ESBRIET 267 mg HARD CAPSULES

Introduction

Package Leaflet: Information for the User

Esbriet 267 mg Hard Capsules

pirfenidone

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.

Contents of the pack:

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

1. What is Esbriet and what is it used for

Esbriet contains the active substance pirfenidone and is used to treat mild to moderate Idiopathic Pulmonary Fibrosis (IPF) in adults.

IPF is a disease in which the tissue of the lungs becomes swollen and scarred over time, making it difficult to breathe deeply. In these circumstances, the lungs have trouble functioning properly. Esbriet helps to reduce scarring and swelling of the lungs, and helps you breathe better.

2. What you need to know before you take Esbriet

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 had angioedema with pirfenidone, including symptoms such as swelling of the face, lips and/or tongue that 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 terminal liver disease
• if you have severe or terminal kidney disease that requires dialysis.

If any of the above applies to you, do not take Esbriet. If you are in doubt, consult your doctor or pharmacist.

Warnings and precautions

Consult your doctor or pharmacist before starting Esbriet

• You may have increased sensitivity to sunlight (photosensitivity reaction) when taking Esbriet. Avoid the sun (also UVA lamps) while taking Esbriet. Use a daily sunscreen and cover your arms, legs, and head to reduce sun exposure (see section 4: Possible side effects).
• Do not take other medicines, such as tetracycline antibiotics (e.g. doxycycline), that may increase your sensitivity to sunlight.
• You must inform your doctor if you have kidney problems.
• You must inform your doctor if you have mild to moderate liver problems.
• You must avoid smoking before and during treatment with Esbriet. Tobacco can reduce the effect of Esbriet.
• Esbriet may cause dizziness and fatigue. Be careful if you need to perform activities that require attention and coordination.
• Esbriet may cause weight loss. Your doctor will monitor your weight while you are taking this medicine.
• Stevens-Johnson syndrome and toxic epidermal necrolysis have been reported in association with Esbriet treatment. Stop taking Esbriet and seek medical attention immediately if you notice any symptoms related to these severe skin reactions described in section 4.

Esbriet may cause serious liver problems. Some cases have been fatal. You will need to have a blood test before starting Esbriet, once a month for the first 6 months, and then every 3 months while taking this medicine, to check your liver is working properly. It is important that you have these blood tests periodically throughout the time you are taking Esbriet.

Children and adolescents

Do not give Esbriet to children and adolescents under 18 years.

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 alter the effect of Esbriet.

The following medicines may increase the side effects of Esbriet:

• enoxacin (a type of antibiotic)
• ciprofloxacin (a type of antibiotic)
• amiodarone (used to treat certain types of heart disease)
• propafenone (used to treat certain types of heart disease)
• fluvoxamine (used to treat depression and obsessive-compulsive disorder [OCD]).

The following medicines may reduce the effectiveness of Esbriet:

• omeprazole (used to treat disorders such as indigestion, gastroesophageal reflux disease)
• rifampicin (a type of antibiotic).

Taking Esbriet with food and drinks

Do not drink grapefruit juice while taking this medicine. Grapefruit juice may make Esbriet not work properly.

Pregnancy and breastfeeding

As a precautionary measure, it is preferable to avoid the use of Esbriet if you are pregnant, are planning to become pregnant, or think you may be pregnant, as the potential risks to the fetus are not known.

If you are breastfeeding or plan to breastfeed, consult your doctor or pharmacist before taking Esbriet. Since it is not known whether Esbriet is excreted in breast milk, your doctor will explain the risks and benefits of taking this medicine during breastfeeding if you decide to do so.

Driving and using machines

Do not drive or operate machinery if you feel dizzy or tired after taking Esbriet.

Esbriet contains sodium

Esbriet contains less than 1 mmol of sodium (23 mg) per capsule, i.e. essentially "sodium-free".

3. How to take Esbriet

Treatment with Esbriet should be initiated and supervised by specialist doctors with experience in the diagnosis and treatment of IPF.

Follow the instructions for administration of this medicine exactly as indicated by your doctor or pharmacist. If you are in doubt, consult your doctor or pharmacist again.

Normally, you will be given this medicine by gradually increasing the dose as follows:

• for the first 7 days, take 1 capsule 3 times a day with food (a total of 801 mg/day)
• between days 8 and 14, take 2 capsules 3 times a day with food (a total of 1,602 mg/day)
• from day 15 (maintenance), take 3 capsules 3 times a day with food (a total of 2,403 mg/day).

The recommended maintenance dose of Esbriet is 3 capsules three times a day with food, a total of 2403 mg/day.

Swallow the capsules whole with water, during or after a meal to reduce the risk of side effects such as nausea (feeling sick) and dizziness. If symptoms persist, consult your doctor.

Dose reduction due to side effects

Your doctor may decide to reduce the dose if you experience side effects such as stomach problems, skin reactions to sunlight or UVA lamps, or significant changes in liver enzymes.

If you take more Esbriet than you should

Go to your doctor, pharmacist, or the emergency department of the nearest hospital immediately if you take more capsules than you should, and take your medicine with you.

If you forget to take Esbriet

If you forget to take a dose, take it as soon as you remember. Do not take a double dose to make up for forgotten doses. Each dose should be separated by an interval of at least 3 hours. Do not take more capsules per day than your prescribed daily dose.

If you stop taking Esbriet

In certain situations, your doctor will advise you to stop taking Esbriet. If for any reason you stop taking Esbriet for more than 14 consecutive days, your doctor will restart your treatment with 1 capsule 3 times a day and gradually increase it to 3 capsules 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 Esbriet and inform your doctor immediately

• if you experience swelling of the face, lips or tongue, itching, rash, difficulty breathing or wheezing, or feeling of fainting, which are signs of angioedema, a severe allergic reaction or anaphylaxis.
• if you notice that you have yellow eyes or skin or dark urine, and possibly accompanied by itching of the skin, pain in the upper right side of the abdomen, loss of appetite, bleeding or bruising more easily than normal, or feeling tired. These could be signs of abnormal liver function and may indicate liver damage, which is a rare side effect of Esbriet.
• if you experience red patches without relief, or circular patches on the trunk, often with central blisters, skin peeling, ulcers in the mouth, throat, nose, genitals, and eyes. These severe skin rashes can be preceded by fever and flu-like symptoms. These signs and symptoms may indicate Stevens-Johnson syndrome or toxic epidermal necrolysis.

Other possible side effects are

If you experience any side effects, talk to your doctor.

Very common side effects(may affect more than 1 in 10 people):

• infections of the throat or respiratory tract that reach the lungs and/or sinusitis
• feeling sick (nausea)
• stomach problems, such as acid reflux, vomiting, and constipation
• diarrhea
• indigestion or stomach heaviness
• weight loss
• decreased appetite
• difficulty sleeping
• fatigue
• dizziness
• headache
• difficulty breathing
• cough
• joint pain.

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

• bladder infections
• drowsiness
• altered taste
• hot flashes
• stomach problems, such as feeling heavy, pain, and discomfort, stomach burning, and flatulence
• blood tests may indicate increased liver enzymes
• skin reactions after sun exposure or use of UVA lamps
• skin problems such as itching, irritation, or redness, dryness, rash
• muscle pain
• weakness or lack of energy
• chest pain
• sunburn.

Uncommon side effects(may affect up to 1 in 100 people):

• Low sodium levels in the blood. This can cause headache, dizziness, confusion, weakness, muscle cramps, or nausea and vomiting.
• blood test results may show decreased white blood cell count.

Reporting of side effects

If you experience 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 national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Esbriet

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, blister, and carton after EXP. The expiry date is the last day of the month shown.

Do not store above 30°C.

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 protect the environment.

6. Contents of the pack and other information

Composition of Esbriet

The active substance is pirfenidone. Each capsule contains 267 mg of pirfenidone. The other ingredients are:

• Inside the capsule: microcrystalline cellulose, sodium croscarmellose, povidone, magnesium stearate.
• Capsule shell: gelatin, titanium dioxide (E171).
• Brown ink for capsule printing: shellac, black iron oxide (E172), red iron oxide (E172), yellow iron oxide (E172), propylene glycol, ammonium hydroxide.

Appearance of the product and pack contents

Esbriet hard capsules have a white to off-white opaque body and a white to off-white opaque cap, with the printing "PFD 267 mg" in brown ink. The capsules contain a white or pale yellow powder.

This medicine is available in a pack for starting treatment for 2 weeks, a pack for maintenance treatment for 4 weeks, or in a bottle.

The pack for starting treatment for 2 weeks contains a total of 63 capsules. It includes 7 blister strips with 3 capsules per strip (1 capsule per cavity for week 1) and 7 blister strips with 6 capsules per strip (2 capsules per cavity for week 2).

The pack for maintenance treatment for 4 weeks contains a total of 252 capsules. It includes 14 blister strips (1 strip every 2 days) with 18 capsules per strip (3 capsules per cavity).

Each of the blister strips in the pack for starting treatment for 2 weeks and the pack for maintenance treatment for 4 weeks is marked with the following symbols as a reminder to take a dose three times a day:

(dawn; morning dose) (sun; afternoon dose) and (moon; night dose).

The bottle contains 270 capsules.

It is possible that not all pack sizes are marketed.

Marketing authorisation holder

Roche Registration GmbH

Emil-Barell-Strasse 1

79639 Grenzach-Wyhlen

Germany

Manufacturer

Roche Pharma AG

Emil-Barell-Str. 1

D-79639 Grenzach-Wyhlen

Germany

You can obtain further information on this medicine from the local representative of the marketing authorisation holder:

Date of last revision of this leaflet:

Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu.

There are also links to other websites on rare diseases and orphan medicines.