PIRFENIDONE 801 MG FILM-COATED TABLETS - patient leaflet, side effects, dosage

Pirfenidone 267 mg and 801 mg Film-coated Tablets

Package leaflet: Information for the patient

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.

• 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 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.

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■ What you need to know before you take Pirfenidone

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 contains sodium

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

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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:

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

The recommended maintenance daily dose of Pirfenidone is 801 mg (3 yellow tablets or 1 purple 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.

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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 If you experience 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.
• If you experience 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.

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.

Contents of the pack and other information

What Pirfenidone contains

267 mg, tablet

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

The other ingredients are colloidal anhydrous silica, microcrystalline cellulose, croscarmellose sodium, povidone, and magnesium stearate

The film coat consists of: polyvinyl alcohol-part hydrolysed (E1203), titanium dioxide (E171), macrogol 3350 (E1521), talc (E553b), iron oxide yellow (E172), and ferrosoferric oxide (E172)

801 mg tablet

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

The other ingredients are colloidal anhydrous silica, microcrystalline cellulose, croscarmellose sodium, povidone, and magnesium stearate

The film coat consists of: polyvinyl alcohol-part hydrolysed (E1203), titanium dioxide (E171), macrogol 3350 (E1521), talc (E553b), iron oxide yellow (E172), ferrosoferric oxide (E172), and iron oxide red (E172)

What Pirfenidone looks like and contents of the pack

Pirfenidone 267 mg Film-coated Tablets are yellow, oval, approximately 12.9 × 5.9 mm, debossed with 3610 on one side andT to the other side. The bottle packs contain one bottle containing 63 tablets or three bottles each containing 84 tablets (252 tablets in total). The blister packs contain 63 film-coated tablets or 252 film-coated tablets. The perforated unit-dose blisters packs contain 63×1 film-coated tablets or 252×1 film-coated tablets. The 267 mg blisters strips are each marked with symbols and abbreviated names of the day as a reminder to take a dose three times a day:

Pirfenidone 801 mg Film-coated Tablets are purple, oval, approximately 20.1 × 9.3 mm, debossed with 3611 on one side andT to the other side. The bottle packs contain one bottle containing 84 tablets or three bottles each containing 84 tablets (252 tablets in total). The blister pack contains 84 film-coated tablets and the multipack contains 252 (3×84) film-coated tablets. The perforated unit-dose blisters packs contains 84×1 film-coated tablets and the multipack contains 252 (3×84×1) 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:

Sunrise symbol (sunrise; morning dose) Sun symbol (sun; daytime dose) and Moon symbol (moon; evening dose).

Mon. Tue. Wed. Thu. Fri. Sat. Sun.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Teva UK Limited, Ridings Point, Whistler Drive, Castleford, WF10 5HX, United Kingdom

Manufacturer

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: 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.

Actavis Ltd., BLB 016 Bulebel Industrial Estate,

Zejun ZTN 3000, Malta

This leaflet was last revised in November 2021

PL 00289/2519

PL 00289/2520

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 the carton after “EXP”. The expiry date refers to the last day of that month.

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