Patient Medication Information: uses, side effects, how to take - NTP-Olanzapine

ABOUT THIS MEDICATION

The name of your medicine is NTP-OLANZAPINE and your doctor has prescribed it to help relieve the symptoms that are bothering you. NTP-

OLANZAPINE can help to control your symptoms and reduce the risk of relapse. Although NTP-OLANZAPINE cannot cure your symptoms, it can help you keep them under control as you continue your treatment.

What the medication is used for:

NTP-OLANZAPINE is used to treat symptoms of schizophrenia and related psychotic disorders as well as those of bipolar disorder.

Your doctor may have prescribed NTP-

OLANZAPINE for another reason. Ask your doctor if you have any questions about why NTP-

OLANZAPINE has been prescribed for you.

What it does:

NTP-OLANZAPINE belongs to a group of medicines called antipsychotics. NTP-OLANZAPINE is used to treat symptoms of schizophrenia and related psychotic disorders as well as those of bipolar disorder. Schizophrenia may cause symptoms such as hallucinations (e.g. hearing, seeing, or sensing things which are not there), delusions, unusual

suspiciousness, feeling withdrawn, lack of emotions. People with schizophrenia may also feel depressed, anxious or tense. Signs and symptoms of bipolar mania include but are not limited to: feeling invincible or all powerful, inflated self-esteem, racing thoughts, easily lose your train of thought, overreaction to what you see or hear,

misinterpretation of events, speeded-up activity,

talking very quickly, talking too loudly, or talking more than usual, decreased need for sleep, and poor judgment.

When it should not be used:

Do not take NTP-OLANZAPINE if you have had an allergic reaction to olanzapine or any of the ingredients listed in the "Nomedicinal Ingredients" section of this leaflet. Signs of allergic reaction may include a skin rash, itching, shortness of breath or swelling of the face, lips or tongue.

What the medicinal ingredient is:

NTP-OLANZAPINE tablets contain the active ingredient called olanzapine.

What the nonmedicinal ingredients are:

2.5 mg, 5 mg, 7.5 mg and 10 mg Tablets: Crospovidone, glycerol triacetate, hypromellose, hydroxypropyl cellulose, lactose monohydrate, macrogol, magnesium stearate, polydextrose, silicified microcrystalline cellulose and titanium dioxide.

15 mg Tablets: Crospovidone, FD & C Blue # 2 indigo carmine aluminium lake, hypromellose, hydroxypropyl cellulose, lactose monohydrate, macrogol, magnesium stearate, polysorbate, silicified microcrystalline cellulose and titanium dioxide.

What dosage forms it comes in:

NTP-OLANZAPINE Tablets:

NTP-OLANZAPINE tablets are available in 2.5 mg, 5 mg, 7.5 mg, 10 mg and 15 mg strengths.

WARNINGS AND PRECAUTIONS

Serious Warnings and Precautions

Studies with various medicines of the group to which NTP-OLANZAPINE belongs, including NTP-OLANZAPINE, when used in elderly patients with dementia have been associated with an increased rate of death. NTP-OLANZAPINE is not indicated in elderly patients with dementia.

Before starting NTP-OLANZAPINE and to get the best possible treatment, be sure to tell your doctor if you:

are pregnant or plan to become pregnant
are breast feeding or plan on breast feeding
have had an allergic reaction to any medicine
which you have taken previously to treat your current condition
have diabetes or a family history of diabetes
have a history of any problems with the way
your heart beats or have any heart problems
have a history of stroke or high blood pressure
have risk factors for developing blood clots such
as: a family history of blood clots, age over 65, smoking, obesity, recent major surgery (such as hip or knee replacement), immobility due to air travel or other reason, or take oral contraceptives ("The Pill").
are a smoker
have ever had blackouts or seizures
are taking any other medicines (prescriptions or
over-the-counter medicines)
drink alcoholic beverages or use drugs
exercise vigorously or work in hot or sunny
places
have a history of liver problems, hepatitis, or
yellowing of the eyes and skin (jaundice)
have prostate problems
have intestinal congestion (paralytic ileus)
have raised pressure within the eye (glaucoma)
suffer from lactose intolerance because NTP-
OLANZAPINE tablets contain lactose

It is important for your doctor to have this information before prescribing your treatment and dosage.

Effects on Newborns:

In some cases, babies born to a mother taking NTP-OLANZAPINE during pregnancy have experienced symptoms that are severe and require the newborn to be hospitalized. Sometimes, the symptoms may resolve on their own. Be prepared to seek immediate emergency medical attention for your newborn if they have difficulty breathing, are overly sleepy, have muscle stiffness, or floppy muscles (like a rag doll), are shaking, or are having difficulty feeding.

INTERACTIONS WITH THIS MEDICATION

Tell all doctors, dentists and pharmacists who are treating you that you are taking NTP-OLANZAPINE.

Tell your doctor or pharmacist that you are taking NTP-OLANZAPINE before you start taking any new medicines.

A combination of NTP-OLANZAPINE with the following medicines might make you feel drowsy:

medicines taken for anxiety or to help you sleep
medicines taken for depression.

The effects of alcohol could be made worse while taking NTP-OLANZAPINE. It is recommended that you DO NOT drink alcohol while taking NTP-OLANZAPINE.

You should tell your doctor if you are taking fluvoxamine (antidepressant), ketoconazole (antifungal), or ciprofloxacin (antibiotic), as these medicines may lead to higher concentrations of olanzapine in your blood.

You should also tell your doctor if you are taking carbamazepine as it may lead to lower concentrations of NTP-OLANZAPINE in your blood, making NTP-OLANZAPINE less effective.

Only take other medicines while you are on NTP-OLANZAPINE if your doctor tells you that you can. DO NOT give NTP-OLANZAPINE to anyone else. Your doctor has prescribed it for you and your condition.

PROPER USE OF THIS MEDICATION

Usual dose:

The most important thing about taking NTP-OLANZAPINE is to take it the way your doctor has prescribed - the right dose, every day. Your doctor has decided on the best dosage for you based on your individual situation and needs. Your doctor may increase or decrease your dose depending on your response.

Although NTP-OLANZAPINE cannot cure your condition, it can help relieve your symptoms. If your symptoms improve or disappear, it is probably because your treatment is working. Studies have shown that, after coming off medication, a relapse of symptoms occurs in about 2 out of 3 patients and is more than double that of patients staying on their medication. That is why it is so important to keep taking NTP-OLANZAPINE, even after your symptoms have improved or disappeared. NTP-OLANZAPINE should be taken for as long as you and your doctor believe it is helping you.

Proper Handling Instructions

NTP-OLANZAPINE Tablets:

NTP-OLANZAPINE tablets should be swallowed whole with a glass of water. NTP-OLANZAPINE tablets can be taken with or without food.

Overdose:

	In case of drug overdose, contact a health care
	practitioner, hospital emergency department or
	regional Poison Control Centre immediately, even if
	there are no symptoms.

Show the doctor your bottle of tablets. Do this even if there are no signs of discomfort or poisoning. The most common signs if you have taken too much NTP-OLANZAPINE are drowsiness and slurred speech.

Missed Dose:

Take your prescribed dose at the same time each day. If you miss a dose of NTP-OLANZAPINE by a few hours, take the dose when you remember. If most of the day has passed, wait until your next scheduled dose and try not to miss any more. Do not take 2 doses at once.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

Like other medicines, NTP-OLANZAPINE can cause some side effects. These side effects are most likely to be minor and temporary. However, some may be serious and need medical attention. Many of the side effects are dose related, so it is important not to exceed your prescribed dose. The most common side effects of NTP-OLANZAPINE are:

drowsiness
weight gain
dizziness
increased appetite
fluid retention
constipation
dry mouth
a feeling of restlessness (akathisia)

You should also tell your doctor if you notice any symptoms that worry you, even if you think the problems are not connected with the medicine or are not listed here.

Because some people experience drowsiness, you should avoid driving a car or operating machinery until you know how NTP-OLANZAPINE affects you. 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 NTP-OLANZAPINE for a few days.

After prolonged use in women, medicines of this type can cause milk secretion or changes in the regularity

of their monthly period. On rare occasions after prolonged use in men, medicines of this type have been associated with breast enlargement. Abnormal liver function tests have also been reported on occasion.

Your doctor should check your body weight before starting NTP-OLANZAPINE and continue to monitor it for as long as you are being treated.

Your doctor should take blood tests before starting NTP-OLANZAPINE. They will monitor blood sugar, and the number of infection fighting white blood cells. Your doctor should continue to monitor your blood for as long as you are being treated.

If you have high levels of prolactin (measured with a blood test) and a condition called hypogonadism you may be at increased risk of breaking a bone due to osteoporosis. This occurs in both men and women.

Do not be alarmed by this list of possible side effects. You may not experience any of them. If any of these side effects are experienced, they are usually mild and temporary.

The following table is based on data from placebo-controlled clinical trials and from post-marketing data.

SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM

Symptom / effect

Talk with your doctor or pharmacist

Stop taking drug and call your doctor or pharmacist

Only if severe

In all cases

Common
New or worsening constipation		X
Uncommon
Slow Heartbeat¹		X
Rare
Liver inflammation [symptoms of fever, yellow skin or eyes, dark urine, weakness, abdominal pain, nausea, vomiting, loss of appetite, itching]²		X*
Low white blood cell count [symptoms of infection, such as cold, flu-like symptoms, fever, sore throat, as well as weakness or general feeling of unwellness]²		X

SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM
Rash²(see also Allergic Reaction below)	X
Seizure [i.e. loss of consciousness with uncontrollable shaking (“fit”)]²			X*
Very rare
Allergic reaction [symptoms include skin rash, hives, swelling, difficulty breathing]²			X*
Bruise easily, excessive bleeding²		X
High fever, muscle rigidity, rapid heartbeat, profuse sweating, irregular pulse^1,2			X*
Increased thirst & hunger, frequent urination^1,2		X
Muscle twitching or abnormal movements of the face or tongue²		X*
Blood clots: swelling, pain and redness in an arm or leg that can be warm to touch. You may develop sudden chest pain, difficulty breathing and heart palpitations²		X
Pancreas inflammation [symptoms of severe abdominal pain, fever, nausea, vomiting]²			X
Long-lasting (greater than 4 hours in duration) and painful erection of the penis²			X
Sudden weakness or numbness in the face, arms, or legs, and speech or vision problems³			X*
Very dark (“tea coloured”) urine, muscle tenderness and/or aching²			X

¹Identified from the clinical trial database.

²Identified from adverse events reported after release onto market.

³Identified from data from 5 placebo-controlled trials in elderly patients with dementia-related psychosis.

* If you think you have these side effects, it is important that you seek medical advice from your doctor immediately. This is not a complete list of side effects. For any unexpected effects while taking NTP-

OLANZAPINE, contact your doctor or pharmacist.

HOW TO STORE IT

All medicines should be kept out of the reach of children. NTP-OLANZAPINE Tablets should be stored at 15-30^oC, protected from light and moisture.

The expiry date of this medicine is printed on the

package label. Do not use the medicine after this date. If your doctor tells you to stop taking NTP-OLANZAPINE or you find that they have passed their expiry date, please return any left over medicine to your pharmacist.

REPORTING SUSPECTED SIDE EFFECTS

You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:

-----------------------------------------------------------------

Report online at
www.healthcanada.gc.ca/medeffect
Call toll-free at 1-866-234-2345
Complete a Canada Vigilance Reporting
Form and:
- Fax toll-free to 1-866-678-6789, or
- Mail to: Canada Vigilance Program Health Canada
  Postal Locator 0701 E Ottawa, ON K1A 0K9

Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect^™Canada Web site at www.healthcanada.gc.ca/medeffect.

NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.

MORE INFORMATION

This document plus the full product monograph, prepared for health professionals can be found by contacting Teva Canada Ltd.

at: 1-800-268-4127 ext. 5005

or druginfo@tevacanada.com

Teva Canada Ltd.

30 Novopharm Court

Toronto, Ontario

Canada, M1B 2K9

NTP-Olanzapine: Uses, Side Effects and Dosage