Patient Medication Information: uses, side effects, how to take - M-Pirfenidone
Serious Warnings and Precautions
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What is M-PIRFENIDONE used for?
- M-PIRFENIDONE is used for the treatment of idiopathic pulmonary fibrosis (IPF) in adults.
How does M-PIRFENIDONE work?
How M-PIRFENIDONE works is not yet fully understood. It may reduce inflammation and fibrosis in your lungs. It may slow down worsening of your IPF.
What are the ingredients in M-PIRFENIDONE?
Medicinal ingredients: pirfenidone
Non-medicinal ingredients: Colloidal silicon dioxide, Croscarmellose sodium, Lactose monohydrate, Magnesium stearate, Polyethylene glycol, Polyvinyl alcohol – Part Hydrolyzed, Povidone, Talc, and Titanium dioxide.
267 mg tablets also contain: Iron oxide yellow.
801 mg tablets also contain: Iron oxide black and Iron oxide red.
M-PIRFENIDONE comes in the following dosage forms:
Tablets: 267 mg and 801 mg.
Do not use M-PIRFENIDONE if:
- you are allergic to pirfenidone or any of the other ingredients in this medicine.
- you have previously experienced angioedema with pirfenidone, including symptoms such as swelling of the face, lips and/or tongue which may be associated with difficulty breathing or wheezing.
- you have severe or end-stage liver disease.
- you have severe or end-stage kidney disease or you require dialysis.
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take M-PIRFENIDONE. Talk about any health conditions or problems you may have, including if you:
- Have liver or kidney problems or disease.
Are pregnant or planning to become pregnant. It is not known whether taking M-PIRFENIDONE may be harmful to an unborn baby.
- Are breastfeeding or planning to do so. It is not known if M-PIRFENIDONE passes into breast milk.
Other warnings you should know about:
Driving and using machines: Before you perform tasks which may require you to be alert and coordinated, wait until you know how you will respond to M-PIRFENIDONE. Dizziness and tiredness can occur when you take M-PIRFENIDONE. Taking M-PIRFENIDONE with food may decrease dizziness. Be careful when driving or using machines.
Increased sensitivity to sunlight: You may become more sensitive to sunlight when taking M-PIRFENIDONE. You should:
- Avoid other medicines which may make you more sensitive to sunlight. Ask your pharmacist if you are not sure.
- Avoid or minimize exposure to direct or indirect sunlight, including through windows and from sunlamps.
- Wear an effective sunblock daily (at least SPF 50, against UVA and UVB).
- Wear clothing that protects against sun exposure such as a wide-brimmed hat and long sleeves.
- Seek shade
M-PIRFENIDONE can cause weight loss. Your healthcare professional will monitor your weight while you are taking this medicine.
Do not drink grapefruit juice during the time that you are taking M-PIRFENIDONE. Grapefruit juice may prevent M-PIRFENIDONE from working properly.
Do not smoke before and during treatment with M-PIRFENIDONE. Cigarette smoking may reduce the effect of M-PIRFENIDONE.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
Serious Drug Interactions
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The following may also interact with M-PIRFENIDONE:
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How to take M-PIRFENIDONE:
- M-PIRFENIDONE should only be prescribed and monitored by healthcare professionals with the appropriate training and experience in the diagnosis and treatment of IPF.
- Always take M-PIRFENIDONE exactly as your healthcare professional has told you. You should check with your healthcare professional if you are not sure.
Swallow the tablets:
- Whole
- With a drink of water
- With food or during or after a meal to reduce the risk of side effects such as persistent stomach problems and dizziness (see Serious side effects and what to do about them)
Usual dose:
M-PIRFENIDONE is usually prescribed in increasing doses as follows:
- 267 mg tablets are yellow in colour.
- 801 mg tablets are purple in colour.
- Days 1 to 7: Take 1 yellow tablet three times a day with food (a total of 3 tablets a day or 801 mg a day)
- Days 8 to 14: Take 2 yellow tablets three times a day with food (a total of 6 tablets a day or 1602 mg a day)
- Day 15 and onwards: Take 3 yellow tablets three times a day with food OR take 1 purple tablet three times a day with food (a total of 2403 mg a day).
Your healthcare professional may reduce your dose if you have:
- skin reactions to sunlight or sun lamps.
- significant changes to your liver enzymes.
- stomach problems.
If your stomach problems do not get better, your healthcare professional may stop treatment with M-PIRFENIDONE. If you have not taken M-PIRFENIDONE for 14 days or more in a row:
- your healthcare professional will restart your treatment with the lowest dose.
- the dose will be gradually increased over 2 weeks to the usual dose.
Overdose:
| If you think you, or a person you are caring for, have taken too much M-PIRFENIDONE, contact a healthcare professional, hospital emergency department, or regional poison control centre immediately, even if there are no symptoms. |
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Missed Dose:
If a dose is missed, the next dose should be taken as originally planned. Double doses should not be taken to make up for forgotten doses.
What are possible side effects from using M-PIRFENIDONE?
These are not all the possible side effects you may have when taking M-PIRFENIDONE. If you experience any side effects not listed here, tell your healthcare professional.
Side effects may include:
- Skin problems such as rash, itchy skin, skin redness, dry skin
- Tiredness, feeling weak or feeling low in energy
- Indigestion, heartburn, acid reflux, decreased appetite, changes in taste, bloating, abdominal pain and discomfort
- Infections of the throat or the airways going into the lungs and/or sinusitis, influenza and/or common cold
- Difficulty sleeping, feeling sleepy
- Headache
- Muscle pain, aching joints/joint pains
- Weight loss
M-PIRFENIDONE may cause liver problems and other abnormal blood test results. You will need blood tests to check your blood levels and to make sure that your liver is working properly. Blood tests should be done before you start taking M-PIRFENIDONE, at monthly intervals for the first 6 months and then every three months while you are taking this medicine. Your healthcare professional will decide when to perform blood tests and will interpret the results.
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
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| Only if severe | In all cases | ||
| VERY COMMON | |||
| Increased Sensitivity to Sunlight: skin reaction/rash to sunlight, blistering and/or marked peeling of the skin | ✔ | ||
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
|---|---|---|---|
| Only if severe | In all cases | ||
| Diarrhea | ✔ | ||
| Fatigue | ✔ | ||
Persistent Stomach Problems: such as nausea, vomiting | ✔ | ||
| COMMON | |||
| Dizziness | ✔ | ||
| UNCOMMON | |||
| Liver Problems (abnormal blood test results related to your liver): yellow skin or eyes, dark urine, abdominal pain, nausea, vomiting, loss of appetite | ✔ | ||
Angioedema: swelling of the face, lips and/or tongue, difficulty breathing or wheezing | ✔ | ||
| RARE | |||
| Allergic Reaction: rash, hives, swelling of the face, lips, tongue or throat, difficulty swallowing or breathing | ✔ | ||
| UNKNOWN FREQUENCY | |||
| Chest pain (angina), slow, fast or irregular heart beats | ✔ | ||
| Severe cutaneous adverse reactions (severe skin reactions): redness, blistering and/or peeling of the skin and/or inside of the lips, eyes, mouth, nasal passages or genitals, accompanied by fever, chills, headache, cough, body aches or swollen glands; fever, severe rash, swollen lymph glands, flu-like feeling, yellow skin or eyes, shortness of breath, dry cough, chest pain or discomfort, urinate less often, less urine. | ✔ | ||
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.
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. |
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Storage:
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- Store tablets at room temperature (15 - 30°C).
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- Keep out of reach and sight of children.
If you want more information about M-PIRFENIDONE:
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- Talk to your healthcare professional
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Find the full product monograph that is prepared for healthcare professionals and
includes this Patient Medication Information by visiting the Health Canada website: (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug- product-database.html); or by contacting Mantra Pharma Inc. at medinfo@mantrapharma.ca, or at 1-833-248-7326.
1000 rue Du Lux, Suite 201
Brossard, Quebec
J4Y 0E3