Product Information for the User

Pirfenidona Accord 267 mg Film-Coated Tablets Pirfenidona Accord 801 mg Film-Coated Tablets

Read this entire product information carefully before starting to take this medicine, as it contains important information for you.

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

This medication contains the active ingredient pirfenidona and is used for the treatment of Idiopathic Pulmonary Fibrosis (IPF).

IPF is a disease in which the lung tissues become swollen and filled with scars over time, making it difficult to breathe deeply. In these circumstances, the lungs have trouble functioning correctly. Pirfenidona helps to reduce lung scarring and swelling, and helps you breathe better.

Do not take Pirfenidona Accord

• if you are allergic to pirfenidona or any of the other components of this medication (listed in section 6)
• if you have previously had angioedema with pirfenidona, 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 medication called fluvoxamina (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 pirfenidona. If you have any doubts, consult your doctor or pharmacist.

Warnings and precautions

Consult your doctor or pharmacist before starting to take pirfenidona

• You may be more sensitive to sunlight (photosensitivity reaction) when taking pirfenidona. Avoid the sun (also UVA lamps) while taking pirfenidona. Use daily sun protection cream and cover your arms, legs, and head to reduce exposure to sunlight (see section 4: Possible side effects).
• Do not take other medications, such as tetracycline antibiotics (e.g. doxiciclina), 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.
• Abstain from smoking before and during treatment with pirfenidona. Tobacco may reduce the effect of pirfenidona.
• Pirfenidona may cause dizziness and fatigue. Be careful if you have to perform activities that require attention and coordination.
• Pirfenidona may cause weight loss. Your doctor will monitor your weight while taking this medication.
• Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS) have been reported in association with pirfenidona treatment. Stop taking pirfenidona and seek medical attention immediately if you notice any symptoms related to these severe skin reactions described in section 4.

Pirfenidona may cause severe liver problems. Some cases have been fatal. You will need to have blood tests before starting to take pirfenidona, once a month for the first 6 months, and then every 3 months while taking this medication, to check the proper functioning of your liver. It is essential to have these blood tests periodically throughout the time you are taking pirfenidona.

Children and adolescents

Do not administer pirfenidona to children and adolescents under 18 years old.

Other medications and Pirfenidona Accord

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

This is especially important if you are taking the following medications, as they may alter the effect of pirfenidona.

The following medications may increase the side effects of pirfenidona:

• enoxacina (a type of antibiotic)
• ciprofloxacino (a type of antibiotic)
• amiodarona (used to treat certain types of cardiopathies)
• propafenona (used to treat certain types of cardiopathies)
• fluvoxamina (used to treat depression and obsessive-compulsive disorder [OCD]).

The following medications may reduce the effectiveness of pirfenidona:

• omeprazol (used to treat conditions such as indigestion, gastroesophageal reflux disease)
• rifampicina (a type of antibiotic).

Taking Pirfenidona Accord with food and drinks

Do not drink grapefruit juice while taking this medication. Grapefruit juice may make pirfenidona not work correctly.

Pregnancy and breastfeeding

As a precaution, it is recommended to avoid using pirfenidona 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 plan to do so, talk to your doctor or pharmacist before taking pirfenidona. As it is not known whether pirfenidona is excreted in breast milk, your doctor will explain the risks and benefits of taking this medication during breastfeeding if you decide to do so.

Driving and operating machinery

Do not drive or operate machinery if you feel dizzy or fatigued after taking pirfenidona.

Pirfenidona Accord contains lactose

Pirfenidona Accord contains lactose. If your doctor has indicated that you have a certain sugar intolerance, consult with them before taking this medication.

Pirfenidona Accord contains sodium

Pirfenidona Accord contains less than 1 mmol of sodium (23 mg) per tablet, which is essentially "sodium-free".

The 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 medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Normally, you will be administered this medication 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 daily maintenance dose of Pirfenidone 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 water, during or after a meal to reduce the risk of side effects such as nausea (feeling of discomfort) and dizziness. If symptoms persist, consult your doctor.

Reduction of the dose due to side effects

Your doctor may decide to reduce the dose if you experience side effects such as stomach problems, skin reactions to sunlight or UV-A lamps, or significant changes in liver enzymes.

If you take more Pirfenidone Accord than you should

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

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

If you forgot 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 compensate for the missed doses. Each dose should be separated by a minimum interval of 3 hours. Do not take more tablets per day than correspond to your prescribed daily dose.

If you interrupt treatment with 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, the 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 other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience 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, rashes, difficulty breathing, or wheezing, or a 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, abdominal pain on the upper right side, loss of appetite, bleeding, or the appearance of bruises 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.
• Flat, red patches on the trunk, often with central blisters, skin peeling, ulcers in the mouth, throat, nose, genitals, and eyes. These severe skin eruptions may be preceded by fever and symptoms similar to the flu (Stevens-Johnson syndrome or toxic epidermal necrolysis).
• Generalized rash, elevated body temperature, and enlargement of lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).

Other possible side effects are

If you experience any type of side effect, consult your doctor.

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

• Throat or respiratory tract infections that reach the lungs and/or sinusitis
• Unpleasant feeling (nausea)
• Stomach problems, such as acid reflux, vomiting, and constipation
• Diarrea
• Indigestion or stomach heaviness
• Weight loss
• Loss of appetite
• Difficulty sleeping
• Tiredness
• Dizziness
• Headache
• Difficulty breathing
• Cough
• Joint pain

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

• Urinary tract infections
• Drowsiness
• Alteration of taste
• Headaches
• Stomach problems, such as feeling heavy, pain, and abdominal discomfort, stomach burning, and flatulence
• Blood tests may indicate an increase in liver enzymes
• Skin reactions after exposure to the sun 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.

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

• Low sodium levels in the blood. This may cause headache, dizziness, confusion, muscle cramps, nausea, and vomiting.
• Blood test results may show a decrease in white blood cells.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:

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

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the label of the bottle, on the blister pack, and on the box after CAD/EXP. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the containers and medications that you no longer need.By doing so, you will help protect the environment.

Pirfenidona Accord Composition

267 mg Tablets

The active ingredient is pirfenidona. Each film-coated tablet contains 267 mg of pirfenidona.

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).

801 mg Tablets

The active ingredient is pirfenidona. Each film-coated tablet contains 801 mg of pirfenidona.

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).

Product Appearance and Packaging Contents

267 mg Tablets

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

801 mg Tablets

Pirfenidona Accord 801 mg film-coated tablets are brown, oval, biconvex, beveled-edge tablets with the inscription "D2" on one side and smooth on the other, measuring 21 x 10 mm.

Pirfenidona Accord film-coated tablets are available in aluminum PVC/PE/PCTFE blisters and perforated single-dose aluminum PVC/PE/PCTFE blisters in the following packaging sizes:

267 mg Tablets

Package sizes: 21, 42, 84, 168 film-coated tablets or 21, 42, 84, 168 perforated single-dose film-coated tablets.

Package for 2-Week Treatment Initiation:

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

Package for Maintenance:

Each multiple package contains a total of 252 film-coated tablets (3 packages, each containing 4 blisters of 21 film-coated tablets or 3 packages, each containing 84 film-coated tablets in perforated single-dose blisters)

801 mg Film-Coated Tablets

Package size: 84 film-coated tablets or 84x1 film-coated tablets in perforated single-dose blisters.

Package for Maintenance:

Each multiple package contains a total of 252 film-coated tablets (3 packages, each containing 4 blisters of 21 film-coated tablets or 3 packages, each containing 84 film-coated tablets in perforated single-dose blisters)

Only some package sizes may be marketed.

Marketing Authorization Holder

Accord Healthcare S.L.U.

World Trade Center

Moll de Barcelona s/n,

Edifici Est, 6th floor,

08039 Barcelona

Spain

Responsible 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

Last Review Date of this Leaflet: October 2024

For detailed information on this medicine, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS): http://www.aemps.gob.es/