Details for: OLANZAPINE ODT
Company: SANIS HEALTH INC
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02352974 | OLANZAPINE ODT | OLANZAPINE | 5 MG | TABLET (ORALLY DISINTEGRATING) | ORAL |
| 02352982 | OLANZAPINE ODT | OLANZAPINE | 10 MG | TABLET (ORALLY DISINTEGRATING) | ORAL |
| 02352990 | 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
Summary Safety Review - Atypical antipsychotics - Assessing the potential risk of Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)
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 ODT is used to treat symptoms of schizophrenia and related psychotic disorders as well as those of bipolar disorder.
Your doctor may have prescribed OLANZAPINE ODT for another reason. Ask your doctor if you have any questions about why OLANZAPINE ODT has been prescribed for you.
What it does
OLANZAPINE ODT belongsto a group of medicines called antipsychotics. OLANZAPINE ODT 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(e.g., hearing, seeing, or sensing things which are not there), delusions, unusual suspiciousness, feeling withdrawn, lack of emotions.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 OLANZAPINE ODT if you have had an allergic reaction to OLANZAPINE ODT or any of the ingredients listed in the "Non-Medicinal 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
Olanzapine.
What the non-medicinal ingredients are
OLANZAPINE ODT (Olanzapine Orally Disintegrating Tablets) 5 mg, 10 mg and 15 mg: Aspartame, Colloidal Silicon Dioxide, Crospovidone, GuarGum, Magnesium Stearate, Mannitol, Microcrystalline Cellulose, Pregelatinized Starch and Sodium Lauryl Sulphate.
What dosage form it comes in
OLANZAPINE ODT Orally Disintegrating Tablets: 5 mg, 10 mg and 15 mg.
Warnings and precautions
Serious Warnings and Precautions
Studies with various medicines of the group to which OLANZAPINE ODT belongs, when used in elderly patients with dementia have been associated with an increased rate of death. OLANZAPINE ODT is not indicated in elderly patients with dementia.
Before starting 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)
- cannot take phenylalanine because OLANZAPINE ODT orally disintegrating tablet contains aspartame, a source of phenylalanine.
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 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 ODT.
Tell your doctor or pharmacist that you are taking OLANZAPINE ODT before you start taking any new medicines.
A combination of 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 ODT. It is recommended that you DO NOT drink alcohol while taking 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 ODT in your blood, making OLANZAPINE ODT less effective.
Only take other medicines while you are on OLANZAPINE ODT if your doctor tells you that you can. DO NOT give 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 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 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 ODT, even after your symptoms have improved or disappeared. OLANZAPINE ODT should be taken for as long as you and your doctor believe it is helping you.
Overdose:
Show the health care practitioner 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 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 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, OLANZAPINEODT 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 ODT are:
- drowsiness
- weight gain
- dizziness
- increased appetite
- fluid retention
- constipation
- dry mouth
- a feeling of restlessness (akathisia)
- decreased blood pressure upon rising from a lying or sitting position.
Events of stuttering (disruptive speech) and increased salivation (salivary hypersecretion) were uncommonly reported. You shouldalso tellyour 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 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 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 ODT and continue to monitor it for as long as you are being treated.
Your doctor should take blood tests before starting OLANZAPINE ODT. 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.
| 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 heartbeat | ✔ | ||
| Rare | |||
| Liver inflammation [symptoms of fever, yellow skin or eyes, dark urine,weakness, abdominal pain, nausea, vomiting, loss of appetite, itching] | ✔ | ||
| 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] | ✔ | ||
| Rash (see also Allergic Reaction below) | ✔ | ||
| Seizure [i.e., loss of consciousness with uncontrollable shaking ("fit")] | ✔ | ||
| Very Rare | |||
| Allergic reaction [symptoms include skin rash, hives, swelling, difficulty breathing] | ✔ | ||
| Bruise easily, excessive bleeding | ✔ | ||
| High fever, muscle rigidity, rapid heartbeat, profuse sweating, irregular pulse | ✔ | ||
| Increased thirst andhunger, frequent urination | ✔ | ||
| Muscle twitching or abnormal movements ofthe face ortongue | ✔ | ||
| 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 palpitations | ✔ | ||
| Pancreas inflammation [symptoms of severe abdominal pain, fever, nausea, vomiting] | ✔ | ||
| Long-lasting (greater than 4 hours in duration) and painful erection of the penis | ✔ | ||
| Sudden weakness or numbness in the face, arms, or legs, and speech or vision problems | ✔ | ||
| Very dark ("tea colored") urine, muscle tenderness and/or aching | ✔ | ||
| 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. | ✔ | ||
This is not a complete list of side effects. For any unexpected effects while taking OLANZAPINE ODT contact your doctor or pharmacist.
How to store
Store tablets between15oC and 30oC. Protect from light and moisture.
All medicines should be kept out of the reach of children. 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 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 side effects associated with the use of health products to Health Canada by:
- Visiting the Web page on Adverse Reaction Reporting (https://www.canada.ca/en/health-canada/services/drugshealth-products/medeffect-canada/adverse-reactionreporting.html) for information on how to report online, by mail or by fax; or
- Calling toll-free at 1-866-234-2345.
NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.
More information
- Talk to your healthcare professional
- Find the full product monograph that is prepared for healthcareprofessionals and includes this Consumer Information by visiting the Health Canada website (https://www.canada.ca/en/healthcanada/services/drugs-health-products/drugproducts/drug-product-database.html), can be obtained by contacting Sanis Health Inc. at:
1-866-236-4076
or quality@sanis.com
This leaflet was prepared by:
Sanis Health Inc.
1 President's Choice Circle
Brampton, Ontario
L6Y 5S5
Last revised: August 25, 2021