Esbriet 267 mg Hard Capsules

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 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

Do not take Esbriet

• 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.

Warnings and precautions

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 and toxic epidermal necrolysis 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.

Children and adolescents

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

Other medicines and Esbriet

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).

Esbriet with food and drink

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

Pregnancy and breast-feeding

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.

Driving and using machines

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

Esbriet contains sodium

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

If you take more Esbriet than you should

Contact your doctor, pharmacist or nearest hospital casualty department immediately if you have taken more capsules than you should, and take your medicine with you.

If you forget to take Esbriet

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 capsules each day than your prescribed daily dose.

If you stop taking Esbriet

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 1 capsule 3 times a day, gradually increasing this to 3 capsules 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):

• 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 breathe
• 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 (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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What Esbriet contains

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

The other ingredients are:

• Capsule filling: microcrystalline cellulose, croscarmellose sodium, povidone, magnesium stearate
• Capsule shell: gelatin, titanium dioxide (E171)
• Capsule brown printing ink: shellac, iron oxide black (E172), iron oxide red (E172), iron oxide yellow (E172), propylene glycol, ammonium hydroxide

What Esbriet looks like and contents of the pack

Esbriet hard capsules (capsules) have a white to off-white opaque body and a white to off-white opaque cap with ‘PFD 267 mg’ printed in brown ink. The capsules contain a white to pale yellow powder.

Your medicine is provided in either a 2-week treatment initiation pack, a 4-week treatment pack or in a bottle.

The 2-week treatment initiation pack contains a total of 63 capsules. There are 7 blister strips with 3 capsules per strip (1 capsule per pocket for Week 1) and 7 blister strips with 6 capsules per strip (2 capsules per pocket for Week 2).

The 4-week treatment pack contains a total of 252 capsules. There are 14 x 2-day blister strips each containing 18 capsules (3 capsules per pocket).

The blisters strips in the 2-week treatment initiation pack and 4-week treatment maintenance pack are each marked with the following symbols as a reminder to take a dose three times a day:

(sunrise; morning dose) (sun; daytime dose) and (moon; evening dose).

The bottle pack contains 270 capsules.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer