Pirfenidone, 534 mg tablets – patient leaflet, side effects, dosage

1. What Pirfenidone Tablets are and what they are used for

Pirfenidone Tablets contain 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 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 Tablets

Do not take Pirfenidone Tablets

• 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 Tablets. If you are unsure ask your doctor or pharmacist.

Warnings and precautions

Talk to your doctor or pharmacist before taking Pirfenidone Tablets.

• You may become more sensitive to sunlight (photosensitivity reaction) when taking pirfenidone. Avoid the sun (including sunlamps) whilst taking Pirfenidone Tablets. 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 Tablets. Cigarette smoking can reduce the effect of Pirfenidone Tablets
• Pirfenidone Tablets 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 Tablets can cause weight loss. Your doctor will monitor your weight whilst you are taking this medicine
• Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported in association with Pirfenidone treatment. Stop using Pirfenidone and seek medical attention immediately if you notice any of the symptoms related to these serious skin reactions described in section 4.

Pirfenidone may cause serious liver problems and some cases have been fatal. You will need a blood test before you start taking Pirfenidone Tablets 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 this medicine.

Children and adolescents

Do not give Pirfenidone Tablets to children and adolescents under the age of 18.

Other medicines and Pirfenidone 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 Tablets.

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 Tablets 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 Tablets contain sodium

Pirfenidone Tablets contain less than 1 mmol sodium (23mg) per tablet, that is to say essentially ‘sodium-free’.

3. How to take Pirfenidone Tablets

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:

• for the first 7 days take a dose of 267mg (oval shaped tablet), 3 times a day with food (a total of 801mg/day)
• from day 8 to 14 take a dose of 534mg (2 oval shaped tablets or 1 capsule shaped tablets), 3 times a day with food (a total of 1,602mg/day)
• from day 15 onwards (maintenance), take a dose of 801mg (3 oval shaped tablets or 1 modified capsule shaped tablet), 3 times a day with food (a total of 2,403mg/day).

The recommended maintenance daily dose of Pirfenidone is 801mg (3 oval shaped tablets or 1 modified capsule shaped tablet) three times a day with food, for a total of 2403mg/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 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 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.

Front View

Package leaflet: Information for the user

Pirfenidone 267mg Tablets Pirfenidone 534mg Tablets Pirfenidone 801mg Tablets

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Process

(Do not print)

180 mm

Back View

If you stop taking Pirfenidone Tablets

In some situations, your doctor may advise you to stop taking Pirfenidone Tablets. If for any reason you have to stop taking the tablets for more than 14 consecutive days, your doctor will restart your treatment with a dose of 267mg 3 times a day, gradually increasing this to a dose of 801mg 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 Tablets and seek medical attention immediately if you notice any of the following symptoms or signs

• Swelling of the face, lips and/or tongue, itching, hives, difficulty breathing or wheezing, or feeling faint, which are signs of angioedema, a serious allergic reaction or anaphylaxis

• Yellowing of the eyes or skin, or dark urine, potentially accompanied by itching of the skin, pain on the upper right side of your stomach area (abdomen), loss of appetite, bleeding or bruising more easily than normal, or feeling tired. These may be signs of abnormal liver function and could indicate liver injury, which is an

  uncommon side effect of Pirfenidone

• Reddish non-elevated, or circular patches on the trunk, often with central blisters, skin peeling, ulcers of mouth, throat, nose, genitals and eyes. These serious skin rashes can be preceded by fever and flu-like symptoms. These signs and symptoms may indicate Stevens-Johnson syndrome or toxic epidermal necrolysis
• Widespread rash, high body temperature and enlarged lymph nodes (DRESS syndrome or drug hypersensitivity syndrome)’.

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):

• infections of the throat or the airways going into the lungs and/or sinusitis
• feeling sick (nausea)
• stomach problems such as acid reflux, vomiting and feeling constipated
• diarrhoea
• indigestion or stomach upset
• weight loss
• decreased appetite
• difficulty sleeping
• tiredness
• dizziness
• headache
• shortness of breath
• cough
• aching joints/joint pains.

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

• bladder infections
• feeling sleepy
• changes in taste
• hot flushes
• stomach problems such as feeling bloated, abdominal pain and discomfort, heart burn and passing wind
• blood tests may show increased levels of liver enzymes
• skin reactions after going out in the sun or using sunlamps
• skin problems such as itchy skin, skin redness or red skin, dry skin, skin rash
• muscle pain
• 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
• 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 Website: www.mhra.gov.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

Do not store above 30°C. 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.

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 Tablets contain

267mg Tablet

The active substance is pirfenidone. Each tablet contains 267mg of pirfenidone.

534mg tablet

The active substance is pirfenidone. Each tablet contains 534mg of pirfenidone.

801mg tablet

The active substance is pirfenidone. Each tablet contains 801mg of pirfenidone.

The other ingredients are: microcrystalline cellulose, croscarmellose sodium, povidone, colloidal silicon dioxide, sodium stearyl fumarate and iron oxide red (E172).

What Pirfenidone Tablets look like and contents of the pack

267mg tablet

Light pink 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 tablets.

The multipack contains 63 (2-week treatment initiation pack 21 + 42) or 252 (continuation pack 3 x 84) tablets.

534mg tablet

Light pink coloured capsule shaped tablets debossed with A107 on one side and plain on the other side.

The blister packs contain 21 or 84 tablets.

801mg tablet

Light pink coloured modified capsule shaped tablets debossed with A108 on one side and plain on the other side.

The blister packs contain 21 or 84 tablets. The multipack contains 252 (continuation pack 3 x 84) tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Wockhardt UK Limited

Ash Road North

Wrexham

LL13 9UF

UK

Manufacturer

Synoptis Industrial Sp. z o.o.

Ul. Rabowicka 15

Jasin

Swarzedz

Wielkopolskie

62-020

Poland

Other sources of information

To listen to or request a copy of this leaflet in Braille, large print or audio please call, free of charge: 0800 198 5000 (UK only). Please be ready to give the following information:

This is a service provided by the Royal National Institute of Blind People.

This leaflet was last revised in 04/2024 pg2/2 180 mm