for you.
If you miss a dose of olanzapine tablets
 Take the missed dose as soon as you remember. If it is almost time for the next dose, just skip the missed dose and take your next dose at the regular time. Do not take two doses of olanzapine tablets at the same time.
To prevent serious side effects, do not stop taking olanzapine tablets suddenly. If you need to stop taking olanzapine tablets, your doctor can tell you how to safely stop taking it.
If you take too much olanzapine tablets
 Call your doctor or poison control center right away, or get emergency treatment.
 Olanzapine tablets can be taken with or without food.
 Olanzapine tablets are usually taken one time each day
Call your doctor if you do not think you are getting better nor have any concerns about your condition while taking olanzapine tablets.
What should I avoid while taking olanzapine tablets
• Olanzapine tablets 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 olanzapine tablets affect you.
• Avoid drinking alcohol while taking olanzapine tablets. Drinking alcohol while you take olanzapine tablets may make you sleepier than if you take olanzapine tablets alone.

Possible side effects

Serious side effects may happen when you take olanzapine tablets, including:
• See “What you need to know before you take Olanzapine tablets”, which describes the increased risk of death in elderly people with dementia-related psychosis and the risks of high blood sugar, high cholesterol and triglyceride levels, and weight gain.
• Increased incidence of stroke or “mini-strokes” called transient ischemic attacks (TIAs) in elderly people with dementia-related psychosis (elderly people who have lost touch with reality due to confusion and memory loss). Olanzapine tablets are not approved for these patients.
• Neuroleptic Malignant Syndrome (NMS): NMS is a rare but very serious condition that can happen in people who take antipsychotic medicines, including olanzapine tablets. NMS can cause death and must be treated in a hospital. Call your doctor right away if you become severely ill and have any of these symptoms:
• High fever
• Excessive sweating
• Rigid muscles
• Confusion
• Changes in your breathing, heartbeat, and blood pressure
• Tardive Dyskinesia: This condition causes body movements that keep happening and that you cannot control. These movements usually affect the face and tongue. Tardive dyskinesia may not go away, even if you stop taking olanzapine tablets. It may also start after you stop taking olanzapine tablets. Tell your doctor if you get any body movements that you cannot control.
• Decreased blood pressure when you change positions, with symptoms of dizziness, fast or slow heartbeat, or fainting.
• Difficulty swallowing, that can cause food or liquid to get into your lungs.
• Seizures: Tell your doctor if you have a seizure during treatment with olanzapine tablets.
• Problems with control of body temperature: You could become very hot, for instance when you exercise a lot or stay in an area that is very hot. It is important for you to drink water to avoid dehydration.
Call your doctor right away if you become severely ill and have any of these symptoms of dehydration:
• sweating too much or not at all
• Dry mouth
• feeling very hot
• feeling thirsty
• Not able to produce urine
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 behaviour, 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.

How to store olanzapine tablets?

• Store olanzapine tablets at room temperature, between 68°F to 77°F (20°C to 25°C).
• Keep olanzapine tablets away from light.
• Keep olanzapine tablets dry and away from moisture.
Keep olanzapine tablets and all medicines out of the reach of children.

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