Active ingredient
- pirfenidone
Legal Category
POM: Prescription only medicine
POM: Prescription only medicine
The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.
Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.
The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PLGB 53835/0003.
Pirfenidone 267 mg Film-coated Tablets Pirfenidone 801 mg Film-coated Tablets
Package leaflet: Information for the user
Pirfenidone Film-coated Tablets
Pirfenidone 267 mg Film-coated Tablets
Pirfenidone 801 mg Film-coated Tablets
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
What is in this leaflet
1. What Pirfenidone Film-coated Tablets are and what they are used for
2. What you need to know before you take Pirfenidone Film-coated Tablets
3. How to take Pirfenidone Film-coated Tablets
4. Possible side effects
5. How to store Pirfenidone Film-coated Tablets
6. Contents of the pack and other information
1. What Pirfenidone Film-coated Tablets are and what they are used for
Pirfenidone Film-coated Tablets contain the active substance pirfenidone and are used for the treatment of mild to moderate Idiopathic Pulmonary Fibrosis (IPF) in adults.
IPF is a condition in which the tissues in your lungs become swollen and scarred over time. This makes it hard for your lungs to work properly and as a result, makes it difficult to breathe deeply. Pirfenidone Film-coated Tablets help to reduce scarring and swelling in the lungs, and helps you breathe better.
2. What you need to know before you take Pirfenidone Film-coated Tablets
Do not take Pirfenidone Film-coated Tablets
If any of the above affects you, do not take Pirfenidone Film-coated Tablets. If you are unsure, ask your doctor or pharmacist.
Warnings and Precautions
Talk to your doctor or pharmacist before taking Pirfenidone Film-coated Tablets
Children and adolescents
Do not give Pirfenidone Film-coated Tablets to children and adolescents under the age of 18.
Other medicines and Pirfenidone Film-coated Tablets
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
This is especially important if you are taking the following medicines, as they may change the effect of Pirfenidone Film-coated Tablets.
Medicines that may increase side effects of Pirfenidone Film-coated Tablets:
Medicines that may reduce how well Pirfenidone Film-coated Tablets work:
Pirfenidone Film-coated Tablets with food and drink
Do not drink grapefruit juice whilst taking this medicine. Grapefruit may stop Pirfenidone Film-coated Tablets from working properly.
Pregnancy and breast feeding
As a precaution, it is preferable to avoid the use of Pirfenidone Film-coated Tablets if you are pregnant, planning to become pregnant, or think you might be pregnant, as the potential risks to the unborn child are unknown.
If you are breast-feeding or plan to breast-feed, speak to your doctor or pharmacist before taking Pirfenidone Film-coated Tablets. As it is unknown whether pirfenidone passes into breast milk, your doctor will discuss the risks and benefits of taking this medicine while breast-feeding if you decide to do so.
Driving and using machines
Do not drive or use machines if you feel dizzy or tired after taking Pirfenidone Film-coated Tablets.
Pirfenidone Film-coated Tablets contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per dose, i.e. is essentially ‘sodium-free’.
3. How to take Pirfenidone Film-coated Tablets
Treatment with Pirfenidone Film-coated Tablets should be started and overseen by a specialist doctor experienced in the diagnosis and treatment of IPF.
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Your medicine will usually be given to you in increasing doses as follows:
Swallow the tablets whole with a drink of water, during or after a meal to reduce the risk of side effects such as nausea (feeling sick) and dizziness. If such side effects, continue, see your doctor.
Dose reduction due to side effects
Your doctor may reduce your dose if you suffer from side effects such as, stomach problems, any skin reactions to sunlight or sun lamps, or significant changes to your liver enzymes.
If you take more Pirfenidone Film-coated Tablets than you should
Contact your doctor, pharmacist or nearest hospital casualty department immediately if you have taken more tablets than you should, and take your medicine with you.
If you forget to take Pirfenidone Film-coated Tablets
If you forget a dose, take it as soon as you remember. Do not take a double dose to make up for a forgotten dose. Each dose should be separated by at least 3 hours. Do not take more tablets each day than your prescribed daily dose.
If you stop taking Pirfenidone Film-coated Tablets
In some situations, your doctor may advise you to stop taking Pirfenidone Film-coated Tablets. If for any reason you have to stop taking Pirfenidone Film-coated Tablets for more than 14 days in a row, your doctor will restart your treatment with a dose of 267 mg three times a day, gradually increasing this to a dose of 801 mg three times a day.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking Pirfenidone Film-coated Tablets and tell your doctor immediately
Talk to your doctor or pharmacist if you get any of the following side effects or any possible side effects not listed in this leaflet.
Very common side effects (may affect more than 1 in 10 people):
Common side effects (may affect up to 1 in 10 people):
Uncommon side effects (may affect up to 1 in 100 people):
Rare side effects (may affect up to 1 in 1,000 people):
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard. By reporting side affects you can help provide more information on the safety of this medicine.
5. How to store Pirfenidone Film-coated Tablets
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the blister and carton after EXP. The expiry date refers to the last day of that month.
This medicinal product does not require any special storage conditions.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help to protect the environment.
6. Contents of the pack and other information
What Pirfenidone Film-coated Tablets contains
Pirfenidone 267 mg Film-coated Tablets:
Pirfenidone 801 mg Film-coated Tablets:
What Pirfenidone Film-coated Tablets looks like and contents of the pack
Pirfenidone 267 mg Film-coated Tablets are light yellow to yellow coloured, oval shaped tablets, debossed with “A106” on one side and plain on the other side.
The blister packs contain 21, 42, 84 or 168 film-coated tablets. The 2-week treatment initiation pack contains 63 (3 blisters of 21) film-coated tablets and the continuation pack contains 252 (12 blisters of 21) film-coated tablets.
The 267 mg blisters strips are each marked with the following symbols and abbreviated names of the day as a reminder to take a dose three times a day:
morning dose
daytime dose
evening dose
Mon. Tue. Wed. Thu. Fri. Sat. Sun.
Pirfenidone 801 mg Film-coated Tablets are light brown to brown coloured, oval shaped tablets, debossed with “A108” on one side and plain on the other side.
The blister packs contain 21, 63 or 84 film-coated tablets. The continuation pack contains 252 (12 blisters of 21) film-coated tablets.
The 801 mg blisters strips are each marked with the following symbols and abbreviated names of the day as a reminder to take a dose three times a day:
morning dose
daytime dose
evening dose
Mon. Tue. Wed. Thu. Fri. Sat. Sun.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Manufacturer
This leaflet was last revised in August 2021
12 Constance Street, International House, London, E16 2DQ, UK
0800 669 6825