Patient Medication Information: uses, side effects, how to take - Mylan-Olanzapine ODT
ABOUT THIS MEDICATION
The name of your medicine is Mylan-Olanzapine and your doctor has prescribed it to help relieve the symptoms that are bothering you. Mylan-Olanzapine can help to control your symptoms and reduce the risk of relapse. Although Mylan-Olanzapine cannot cure your symptoms, it can help you keep them under control as you continue your treatment.
What the medication is used for:
Mylan-Olanzapine is used to treat symptoms of schizophrenia and related psychotic disorders as well as those of bipolar disorder.
Your doctor may have prescribed Mylan-Olanzapine for another reason. Ask your doctor if you have any questions about why Mylan-Olanzapine has been prescribed for you.
What is does:
Mylan-Olanzapine belongs to a group of medicines called antipsychotics. Mylan-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(e.g. hearing, seeing, or sensing things which are not there), delusions, unusual suspiciousness, feeling withdrawn, lack of emotions.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 judgement.
When it should not be used:
Do not take Mylan-Olanzapine if you have had an allergic reaction to Mylan-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:
Mylan-Olanzapine tablets and Mylan-Olanzapine ODT contain the active ingredient called olanzapine.
What the nonmedicinal ingredients are:
Mylan-Olanzapine:
Nonmedicinal ingredients include: lactose monohydrate, maize starch, pregelatinized maize starch, crospovidone and magnesium stearate.
Coating (2.5 mg, 5 mg, 7.5 mg, 10 mg) ingredients include: lecithin, partially hydrolyzed polyvinyl alcohol, talc, titanium dioxide and xanthan gum
Coating (15 mg) ingredients include: FD&C Blue No. 2 aluminium lake, lecithin, partially hydrolyzed polyvinyl alcohol, talc, titanium dioxide and xanthan gum
Coating (20 mg) ingredients include: FD&C Red No. 40 aluminium lake, FD&C Yellow No. 6 aluminium lake, FD&C Blue No. 2 aluminium lake, hypromellose, iron oxide, lactose monohydrate, lecithin, partially hydrolyzed polyvinyl alcohol, polyethylene glycol, talc, titanium dioxide and xanthan gum.
Mylan-Olanzapine Orally Disintegrating Tablets:
Mylan-Olanzapine ODT contains the following inactive ingredients: Aspartame, colloidal silicon dioxide, crospovidone, guar gum, magnesium stearate, mannitol, microcrystalline cellulose, sodium lauryl sulfate.
What dosage forms it comes in:
Mylan-Olanzapine tablets are available in 2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg and 20 mg strengths.
The 2.5 mg tablet is a normal convex round, white film coated tablet debossed with ‘OZ’ on one side and ‘G’ on the other side. 2.5
The 5 mg tablet is a normal convex round, white film coated tablet debossed with ‘OZ’ on one side and ‘G’ on the other side. 5
The 7.5 mg tablet is a normal convex round, white film coated tablet debossed with ‘OZ’ on one side and ‘G’ on the other side. 7.5
The 10 mg tablet is a normal convex round, white film coated tablet debossed with ‘OZ’ on one side and ‘G’ on the other side. 10
The 15 mg tablet is a normal convex ellipse shaped, blue film coated tablet debossed with ‘OZ 15’ on one side and ‘G’ on the other side.
The 20 mg tablet is a normal convex ellipse shaped, pink film coated tablet debossed with ‘OZ 20’ on one side and ‘G’ on the other side.
Mylan-Olanzapine Tablets are available in bottles containing 30 tablets and bottles containing 100 tablets.
Mylan-Olanzapine ODT Tablets are available 5 mg, 10 mg, 15 mg and 20 mg strengths.
The 5 mg, 10 mg, 15 mg and 20 mg tablets are yellow, round, flat faced with bevelled edges.
| They are debossed in the following manner | |
| 5 mg | “OE1” on side and “M” on the other side |
| 10 mg | “OE2” on side and “M” on the other side |
| 15 mg | “OE3” on side and “M” on the other side |
| 20 mg | “OE4” on side and “M” on the other side |
Mylan-Olanzapine ODT is available in bottles containing 100 tablets and cartons containing 30 tablets (5 blister packs each with 6 tablets per blister pack) of strengths 5 mg, 10 mg, 15 mg and 20 mg.
WARNINGS AND PRECAUTIONS
O
Serious Warnings and Precautions
Studies with various medicines of the group to which Mylan-Olanzapine belongs, including olanzapine, when used in elderly patients with dementia have been associated with an increased rate of death. Mylan-Olanzapine is not indicated in elderly patients with dementia.
DICATION
Before starting Mylan-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 (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 Mylan-Olanzapine tablets contain lactose
cannot take phenylalanine because Mylan-Olanzapine
ODT 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 Mylan-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 Mylan-Olanzapine.
Tell your doctor or pharmacist that you taking Mylan-Olanzapine before you start taking any new medicines.
A combination of Mylan-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 Mylan-Olanzapine. It is recommended that you DO NOT drink alcohol while taking Mylan-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 Mylan-Olanzapine in your blood, making Mylan-Olanzapine less effective.
Only take other medicines while you are on Mylan-Olanzapine if your doctor tells you that you can. DO NOT give Mylan-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 Mylan-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 Mylan-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 Mylan-Olanzapine, even after your symptoms have improved or disappeared. Mylan-Olanzapine should be taken for as long as you and your doctor believe it is helping you.
Proper Handling Instructions
Mylan-Olanzapine Tablets:
Mylan-Olanzapine tablets should be swallowed whole with a glass of water. Mylan-Olanzapine tablets can be taken with or without food.
Mylan-Olanzapine ODT:
Mylan-Olanzapine ODT should be handled carefully with dry hands. Mylan-Olanzapine ODT tablets can be taken with or without food.
Follow the instructions below for blister pack:
| 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 125 mL (4 ounces) of liquid (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 Mylan-Olanzapine are drowsiness and slurred speech.
Missed Dose:
Take your prescribed dose at the same time each day. If you miss a dose of Mylan-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, Mylan-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 Mylan-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 Mylan-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 Mylan-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
Mylan-Olanzapine and continue to monitor it for as long as you are being treated.
Your doctor should take blood tests before starting
Mylan-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.
| 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. |
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 | X | ||
| 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* | ||
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 | X | ||
| Pancreas inflammation [symptoms of severe abdominal pain, fever, nausea, vomiting]2 | X | ||
| Long-lasting (greater than 4 hours in duration) and painful erection of the penis2 | X | ||
| Sudden weakness or numbness in the face, arms, or legs, & speech or vision problems3 | X* | ||
| Very dark (“tea coloured”) urine, muscle tenderness and/or aching2 | X | ||
| 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. | X | ||
1Identified from the clinical trial database.
2Identified from adverse events reported after release onto market.
3Identified 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 Mylan-Olanzapine, contact your doctor or pharmacist.
HOW TO STORE IT
Store Mylan-Olanzapine tablets at 15oC – 30oC. Protect from light and moisture.
All medicines should be kept out of reach of children. Mylan-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 Mylan-Olanzapine or you find that they have passed their expiry date, please return any left over medicine to your pharmacist.
Reporting Side Effects
You can help improve the safe use of health products for Canadians by reporting serious and unexpected side effects to Health Canada. Your report may help to identify new side effects and change the product safety information. 3 ways to report:
Postage paid labels and the Consumer Side Effect Reporting Form are available at MedEffect. 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
This document can be found at: www.mylan.ca.
The full Product Monograph prepared for health professionals can be obtained by contacting the sponsor, Mylan Pharmaceuticals ULC at: 1-800-575-1379
Etobicoke, Ontario M8Z 2S6
Last revised: February 17, 2017
Mylan Pharmaceuticals ULC Etobicoke, ON M8Z 2S6 1-800-575-1379 www.mylan.ca