Patient Medication Information: uses, side effects, how to take - Jamp Pirfenidone (Jamp Pharma, 267 mg, 801 mg)
Serious Warnings and Precautions
|
|---|
What is JAMP Pirfenidone used for?
- JAMP Pirfenidone is used for the treatment of idiopathic pulmonary fibrosis (IPF) in adults.
How does JAMP Pirfenidone work?
How JAMP 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 JAMP Pirfenidone?
Medicinal ingredient: pirfenidone
Non-medicinal ingredients:
267 mg tablets: colloidal silicon dioxide, croscarmellose sodium, iron oxide yellow, macrogol, mannitol, microcrystalline cellulose, povidone, sodium stearyl fumarate, talc and titanium dioxide.
801 mg tablets: colloidal silicon dioxide, croscarmellose sodium, iron oxide black, iron oxide red, macrogol, mannitol, microcrystalline cellulose, povidone, sodium stearyl fumarate, talc and titanium dioxide.
JAMP Pirfenidone comes in the following dosage forms:
267 mg (yellow), 801 mg (brown) film-coated tablets
Do not use JAMP 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 JAMP 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 JAMP Pirfenidone may be harmful to an unborn baby.
- Are breastfeeding or planning to do so. It is not known if JAMP 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 JAMP Pirfenidone. Dizziness and tiredness can occur when you take JAMP Pirfenidone. Taking JAMP 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 JAMP 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.
JAMP 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 JAMP Pirfenidone. Grapefruit juice may prevent JAMP Pirfenidone from working properly.
Do not smoke before and during treatment with JAMP Pirfenidone. Cigarette smoking may reduce the effect of JAMP Pirfenidone.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
Serious Drug Interactions
|
|---|
The following may also interact with JAMP Pirfenidone:
|
|---|
How to take JAMP Pirfenidone:
|
|---|
- Swallow the tablets:
|
|---|
Usual dose:
JAMP Pirfenidone is usually prescribed in increasing doses as follows:
If taking tablets:
- 267 mg tablets are yellow in colour.
- 801 mg tablets are brown in colour.
Days 1 to 7: Take 1 yellow tablet three times a day with food (a total of 3 tablets a
- 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 brown 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 JAMP Pirfenidone.
If you have not taken JAMP 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 JAMP Pirfenidone, contact a healthcare professional, hospital emergency department, or regional poison control centre immediately, even if there are no symptoms. |
|---|
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 JAMP Pirfenidone?
These are not all the possible side effects you may have when taking JAMP 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
JAMP 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 JAMP 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 | |||||
|---|---|---|---|---|---|---|---|
| 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 | √ | ||||||
| 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 heartbeats | √ | ||||||
| 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 | √ | ||||||
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 | |||
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. |
|---|
Storage:
- Store tablets at controlled room temperature or room temperature, 15-30°C.
- Keep out of reach and sight of children.
If you want more information about JAMP Pirfenidone:
- 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://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug- product-database.html); or by calling 1-866-399- 9091.
JAMP Pharma Corporation
1310, rue Nobel
Boucherville, Quebec
J4B 5H3, Canada
