Patient Medication Information: uses, side effects, how to take - Act Olanzapine
ABOUT THIS MEDICATION
The name of your medicine is ACT OLANZAPINE and your doctor has prescribed it to help relieve the symptoms that are bothering you. ACT OLANZAPINE can help to control your symptoms and reduce the risk of relapse. Although ACT OLANZAPINE cannot cure your symptoms, it can help you keep them under control as you continue your treatment.
UWhat the medication is used for:
ACT OLANZAPINE is used to treat symptoms of schizophrenia and related psychotic disorders as well as those of bipolar disorder.
Your doctor may have prescribed ACT OLANZAPINE for another reason. Ask your doctor if you have any questions about why ACT OLANZAPINE has been prescribed for you.
UWhat it does:
ACT OLANZAPINE belongs to a group of medicines called antipsychotics. ACT 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(e.g. hearing, seeing, or sensing things which are not there), delusions, unusual suspiciousness, feeling withdrawn, lack of emotions.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.
UWhen it should not be used:
Do not use ACT OLANZAPINE if you have or 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.
UWhat the medicinal ingredient is:U
ACT OLANZAPINE Tablets contain the active ingredient called olanzapine.
What the nonmedicinal ingredients are:
ACT OLANZAPINE tablets contain the following inactive ingredients:
crospovidone, hydroxypropyl cellulose, lactose monohydrate, low substituted hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, lecithin, polyvinyl alcohol, talc, titanium dioxide, xanthan gum, FD&C Blue #2, FD&C Red #40 and FD&C Yellow #6.
Please note that colorants are only present in the 15 mg and 20 mg strengths.
UWhat dosage forms it comes in:
ACT OLANZAPINE Tablets are available in 2.5mg, 5 mg, 7.5 mg, 10 mg, 15 mg and 20 mg tablets.
WARNINGS AND PRECAUTIONS
Serious Warnings and Precautions
Studies with various medicines of the group to which olanzapine belongs, including ACT OLANZAPINE, when used in elderly patients with dementia have been associated with an increased rate of death. ACT OLANZAPINE is not indicated in elderly patients with dementia.
Before starting ACT 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 (prescription 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 ACT 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 ACT 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 ACT OLANZAPINE.
Tell your doctor or pharmacist that you are taking ACT OLANZAPINE before you start taking any new medicines.
A combination of ACT 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 ACT OLANZAPINE. It is recommended that you DO NOT drink alcohol while taking ACT 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 olanzapine in your blood, making ACT OLANZAPINE less effective.
Only take other medicines while you are on ACT OLANZAPINE if your doctor tells you that you can. DO NOT give ACT OLANZAPINE to anyone else. Your doctor has prescribed it for you and your condition.
PROPER USE OF THIS MEDICATION
UUsual dose:
The most important thing about taking ACT 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 ACT 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 ACT OLANZAPINE, even after your symptoms have improved or disappeared. ACT OLANZAPINE should be taken for as long as you and your doctor believe it is helping you.
Proper Handling Instructions
ACT OLANZAPINE tablets should be swallowed whole with a glass of water. ACT OLANZAPINE tablets can be taken with or without food.
UOverdoseU:
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 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 are drowsiness and slurred speech.
UMissed Dose:
Take your prescribed dose at the same time each day. If you miss a dose of ACT 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, ACT 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 ACT 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
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 ACT 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 ACT 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. As well, abnormal liver function tests have been reported on occasion.
Your doctor should check your body weight before starting ACT OLANZAPINE and continue to monitor it for as long as you are being treated.
Your doctor should take blood tests before starting ACT 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 seek immediate emergency medical attention | |
| Only if severe | In all cases | ||
| Common | |||
| New or worsening constipation | ✓ | ||
| Uncommon | |||
| Slow heartbeatP 1 | ✓ | ||
| Rare | |||
| Liver inflammation [symptoms of fever, yellow skin or eyes, dark urine, weakness, abdominal pain, nausea, vomiting, loss of appetite, itching]P 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]P 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 seek immediate emergency medical attention |
|---|
| Only if severe | In all cases | ||
|---|---|---|---|
| RashP 2 P (see also Allergic Reaction below) | ✓ | ||
| Seizure [ i.e. loss of consciousness with uncontrollable shaking (“fit”)]P 2 | ✓* | ||
| Very Rare | |||
| Allergic Reaction [symptoms include skin rash, hives, swelling, difficulty breathing ]P 2 | ✓* | ||
| Bruise easily, excessive bleedingP 2 | ✓ | ||
| High fever, muscle rigidity, rapid heartbeat, profuse sweating, irregular pulse P 1,2 | ✓* | ||
| Increased thirst & hunger, frequent urinationP 1,2 | ✓ | ||
| Muscle twitching or abnormal movements of the face or tongueP 2 | ✓* | ||
| 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.P 2 | ✓ | ||
| Pancreas inflammation [symptoms of severe abdominal pain, fever, nausea, vomiting]P 2 | ✓ | ||
| Long-lasting (greater than 4 hours in duration) and painful erection of the penisP 2 | ✓ | ||
| Sudden weakness or numbness in the face, arms, or legs, and speech or vision problemsP 3 | ✓* | ||
| Very dark (“tea coloured”) urine, muscle tenderness and/or achingP 2 | ✓ | ||
| 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. | ✓ | ||
P 1 P Identified from the clinical trial database.
P 2 P Identified from adverse events reported after release onto market
P 3 P 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 ACT OLANZAPINE, contact your doctor or pharmacist.
HOW TO STORE IT
All medicines should be kept out of the reach of children. ACT OLANZAPINE should be stored in its original package at room temperature (between 15°C and 30°C), in a dry place and out of direct light. The expiry date of this medicine is printed on the label. Do not use the medicine after this date. If you doctor tells you to stop taking ACT OLANZAPINE or you find that they have passed their expiry date, please return any left over medicine to your pharmacist.
UREPORTING 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:
Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffectP ™ PCanada 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 the sponsor, Actavis Pharma Company, at: 1-866-254-6111.
Actavis Pharma Company