Esbriet 267 mg hard capsules

Esbriet contains 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. Esbriet helps to reduce scarring and swelling in the lungs, and helps you breathe better.

Do not take Esbriet

- if you are allergic (hypersensitive) to the active substance pirfenidone or any of the other ingredients in this medicine (for the full list of ingredients see section 6: Further information) - 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.

Take special care with Esbriet

- You may become moresensitive 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, suchas tetracycline antibiotics (such as doxycycline), which may make you more sensitive to sunlight.
- 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.

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.

Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

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:
- ciprofloxacin (a type of antibiotic)
- amiodarone (used to treat some types of heart disease)
- propafenone (used to treat some types of heart disease).

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).

Ask your doctor or pharmacist for advice before taking any medicine.

Taking Esbriet with food and drink

Take this medicine during or after a meal to reduce the risk of side effects such as nausea (feeling sick) and dizziness (see section 4: Possible side effects).

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

Pregnancy and breastfeeding

Do not take this medicine if you are pregnant, planning to become pregnant or think you might be pregnant. The risk to the unborn child is unknown.

If you are breastfeeding, speak to your doctor or pharmacist before taking Esbriet. It is not known if Esbriet passes into breast milk. If you are breastfeeding and you need to take Esbriet, your doctor will discuss the risks and benefits of taking this medicine while breastfeeding.

Ask your doctor or pharmacist for advice before taking any medicine.

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

Always take Esbriet exactly as your doctor has told you. You should 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 1 capsule 3 times a day with food (a total of 801 mg/day) - from day 8 to 14 take 2 capsules, 3 times a day with food (a total of 1602 mg/day) - from day 15 onwards, take 3 capsules 3 times a day with food (a total of 2403 mg/day).

Swallow the capsules 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 Esbriet than you should
Contact your doctor, pharmacist or nearest hospital casualty department immediatelyif 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, but separate each dose by at least 3 hours. Do not take a double dose to make up for a forgotten dose.

If you stop taking Esbriet

Do not stop taking Esbriet unless your doctor tells you to. 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.

If you have any questions on the use of this medicine, ask your doctor or pharmacist.

Like all medicines, Esbriet can cause side effects, although not everybody gets them.

The frequency of possible side effects listed below is defined using the following convention: - very common (affects more than 1 user in 10)
- common (affects 1 to 10 users in 100)
- uncommon (affects 1 to 10 users in 1000).

Stop taking Esbriet and tell your doctor immediately
- If you experience a serious allergic (hypersensitivity) reaction such as swelling of the face, lips and/or tongue, difficulty breathing or wheezing.
- If you experience a severe skin reaction to sunlight or sunlamps such as blistering and/or marked peeling of the skin. Severe photosensitivity reactions are uncommon. Avoid the sun (including sunlamps) whilst taking Esbriet, wear sunblock daily and cover your arms, legs and head to reduce exposure to sunlight to limit this reaction.

Other side effects may include

Tell your doctor or pharmacist as soon as possible if you notice any of the following side effects listed below.

Very common side effects affects more than 1 user in 10 skin reactions after going out in the sun or using sunlamps feeling sick nausea tiredness diarrhoea indigestion or stomach upset.

Common side effects affects 1 to 10 users in 100 infections of the throat or the airways going into the lungs andor sinusitis bladder infections weight loss loss of appetite difficulty sleeping

dizziness, headache 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 jointsjoint pains feeling weak or feeling low in energy chest pain sunburn.

If any of the side effects becomes serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Keep out of the reach and sight of children.

Do not use Esbriet 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 store this medicine above 30ºC.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

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 (body): gelatin, indigo carmine (E132), titanium dioxide (E171) - Capsule shell (cap): gelatin, red iron oxide (E172), yellow iron oxide (E172), titanium dioxide (E171)
- Capsule brown printing ink: shellac, iron oxide black (E172), iron oxide red (E172), iron oxide yellow (E172).

What Esbriet looks like and contents of the pack

Esbriet hard capsules (capsules) have a blue opaque body and a gold opaque cap with ?InterMune 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 - a Week-1 blister card containing 21 capsules (1 capsule per pocket) and a Week-2 blister card containing 42 capsules (2 capsules per pocket).

The 4-week treatment pack contains 4 x 1-week blister cards each containing 63 capsules (3 capsules per pocket) for a total of 252 capsules.

The bottle pack contains 270 capsules.

Not all pack sizes may be marketed.

Marketing Authorisation holder and Manufacturer

Marketing Authorisation holder
InterMune UK Ltd., 4th Floor, One Victoria Street, Bristol,
BS1 6AA, United Kingdom.

Manufacturer
Catalent UK Packaging Limited (trading as Catalent Pharma Solutions), Sedge Close, Headway, Great Oakley, Corby, Northamptonshire, NN18 8HS, United Kingdom.

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