Pirfenidone Accord

Leaflet accompanying the packaging: patient information

Pirfenidone Accord, 267 mg, film-coated tablets

Pirfenidone Accord, 801 mg, film-coated tablets

Pirfenidone

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

Keep this 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. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.

Table of contents of the 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 packaging 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 inflamed and scarred over time, leading to difficulty breathing deeply. This makes it difficult for the lungs to work properly. Pirfenidone Accord helps reduce scarring and inflammation of the lungs and makes it easier to breathe.

2. Important information before taking Pirfenidone Accord

When not to take Pirfenidone Accord

• if the patient is allergic to pirfenidone or any of the other ingredients of this medicine (listed in section 6)
• if the patient has previously experienced angioedema while taking pirfenidone, including symptoms such as swelling of the face, lips, and/or tongue, which may have been associated with difficulty breathing or wheezing
• if the patient is taking a medicine called fluvoxamine (used to treat depression and obsessive-compulsive disorder)
• in cases of severe or end-stage liver failure
• in cases of severe or end-stage kidney failure requiring dialysis

If any of these conditions occur, do not take Pirfenidone Accord. In case of doubt, consult a doctor or pharmacist.

Warnings and precautions

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

• During treatment with Pirfenidone Accord, increased sensitivity to sunlight may develop (photosensitivity reaction). During treatment with Pirfenidone Accord, avoid exposure to sunlight (including sunbeds). Use sunscreens and cover arms, legs, and head to limit sun exposure (see section 4: Possible side effects).
• Do not take other medicines, such as tetracycline antibiotics (e.g., doxycycline), which may increase sensitivity to sunlight.
• Tell your doctor about kidney function disorders.
• Tell your doctor about mild or moderate liver function disorders.
• Before starting treatment with Pirfenidone Accord and during treatment, stop smoking. Smoking may reduce the effect of Pirfenidone Accord.
• Pirfenidone Accord may cause dizziness and fatigue. Be careful when performing tasks that require attention and coordination.
• Pirfenidone Accord may cause weight loss. Your doctor will monitor your weight while taking this medicine.
• Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug rash with eosinophilia and systemic symptoms (DRESS) have been reported in association with Pirfenidone Accord treatment. Stop taking Pirfenidone Accord and seek medical attention immediately if you experience any symptoms of these severe skin reactions, described in section 4.

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 once a month for the first 6 months of treatment, and then every 3 months throughout the treatment period to monitor liver function.
It is essential to perform regular blood tests throughout the treatment period with Pirfenidone Accord.

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, have recently taken, or might take.
This is especially important for the following medicines, as they may affect the way Pirfenidone Accord works.
Medicines that may increase the risk of side effects 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 effect 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 this medicine. Grapefruit may interfere with the proper functioning of Pirfenidone Accord.

Pregnancy and breastfeeding

As a precaution, it is recommended to avoid taking Pirfenidone Accord if you are pregnant, plan to become pregnant, or think 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 any machinery if you experience dizziness or fatigue after taking Pirfenidone Accord.

Pirfenidone Accord contains lactose

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

Pirfenidone Accord contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is essentially 'sodium-free'.

3. How to take Pirfenidone Accord

Treatment with Pirfenidone Accord should be initiated and supervised by a specialist doctor with experience 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 (a total of 801 mg per day);
• from day 8 to 14, take a dose of 534 mg (2 yellow tablets) 3 times a day with food (a total of 1602 mg per day);
• from day 15 (maintenance treatment), take a dose of 801 mg (3 yellow tablets or 1 brown tablet) 3 times a day with food (a total of 2403 mg per day).

The recommended daily maintenance dose of Pirfenidone Accord is 801 mg (3 yellow tablets or 1 brown tablet) 3 times a day, taken with food, which is a total of 2403 mg per 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 (vomiting) and dizziness. If symptoms persist, consult your doctor.
Dose reduction due to side effects
Your doctor may reduce the dose of Pirfenidone Accord if you experience side effects, such as stomach problems, any skin reactions to sunlight or sunbeds, 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, for any reason, 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 notice any of the following symptoms:

• Swelling of the face, lips, and/or tongue, itching, hives, difficulty breathing or wheezing, or feeling faint. These are symptoms of a severe allergic reaction called angioedema or anaphylaxis.
• Yellowing of the eyes or skin, or dark urine, which may be accompanied by itching of the skin, pain in the upper right abdomen, loss of appetite, bleeding, or bruising more easily than usual, or feeling tired. 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 of 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 reflux, vomiting, constipation
• diarrhea
• indigestion or stomach upset
• weight loss
• decreased appetite
• sleep disorders
• 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 disorders
• 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 sunbeds
• skin problems, such as itching, redness, dryness, skin 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 leaflet, tell your doctor or pharmacist. You can also report side effects directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
You can also report side effects to the marketing authorization holder.
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 packaging 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 inscription "D1" on one side and smooth on the other.
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 inscription "D2" on one side and smooth on the other.
Pirfenidone Accord, film-coated tablets are packaged in a blister pack of PVC/PE/PCTFE/Aluminum and a single-dose blister pack of PVC/PE/PCTFE/Aluminum.
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 tablet.

Starting treatment pack for 2-week treatment:

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

Maintenance treatment pack:

Each outer carton contains a total of 252 film-coated tablets (3 cartons, each containing 4 blisters of 21 film-coated tablets or 3 cartons, each containing 84 x 1 film-coated tablet in single-dose blisters).
801 mg tablets
Pack sizes: 84 film-coated tablets or 84 x 1 film-coated tablet.

Maintenance treatment pack:

Each outer carton contains a total of 252 film-coated tablets (3 cartons, each containing 4 blisters of 21 film-coated tablets or 3 cartons, each containing 84 x 1 film-coated tablet in single-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 leaflet: March 2025