Pirfenidone Accord 267 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

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

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

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

Leaflet contents:

1. What Pirfenidone Accord is and what it is used for
2. What you need to know 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 Pirfenidone Accord is and what it is used for

This medicine contains the active substance pirfenidone and is used for the treatment of Idiopathic Pulmonary Fibrosis (IPF).

IPF is a disease in which lung tissues become inflamed and progressively scarred over time, making it difficult to breathe deeply. In these circumstances, the lungs have difficulty functioning properly. Pirfenidone helps reduce scarring and inflammation in the lungs, helping you breathe better.

2. What you need to know before taking Pirfenidone Accord

Do not take Pirfenidone Accord

• if you are allergic to pirfenidone or to any of the other ingredients of this medicine (listed in section 6)
• if you have previously experienced angioedema with pirfenidone, including symptoms such as swelling of the face, lips and/or tongue, which 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 end-stage liver disease
• if you have severe or end-stage kidney disease requiring dialysis.

If any of the above apply to you, do not take pirfenidone. If you have any doubts, consult your doctor or pharmacist.

Warnings and precautions

Talk to your doctor or pharmacist before starting pirfenidone

• You may become more sensitive to sunlight (photosensitivity reaction) while taking pirfenidone. Avoid sunlight (including UVA lamps) while taking pirfenidone. Use sunscreen daily and cover your arms, legs, and head to reduce sun exposure (see section 4: Possible side effects).
• Do not take other medicines such as tetracycline antibiotics (e.g. doxycycline) that may increase your sensitivity to sunlight. Inform your doctor if you have kidney problems.
• Inform your doctor if you have mild to moderate liver problems.
• You must refrain from smoking before and during treatment with pirfenidone. Tobacco may reduce the effect of pirfenidone.
• Pirfenidone may cause dizziness and fatigue. Be cautious if you need to perform activities requiring 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 immediate medical attention if you notice any symptoms related to these serious skin reactions described in section 4.

Pirfenidone can cause serious liver problems. Some cases have been fatal. You will need a blood test before starting pirfenidone, once a month for the first 6 months, and then every 3 months while taking this medicine, to check that your liver is functioning properly. It is important that you have these blood tests performed regularly 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 need to 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 heart conditions)
• propafenone (used to treat certain heart conditions)
• fluvoxamine (used to treat depression and obsessive-compulsive disorder [OCD]).

The following medicines may reduce the effectiveness of pirfenidone:

• omeprazole (used to treat conditions 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 cause pirfenidone to not work properly.

Pregnancy and breastfeeding

As a precautionary measure, it is preferable to avoid using pirfenidone 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 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 informed you that you have an intolerance to certain 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 physicians experienced in the diagnosis and treatment of IPF.

Always follow exactly the instructions for administration of this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

You will normally be given this medicine with a gradual dose increase as follows:

• during the first 7 days, take a dose of 267 mg (1 yellow tablet) three times a day with food (a total of 801 mg/day)
• from days 8 to 14, take a dose of 534 mg (2 yellow tablets) three times a day with food (a total of 1,602 mg/day)
• from day 15 onwards (maintenance), take a dose of 801 mg (3 yellow tablets or 1 brown tablet) three times a day with food (a total of 2,403 mg/day).

The recommended maintenance daily dose of Pirfenidone is 801 mg (3 yellow tablets or 1 brown tablet) three times a day with meals, for 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 unwell) and dizziness. If symptoms persist, contact your doctor.

Dose reduction due to side effects

Your doctor may decide to reduce your 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

Contact your doctor, pharmacist, or the nearest hospital emergency department immediately if you take more tablets than you should, and take your medication with you.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at 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 a minimum interval of 3 hours. Do not take more tablets per day than prescribed in your daily dose.

If you stop taking Pirfenidone Accord

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

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

Stop taking pirfenidone and seek immediate medical attention 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 faint, which are signs of angioedema, a serious allergic reaction or anaphylaxis.
• Yellowing of the eyes or skin, dark urine, possibly accompanied by itching of the skin, pain in the upper right side of the abdomen (stomach area), 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 an uncommon adverse effect of pirfenidone.
• Non-elevated or circular red patches on the trunk, often with central blisters, skin peeling, mouth, throat, nose, genital, or eye ulcers. These severe skin rashes may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome or toxic epidermal necrolysis).
• Widespread rash, high body temperature, and enlarged lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).

Other possible adverse effects are

If you experience any adverse effect, consult your doctor.

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

• Throat or respiratory tract infections reaching the lungs and/or sinusitis
• Feeling unwell (nausea)
• Stomach problems such as acid reflux, vomiting, and constipation
• Diarrhea
• Indigestion or stomach discomfort
• Weight loss
• Decreased appetite
• Difficulty sleeping
• Tiredness
• Dizziness
• Headache
• Difficulty breathing
• Cough
• Joint pain

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

• Bladder infections
• Drowsiness
• Taste disturbance
• Hot flushes
• Stomach problems such as feeling of fullness, abdominal pain and discomfort, heartburn, and flatulence
• Blood tests may show increased liver enzymes
• Skin reactions after exposure to sunlight or use of UVA lamps
• Skin problems such as itching, irritation, or redness, dryness, rash
• Muscle pain
• Weakness or lack of energy
• Chest pain
• Sunburn

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

• Low levels of sodium 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 adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines:

https://www.notificaram.es. By reporting adverse 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 stated on the label of the bottle, blister pack, and carton after EXP. The expiry date refers to 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 any unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Pirfenidone Accord

Tablets 267 mg

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

The other components 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).

Tablets 801 mg

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

The other components 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 contents of the pack

Tablets 267 mg

Pirfenidone Accord 267 mg film-coated tablets are yellow, oval, biconvex, film-coated tablets with bevelled edges, marked with the inscription “D1” on one side and smooth on the other, measuring 13 x 7 mm.

Tablets 801 mg

Pirfenidone Accord 801 mg film-coated tablets are brown, oval, biconvex, film-coated tablets with bevelled edges, marked with the inscription "D2" on one face and smooth on the other, measuring 21 x 10 mm.

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

Tablet 267 mg

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

Starting treatment pack for 2 weeks:

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

Maintenance pack:

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 film-coated tablets in perforated unit-dose blisters).

Film-coated tablets 801 mg

Pack size: 84 film-coated tablets or 84x1 film-coated tablets in perforated unit-dose blisters.

Maintenance pack:

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 film-coated tablets in perforated unit-dose blisters).

Only some pack sizes may be commercially available.

Marketing Authorization Holder

Accord Healthcare S.L.U.

World Trade Center

Moll de Barcelona s/n,

Edifici Est, 6th floor,

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, The 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 latest revision of this leaflet: October 2024

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