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

Read all of this leaflet carefully before you start taking this medicine. It contains information that is important to you.

  • Save this information, 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 give it to others. 
    It can harm them, even if they show signs of illness similar to yours.
  • If you get any side effects, talk to your doctor or pharmacist. 
    This also applies to any side effects not mentioned in this information. See section 4. 

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 packaging and other information 

1. What Esbriet is and what it is used for

Esbriet contains the active substance pirfenidone and it is used to treat mild to moderate idiopathic pulmonary fibrosis (IPF) in adults.

IPF is a disease that causes the lung tissue to swell and scar over time, making it difficult to breathe deeply. This makes it difficult for your lungs to function properly. Esbriet helps reduce scarring and swelling in the lungs and allows you to breathe easier.

2. What you need to know before taking 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 experienced angioedema during treatment with pirfenidone, with symptoms such as swelling of the face, lips, and/or tongue which may be associated with difficulty breathing or wheezing,
  • if you are taking the medicine fluvoxamine (used to treat depression and obsessive-compulsive disorder),
  • if you have severe liver disease or end-stage liver disease,
  • if you have severe kidney disease or end-stage kidney disease that requires dialysis.

If any of the above applies to you, do not take Esbriet. If you are not sure, ask your doctor or pharmacist.

Warnings and cautions

Talk to your doctor or pharmacist before taking Esbriet.

  • You may become more sensitive to sunlight (photosensitivity reaction) when you take Esbriet. Avoid the sun (including sunlight) when taking Esbriet. Use sunscreen every day and cover your arms and legs and your head to reduce sun exposure (see section 4: Possible side effects ).
  • Do not take other medicines, such as antibiotics of the type tetracycline s (eg, doxycycline ), as these can make you more sensitive to sunlight. 
  • Tell your doctor if you have kidney problems.
  • Tell your doctor if you have mild to moderate liver problems.
  • You should not smoke before and during treatment with Esbriet. Cigarette smoking may reduce the effects of Esbriet.
  • Esbriet can cause dizziness and fatigue. Be careful if you have to participate in activities where you have to be alert and have good coordination.
  • Esbriet can cause weight loss. Your doctor will check your weight while you are taking this medicine.

Esbriet can cause serious liver problems and some cases have been life-threatening. You will be given blood tests before you start taking Esbriet, then every month for the first six months, and then every three months while you are taking the medicine to check that your liver is working properly. These regular blood tests must be taken while you are taking Esbriet.

Children and young people

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, nor might take any other medicines.

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

Drugs that may increase the side effects of Esbriet

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

Drugs that may reduce the effect of Esbriet

  • omeprazole (used to treat indigestion, acid reflux),
  • rifampicin (a type of antibiotic ).

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

Esbriet with food and drink

You should not drink grapefruit juice while taking this medicine. Grapefruit can prevent Esbriet from working properly.

Pregnancy and breastfeeding

As a precaution, it is better to avoid using Esbriet if you are pregnant, planning to become pregnant, or think you may be pregnant because the risks to the unborn baby are unknown.

If you are breast-feeding or planning to breast-feed, ask your doctor or pharmacist for advice before taking Esbriet. As it is unknown if Esbriet passes into breast milk, your doctor will discuss the risks and benefits of this medicine while you are breast-feeding if you decide to do so.

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

Driving and using machines

Do not drive or use any tools or machines if you feel dizzy or tired after taking Esbriet.

Esbriet contains sodium

Esbriet contains less than 1 mmol (23 mg) sodium per tablet, ie essentially ‘sodium-free’.

3. How to take Esbriet

Treatment with Esbriet should be initiated and supervised by a specialist experienced in the diagnosis and treatment of idiopathic pulmonary fibrosis.

Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.

The drug is usually given in increasing doses as follows:

  • For the first 7 days, take a dose of 267 mg (1 yellow tablet) 3 times a day with food (a total of 801 mg per day).
  • On days 8 to 14, take a dose of 534 mg (2 yellow tablets or 1 orange tablet) 3 times a day with food (a total of 1,602 mg per day).
  • From day 15 onwards (maintenance treatment), take a dose of 801 mg (3 yellow tablets or 1 brown tablet) 3 times a day with food (a total of 2,403 mg per day).

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

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

Lower dose because of side effect s

Your doctor may reduce your dose if you experience certain side effects such as stomach problems, skin reactions caused by sunlight or sunlight, or major changes in your liver enzyme levels.

If you take more Esbriet than you should

If you have taken too many tablets, contact your doctor, pharmacist, or nearest emergency department immediately and take 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 a forgotten dose. There should be at least 3 hours between each dose. Do not take more tablets each day than your daily prescribed dose.

If you stop taking Esbriet

In some situations, your doctor may advise you to stop taking Esbriet. If for any reason you need to stop Esbriet treatment for more than 14 consecutive days, your doctor will start treatment again with a dose of 267 mg 3 times daily and gradually increase the dose one to 801 mg 3 times daily.

If you have any further questions on the use of this product, 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 tell your doctor straight away

  • If you experience swelling of the face, lips, and/or tongue, itching, hives, difficulty breathing or wheezing, or feeling weak. These symptoms are signs of angioedema or anaphylaxis, severe allergic reactions.
  • If you experience yellowing of the eyes or skin or dark-colored urine, possibly accompanied by itching, pain in the right upper abdomen (stomach), poor appetite, bleeding or bruising that occurs more easily than usual or feeling tired. These may be signs of abnormal liver function and may indicate liver damage, which is a less common side effect of Esbriet.

Other side effects are

Talk to your doctor if you get any side effects.

The very common side effect is (can occur in more than 1 in 10)

  • skin reactions after staying out in the sun or using a sun lamp
  • nausea
  • fatigue
  • diarrhea
  • indigestion or stomach upset
  • poor appetite
  • headache.

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

  • throat infections or respiratory infections that spread to the lungs and/or sinuses
  • infection is in the bladder
  • weight loss
  • difficulty sleeping
  • dizziness
  • somnolence
  • taste changes
  • hot flashes
  • shortness of breath
  • cough
  • stomach problems such as acid reflux, vomiting, feeling bloated, abdominal pain and discomfort, heartburn, constipation, and flatulence
  • Blood tests may show elevated levels of liver enzymes
  • skin problems such as itching, redness or red skin, dry skin, rash
  • muscle aches, joint pain/joint pain
  • the feeling of weakness or lack of energy
  • chest pain
  • sun damage.

Less common side effects are (may occur in up to 1 in 100 people):

  • Low levels of sodium in the blood. This can cause headaches, dizziness, confusion, weakness, muscle cramps, or nausea and vomiting.

Rare side effects are (may affect up to 1 in 1000 people):

  • Blood tests may show a decrease in the number of white blood cells.

5. How to store the 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 can label, blister and carton after EXP. The expiration date is the last day of the specified month.

This medicine does not require any special storage instructions.

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.

6. Contents of the packaging and other information

Content declaration

267 mg tablet

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

The other ingredients are: microcrystalline cellulose, croscarmellose sodium, povidone K30, colloidal anhydrous silica, magnesium stearate

The film coating contains polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc, yellow iron dioxide (E172).

534 mg tablet

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

The other ingredients are: microcrystalline cellulose, croscarmellose sodium, povidone K30, colloidal anhydrous silica, magnesium stearate

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

801 mg tablet

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

The other ingredients are: microcrystalline cellulose, croscarmellose sodium, povidone K30, colloidal anhydrous silica, magnesium stearate

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

What the medicine looks like and the contents of the pack

267 mg tablet

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

The packs contain either one jar of 21 tablets, two cans of 21 tablets (42 tablets in total), one jar of 42 tablets, one jar of or two cans of 90 tablets (180 tablets in total).

The blister packs contain 21, 42, 84 or 168 film-coated tablets and the multiple packs contain 63 (2-week starter pack 21 + 42) or 252 (continuation pack 3 x 84) film-coated tablets.

The 267 mg blister strips contain 63 film-coated tablets and are each marked with the following symbols and abbreviated names of the days as a reminder to take a dose three times a day:

(sunrise; morning dose), (sun; noon dose) and (moon; evening dose).

Mon. Tis. We. Tor. Fri. Sat. Sun.

534 mg tablet

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

The packs contain either a can of 21 tablets or a can of 90 tablets.

801 mg tablet

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

The packs contain a jar of 90 tablets.

The blister pack contains 84 film-coated tablets and the multiple packs contain 252 (continuation packs 3 x 84) film-coated tablets.

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

Dose

Mon. Tis. We. Tor. Fri. Sat. Sun.

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-Strasse 1 
D-79639 Grenzach-Wahlen 
Germany

Contact the representative of the marketing authorization holder to find out more about this medicine:

Finland / FinlandRoche OyPuh / Tel: +358 (0) 10 554 500

Muhammad Nadeem

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