Esbriet 801 mg Film-coated Tablets

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 Esbriet is and what it is used for
2. What you need to know before you take Esbriet
3. How to take Esbriet
4. Possible side effects
5 How to store Esbriet
6. Contents of the pack and other information

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

Talk to your doctor or pharmacist before taking Esbriet

• You may become more sensitive to sunlight (photosensitivity reaction) when taking Esbriet. Avoid the sun (including sunlamps) whilst taking Esbriet. 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 Esbriet. Cigarette smoking can reduce the effect of Esbriet.
• Esbriet may cause dizziness and tiredness. Be careful if you have to take part in activities where you have to be alert and co-ordinated.
• Esbriet 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 Esbriet treatment. Stop using Esbriet and seek medical attention immediately if you notice any of the symptoms related to these serious skin reactions described in section 4.

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

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

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 Esbriet.

Medicines that may increase side effects of Esbriet:

• 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 Esbriet works:

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

Do not drink grapefruit juice whilst taking this medicine. Grapefruit may prevent Esbriet from working properly.

As a precautionary measure, it is preferable to avoid the use of Esbriet 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 Esbriet. As it is unknown whether Esbriet 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.

Do not drive or use machines if you feel dizzy or tired after taking Esbriet.

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

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 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.

In some situations, your doctor may advise you to stop taking Esbriet. If for any reason you have to stop taking Esbriet 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.

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.

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 (see details below). By reporting side effects you can help provide more information on the safety of this medicine.

United Kingdom

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267 mg tablet

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

The other ingredients are: microcrystalline cellulose, croscarmellose sodium (see Section 2 ‘Esbriet contains sodium’), povidone K30, colloidal anhydrous silica, magnesium stearate

The film coat consists of: polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc, iron oxide yellow (E172)

801 mg tablet

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

The other ingredients are: microcrystalline cellulose, croscarmellose sodium (see Section 2 ‘Esbriet contains sodium’), povidone K30, colloidal anhydrous silica, magnesium stearate

The film coat consists of: polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc, iron oxide red (E172) and iron oxide black (E172)

267 mg tablet

Esbriet 267 mg film-coated tablets are yellow, oval, biconvex film-coated tablets, debossed with “PFD”.

The bottle packs contain one bottle containing 21 tablets, two bottles each containing 21 tablets (42 tablets in total), one bottle containing 42 tablets, one bottle containing 90 tablets, two bottles each containing 90 tablets (180 tablets in total) or one bottle containing 180 tablets.

The blister packs contain 21, 42, 84 or 168 film-coated tablets and the multipacks contain 63 (2-week treatment initiation pack 21+42) or 252 (continuation pack 3x84) film-coated tablets.

The 267 mg blisters strips containing 63 film-coated tablets 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; morning dose) (sun; daytime dose) and (moon; evening dose).

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

801 mg tablet

Esbriet 801 mg film-coated tablets are brown, oval, biconvex film-coated tablets, debossed with “PFD”.

The bottle pack contains one bottle containing 90 tablets.

The blisters pack contains 84 film-coated tablets and the multipack contains 252 (continuation pack 3x84) 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; morning dose) (sun; daytime dose) and (moon; evening dose).

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

Not all pack sizes may be marketed.

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder: