Es briet

Package leaflet: Information for the user

Esbriet 267 mg hard capsules

pirfenidone
Please read all of this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.
  Contents of this leaflet:

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

1. What Esbriet is and what it is used for

Esbriet contains the active substance pirfenidone and is used to treat idiopathic pulmonary fibrosis (Idiopathic Pulmonary Fibrosis - IPF) in adult patients.
IPF is a disease in which lung tissues become inflamed and damaged over time, leading to difficulty in taking deep breaths. This impairs proper lung function. Esbriet helps reduce lung damage and inflammation, and helps improve breathing.

2. What you should know before taking Esbriet

Do not take Esbriet

• if you are allergic to pirfenidone or to 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 conditions apply to you, do not take Esbriet. If in doubt, consult 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) while taking Esbriet. Avoid sun exposure (including sunlamps and tanning beds) during treatment with Esbriet. Apply sunscreen daily and cover your arms, legs, and head to reduce exposure to sunlight (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.
• Inform your doctor if you have kidney problems.
• Inform your doctor if you have mild to moderate liver problems.
• Stop smoking before and during treatment with Esbriet. Cigarette smoking may reduce the effect of Esbriet.
• Esbriet may cause dizziness and fatigue. Be cautious if you need to perform activities requiring mental alertness and coordination.
• Esbriet may cause weight loss. Your doctor will monitor your weight during treatment with this medicine.
• Cases of Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS) have been reported during treatment with Esbriet. If you notice any of the symptoms related to these serious skin reactions described in section 4, stop taking Esbriet immediately and contact a doctor without delay.
• Esbriet may cause severe liver problems, which in some cases have been fatal. You will need to have a blood test before starting Esbriet, monthly for the first 6 months, and then every 3 months during treatment to monitor proper liver function. It is important that you attend these blood tests regularly while taking Esbriet.

Children and adolescents

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

Other medicines and Esbriet

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This section is particularly important if you are taking the following medicines, as they may alter the effect of Esbriet.

Medicines that may increase the side effects of Esbriet:

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

Medicines that may reduce the effectiveness of Esbriet:

• omeprazole (used to treat conditions such as indigestion and gastroesophageal reflux disease)
• rifampicin (a type of antibiotic)

Esbriet with food and drink

Do not drink grapefruit juice while taking this medicine. Grapefruit may interfere with the proper action of Esbriet.

Pregnancy and breastfeeding

As a precautionary measure, it is advisable to avoid using Esbriet during pregnancy, or if you suspect you might be pregnant or are planning a pregnancy, as the risks to the unborn baby are unknown.

If you are breastfeeding or intend to breastfeed, consult your doctor or pharmacist before taking Esbriet. Since it is not known whether Esbriet passes into breast milk, your doctor will assess the risks and benefits of taking this medicine during breastfeeding if you decide to breastfeed.

Driving and using machines

Do not drive or operate machinery if you experience dizziness or fatigue after taking Esbriet.

Esbriet contains sodium

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

3. How to take Esbriet

Treatment with Esbriet must be initiated and supervised by a specialist physician experienced in the diagnosis and treatment of IPF.
Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The medicine will usually be introduced in gradually increasing doses as follows:

• for the first 7 days, take 1 capsule three times a day with food (for a total of 801 mg/day)
• from day 8 to day 14, take 2 capsules three times a day with food (for a total of 1,602 mg/day)
• from day 15 onwards (maintenance phase), take 3 capsules three times a day with food (for a total of 2,403 mg/day). The recommended daily maintenance dose of Esbriet is 3 capsules three times a day with food, for a total of 2,403 mg/day. Swallow the entire capsule with water during or after meals to reduce the risk of adverse effects such as nausea and dizziness. If symptoms persist, consult your doctor.
  Dose reduction due to adverse reactions
  Your doctor may reduce the dose if you experience adverse effects such as stomach problems, skin reactions to sunlight or sunlamps, or significant changes in liver enzymes.

If you take more Esbriet than you should
If you have taken more capsules than prescribed, contact your doctor, pharmacist, or nearest emergency department immediately and bring the medicine with you.

If you forget to take Esbriet
If you miss a dose, take it as soon as you remember. Do not take a double dose to make up for the missed dose. There must be at least three hours between doses. Do not take more capsules in one day than prescribed according to the daily dosage.

If you stop taking Esbriet
In certain specific cases, your doctor may advise you to stop taking Esbriet. If for any reason you need to interrupt treatment for more than 14 consecutive days, your doctor will restart treatment with 1 capsule three times a day, gradually increasing the dose up to 3 capsules three times a day.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Stop taking Esbriet and contact your doctor immediately if you notice any of the following symptoms or signs:

• Swelling of the face, lips and/or tongue, itching, hives, difficulty breathing or shortness of breath, or feeling faint, which are symptoms of angioedema, a severe allergic reaction or anaphylaxis.
• Yellowing of the whites of the eyes or of the skin, or dark urine, possibly accompanied by skin itching, pain in the upper right part of the stomach area (abdomen), loss of appetite, increased tendency to bleed or bruise, or feeling tired. These may be signs of impaired liver function and could indicate liver damage, which is an uncommon side effect of Esbriet.
• Flat, red spots (not raised) or circular rashes on the trunk, often with central blisters, peeling of the skin, ulcers in the mouth, throat, nose, genitals, and eyes. These serious skin reactions may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome or toxic epidermal necrolysis).
• Widespread rash, high body temperature, and swollen lymph nodes (drug reaction with eosinophilia and systemic symptoms or drug hypersensitivity syndrome).

Other possible side effects include
Talk to your doctor if you notice any side effect.
Very common side effects (affect more than 1 in 10 patients):

• Throat or airway infections reaching the lungs and/or sinusitis
• Feeling unwell (nausea)
• Stomach problems such as acid reflux, vomiting, and constipation
• Diarrhoea
• Indigestion or stomach discomfort
• Weight loss
• Decreased appetite
• Sleep disturbances
• Dizziness
• Headache
• Shortness of breath
• Cough
• Joint pain

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

• Bladder infections
• Drowsiness
• Taste disturbances
• Hot flushes
• Stomach problems such as bloating sensation, pain and abdominal discomfort, heartburn, and gas
• Blood tests may show increased liver enzyme levels
• Skin reactions after sun exposure or use of sunlamps
• Skin problems such as itching, redness, dry skin, rash
• Muscle pain
• Feeling weak or lacking energy
• Chest pain
• Sunburn

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

• Low levels of sodium in the blood, which may cause headache, dizziness, confusion, weakness, muscle cramps, or nausea and vomiting.
• Blood tests may show a reduction in white blood cells.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store 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 label of the bottle, on the blister
and on the carton after Exp./EXP. The expiry date refers to the last day of that month.
Do not store the medicine at temperatures above 30°C.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Esbriet contains
The active substance is pirfenidone. Each capsule contains 267 mg of pirfenidone.
The other components are:

• capsule contents: microcrystalline cellulose, sodium croscarmellose (see section 2 “Esbriet contains sodium”), povidone, magnesium stearate
• capsule shell: gelatin, titanium dioxide (E171)
• brown printing ink for the capsule: shellac, black iron oxide (E172), red iron oxide (E172), yellow iron oxide (E172), propylene glycol, ammonium hydroxide. Description of the appearance of Esbriet and contents of the pack Esbriet hard capsules (capsules) have an opaque white to off-white body and an opaque white to off-white cap, with the imprint ‘PFD 267 mg’ printed in brown ink. The capsule contains a white to pale yellow powder. The medicine is available in two-week starter packs, four-week treatment packs, or in a bottle. The two-week starter pack contains a total of 63 capsules. It consists of 7 blister strips with 3 capsules in each strip (1 capsule per blister for Week 1) and 7 blister strips with 6 capsules in each strip (2 capsules per blister for Week 2). The four-week treatment pack contains a total of 252 capsules. It consists of 14 two-day divisible blister strips, each containing 18 capsules (3 capsules per blister). Each blister strip in the two-week starter pack and the four-week maintenance pack is marked with the following symbols, to be used as a reminder for taking a dose three times daily.

(sunrise; morning dose), (sun; midday dose), and (moon; evening dose).
The bottle contains 270 capsules.
Not all pack sizes may be marketed.
Marketing Authorization Holder
Roche Registration GmbH
Emil-Barell-Strasse 1
79639 Grenzach-Wyhlen
Germany
Manufacturer
Roche Pharma AG
Emil-Barell-Strasse 1
D-79639 Grenzach-Wyhlen
Germany
For further information on this medicinal product, contact the local representative of the Marketing Authorization Holder:
België/Belgique/Belgien Lietuva
N.V. Roche S.A. UAB “Roche Lietuva”
Tél/Tel: +32 (0) 2 525 82 11 Tel: +370 5 2546799
България Luxembourg/Luxemburg
Рош България ЕООД (See/siehe Belgique/Belgien)
Тел: +359 2 818 44 44
Česká republika Magyarország
Roche s. r. o. Roche (Magyarország) Kft.
Tel: +420 - 2 20382111 Tel: +36 1 279 4500
Danmark Malta
Roche Pharmaceuticals A/S (See Ireland)
Tlf: +45 - 36 39 99 99
Deutschland Nederland
Roche Pharma AG Roche Nederland B.V.
Tel: +49 (0) 7624 140 Tel: +31 (0) 348 438050
Eesti Norge
Roche Eesti OÜ Roche Norge AS
Tel: + 372 - 6 177 380 Tlf: +47 - 22 78 90 00
Ελλάδα Österreich
Roche (Hellas) A.E. Roche Austria GmbH
Τηλ: +30 210 61 66 100 Tel: +43 (0) 1 27739
España Polska
Roche Farma S.A. Roche Polska Sp.z o.o.
Tel: +34 - 91 324 81 00 Tel: +48 - 22 345 18 88
France Portugal
Roche Roche Farmacêutica Química, Lda
Tél: +33 (0) 1 47 61 40 00 Tel: +351 - 21 425 70 00
Hrvatska România
Roche d.o.o. Roche România S.R.L.
Tel: +385 1 4722 333 Tel: +40 21 206 47 01
Ireland Slovenija
Roche Products (Ireland) Ltd. Roche farmacevtska družba d.o.o.
Tel: +353 (0) 1 469 0700 Tel: +386 - 1 360 26 00
Ísland Slovenská republika
Roche Pharmaceuticals A/S Roche Slovensko, s.r.o.
c/o Icepharma hf Tel: +421 - 2 52638201
Sími: +354 540 8000
Italia Suomi/Finland
Roche S.p.A. Roche Oy
Tel: +39 - 039 2471 Puh/Tel: +358 (0) 10 554 500
Κύπρος Sverige
Γ.Α.Σταμάτης & Σια Λτδ. Roche AB
Τηλ: +357 - 22 76 62 76 Tel: +46 (0) 8 726 1200
Latvija United Kingdom (Northern Ireland)
Roche Latvija SIA Roche Products (Ireland) Ltd.
Tel: +371 - 6 7039831 Tel: +44 (0) 1707 366000
More detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu . In addition, links to other websites on rare diseases and their therapeutic treatments are provided.

Patient Information Leaflet: Information for the User

Esbriet 267 mg film-coated tablets, 534 mg film-coated tablets, 801 mg film-coated tablets

pirfenidone
Please read all of this leaflet carefully before taking this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4. Contents of this leaflet:
  1. What Esbriet is and what it is used for
  2. What you need to know before taking Esbriet
  3. How to take Esbriet
  4. Possible side effects
  5. How to store Esbriet
  6. Contents of the pack and other information

1. What Esbriet is and what it is used for

Esbriet contains the active substance pirfenidone and is used to treat idiopathic pulmonary fibrosis (Idiopathic Pulmonary Fibrosis - IPF) in adult patients.
IPF is a disease in which lung tissues become inflamed and damaged over time, leading to difficulty in breathing deeply. This makes it difficult for the lungs to function properly. Esbriet helps reduce lung damage and inflammation, and helps improve breathing.

2. What you should know before taking Esbriet

Do not take Esbriet

• if you are allergic to pirfenidone or to 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 you have any of the conditions listed above, do not take Esbriet. If you are in any doubt, consult 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) while taking Esbriet. Avoid sun exposure (including tanning lamps) during treatment with Esbriet. Apply sunscreen daily 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.
• if you have kidney problems, inform your doctor.
• if you have mild to moderate liver problems, inform your doctor.
• stop smoking before and during treatment with Esbriet. Cigarette smoking may reduce the effect of Esbriet.
• Esbriet may cause dizziness and fatigue. Be cautious if you need to perform activities requiring mental alertness and coordination.
• Esbriet may cause weight loss. Your doctor will monitor your weight during treatment with this medicine.
• cases of Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS) have been reported in association with Esbriet treatment. If you notice any of the symptoms related to these serious skin reactions described in section 4, stop treatment with Esbriet and seek immediate medical advice. Esbriet may cause severe liver problems, which in some cases have been fatal. You will need to have a blood test before starting Esbriet, monthly for the first 6 months, and then every 3 months during treatment to monitor proper liver function. It is important that you attend these regular blood tests while taking Esbriet.

Children and adolescents
Do not administer Esbriet to children and adolescents under 18 years of age.

Other medicines and Esbriet
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This section is particularly important if you are taking the following medicines, as they may alter the effect of Esbriet.

Medicines that may increase the side effects of Esbriet:

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

Medicines that may reduce the effectiveness of Esbriet:

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

Esbriet with food and drink
Do not drink grapefruit juice while taking this medicine. Grapefruit may interfere with the proper action of Esbriet.

Pregnancy and breastfeeding
As a precautionary measure, it is preferable to avoid using Esbriet during pregnancy, if you suspect you might be pregnant, or if you are planning a pregnancy, since the potential risks to the fetus are unknown.

If you are breastfeeding or intend to breastfeed, consult your doctor or pharmacist before taking Esbriet. Since it is not known whether Esbriet passes into breast milk, your doctor will evaluate the risks and benefits of taking this medicine during breastfeeding if you decide to breastfeed.

Driving and using machines
Do not drive or operate machinery if you experience dizziness or fatigue after taking Esbriet.

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

3. How to take Esbriet

Treatment with Esbriet should be initiated and supervised by a physician experienced in the diagnosis and treatment of IPF.
Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The medicine will usually be administered in gradually increasing doses as follows:

• for the first 7 days, take a dose of 267 mg (1 yellow tablet) three times a day with food (total daily dose: 801 mg)
• from day 8 to day 14, take a dose of 534 mg (2 yellow tablets or 1 orange tablet) three times a day with food (total daily dose: 1,602 mg)
• from day 15 onwards (maintenance phase), take a dose of 801 mg (3 yellow tablets or 1 brown tablet) three times a day with food (total daily dose: 2,403 mg). The recommended maintenance dose of Esbriet for patients with IPF is 801 mg (3 yellow tablets or 1 brown tablet) three times a day with food, for a total daily dose of 2,403 mg. Swallow the tablet whole with water during or after meals to reduce the risk of adverse effects such as nausea and dizziness. If symptoms persist, consult your doctor.

Dose reduction due to adverse reactions
Your doctor may reduce your dose if you experience adverse reactions such as stomach problems, skin reactions to sunlight or tanning lamps, or significant changes in liver enzymes.

If you take more Esbriet than you should
If you have taken more tablets than prescribed, contact your doctor, pharmacist, or nearest emergency department immediately, and bring the 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 a forgotten dose. There must be at least three hours between doses. Do not take more tablets in one day than prescribed according to the daily dose.

If you stop taking Esbriet
In certain specific cases, your doctor may advise you to stop taking Esbriet. If you need to stop treatment with Esbriet for more than 14 consecutive days for any reason, your doctor will restart treatment with a dose of 267 mg three times a day, gradually increasing the dose up to 801 mg three times a day.

If you have any questions about how to use this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
Stop taking Esbriet and contact your doctor immediately if you notice any of the following symptoms or signs:

• Swelling of the face, lips and/or tongue, itching, rash, difficulty breathing or shortness of breath, or feeling faint, which are symptoms of angioedema, a serious allergic reaction or anaphylaxis.
• Yellowing of the whites of the eyes or of the skin, or dark urine, possibly accompanied by itching of the skin, pain in the upper right part of the stomach area (abdomen), loss of appetite, increased tendency to bleeding or bruising, or feeling tired. These may be signs of liver function impairment and could indicate liver damage, which is an uncommon side effect of Esbriet.
• Flat, red spots (not raised) or circular rashes on the trunk, often with central blisters, peeling of the skin, or ulcers in the mouth, throat, nose, genitals, and eyes. These serious skin rashes may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome or toxic epidermal necrolysis).
• Widespread rash, high body temperature, and swollen lymph nodes (drug reaction with eosinophilia and systemic symptoms or drug hypersensitivity syndrome).

Other possible side effects include
Talk to your doctor if you experience any side effect.

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

• Throat or airway infections reaching the lungs and/or sinusitis
• Feeling unwell (nausea)
• Stomach problems such as acid reflux, vomiting, and constipation
• Diarrhoea
• Indigestion or stomach discomfort
• Weight loss
• Decreased appetite
• Sleep disturbances
• Tiredness
• Dizziness
• Headache
• Shortness of breath
• Cough
• Joint pain

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

• Bladder infections
• Drowsiness
• Taste disturbances
• Hot flushes
• Stomach problems such as bloating sensation, abdominal pain and discomfort, heartburn, and flatulence
• Blood tests may show increased liver enzyme levels
• Skin reactions after exposure to sunlight or use of sunlamps
• Skin problems such as itching, redness, dry skin, rash
• Muscle pain
• Feeling weak or lacking energy
• Chest pain
• Sunburn.

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

• Low levels of sodium in the blood, which may cause headache, dizziness, confusion, weakness, muscle cramps, or nausea and vomiting.
• Blood tests may show a reduction in white blood cells.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system referred to in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Esbriet

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the bottle label, on the blister and on the carton after Exp./EXP. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Esbriet contains
267 mg tablets
The active substance is pirfenidone. Each film-coated tablet contains 267 mg of pirfenidone.
The other components are: microcrystalline cellulose, sodium croscarmellose (see section 2 "Esbriet contains sodium"), povidone K30, anhydrous colloidal silica, magnesium stearate.
Tablet coating: polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc, yellow iron oxide (E172) and red iron oxide (E172).

534 mg tablets
The active substance is pirfenidone. Each film-coated tablet contains 534 mg of pirfenidone.
The other components are: microcrystalline cellulose, sodium croscarmellose (see section 2 "Esbriet contains sodium"), povidone K30, anhydrous colloidal silica, magnesium stearate.
Tablet coating: polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc, yellow iron oxide (E172) and red iron oxide (E172).

801 mg tablets
The active substance is pirfenidone. Each film-coated tablet contains 801 mg of pirfenidone.
The other components are: microcrystalline cellulose, sodium croscarmellose (see section 2 "Esbriet contains sodium"), povidone K30, anhydrous colloidal silica, magnesium stearate.
Tablet coating: polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc, red iron oxide (E172) and black iron oxide (E172).

Description of the appearance of Esbriet and contents of the pack
267 mg tablets
Esbriet 267 mg film-coated tablets are yellow, oval, biconvex, with "PFD" printed on them.
Bottle packs contain either one bottle of 90 tablets, two bottles each containing 90 tablets (180 tablets in total), or one bottle of 180 tablets.
Blister packs contain 21, 42, 84 or 168 film-coated tablets, while multiple packs contain 63 film-coated tablets (starter pack: 21 tablets for 2 weeks + 42 tablets) or 252 film-coated tablets (maintenance pack: 3x84 tablets).

534 mg tablets
Esbriet 534 mg film-coated tablets are orange, oval, biconvex, with "PFD" printed on them.
Bottle packs contain either one bottle of 21 tablets or one bottle of 90 tablets.

801 mg tablets
Esbriet 801 mg film-coated tablets are brown, oval, biconvex, with "PFD" printed on them.
The bottle pack contains one bottle of 90 tablets.
The blister pack contains 84 film-coated tablets, while the multiple pack contains 252 film-coated tablets (maintenance pack: 3x84 tablets).

The 801 mg blister strips are marked with the following symbols and abbreviated day names as a reminder to take a dose three times daily:

(dawn; morning dose) (sun; midday dose) and (moon; evening dose).
Mon. Tue. Wed. Thu. Fri. Sat. Sun.

Not all pack sizes may be marketed.

Marketing Authorization Holder
Roche Registration GmbH
Emil-Barell-Strasse 1
79639 Grenzach-Wyhlen
Germany

Manufacturer
Roche Pharma AG
Emil-Barell-Strasse 1
D-79639 Grenzach-Wyhlen
Germany

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

België/Belgique/Belgien Lietuva
N.V. Roche S.A. UAB “Roche Lietuva”
Tél/Tel: +32 (0) 2 525 82 11 Tel: +370 5 2546799

България Luxembourg/Luxemburg
Рош България ЕООД (Voir/siehe Belgique/Belgien)
Тел: +359 2 818 44 44

Česká republika Magyarország
Roche s. r. o. Roche (Magyarország) Kft.
Tel: +420 - 2 20382111 Tel: +36 1 279 4500

Danmark Malta
Roche Pharmaceuticals A/S (See Ireland)
Tlf: +45 - 36 39 99 99

Deutschland Nederland
Roche Pharma AG Roche Nederland B.V.
Tel: +49 (0) 7624 140 Tel: +31 (0) 348 438050

Eesti Norge
Roche Eesti OÜ Roche Norge AS
Tel: + 372 - 6 177 380 Tlf: +47 - 22 78 90 00

Ελλάδα Österreich
Roche (Hellas) A.E. Roche Austria GmbH
Τηλ: +30 210 61 66 100 Tel: +43 (0) 1 27739

España Polska
Roche Farma S.A. Roche Polska Sp.z o.o.
Tel: +34 - 91 324 81 00 Tel: +48 - 22 345 18 88

France Portugal
Roche Roche Farmacêutica Química, Lda
Tél: +33 (0) 1 47 61 40 00 Tel: +351 - 21 425 70 00

Hrvatska România
Roche d.o.o. Roche România S.R.L.
Tel: +385 1 4722 333 Tel: +40 21 206 47 01

Ireland Slovenija
Roche Products (Ireland) Ltd. Roche farmacevtska družba d.o.o.
Tel: +353 (0) 1 469 0700 Tel: +386 - 1 360 26 00

Ísland Slovenská republika
Roche Pharmaceuticals A/S Roche Slovensko, s.r.o.
c/o Icepharma hf Tel: +421 - 2 52638201
Sími: +354 540 8000

Italia Suomi/Finland
Roche S.p.A. Roche Oy
Tel: +39 - 039 2471 Puh/Tel: +358 (0) 10 554 500

Κύπρος Sverige
Γ.Α.Σταμάτης & Σια Λτδ. Roche AB
Τηλ: +357 - 22 76 62 76 Tel: +46 (0) 8 726 1200

Latvija United Kingdom (Northern Ireland)
Roche Latvija SIA Roche Products (Ireland) Ltd.
Tel: +371 - 6 7039831 Tel: +44 (0) 1707 366000

More detailed information on this medicinal product is available on the European Medicines Agency website: http://www.ema.europa.eu.
In addition, links to other websites on rare diseases and their therapeutic treatments are provided.