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: PL 25258/0372 .
Pirfenidone 267, 534, 801 mg film-coated tablets
Package leaflet: Information for the patient
Pirfenidone 267 mg film-coated tablets
Pirfenidone 534 mg film-coated tablets
Pirfenidone 801 mg film-coated tablets
Pirfenidone
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
Keep this leaflet. You may need to read it again.
What is in this leaflet
1. What Pirfenidone is and what it is used for
2. What you need to know before you take Pirfenidone
3. How to take Pirfenidone
4. Possible side effects
5. How to store Pirfenidone
6. Contents of the pack and other information
1. What Pirfenidone is and what it is used for
Pirfenidone contains the active substance pirfenidone and it is 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, and as a result makes it difficult to breathe deeply. This makes it hard for your lungs to work properly. Pirfenidone helps to reduce scarring and swelling in the lungs, and helps you breathe better.
2. What you need to know before you take Pirfenidone
Do not take Pirfenidone
If any of the above affects you, do not take Pirfenidone. If you are unsure ask your doctor or pharmacist.
Warnings and precautions
Talk to your doctor or pharmacist before taking Pirfenidone
Pirfenidone may cause serious liver problems and some cases have been fatal. You will need a blood test before you start taking Pirfenidone and at monthly intervals for the first 6 months and then every 3 months thereafter whilst you are taking this medicine to check whether your liver is working properly. It is important that you have these regular blood tests for as long as you are taking Pirfenidone.
Children and adolescents
Do not give Pirfenidone to children and adolescents under the age of 18.
Other medicines and Pirfenidone
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.
Medicines that may increase side effects of Pirfenidone:
Medicines that may reduce how well Pirfenidone works:
Pirfenidone with food and drink
Do not drink grapefruit juice whilst taking this medicine. Grapefruit may prevent Pirfenidone from working properly.
Pregnancy and breast-feeding
As a precautionary measure, it is preferable to avoid the use of Pirfenidone 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. 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.
Pirfenidone film-coated tablets contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.
3. How to take Pirfenidone
Treatment with Pirfenidone 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:
The recommended maintenance daily dose of Pirfenidone is 801 mg (3 yellow tablets or 1 brown tablet) three times a day with food, for a total of 2403 mg/day.
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 symptoms 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 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
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
In some situations, your doctor may advise you to stop taking Pirfenidone. If for any reason you have to stop taking Pirfenidone for more than 14 consecutive days, your doctor will restart your treatment with a dose of 267 mg 3 times a day, gradually increasing this to a dose of 801 mg 3 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 and tell your doctor immediately
Other side effects may include
Talk to your doctor if you get any side effects.
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 or pharmacist. 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.co.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Pirfenidone
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 bottle label, blister and carton after EXP. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What Pirfenidone contains
Pirfenidone 267 mg film-coated tablets: Each film-coated tablet contains 267 mg of pirfenidone.
Pirfenidone 534mg film-coated tablets: Each film-coated tablet contains 534 mg of pirfenidone.
Pirfenidone 801mg film-coated tablets: Each film-coated tablet contains 801 mg of pirfenidone.
Tablet core: Microcrystalline cellulose, Povidone (K-29/32), Croscarmellose Sodium, Silica colloidal anhydrous & Magnesium Stearate.
Film-coating (267 mg): Polyvinyl alcohol, Titanium Dioxide(E171), Macrogol, Talc & Iron oxide Yellow (E172).
Film-coating (534 mg): Polyvinyl alcohol, Titanium Dioxide (E171), Macrogol, Talc, Iron oxide Yellow (E172) & Iron oxide red (E172).
Film-coating (801 mg): Polyvinyl alcohol, Titanium Dioxide (E171), Macrogol, Talc, Iron oxide red (E172) & Iron oxide black (E172).
What Pirfenidone looks like and contents of the pack
Pirfenidone 267/534/807 mg film-coated tablets are packaged in blisters composed by PVC/Aclar– Aluminium, opaque PVC/Aclar-Aluminium, PVC/Aluminium & PVC/PVdC – Aluminium.
Pirfenidone 267 mg film-coated tablets: yellow, oval-shaped, approximately 13.15 x 6.15 mm biconvex film coated tablets, plain on both sides.
The blister packs contain 21, 30, 60, 84, 90, 250, 270, 63 (2-week treatment initiation pack) or 252 (Continuation pack) film-coated tablets.
Pirfenidone 534 mg film-coated tablets: orange, oval-shaped, approximately 16.25 x 8.45 mm biconvex film coated tablets, plain on both sides.
The blister packs contain 21, 30, 60, 63, 84, 90, 250, 252, 270 film-coated tablets.
Pirfenidone 801 mg film-coated tablets: brown, oval-shaped, approximately 20.15 x 9.45 mm biconvex film coated tablets, plain on both sides.
The blister packs contain 21, 30, 60, 63, 84, 90, 250, 270 or 252 (Continuation pack) film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Manufacturer
This leaflet was last revised in March 2022.
Building 2, 1st Floor, Croxley Park, Watford, WD18 8YA
+44 (0)1923 202 950
+44 (0)1923 202 950