PIRFENIDONE ACCORD 801 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Pirfenidone Accord 267 mg film-coated tablets EFG Pirfenidone Accord 801 mg film-coated tablets EFG

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack:

1. What is Pirfenidone Accord and what is it used for
2. What you need to know before you take Pirfenidone Accord
3. How to take Pirfenidone Accord
4. Possible side effects
5. Storage of Pirfenidone Accord
6. Contents of the pack and further information

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

This medicine contains the active substance pirfenidone and is used to treat Idiopathic Pulmonary Fibrosis (IPF).

IPF is a disease in which the lung tissue becomes swollen and scarred over time, making it difficult to breathe deeply. In these circumstances, the lungs have difficulty functioning properly. Pirfenidone helps reduce scarring and swelling of the lungs, and helps you breathe better.

2. What you need to know before you take Pirfenidone Accord

Do not 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 had angioedema with pirfenidone, including symptoms such as swelling of the face, lips, and/or tongue that 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 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 pirfenidone. If you are in doubt, consult your doctor or pharmacist.

Warnings and precautions

Consult your doctor or pharmacist before starting to take pirfenidone

• You may have increased sensitivity to sunlight (photosensitivity reaction) when taking pirfenidone. Avoid the sun (also UVA lamps) while taking pirfenidone. Use a sunscreen 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 antibiotics of the tetracycline group (e.g., doxycycline), which may increase your sensitivity to sunlight. You should inform your doctor if you have kidney problems.
• You should inform your doctor if you have mild to moderate liver problems.
• You should avoid smoking before and during treatment with pirfenidone. Smoking may reduce the effect of pirfenidone.
• Pirfenidone may cause dizziness and fatigue. Be careful if you need to perform activities that require attention and coordination.
• Pirfenidone may cause weight loss. Your doctor will monitor your weight while you are taking this medicine.
• Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS) have been reported in association with pirfenidone treatment. Stop taking pirfenidone and seek medical attention immediately if you notice any of the symptoms related to these severe skin reactions described in section 4.

Pirfenidone may cause serious liver problems. Some cases have been fatal. You will need to have a blood test before starting to take pirfenidone, once a month for the first 6 months, and then every 3 months while taking this medicine, to check your liver function. It is essential that you have these blood tests periodically throughout the time you are taking pirfenidone.

Children and adolescents

Do not give pirfenidone to children and adolescents under 18 years of age.

Other medicines and Pirfenidone Accord

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 alter the effect of pirfenidone.

The following medicines may increase the side effects of pirfenidone:

• enoxacin (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 medicines may reduce the effectiveness of pirfenidone:

• omeprazole (used to treat disorders such as indigestion, gastroesophageal reflux disease)
• rifampicin (a type of antibiotic).

Taking Pirfenidone Accord with food and drinks

Do not drink grapefruit juice while taking this medicine. Grapefruit juice may make pirfenidone not work properly.

Pregnancy and breastfeeding

As a precautionary measure, it is preferable to avoid the use of pirfenidone if you are pregnant, planning to become pregnant, or think you may be pregnant, as the potential risks to the fetus are not known.

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

Driving and using machines

Do not drive or operate machinery if you feel dizzy or tired after taking pirfenidone.

Pirfenidone Accord contains lactose

Pirfenidone Accord contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult with them before taking this medicine.

Pirfenidone Accord contains sodium

Pirfenidone Accord contains less than 1 mmol of sodium (23 mg) per tablet, i.e., essentially "sodium-free".

3. How to take Pirfenidone Accord

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

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

Normally, you will be given this medicine by gradually increasing the dose 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/day)
• between days 8 and 14, take a dose of 534 mg (2 yellow tablets), 3 times a day with food (a total of 1,602 mg/day)
• from day 15 (maintenance), 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/day).

The recommended maintenance dose of Pirfenidone is 801 mg (3 yellow tablets or 1 brown tablet) three times a day with food, a total of 2,403 mg/day.

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

Dose reduction due to side effects

It is possible that your doctor may decide to reduce the dose if you experience side effects such as stomach problems, skin reactions to sunlight or UVA lamps, or significant changes in liver enzymes.

If you take more Pirfenidone Accord than you should

Go to your doctor, pharmacist, or the emergency department of the nearest hospital immediately if you take more tablets than you should, and take your medicine with you.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, telephone: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Pirfenidone Accord

If you forget to take a dose, take it as soon as you remember. Do not take a double dose to make up for forgotten doses. Each dose should be separated by an interval of at least 3 hours. Do not take more tablets per day than your prescribed daily dose.

If you stop taking Pirfenidone Accord

In certain situations, your doctor will advise you to stop taking pirfenidone. If for any reason you stop taking pirfenidone for more than 14 consecutive days, your doctor will restart your treatment with a dose of 267 mg 3 times a day and gradually increase it to 801 mg 3 times a day.

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 pirfenidone 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 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, pain in the upper right side of the 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 pirfenidone.
• Red patches or circular patches on the trunk, often with central blisters, skin peeling, ulcers in the mouth, throat, nose, genitals, and eyes. These severe skin rashes may be preceded by fever and symptoms similar to those of the flu (Stevens-Johnson syndrome or toxic epidermal necrolysis).
• Widespread rash, high 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.

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

• infections of the throat or respiratory tract that reach the lungs and/or sinusitis
• feeling sick (nausea)
• stomach problems, such as acid reflux, vomiting, and constipation
• diarrhea
• indigestion or stomach heaviness
• weight loss
• decreased appetite
• difficulty sleeping
• fatigue
• dizziness
• headache
• difficulty breathing
• cough
• joint pain

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

• bladder infections
• drowsiness
• altered taste
• hot flashes
• stomach problems, such as feeling heavy, pain, and discomfort, heartburn, and flatulence
• blood tests may indicate increased liver enzymes
• skin reactions after exposure to sunlight or UVA lamps
• skin problems such as itching, irritation, or redness, dryness, rash
• muscle pain
• weakness or lack of 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, confusion, weakness, muscle cramps, or nausea and vomiting.
• blood test results may show decreased white blood cells.

Reporting of side effects

If you experience any side effects, consult your doctor or pharmacist, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines:

https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Pirfenidone Accord

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 label of the bottle, on the blister, and on the carton after EXP. The expiry date is the last day of the month indicated.

This medicine does not require any special storage conditions.

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 further information

Composition of Pirfenidone Accord

267 mg tablets

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

The other ingredients are: lactose monohydrate, copovidone, sodium croscarmellose (E468), magnesium stearate (E572).

The film coating consists of: polyvinyl alcohol (E1203), titanium dioxide (E171), macrogol 4000 (E1521), talc (E553b), yellow iron oxide (E172).

801 mg tablets

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

The other ingredients are: lactose monohydrate, copovidone, sodium croscarmellose (E468), magnesium stearate (E572).

The film coating consists of: polyvinyl alcohol (E1203), titanium dioxide (E171), macrogol 4000 (E1521), talc (E553b), black iron oxide (E172) and red iron oxide (E172).

Appearance of the product and pack contents

267 mg tablets

Pirfenidone Accord 267 mg film-coated tablets are yellow, oval, biconvex, film-coated tablets with beveled edges, with the inscription "D1" on one side and smooth on the other, with a size of 13 x 7 mm.

801 mg tablets

Pirfenidone Accord 801 mg film-coated tablets are brown, oval, biconvex, film-coated tablets with beveled edges, with the inscription "D2" on one side and smooth on the other, with a size of 21 x 10 mm.

Pirfenidone Accord film-coated tablets are available in aluminum PVC/PE/PCTFE blisters and unit-dose perforated aluminum PVC/PE/PCTFE blisters with the following pack sizes:

267 mg tablet

Pack sizes: 21, 42, 84, 168 film-coated tablets or 21, 42, 84, 168 unit-dose perforated film-coated tablets.

Package for treatment initiation for 2 weeks:

Each multiple pack contains a total of 63 film-coated tablets (1 pack with 1 blister of 21 tablets and 1 pack with 2 blisters of 21 tablets or 1 pack with 21 and 42 unit-dose perforated film-coated tablets).

Maintenance package:

Each multiple pack contains a total of 252 film-coated tablets (3 packs, each containing 4 blisters of 21 tablets or 3 packs each containing 84 unit-dose perforated film-coated tablets).

801 mg film-coated tablets

Pack size: 84 film-coated tablets or 84 x 1 unit-dose perforated film-coated tablets.

Maintenance package:

Each multiple 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 unit-dose perforated film-coated tablets).

Not all pack sizes may be marketed.

Marketing authorization holder

Accord Healthcare S.L.U.

World Trade Center

Moll de Barcelona s/n,

Edifici Est, 6ª planta,

08039 Barcelona

Spain

Manufacturer

Laboratori Fundació Dau

C/ C, 12-14 Pol.

Ind. Zona Franca,

Barcelona, 08040, Spain

Or

Accord Healthcare Polska Sp. z o.o.

Ul. Lutomierska 50, 95-200,

Pabianice, Poland

Or

Accord Healthcare B.V.

Winthontlaan 200, 3526 KV

Utrecht, Netherlands

Or

Pharmadox Healthcare Limited

KW20A Kordin

Industrial Park,

Paola PLA 3000, Malta

Or

Accord Healthcare Single Member S.A.,

64th Km National Road Athens Lamia,

Schimatari, 32009, Greece

Date of last revision of this leaflet: October 2024

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS): http://www.aemps.gob.es/