Pirfenidone Accord

Package leaflet: Information for the user

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

Generic medicine
Please read this leaflet carefully before taking this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as yours, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.
  Contents of this leaflet:

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

Pirfenidone Accord contains the active substance pirfenidone and is used for the treatment of idiopathic pulmonary fibrosis (Idiopathic Pulmonary Fibrosis - IPF) in adult patients.
IPF is a disease in which lung tissues become inflamed and damaged over time, leading to difficulty in breathing deeply. This makes it difficult for the lungs to function properly. Pirfenidone Accord helps reduce lung damage and inflammation, and helps improve breathing.

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 conditions apply to you, do not take Pirfenidone Accord. If in doubt, consult your doctor or pharmacist.
Warnings and precautions
Talk to your doctor or pharmacist before taking Pirfenidone Accord.

• you may become more sensitive to sunlight (photosensitivity reaction) while taking Pirfenidone Accord. Avoid sun exposure (including sunlamps and tanning beds) during treatment with Pirfenidone Accord. Apply sunscreen daily and cover your arms, legs and head to reduce exposure to sunlight (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.

• if you have kidney problems, inform your doctor.

• if you have mild to moderate liver problems, inform your doctor.

• stop smoking before and during treatment with Pirfenidone Accord. Cigarette smoking may reduce the effect of Pirfenidone Accord.

• Pirfenidone Accord may cause dizziness and fatigue. Be cautious if performing activities requiring mental alertness and coordination.

• Pirfenidone Accord may cause weight loss. Your doctor will monitor your weight during treatment with this medicine.

• cases of Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS) have been reported during treatment with Pirfenidone Accord. If you notice any symptoms related to these serious skin reactions described in section 4, stop treatment with Pirfenidone Accord and seek immediate medical advice. Pirfenidone Accord can cause serious liver problems, which in some cases have been fatal. You will need to have blood tests before starting Pirfenidone Accord, monthly for the first 6 months, and then every 3 months thereafter during treatment to monitor proper liver function. It is important that you attend these blood tests regularly while taking Pirfenidone Accord.
  Children and adolescents
  Do not give Pirfenidone Accord to children and adolescents under 18 years of age.
  Other medicines and Pirfenidone Accord
  Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This section is particularly important if you are taking the following medicines, as they may alter the effect of Pirfenidone Accord.
  Medicines that may increase the side effects of Pirfenidone Accord:

• 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]).

Medicines that may reduce the effectiveness of Pirfenidone Accord:

• omeprazole (used to treat conditions such as indigestion, 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 action of Pirfenidone Accord.
Pregnancy and breastfeeding
As a precautionary measure, it is preferable to avoid using Pirfenidone Accord during pregnancy, or if you suspect you might be pregnant or are planning a pregnancy, since the potential risks to the fetus are unknown.
If you are breastfeeding or intend to breastfeed, consult your doctor or pharmacist before taking Pirfenidone Accord. Since it is not known whether Pirfenidone Accord passes into breast milk, your doctor will assess the risks and benefits of taking this medicine during breastfeeding if you decide to breastfeed.
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 your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this medicine.
Pirfenidone Accord contains sodium
Pirfenidone Accord contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially "sodium-free".

3. How to take Pirfenidone Accord

Treatment with Pirfenidone Accord must be initiated and supervised by a specialist physician experienced in the diagnosis and treatment of IPF.
Take this medicine exactly as prescribed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The medicine will usually be administered in gradually increasing doses as follows:

• for the first 7 days, take a dose of 267 mg (1 yellow tablet) three times a day with food (for a total of 801 mg/day)
• from day 8 to day 14, take a dose of 534 mg (2 yellow tablets) three times a day with food (for a total of 1,602 mg/day)
• from day 15 onwards (maintenance phase), take a dose of 801 mg (3 yellow tablets or 1 brown tablet) three times a day with food (for a total of 2,403 mg/day). The recommended daily maintenance dose of Pirfenidone Accord for patients with IPF is 801 mg (3 yellow tablets or 1 brown tablet) three times daily with food, for a total daily dose of 2,403 mg. Swallow the tablet whole with water during or after meals to reduce the risk of adverse effects such as nausea and dizziness. If symptoms persist, consult your doctor.

Dose reduction due to adverse reactions
Your doctor may reduce your dose if you experience adverse effects such as stomach problems, skin reactions to sunlight or tanning lamps, or significant changes in liver enzymes.

If you take more Pirfenidone Accord than you should
If you have taken more tablets than prescribed, contact your doctor, pharmacist, or nearest emergency department immediately, and bring the medicine with you.

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 the missed dose. There must be at least three hours between doses. Do not take more tablets in one day than prescribed according to your daily dose.

If you stop taking Pirfenidone Accord
In certain specific cases, your doctor may instruct you to stop taking Pirfenidone Accord. If for any reason you need to stop treatment with Pirfenidone Accord for more than 14 consecutive days, your doctor will restart treatment with a dose of 267 mg three times a day, gradually increasing the dose up to 801 mg three times a day.

If you have any questions about how to use this medicine, consult 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 Accord and contact your doctor immediately if you notice any of the following symptoms or signs:

• Swelling of the face, lips and/or tongue, itching, hives, difficulty breathing or shortness of breath, or feeling faint, which are symptoms of angioedema, a serious allergic reaction or anaphylaxis.
• Yellowing of the whites of the eyes or of the skin, or dark urine, possibly accompanied by itchy skin, pain in the upper right part of the stomach (abdomen), loss of appetite, increased tendency to bleeding or bruising, or feeling tired. These may be signs of liver function impairment and could indicate liver damage, which is an uncommon side effect of Pirfenidone Accord.
• Flat, reddish, often circular rashes on the trunk, often with central blisters, peeling of the skin, mouth, throat, nose, genital or eye ulcers. These serious skin rashes may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome or toxic epidermal necrolysis).
• Widespread rash, high body temperature, and swollen lymph nodes (drug reaction with eosinophilia and systemic symptoms or drug hypersensitivity syndrome).

Other possible side effects include
Talk to your doctor if you notice any side effect.

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

• Throat or lower respiratory tract infections and/or sinusitis
• Feeling unwell (nausea)
• Stomach problems such as acid reflux, vomiting, and constipation
• Diarrhoea
• Indigestion or stomach discomfort
• Weight loss
• Decreased appetite
• Sleep disturbances
• Tiredness
• Dizziness
• Headache
• Shortness of breath
• Cough
• Joint pain.

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

• Bladder infections
• Drowsiness
• Taste disturbances
• Hot flushes
• Stomach problems such as bloating, pain and abdominal discomfort, heartburn, and flatulence
• Blood tests may show increased liver enzyme levels
• Skin reactions after exposure to sunlight or use of sunlamps
• Skin problems such as itching, redness, dry skin, rash
• Muscle pain
• Feeling weak or lacking energy
• Chest pain
• Sunburn.

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

• Low levels of sodium in the blood, which may cause headache, dizziness, confusion, weakness, muscle cramps, or nausea and vomiting.
• Blood tests may show a reduction in white blood cells.

Reporting of side effects
If you get any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
Reporting side effects 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/EXP. The expiry date refers to the last day of that month.
This medicine requires no special storage conditions.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents 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 components are: monohydrate lactose, 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 tablet
The active substance is pirfenidone. Each film-coated tablet contains 801 mg of
pirfenidone.
The other components are: monohydrate lactose, 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), red iron oxide (E172).

Description of the appearance of Pirfenidone Accord and contents of the pack
267 mg tablet
Pirfenidone Accord 267 mg film-coated tablets are yellow, oval, biconvex, film-coated tablets with bevelled edges, marked with the code "D1" on one side and smooth on the other side, measuring 13 x 7 mm.
801 mg tablet
Pirfenidone Accord 801 mg film-coated tablets are brown, oval, biconvex, film-coated tablets with bevelled edges, marked with the code "D2" on one side and smooth on the other side, measuring 21 x 10 mm.

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

267 mg tablets
Pack contents: 21, 42, 84, 168 film-coated tablets or 21x1, 42x1, 84x1, 168x1 film-coated tablets in perforated, divisible unit-dose blisters.

Starting treatment pack (2 weeks):
Each multiple pack contains a total of 63 film-coated tablets. (1 pack containing 3 blisters of 7 tablets and 1 pack containing 6 blisters of 7 film-coated tablets, or 1 pack containing 3 perforated, divisible unit-dose blisters of 7 film-coated tablets and 1 pack containing 6 perforated, divisible unit-dose blisters of 7 film-coated tablets)

Maintenance pack:
Each multiple pack contains a total of 252 film-coated tablets. (3 packs, each containing 12 blisters of 7 film-coated tablets, or 3 packs, each containing 12 perforated, divisible unit-dose blisters of 7 film-coated tablets)

801 mg tablets
Pack contents: 84 film-coated tablets or 84x1 film-coated tablets in perforated, divisible unit-dose blisters.

Maintenance pack:
Each multiple pack contains a total of 252 film-coated tablets. (3 packs, each containing 12 blisters of 7 film-coated tablets, or 3 packs, each containing 12 perforated, divisible unit-dose blisters of 7 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
Accord Healthcare Polska Sp. z o.o.
Ul. Lutomierska 50, 95-200,
Pabianice, Poland
Accord Healthcare B.V.
Winthontlaan 200, 3526 KV
Utrecht, The Netherlands
Pharmadox Healthcare Limited
KW20A Kordin
Industrial Park,
Paola PLA 3000, Malta
Accord Healthcare Single Member S.A.
64th Km National Road Athens,
Lamia, Schimatari, 32009, Greece

This medicinal product is authorized in the European Economic Area Member States under the following names:

| Marketing Authorization Holder | Country | Invented Name | |-------------------------------|--------|---------------| | Accord Healthcare B.V., NL | NL | Pirfenidone Accord 267 mg/801 mg Filmomhulde tabletten | | | DE | Pirfenidon Accord 267 mg/801 mg Filmtabletten | | | DK | Pirfenidone Accord | | | NO | Pirfenidone Accord | | | SE | Pirfenidone Accord | | | FI | Pirfenidone Accord | | Accord Healthcare S.L.U., ES | ES | Pirfenidone Accord 267 mg/801 mg comprimidos recubiertos con película | | | IT | Pirfenidone Accord | | | AT | Pirfenidon Accord 267 mg/801 mg Filmtabletten | | | BE | Pirfenidone Accord 267 mg/801 mg Filmtabletten | | | EE | Pirfenidone Accord | | | LT | Pirfenidone Accord 267 mg plėvele dengtos tabletės, Pirfenidone Accord 801 mg plėvele dengtos tabletės | | | LV | Pirfenidone Accord 267 mg/801 mg apvalkotās tabletes | | | CY | PIRFENIDONE ACCORD | | | EL | PIRFENIDONE/ACCORD | | | PT | Pirfenidone Accord | | | PL | Pirfenidone Accord | | Accord Healthcare Polska Sp. z o.o., PL | HR | Pirfenidon Accord 267 mg filmom obložene tablete, Pirfenidon Accord 801 mg filmom obložene tablete | | | CZ | Pirfenidone Accord | | | SI | Pirfenidon Accord 267 mg/801 mg filmsko obložene tablete | | | SK | Pirfenidón Accord 267 mg/801 mg | | Accord Healthcare Ireland, IE | IE | Pirfenidone Accord 267 mg/801 mg film-coated tablets | | Accord Healthcare France SAS, FR | FR | PIRFENIDONE ACCORD 267mg, comprimé pelliculé, PIRFENIDONE ACCORD 801mg, comprimé pelliculé |