Pirfenidone Accord

Package Leaflet: Information for the Patient

Pirfenidone Accord, 267 mg, Film-Coated Tablets

Pirfenidone Accord, 801 mg, Film-Coated Tablets

Pirfenidone

Read the package leaflet carefully before taking the medicine, as it contains important information for you.

Keep this package leaflet. You may need to read it again.

• In case of any doubts, consult a doctor, pharmacist, or nurse.
• This medicine has been prescribed specifically for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this package leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Contents of the Package Leaflet:

• 1. What is Pirfenidone Accord and what is it used for
• 2. Important information before taking Pirfenidone Accord
• 3. How to take Pirfenidone Accord
• 4. Possible side effects
• 5. How to store Pirfenidone Accord
• 6. Contents of the pack and other information

1. What is Pirfenidone Accord and what is it used for

Pirfenidone Accord contains the active substance pirfenidone and is used to treat idiopathic pulmonary fibrosis (IPF) in adults. Idiopathic pulmonary fibrosis is a disease in which the lung tissue becomes thickened and scarred, making it difficult to breathe properly. Pirfenidone Accord helps to reduce scarring and swelling in the lungs and makes it easier to breathe.

2. Important information before taking Pirfenidone Accord

When not to take Pirfenidone Accord

• 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 (a condition characterized by swelling of the face, lips, and tongue, and difficulty breathing) while taking pirfenidone
• if you are taking fluvoxamine (a medicine used to treat depression and obsessive-compulsive disorder)
• in case of severe or end-stage liver disease
• in case of severe or end-stage kidney disease requiring dialysis

If any of these conditions apply to you, do not take Pirfenidone Accord. If in doubt, consult your doctor or pharmacist.

Warnings and precautions

Before starting treatment with Pirfenidone Accord, discuss with your doctor or pharmacist if:

• you experience increased sensitivity to sunlight while taking Pirfenidone Accord. Avoid exposure to sunlight (including sunlamps) and use sunscreens and protective clothing to minimize exposure to sunlight (see section 4: Possible side effects)
• you are taking other medicines that may increase sensitivity to sunlight, such as tetracycline antibiotics (e.g., doxycycline)
• you have kidney problems
• you have mild or moderate liver problems
• you smoke. Smoking may reduce the effectiveness of Pirfenidone Accord
• you experience dizziness or fatigue. Be cautious when performing tasks that require attention and coordination
• Pirfenidone Accord may cause weight loss. Your doctor will monitor your weight
• there have been reports of Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug rash with eosinophilia and systemic symptoms (DRESS) in patients taking Pirfenidone Accord. If you experience any symptoms of these severe skin reactions, stop taking Pirfenidone Accord and seek medical attention immediately

Pirfenidone Accord may cause severe liver damage, and some cases have been fatal. Before starting treatment with Pirfenidone Accord, perform blood tests, which will be repeated monthly for the first 6 months of treatment, and then every 3 months for the duration of treatment to monitor liver function. It is essential to perform regular blood tests throughout the treatment period.

Children and adolescents

Pirfenidone Accord should not be given to children and adolescents under 18 years of age.

Pirfenidone Accord and other medicines

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take. This is especially important if you are taking any of the following medicines, as they may affect the action of Pirfenidone Accord:

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

Medicines that may reduce the effectiveness of Pirfenidone Accord:

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

Pirfenidone Accord with food and drink

Do not drink grapefruit juice while taking Pirfenidone Accord, as it may interfere with the medicine's action.

Pregnancy and breastfeeding

As a precaution, avoid taking Pirfenidone Accord if you are pregnant, plan to become pregnant, or suspect you may be pregnant, as the potential risk to the unborn child is unknown. If you are breastfeeding or plan to breastfeed, consult your doctor or pharmacist before taking Pirfenidone Accord. It is not known whether Pirfenidone Accord passes into breast milk, so your doctor will discuss the risks and benefits of taking this medicine while breastfeeding.

Driving and using machines

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

Pirfenidone Accord contains lactose

Pirfenidone Accord contains lactose. If you have previously been diagnosed with intolerance to some sugars, consult your doctor before taking the medicine.

Pirfenidone Accord contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which is considered "sodium-free".

3. How to take Pirfenidone Accord

Treatment with Pirfenidone Accord should be initiated and supervised by a specialist doctor experienced in the diagnosis and treatment of idiopathic pulmonary fibrosis. Always take this medicine exactly as your doctor or pharmacist has told you. If you are unsure, consult your doctor or pharmacist. The medicine is usually taken 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 (total daily dose: 801 mg)
• from day 8 to 14, take a dose of 534 mg (2 yellow tablets) 3 times a day with food (total daily dose: 1602 mg)
• from day 15 (maintenance treatment), take a dose of 801 mg (3 yellow tablets or 1 brown tablet) 3 times a day with food (total daily dose: 2403 mg)

The recommended maintenance dose is 801 mg (3 yellow tablets or 1 brown tablet) 3 times a day with food, which is a total daily dose of 2403 mg. Swallow the tablets whole with water, during or after meals, to reduce the risk of side effects such as nausea and dizziness. If symptoms persist, consult your doctor.

Reducing the dose due to side effects

Your doctor may reduce the dose of Pirfenidone Accord if you experience side effects such as stomach problems, skin reactions to sunlight or sunlamps, or significant changes in liver enzyme activity.

Taking more than the recommended dose of Pirfenidone Accord

If you have taken more tablets than recommended, contact your doctor, pharmacist, or the nearest hospital emergency department immediately and take the medicine with you.

Missing a dose of Pirfenidone Accord

If you miss a dose, take it as soon as possible. Do not take a double dose to make up for the missed dose. Maintain at least a 3-hour interval between doses. Do not take more tablets in a day than the recommended daily dose.

Stopping treatment with Pirfenidone Accord

In certain situations, your doctor may advise you to stop taking Pirfenidone Accord. If you stop taking Pirfenidone Accord for more than 14 consecutive days, your doctor will restart treatment with a dose of 267 mg 3 times a day, gradually increasing the dose to 801 mg 3 times a day. If you have any further doubts about taking this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Pirfenidone Accord can cause side effects, although not everybody gets them. Stop taking Pirfenidone Accord and seek medical attention immediately if you experience any of the following symptoms:

• swelling of the face, lips, and tongue, itching, hives, difficulty breathing or wheezing, or a feeling of fainting. These are symptoms of a severe allergic reaction called angioedema or anaphylaxis
• yellowing of the eyes or skin, dark urine, which may be accompanied by itching, pain in the upper right abdomen, loss of appetite, bleeding, or easy bruising, or a feeling of fatigue. These may be signs of abnormal liver function and may indicate liver damage, which is an uncommon side effect of Pirfenidone Accord
• red, non-raised, or circular spots on the torso, often with centrally located blisters, peeling skin, ulcers in the mouth, throat, nose, genitals, and eyes. These severe skin rashes may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome or toxic epidermal necrolysis)
• widespread rash, high fever, and swollen lymph nodes (DRESS or drug hypersensitivity syndrome)

Other side effects that may occur

Talk to your doctor if you experience any side effects. Very common side effects(may affect more than 1 in 10 people):

• infections of the throat or respiratory tract leading to the lungs and/or sinusitis
• nausea
• stomach problems, such as gastroesophageal reflux, vomiting, constipation
• diarrhea
• indigestion or stomach upset
• weight loss
• decreased appetite
• sleep disturbances
• fatigue
• dizziness
• headache
• shortness of breath
• cough
• joint pain

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

• urinary tract infections
• drowsiness
• taste disturbances
• hot flushes
• stomach problems, such as bloating, abdominal pain, and discomfort in the abdominal area, heartburn, constipation, and gas
• blood tests may show increased liver enzyme activity
• skin reactions to sunlight or sunlamps
• skin problems, such as itching, redness, dryness, rash
• muscle pain
• feeling weak or lacking energy
• chest pain
• sunburn

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

• low sodium levels in the blood. This may cause headache, dizziness, disorientation, weakness, muscle cramps, or nausea and vomiting
• blood tests may show a decrease in white blood cell count

Reporting side effects

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

5. How to store Pirfenidone Accord

Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date stated on the carton and blister after EXP. The expiry date refers to the last day of the month. There are no special storage instructions for this medicine. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Pirfenidone Accord contains

267 mg tablet
The active substance is pirfenidone. Each film-coated tablet contains 267 mg of pirfenidone. The other ingredients are lactose monohydrate, copovidone, croscarmellose sodium, magnesium stearate. The tablet coating contains polyvinyl alcohol, titanium dioxide (E 171), macrogol 4000, talc, yellow iron oxide (E 172).
801 mg tablet
The active substance is pirfenidone. Each film-coated tablet contains 801 mg of pirfenidone. The other ingredients are lactose monohydrate, copovidone, croscarmellose sodium, magnesium stearate. The tablet coating contains polyvinyl alcohol, titanium dioxide (E 171), macrogol 4000, talc, black iron oxide (E 172), red iron oxide (E 172).

What Pirfenidone Accord looks like and contents of the pack

267 mg tablet
Pirfenidone Accord, 267 mg, film-coated tablets are yellow, oval, 13 mm x 7 mm in size, biconvex with beveled edges, with the imprint "D1" on one side and plain on the other side.
801 mg tablet
Pirfenidone Accord, 801 mg, film-coated tablets are brown, oval, 21 mm x 10 mm in size, biconvex with beveled edges, with the imprint "D2" on one side and plain on the other side.
Pirfenidone Accord, film-coated tablets are packaged in PVC/PE/PCTFE/Aluminum blisters and unit-dose blisters.
267 mg tablets
Pack sizes: 21, 42, 84, 168 film-coated tablets or 21 x 1, 42 x 1, 84 x 1, 168 x 1 film-coated tablets.

Starter pack for 2-week treatment:

Each pack contains a total of 63 film-coated tablets (1 pack containing 1 blister of 21 film-coated tablets and 1 pack containing 2 blisters of 21 film-coated tablets or 1 pack containing 21 x 1 film-coated tablet and 1 pack containing 42 x 1 film-coated tablets in unit-dose blisters).

Maintenance pack:

Each pack contains a total of 252 film-coated tablets (3 packs, each containing 4 blisters of 21 film-coated tablets or 3 packs, each containing 84 x 1 film-coated tablets in unit-dose blisters).
801 mg tablets
Pack sizes: 84 film-coated tablets or 84 x 1 film-coated tablets.

Maintenance pack:

Each pack contains a total of 252 film-coated tablets (3 packs, each containing 4 blisters of 21 film-coated tablets or 3 packs, each containing 84 x 1 film-coated tablets in unit-dose blisters). Not all pack sizes may be marketed.

Marketing authorization holder

Accord Healthcare Polska Sp. z o.o.
Taśmowa 7
02-677 Warsaw
Phone: +48 22 577 28 00

Manufacturer/Importer

Accord Healthcare Polska Sp.z o.o.
Lutomierska 50
95-200 Pabianice
Laboratori Fundació Dau,
C/ C, 12-14 Pol., Ind. Zona Franca,
Barcelona 08040,
Spain
Accord Healthcare B.V.
Winthontlaan 200
Utrecht, 3526 KV,
Netherlands
Pharmadox Healthcare Limited,
KW20A Kordin Industrial Park, Paola, PLA 3000
Malta
Accord Healthcare Single Member S.A.
64th Km National Road Athens,
32009 Lamia, Schimatari
Greece

This medicine is authorized in the Member States of the European Economic Area under the following names:

Date of last revision of the package leaflet: March 2025