Details for: OLANZAPINE ODT
Company: PRO DOC LIMITEE
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02338645 | OLANZAPINE ODT | OLANZAPINE | 5 MG | TABLET (ORALLY DISINTEGRATING) | ORAL |
| 02338653 | OLANZAPINE ODT | OLANZAPINE | 10 MG | TABLET (ORALLY DISINTEGRATING) | ORAL |
| 02338661 | OLANZAPINE ODT | OLANZAPINE | 15 MG | TABLET (ORALLY DISINTEGRATING) | ORAL |
Summary Reports
Summary Safety Review - Atypical antipsychotics - Assessing the Potential Risk of Urinary Retention
Summary Safety Review - Atypical Antipsychotics - Liver failure
Consumer Information
This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.
What the medication is used for
Olanzapine and Olanzapine ODT are used to treat symptoms of schizophrenia and related psychotic disorders as well as those of bipolar disorder.
Your doctor may have prescribed Olanzapine or Olanzapine ODT for another reason. Ask your doctor if you have any questions about why Olanzapine or Olanzapine ODT has been prescribed for you.
What it does
Olanzapine and Olanzapine ODT belong to a group of medicines called antipsychotics. Olanzapine and Olanzapine ODT are 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(e.g. hearing, seeing, or sensing things which are not there), delusions, unusual suspiciousness, feeling withdrawn, lack of emotions.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 Olanzapine or Olanzapine ODT if you have had an allergic reaction to Olanzapine or Olanzapine ODT or any of the ingredients listed in the “What the nonmedicinal ingredients are” 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
Olanzapine tablets and Olanzapine orally disintegrating tablets contain the active ingredient called olanzapine.
What the non-medicinal ingredients are
Olanzapine tablets contain the following inactive ingredients: lactose monohydrate, hydroxypropyl cellulose, cellulose microcrystalline, crospovidone, magnesium stearate, polyvinyl alcohol, polyethylene glycol, titanium dioxide, talc and indigo carmine (for the 15 mg only).
Olanzapine orally disintegrating tablets (ODT) contain the following inactive ingredients: colloidal silicon dioxide, crospovidone, flavouring mint powder, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate and talc.
What dosage form it comes in
Olanzapine tablets are available in 2.5 mg, 5 mg, 7.5 mg, 10 mg and 15 mg strengths.
Olanzapine orally disintegrating tablets are available in 5 mg, 10 mg and 15 mg. strengths.
Warnings and precautions
Serious Warnings and Precautions
Studies with various medicines of the group to which olanzapine belongs, when used in elderly patients with dementia have been associated with an increased rate of death. Olanzapine and Olanzapine ODT are not indicated in elderly patients with dementia.
BEFORE starting Olanzapine or Olanzapine ODT 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-thecounter 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 Olanzapine and Olanzapine ODT 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 Olanzapine or
Olanzapine ODT 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 Olanzapine or Olanzapine ODT.
Tell your doctor or pharmacist that you are taking Olanzapine or Olanzapine ODT before you start taking any new medicines.
A combination of Olanzapine or Olanzapine ODT 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 Olanzapine or Olanzapine ODT. It is recommended that you DO NOT drink alcohol while taking Olanzapine or Olanzapine ODT.
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 Olanzapine or Olanzapine ODT in your blood, making Olanzapine or Olanzapine ODT less effective.
Only take other medicines while you are on Olanzapine or Olanzapine ODT if your doctor tells you that you can. DO NOT give Olanzapine or Olanzapine ODT 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 Olanzapine or Olanzapine ODT 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 Olanzapine and Olanzapine ODT 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 Olanzapine or Olanzapine ODT, even after your symptoms have improved or disappeared. Olanzapine or Olanzapine ODT should be taken for as long as you and your doctor believe it is helping you.
Proper Handling Instructions:
Olanzapine tablets should be swallowed whole with a glass of
water. Olanzapine tablets can be taken with or without food.
Olanzapine ODT: Follow the instructions below:
- Gently push the tablet out from the blister.
- Put the tablet directly into your mouth. It will begin to dissolve in your mouth within a few seconds. You can also place the tablet directly into a full glass of water, milk, coffee, orange juice or apple juice. Stir and drink all of the contents immediately.
Overdose
Show the health care practitioner your box or 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 Olanzapine or Olanzapine ODT are drowsiness and slurred speech.
Missed Dose
Take your prescribed dose at the same time each day. If you miss a dose of Olanzapine or Olanzapine ODT 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, Olanzapine and Olanzapine ODT 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 oral Olanzapine and Olanzapine ODT are:
- drowsiness
- weight gain
- dizziness
- increased appetite
- fluid retention
- constipation
- dry mouth
- feeling of restlessness (akathisia)
- decreased blood pressure upon rising from a lying or sitting position.
Events of stuttering (disruptive speech) were uncommonly reported. 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 Olanzapine or Olanzapine ODT 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 Olanzapine or Olanzapine ODT 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. As well, abnormal liver function tests have been reported on occasion.
Your doctor should check your body weight before starting Olanzapine or Olanzapine ODT and continue to monitor it for as long as you are being treated.
Your doctor should take blood tests before starting Olanzapine or Olanzapine ODT. They will monitor blood sugar, and the number of leucocytes (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.
| Symptom / effect | Talk to your healthcare professional Only if severe | Talk to your healthcare professional In all cases | Stop taking drug and get immediate medical help |
|---|---|---|---|
| Common | |||
| New or worsening constipation | ✔ | ||
| Uncommon | |||
| Slow heartbeat1 | ✔ | ||
| Rare | |||
| Liver inflammation (symptoms of fever, yellow skin or eyes, dark urine, weakness, abdominal pain, nausea, vomiting, loss of appetite, itching) 2 | ✔* | ||
| 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 | ✔ | ||
| Rash2 (see also Allergic Reaction below) | ✔ | ||
| Seizure [i.e. loss of consciouness with uncontrollable shaking (“fit”)] 2 | ✔* | ||
| Very Rare | |||
| Allergic reaction (symptoms include skin rash, hives, swelling difficulty breathing) 2 | ✔* | ||
| Bruise easily, excessive bleeding 2 | ✔ | ||
| High fever, muscle rigidity, rapid heartbeat, profuse sweating, irregular pulse 1,2 | ✔* | ||
| Increased thirst & hunger, frequent urination 1,2 | ✔ | ||
| Muscle twitching or abnormal movements of the face or tongue2 | ✔* | ||
| 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 | ✔ | ||
| Pancreas inflammation (symptoms of severe abdominal pain, fever, nausea, vomiting) 2 | ✔ | ||
| Long-lasting (greater than 4 hours in duration) and painful erection of the penis2 | ✔ | ||
| Sudden weakness or numbness in the face, arms, or legs and speech or vision problems3 | ✔* | ||
| Very dark (“tea coloured”) urine, muscle tenderness and/or aching2 | ✔ | ||
| Serious skin reactions: (Drug Reaction with Eosinophilia and Systemic Symptoms [DRESS]): skin rash or redness developing into widespread rash with blisters and peeling skin, swollen lymph nodes and fever | ✔ | ||
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 Olanzapine or Olanzapine ODT, contact your doctor or pharmacist.
How to store
All medicines should be kept out of reach of children. Olanzapine and Olanzapine ODT should be stored in their original package between 15 and 30 °C, 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 Olanzapine or Olanzapine ODT or you find that they have passed their expiry date, please return any left-over medicine to your pharmacist.
Reporting 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 https://www.canada.ca/en/healthcanada/services/drugs-health-products/medeffect-canada.html
- 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 0701E
Ottawa, Ontario
K1A 0K9
Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffectTM Canada Web site at https://www.canada.ca/en/health-canada/services/drugshealth-products/medeffect-canada.html .
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 the sponsor, Pro Doc Ltée at 1-800-361-8559, www.prodoc.qc.ca or info@prodoc.qc.ca
This leaflet was prepared by Pro Doc Ltée, Laval, Québec, H7L 3W9
Date prepared: October 19, 2018