Pirfenidone 534 mg film-coated tablets

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.

• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

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

Do not take Pirfenidone

• if you are allergic to pirfenidone or any of the other ingredients of this medicine (listed in section 6)
• if 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
• if you are taking a medicine called fluvoxamine (used to treat depression and obsessive compulsive disorder [OCD])
• if you have severe or end stage liver disease
• if you have severe or end stage kidney disease requiring dialysis.

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

• You may become more sensitive to sunlight (photosensitivity reaction) when taking Pirfenidone. Avoid the sun (including sunlamps) whilst taking Pirfenidone. Wear sunblock daily and cover your arms, legs and head to reduce exposure to sunlight (see section 4: Possible side effects).
• You should not take other medicines, such as tetracycline antibiotics (such as doxycycline), which may make you more sensitive to sunlight.
• You should tell your doctor if you suffer from kidney problems.
• You should tell your doctor if you suffer from mild to moderate liver problems.
• You should stop smoking before and during treatment with Pirfenidone. Cigarette smoking can reduce the effect of Pirfenidone
• Pirfenidone may cause dizziness and tiredness. Be careful if you have to take part in activities where you have to be alert and co-ordinated.
• Pirfenidone can cause weight loss. Your doctor will monitor your weight whilst you are taking this medicine.

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:

• enoxacin (a type of antibiotic)
• ciprofloxacin (a type of antibiotic)
• amiodarone (used to treat some types of heart disease)
• propafenone (used to treat some types of heart disease)
• fluvoxamine (used to treat depression and obsessive compulsive disorder (OCD)).

Medicines that may reduce how well Pirfenidone works:

• omeprazole (used in the treatment of conditions such as indigestion, gastroesophageal reflux disease)
• rifampicin (a type of antibiotic).

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’.

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.

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):

• skin reactions after going out in the sun or using sunlamps
• feeling sick (nausea)
• tiredness
• diarrhoea
• indigestion or stomach upset
• loss of appetite
• headache.

Common side effects (may affect up to 1 in 10 people):

• infections of the throat or the airways going into the lungs and/or sinusitis
• bladder infections
• weight loss
• difficulty sleeping
• dizziness
• feeling sleepy
• changes in taste
• hot flushes
• shortness of breath
• cough
• stomach problems such as acid reflux, vomiting, feeling bloated, abdominal pain and discomfort, heart burn, feeling constipated and passing wind
• blood tests may show increased levels of liver enzymes
• skin problems such as itchy skin, skin redness or red skin, dry skin, skin rash
• muscle pain, aching joints/joint pains
• feeling weak or feeling low in energy
• chest pain
• sunburn.

Uncommon side effects (may affect up to 1 in 100 people):

• low levels of sodium in the blood. This may cause headache, dizziness, confusion, weakness, muscle cramps or nausea and vomiting.

Rare side effects (may affect up to 1 in 1,000 people):

• blood tests may show decrease in white blood cells.

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.

What Pirfenidone contains

• The active substance is pirfenidone.

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.

• The other ingredients are:

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