Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - esbriet

Document Subject

Generated Narrative: MedicinalProductDefinition mp6455d7711efcb7c39e76872d121d19e0

identifier: http://ema.europa.eu/identifier/EU/1/11/667/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Esbriet 267 mg hard capsules

type: Full name

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part: nan

type: Invented name part

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part: nan

type: Scientific name part

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type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-6455d7711efcb7c39e76872d121d19e0

identifier: http://ema.europa.eu/identifier/EU/1/11/667/001

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - esbriet

Attesters

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

Esbriet contains the active substance pirfenidone and it is used for the treatment of 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 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 .

Treatment with Esbriet should be started and overseen by a specialist doctor experienced in the diagnosis and treatment of IPF.

Always take this medicine exactly as your doctor or pharmacist has told you. 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 1,602 mg/day)

from day 15 onwards (maintenance), take 3 capsules, 3 times a day with food (a total of

2,403 mg/day).

The recommended maintenance daily dose of Esbriet is 3 capsules three times a day with food, for 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 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.

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

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

Stop taking Esbriet and tell your doctor immediately

If you experience swelling of the face, lips and/or tongue, itching, hives, difficulty breathing or wheezing, or feeling faint, which are signs of angioedema, a serious allergic reaction or anaphylaxis.

If you experience yellowing of the eyes or skin, or dark urine, potentially accompanied by itching of the skin, pain on the upper right side of your stomach area (abdomen), loss of appetite, bleeding or bruising more easily than normal, or feeling tired. These may be signs of abnormal liver function and could indicate liver injury, which is an uncommon side effect of Esbriet.

If you experience reddish non-elevated, or circular patches on the trunk, often with central blisters, skin peeling, ulcers of mouth, throat, nose, genitals and eyes. These serious 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 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 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.

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 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.

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 label, blister and carton after EXP. The expiry date refers to the last day of that month.

Do not store this medicine above 30 C.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help 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 (see Section 2 Esbriet contains 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

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

Manufacturer

Roche Pharma AG Emil-Barell-Str. 1 D-79639 Grenzach-Wyhlen Germany

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

Belgi /Belgique/Belgien N.V. Roche S.A.
T l/Tel: +32 (0) 2 525 82 Lietuva
UAB Roche Lietuva
Tel: +370 5 2546

: +359 2 818 44 Luxembourg/Luxemburg (Voir/siehe Belgique/Belgien)

esk republika Roche s. r. o.
Tel: +420 - 2 20382Magyarorsz g Roche (Magyarorsz g) Kft.
Tel: +36 1 279 4Danmark Roche Pharmaceuticals A/S
Tlf: +45 - 36 39 99 Malta (See Ireland)

Deutschland Roche Pharma AG
Tel: +49 (0) 7624 Nederland Roche Nederland B.V.
Tel: +31 (0) 348 438Eesti Roche Eesti O
Tel: + 372 - 6 177 Norge Roche Norge AS
Tlf: +47 - 22 78 90
Roche (Hellas) A.E.
: +30 210 61 66 sterreich Roche Austria GmbH
Tel: +43 (0) 1 27Espa a Roche Farma S.A.
Tel: +34 - 91 324 81 Polska Roche Polska Sp.z o.o.
Tel: +48 - 22 345 18 France Roche
T l: +33 (0) 1 47 61 40 Portugal Roche Farmac utica Qu mica, Lda
Tel: +351 - 21 425 70 Hrvatska Roche d.o.o.
Tel: +385 1 4722 Rom nia
Roche Rom nia S.R.L.
Tel: +40 21 206 47 Ireland Roche Products (Ireland) Ltd.
Tel: +353 (0) 1 469 0Slovenija Roche farmacevtska dru ba d.o.o.
Tel: +386 - 1 360 26 sland Roche Pharmaceuticals A/S
c/o Icepharma hf
S mi: +354 540 8Slovensk republika Roche Slovensko, s.r.o.
Tel: +421 - 2 52638Italia Roche S.p.A.
Tel: +39 - 039 2Suomi/Finland Roche Oy
Puh/Tel: +358 (0) 10 554
. . & .
: +357 - 22 76 62 Sverige Roche AB
Tel: +46 (0) 8 726 1Latvija Roche Latvija SIA
Tel: +371 - 6 7039United Kingdom (Northern Ireland) Roche Products (Ireland) Ltd.
Tel: +44 (0) 1707 366This leaflet was last revised in

Detailed information on this medicine is available on the European Medicines Agency web site: