Patient Medication Information: uses, side effects, how to take - Ava-Olanzapine
ABOUT THIS MEDICATION
The name of your medicine is AVA-OLANZAPINE and your doctor has prescribed it to help relieve the symptoms that are bothering you. AVA-OLANZAPINE can help to control your symptoms and reduce the risk of relapse. Although AVA-OLANZAPINE cannot cure your symptoms, it can help you keep them under control as you continue your treatment.
What the medication is used for:
AVA-OLANZAPINE is used to treat symptoms of schizophrenia and related psychotic disorders as well as those of bipolar disorder.
Your doctor may have prescribed AVA-OLANZAPINE for another reason. Ask your doctor if you have any questions about why AVA-OLANZAPINE has been prescribed for you.
What it does:
AVA-OLANZAPINE belongs to a group of medicines called antipsychotics/antimanics. AVA-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(e.g. hearing, seeing, or sensing things which are not there), delusions, unusual suspiciousness, feeling withdrawn, lack of emotions.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 AVA-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:
AVA-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:
AVA-OLANZAPINE Tablets:
AVA-OLANZAPINE tablets are available in 2.5mg, 5mg, 7.5mg, 10mg and 15mg strengths.
WARNINGS AND PRECAUTIONS
Serious Warnings and Precautions
Studies with various medicines of the group to which AVA-Olanzapine belongs, including AVA-Olanzapine, when used in elderly patients with dementia have been associated with an increased rate of death. AVA-Olanzapine is not indicated in elderly patients with dementia.
Before starting AVA-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 heart problems
- have a history of stroke or high blood pressure
- 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 AVA-OLANZAPINE tablets contain lactose
It is important for your doctor to have this information before prescribing your treatment and dosage.
INTERACTIONS WITH THIS MEDICATION
Tell all doctors, dentists and pharmacists who are treating you that you are taking AVA-OLANZAPINE.
Tell your doctor or pharmacist that you are taking AVA-OLANZAPINE before you start taking any new medicines.
A combination of AVA-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 AVA-OLANZAPINE. It is recommended that you DO NOT drink alcohol while taking AVA-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 AVA-OLANZAPINE in your blood, making AVA-OLANZAPINE less effective.
Only take other medicines while you are on AVA-OLANZAPINE if your doctor tells you that you can. DO NOT give AVA-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 AVA-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 AVA-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 AVA-OLANZAPINE, even after your symptoms have improved or disappeared. AVA-OLANZAPINE should be taken for as long as you and your doctor believe it is helping you.
Proper Handling Instructions
AVA-OLANZAPINE Tablets:
AVA-OLANZAPINE tablets should be swallowed whole with a glass of water. AVA-OLANZAPINE tablets can be taken with or without food.
Overdose:
If you take too much, immediately contact your doctor or go to your nearest hospital emergency department. 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 AVA-OLANZAPINE are drowsiness and slurred speech.
Missed Dose:
Take your prescribed dose at the same time each day. If you miss a dose of AVA-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, AVA-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 AVA-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 AVA-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 AVA-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 and on rare occasion breast enlargement in men. Abnormal liver function tests have also been reported on occasion.
Do not be alarmed by this list of side effects, you may not experience any of them. If any of these side effects are experienced, they are usually mild and temporary.
| 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 | ||
| 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 | ||
| 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 pulse1,2 | X* | ||
| Increased thirst & hunger, frequent urination1,2 | X | ||
| Muscle twitching or abnormal movements of the face or tongue2 | X* | ||
| Pancreas inflammation [symptoms of severe abdominal pain, fever, nausea, vomiting]2 | X | ||
| Priapism [prolonged and painful erection]2 | 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 | ||
1 Identified from the clinical trial database.
2 Identified from adverse events reported after release onto market. 3 Identified 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 AVA-OLANZAPINE, contact your doctor or pharmacist.
HOW TO STORE IT
All medicines should be kept out of the reach of children. AVA-OLANZAPINE should be stored in its original package at room temperature, in a dry place and out of direct light. 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
AVA-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 0701C
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
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 obtained by contacting, Avanstra Inc.: 1-855-709-3678 or medinfo@avanstra.com
Avanstra Inc.
Calgary (Alberta)
T3N 0A4
Website: www.avanstra.com