Prospect: Information for the user

Esbriet 267mg film-coated tablets

Esbriet 534mg film-coated tablets

Esbriet 801mg film-coated tablets

pirfenidona

Read this prospect carefully before starting to take this medicine, because it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed only for you and should not be given to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

1.What is Esbriet and for what it is used

2.What you need to know before starting to take Esbriet

3.How to take Esbriet

4.Possible adverse effects

5.Storage of Esbriet

6.Contents of the package and additional information

Esbriet contains the active ingredient pirfenidone and is used for the treatment of Idiopathic Pulmonary Fibrosis (IPF) in adults.

IPF is a disease in which the lung tissues become inflamed and filled with scars over time, making it difficult to breathe deeply. In these circumstances, the lungs have trouble functioning correctly. Esbriet helps to reduce lung scarring and inflammation, and helps you breathe better.

Do not take Esbriet

• If you are allergic to pirfenidone or any of the other components of this medication (listed in section 6)
• If you have previously had angioedema with pirfenidone, including symptoms such as facial swelling, lips, and/or tongue that may be associated with difficulty breathing or wheezing
• If you are taking a medication 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 have any doubts, consult your doctor or pharmacist.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Esbriet

• You may be more sensitive to sunlight (photosensitivity reaction) when taking Esbriet. Avoid the sun (also UV lamps) while taking Esbriet. Use daily sunscreen and cover your arms, legs, and head to reduce exposure to sunlight (see section 4: Possible side effects).
• Do not take other medications, 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 should avoid smoking before and during treatment with Esbriet. Tobacco may reduce the effect of Esbriet.
• Esbriet may cause dizziness and fatigue. Be careful if you have to perform activities that require attention and coordination.
• Esbriet may cause weight loss. Your doctor will monitor your weight while you are taking this medication.
• Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS) 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 severe liver problems. Some cases have been fatal. You will need to have a blood test before starting to take Esbriet, once a month for the first 6 months, and then every 3 months while taking this medication, to check the proper functioning of your liver. It is essential that you have these blood tests periodically throughout the time you are taking Esbriet.

Children and adolescents

Do not administer Esbriet to children and adolescents under 18 years old.

Other medications and Esbriet

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

This is especially important if you are taking the following medications, as they may alter the effect of Esbriet.

The following medications may increase the side effects of Esbriet:

• Enoxacina (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 medications may reduce the effectiveness of Esbriet:

• Omeprazole (used to treat conditions such as indigestion and gastroesophageal reflux disease)
• Rifampicin (a type of antibiotic).

Taking Esbriet with food and drinks

Do not drink grapefruit juice while taking this medication. Grapefruit juice may make Esbriet not work correctly.

Pregnancy and breastfeeding

As a precaution, it is recommended to avoid using Esbriet if you are pregnant, planning to become pregnant, or think you may be pregnant, as the potential risks to the fetus are unknown.

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

Driving and operating machinery

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 tablet, which is essentially "sodium-free".

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

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

This medication will normally be administered by gradually increasing the dose as follows:

• During the first 7 days, take a dose of 267mg (1 yellow tablet), 3 times a day with food (a total of 801mg/day)
• Between days 8 and 14, take a dose of 534mg (2 yellow tablets or 1 orange tablet), 3 times a day with food (a total of 1.602mg/day)
• From day 15 (maintenance), take a dose of 801mg (3 yellow tablets or 1 brown tablet), 3 times a day with food (a total of 2.403mg/day).

The recommended daily maintenance dose of Esbriet is 801mg (3 yellow tablets or 1 brown tablet) three times a day with food, a total of 2403mg/day.

Swallow the tablets whole with water, during or after a meal to reduce the risk of side effects such as nausea (feeling of discomfort) 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 UV-A lamps, or significant changes in liver enzymes.

If you take more Esbriet than you should

Go to your doctor, pharmacist, or the nearest hospital emergency department immediately if you take more tablets than you should, and bring your medication 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 compensate for the missed doses. Each dose should be separated by a minimum interval of 3 hours. Do not take more tablets per day than correspond to your prescribed daily dose.

If you interrupt treatment with 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, the doctor will restart your treatment with a dose of 267mg 3 times a day and gradually increase it to 801mg 3 times a day.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Stop taking Esbriet and seek medical attention immediately if you notice any of the following symptoms or signs:

?Swelling of the face, lips, or tongue, itching, hives, difficulty breathing or wheezing, or a feeling of fainting, which are signs of angioedema, a severe allergic reaction or anaphylaxis.

?Yellowing of the eyes or skin or dark urine, and possibly accompanied by itching of the skin, stomach pain on the upper right side (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.

?Flat red patches, or circular patches on the trunk, often with central blisters, skin peeling, mouth ulcers, throat, nose, genital, and eye ulcers. These severe skin eruptions may be preceded by fever and symptoms similar to the flu (Stevens-Johnson syndrome or toxic epidermal necrolysis).

?Generalized rash, elevated body temperature, and enlarged lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).

Other possible side effects are

If you experience any type of side effect, consult your doctor.

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

• Throat or respiratory tract infections that reach the lungs and/or sinusitis
• Unpleasant feeling (nausea)
• Stomach problems, such as acid reflux, vomiting, and constipation
• Dyspepsia
• Diarrhea
• Indigestion or stomach heaviness
• Weight loss
• Loss of appetite
• Difficulty sleeping
• Tiredness
• Dizziness
• Headache
• Difficulty breathing
• Cough
• Joint pain

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

• Urinary tract infections
• Drowsiness
• Alteration of taste
• Headaches
• Stomach problems, such as feeling heavy, pain, and abdominal discomfort, stomach burning, and flatulence
• Blood tests may indicate increased liver enzymes
• Skin reactions after exposure to the sun or the use of UVA lamps
• Cutaneous problems such as itching, irritation, or redness, dryness, rash
• Muscle pain
• Weakness or lack of energy
• Chest pain
• Sunburn.

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

• Low levels of sodium in the blood. This can cause headaches, dizziness, confusion, muscle cramps, nausea, and vomiting.
• Blood test results may show a decrease in white blood cells.

Reporting side effects

If you experienceany type of side effect, consult your doctor or pharmacist,even if it is apossibleside effect that does not appear in this prospectus.You can also report them directly through thenational reporting system included in theAppendix V. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the label of the bottle, on the blister pack, and on the box after CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the containers and medications that you no longer need. By doing so, you will help protect the environment.

Composition of Esbriet

Tablets of 267mg

The active ingredient is pirfenidone. Each film-coated tablet contains 267mg of pirfenidone.

The other components are: microcrystalline cellulose, sodium croscarmellose (see section 2 “Esbriet contains sodium”), povidone K30, anhydrous colloidal silica, magnesium stearate.

The film coating consists of: polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc, yellow iron oxide (E172).

Tablets of 534mg

The active ingredient is pirfenidone. Each film-coated tablet contains 534mg of pirfenidone.

The other components are: microcrystalline cellulose, sodium croscarmellose (see section 2 “Esbriet contains sodium”), povidone K30, anhydrous colloidal silica, magnesium stearate.

The film coating consists of: polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc, yellow iron oxide (E172) and red iron oxide (E172).

Tablets of 801mg

The active ingredient is pirfenidone. Each film-coated tablet contains 801mg of pirfenidone.

The other components are: microcrystalline cellulose, sodium croscarmellose (see section 2 “Esbriet contains sodium”), povidone K30, anhydrous colloidal silica, magnesium stearate.

The film coating consists of: polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc, red iron oxide (E172) and black iron oxide (E172).

Appearance of the product and contents of the pack

Tablets of 267mg

Esbriet 267mg film-coated tablets are yellow, oval, biconvex film-coated tablets with the inscription “PFD”.

The pack sizes in bottles contain a bottle with 90 tablets, or two bottles with 90 tablets each (180 tablets in total).

The blister pack sizes contain 21, 42, 84 or 168 film-coated tablets and the multiple pack sizes contain 63 film-coated tablets (initiation treatment of 2 weeks 21 + 42) or 252 film-coated tablets (maintenance pack 3x84).

Tablets of 534mg

Esbriet 534mg film-coated tablets are orange, oval, biconvex film-coated tablets with the inscription “PFD”.

The pack sizes in bottles contain a bottle with 21 tablets or a bottle with 90 tablets.

Tablets of 801mg

Esbriet 801mg film-coated tablets are brown, oval, biconvex film-coated tablets with the inscription “PFD”.

The pack size in a bottle contains a bottle with 90 tablets.

The blister pack size contains 84 film-coated tablets and the multiple pack size contains 252 film-coated tablets (maintenance pack 3x84).

Each strip of the blister pack of 801mg tablets is marked with the following symbols and abbreviations, as a reminder to take a dose three times a day:

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

LU, MA, MI, JU, VI, SA, DO

Only some pack sizes may be marketed.

Marketing authorisation holder

Roche Registration GmbH

Emil-Barell-Strasse 1

79639 Grenzach-Wyhlen

Germany

Responsiblefor manufacturing

Roche Pharma AG

Emil-Barell-Str. 1

D-79639 Grenzach-Wyhlen

Germany

For further information about this medicinal product, please contact the local representative of the marketing authorisation holder:

Last update of the summary of product characteristics:

The detailed information on this medicinal product is available on the website of the European Medicines Agency:http://www.ema.europa.eu.

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