Patient Medication Information: uses, side effects, how to take - Jamp Olanzapine Fc
What the medication is used for:
JAMP OLANZAPINE FC and JAMP 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 JAMP OLANZAPINE FC or JAMP OLANZAPINE ODT for
another reason. Ask your doctor if you have any questions about why JAMP OLANZAPINE FC or JAMP OLANZAPINE ODT has been prescribed for you.
What it does:
JAMP OLANZAPINE FC and JAMP OLANZAPINE
ODT belong to a group of medicines called antipsychotics. JAMP OLANZAPINE FC and JAMP 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or sensing things which are not there), delusions, unusual suspiciousness, feeling withdrawn, lack of emotions.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 JAMP OLANZAPINE FC or JAMP OLANZAPINE ODT if you have had an allergic reaction to olanzapine or any of the ingredients listed in the “Nonmedicinal 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:
JAMP OLANZAPINE FC (film coated) tablets and JAMP OLANZAPINE ODT (orally disintegrating tablets) contain the active ingredient called olanzapine.
What the nonmedicinal ingredients are:
JAMP OLANZAPINE FC Film Coated Tablets:
JAMP OLANZAPINE FC tablets contain the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, crospovidone, hydroxypropylcellulose, talc, magnesium stearate, polyvinyl alcohol, titanium dioxide, lecithin, xanthan gum, FD&C blue #2 (15 mg), indigo carmine aluminium lake (15 mg), yellow iron oxide (15 & 20 mg), black iron oxide (15 & 20 mg), red iron oxide (20 mg).
JAMP OLANZAPINE ODT Orally Disintegrating Tablets:
JAMP OLANZAPINE ODT contains the following inactive ingredients: crospovidone, lactose monohydrate, colloidal silicon dioxide, hydroxypropylcellulose, mint powder, talc, and magnesium stearate.
What dosage forms it comes in:
JAMP OLANZAPINE FC Tablets:
JAMP OLANZAPINE FC tablets are available in 2.5 mg (white), 5 mg (white), 7.5 mg (white), 10 mg (white), 15 mg (light blue), and 20 mg (pink) strengths. JAMP OLANZAPINE FC tablets are packaged in aluminum blisters of 3X10, in a carton and bottles of 100 tablets.
JAMP OLANZAPINE ODT:
JAMP OLANZAPINE ODT orally disintegrating tablets are available in 5 mg (yellow), 10 mg (yellow), 15 mg (yellow), and 20 mg (yellow) strengths. JAMP OLANZAPINE ODT tablets are packaged in
65
JAMP OLANZAPINE FC and ODT Tablets Product Monograph
IMPORTANT: PLEASE READ
ABOUT THIS MEDICATION
aluminum blisters of 7 and 30 (3X10), in a carton. JAMP OLANZAPINE ODT tablets are also available in bottles of 100 tablets. Bottles include a desiccant.
muscle stiffness, or floppy muscles (like a rag doll), are shaking, or are having difficulty feeding.
Tell all doctors, dentists and pharmacists who are treating you that you are taking JAMP OLANZAPINE FC or JAMP OLANZAPINE ODT.
Tell your doctor or pharmacist that you are taking JAMP OLANZAPINE FC or JAMP OLANZAPINE
ODT before you start taking any new medicines.
Before starting JAMP OLANZAPINE FC or JAMP 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-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 JAMP OLANZAPINE FC and JAMP OLANZAPINE ODT 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 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
A combination of JAMP OLANZAPINE FC or JAMP 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 JAMP OLANZAPINE FC or JAMP
OLANZAPINE ODT. It is recommended that you DO NOT drink alcohol while taking JAMP OLANZAPINE FC or JAMP 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 in your blood, making JAMP OLANZAPINE FC or JAMP OLANZAPINE ODT less effective.
Only take other medicines while you are on JAMP OLANZAPINE FC or JAMP OLANZAPINE ODT if your doctor tells you that you can. DO NOT give JAMP OLANZAPINE FC or JAMP OLANZAPINE
ODT to anyone else. Your doctor has prescribed it for you and your condition.
Usual dose:
The most important thing about taking JAMP OLANZAPINE FC or JAMP 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 JAMP OLANZAPINE FC and JAMP 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
IMPORTANT: PLEASE READ
WARNINGS AND PRECAUTIONS
INTERACTIONS WITH THIS MEDICATION
PROPER USE OF THIS MEDICATION
Serious Warnings and Precautions
Studies with various medicines of the group to which JAMP OLANZAPINE FC and JAMP
OLANZAPINE ODT belong, when used in elderly patients with dementia have been associated with an increased rate of death. JAMP OLANZAPINE FC and JAMP OLANZAPINE ODT are not indicated in elderly patients with dementia.
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 JAMP OLANZAPINE FC or JAMP OLANZAPINE ODT,
even after your symptoms have improved or disappeared. JAMP OLANZAPINE FC and JAMP OLANZAPINE ODT should be taken for as long as you and your doctor believe it is helping you.
Proper Handling Instructions
JAMP OLANZAPINE FC Tablets:
JAMP OLANZAPINE FC tablets should be swallowed whole with a glass of water. JAMP OLANZAPINE FC tablets can be taken with or without food.
JAMP OLANZAPINE ODT:
JAMP OLANZAPINE ODT should be handled carefully with dry hands.
Follow the instructions below:
- 1. Separate one blister cell from the strip by tearing along the dotted line
- 2. Carefully peel off the backing foil
- 3. Gently push the tablet out from the bottom of the blister.
- 4. Avoid touching the tablet with your hands. 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 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 JAMP OLANZAPINE FC or JAMP 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 JAMP OLANZAPINE FC or JAMP 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.
Like other medicines, JAMP OLANZAPINE FC and JAMP 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 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 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 JAMP OLANZAPINE FC or JAMP 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 JAMP OLANZAPINE FC or JAMP 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 JAMP OLANZAPINE FC or JAMP OLANZAPINE ODT and continue to monitor it for as long as you are being treated.
Your doctor should take blood tests before starting JAMP OLANZAPINE FC or JAMP 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.
IMPORTANT: PLEASE READ
If you think you have taken too much JAMP OLANZAPINE FC or JAMP OLANZAPINE ODT, contact a health care practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.
THEM
SIDE EFFECTS AND WHAT TO DO ABOUT
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 | √ | |||||
| 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 consciousness with uncontrollable shaking (“fit”)]2 | √* | |||||
| Very Rare | ||||||
| Allergic reaction [symptoms include skin rash, hives, swelling, difficulty breathing]2 | √* | |||||
| Bruise easily, excessive bleeding2 | √ | |||||
| High fever, muscle rigidity, rapid heartbeat, profuse sweating, irregular pulse1,2 | √* | |||||
| 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 | |||
| Onl y if seve re | In all cases | ||||
| Increased thirst & hunger, frequent urination1,2 | √ | ||||
| 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 Eosinophiliaand Systemic Symptoms [DRESS]): skin rash or redness developing into Widespread rash with blisters and peeling skin, swollen lymph nodes and fever. | √ | ||||
IMPORTANT: PLEASE READ
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 JAMP OLANZAPINE FC Tablets or JAMP OLANZAPINE ODT orally disintegrating tablets, contact your doctor or pharmacist.
HOW TO STORE IT
All medicines should be kept out of the reach and sight of children.
JAMP OLANZAPINE FC and JAMP OLANZAPINE ODT should be stored in its original package at room temperature (15 ºC – 30 º), 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 JAMP OLANZAPINE FC or JAMP 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:
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
If you want more information about JAMP OLANZAPINE FC or JAMP OLANZAPINE ODT:
- Talk to your healthcare professional.
- Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website; (https://health-products.canada.ca/dpd-bdpp/index-eng.jsp); or the manufacturer’s website (www.jamppharma.com), or by calling the sponsor at: 1-866-399-9091
JAMP Pharma Corporation
1310 rue Nobel
Boucherville, Québec
J4B 5H3, Canada
Last Revised: July 20, 2020
IMPORTANT: PLEASE READ