PIRFENIDONE 267 mg Tabletki Powlekane

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1. Pirfenidone Accord 267 mg film-coated tablets
   1. What is Pirfenidone Accord 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. Package contents and other information

Pirfenidone Accord 267 mg film-coated tablets

Pirfenidone Accord 801 mg film-coated tablets
Generic medicine

Read this leaflet carefully before you start to take 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 pass it on to others, even if their symptoms are the same as yours, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell 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 you take 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 is Pirfenidone Accord and what it is used for

Pirfenidone Accord contains the active ingredient pirfenidone and is used for the treatment of idiopathic pulmonary fibrosis (Idiopathic Pulmonary Fibrosis - IPF) in adult patients.
IPF is a disease in which the tissues of the lungs become inflamed and damaged over time, leading to difficulty breathing deeply. This makes it difficult for the lungs to function properly. Pirfenidone Accord helps to reduce damage and swelling of the lungs, and helps 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 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 be more sensitive to sunlight during treatment with Pirfenidone Accord (photosensitivity reaction). Avoid sun exposure (including sunbeds) while taking 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-based antibiotics (like doxycycline), which can make you more sensitive to sunlight.
• if you have kidney problems, tell your doctor.
• if you have mild to moderate liver problems, tell your doctor.
• stop smoking before and during treatment with Pirfenidone Accord. Cigarette smoking can reduce the effect of Pirfenidone Accord.
• Pirfenidone Accord can cause dizziness and fatigue. Be careful if you need to perform activities that require mental alertness and coordination.
• Pirfenidone Accord can cause weight loss. Your doctor will check your weight while you are taking this medicine.
• cases of Stevens-Johnson syndrome, toxic epidermal necrolysis and drug reaction with eosinophilia and systemic symptoms have been reported in association with treatment with Pirfenidone Accord. If you notice any of the symptoms relating to these serious skin reactions, described in section 4, stop taking Pirfenidone Accord and seek immediate medical attention. Pirfenidone Accord can cause serious liver problems which have been fatal in some cases. You will need to have a blood test before starting to take Pirfenidone Accord, monthly for the first 6 months and then every 3 months during the period you are taking this medicine to check your liver function. During the period you are taking Pirfenidone Accord it is important that you have these regular blood tests. Children and adolescentsDo not give Pirfenidone Accord to children and adolescents under 18 years of age. Other medicines and Pirfenidone AccordTell 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 can change the effect of Pirfenidone Accord. Medicines that can increase the side effects of Pirfenidone Accord:
• enoxacin (a type of antibiotic)
• ciprofloxacin (a type of antibiotic)
• amiodarone (used to treat some types of heart conditions)
• propafenone (used to treat some types of heart conditions)
• fluvoxamine (used to treat depression and obsessive compulsive disorder [OCD]).

Medicines that can reduce the effectiveness of Pirfenidone Accord:

• omeprazole (used to treat conditions such as indigestion, gastro-oesophageal reflux disease)
• rifampicin (a type of antibiotic).

Pirfenidone Accord with food and drink
Do not drink grapefruit juice while taking this medicine. Grapefruit can
interfere with the correct action of Pirfenidone Accord.

Pregnancy and breastfeeding
As a precautionary measure, it is preferable to avoid the use of Pirfenidone Accord if you are pregnant, suspect you are pregnant or are planning a pregnancy as the potential risks to the foetus are not
known.
If you are breastfeeding or intend to breastfeed, ask your doctor or pharmacist before
taking Pirfenidone Accord. As it is not known whether Pirfenidone Accord passes into breast milk, the
doctor will consider the risks and benefits of taking this medicine while breastfeeding if
you have decided to breastfeed.

Driving and using machines
Do not drive or use machines if you experience dizziness or fatigue after taking Pirfenidone
Accord.

Pirfenidone Accord contains lactose
Pirfenidone Accord contains lactose. If you have been told by your doctor that you have an intolerance to some sugars,
contact your doctor before taking this medicine.

Pirfenidone Accord contains sodium
Pirfenidone Accord contains less than 1 mmol (23 mg) of sodium per tablet, that is to say essentially “sodium-free”.

3. How to take Pirfenidone Accord

Treatment with Pirfenidone Accord must be initiated and supervised by a specialist doctor
experienced in the diagnosis and treatment of IPF.
Take this medicine following exactly the instructions of your doctor or pharmacist. If
you have any doubts, consult your doctor or pharmacist.
The medicine will usually be administered to you 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 (for a total of 801 mg/day)
• from day 8 to day 14, take a dose of 534 mg (2 yellow tablets), 3 times a day with food (for 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) 3 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 a day with food, for a total of 2,403 mg/day. Swallow the entire tablet with water during or after meals to reduce the risk of side effects such as nausea and dizziness. If symptoms persist, consult your doctor. Dose reduction due to side effects The doctor may reduce the dose if you experience side 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 shouldIf you have taken more tablets than you should, contact your doctor, pharmacist or the nearest emergency room immediately, and take the medicine with you. If you forget to take Pirfenidone AccordIf you forget to take a dose, take it as soon as you remember. Do not take a double dose to make up for a missed dose. At least three hours must pass between one dose and the next. Do not take more tablets in a day than those prescribed according to the daily dose. If you stop taking Pirfenidone AccordIn some specific cases, your doctor may advise you to stop taking Pirfenidone Accord. If for any reason you need to stop treatment with Pirfenidone Accord for a period longer than 14 consecutive days, your doctor will restart treatment with a dose of 267 mg 3 times a day, gradually increasing this dose to 801 mg 3 times a day. If you have any doubts about the use of this medicine, 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 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 skin, or dark urine, potentially accompanied by itchy skin, pain in the upper right area of the stomach (abdomen), loss of appetite, increased tendency to bleed or bruise, or feeling tired. These may be signs of impaired liver function and may indicate liver damage, which is an uncommon side effect of Pirfenidone Accord.
• Flat or circular reddish spots on the trunk, often with blisters in the center, skin peeling, 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 body temperature, and swollen lymph nodes (drug reaction with eosinophilia and systemic symptoms syndrome or drug hypersensitivity syndrome). Other side effects may includeTalk to your doctor if you notice any side effect. Very common side effects(affect more than 1 in 10 people):
• throat or airway infections that reach 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
• sleep disorders
• fatigue
• dizziness
• headache
• shortness of breath
• cough
• painful joints/joint pain.

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

• bladder infections
• drowsiness
• taste alterations
• hot flushes
• stomach problems such as, feeling bloated, pain and abdominal discomfort, heartburn, and passing gas
• blood tests may show increased levels of liver enzymes
• skin reactions after exposure to the sun or use of sunbeds
• 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 can cause headache, dizziness, confusion, weakness, muscle cramps, or nausea and vomiting.
• blood tests may show a decrease in white blood cells. Reporting of side effectsIf you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly through the national reporting system at: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. 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 which is stated on the package and blister after
Expiry/EXP. The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.
Do not dispose of any medicine in 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 ingredient 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 tablet
The active ingredient 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), red iron oxide (E172).

Description of the appearance of Pirfenidone Accord and package contents

267 mg tablet
Pirfenidone Accord 267 mg film-coated tablets are film-coated tablets of
yellow color, oval, biconvex, with beveled edges, with the inscription “D1” on one side and smooth on the other
side, with dimensions of 13 x 7 mm.

801 mg tablet
Pirfenidone Accord 801 mg film-coated tablets are film-coated tablets of
brown color, oval, biconvex, with beveled edges, with the inscription “D2” on one side and smooth on the other
side, with dimensions of 21 x 10 mm.
Pirfenidone Accord film-coated tablets are available in aluminum foil blisters
PVC/PE/PCTFE and perforated blister divisible per unit dose in aluminum foil
PVC/PE/PCTFE in the following packs:
267 mg tablets
Package contents: 21, 42, 84, 168 film-coated tablets or 21x1, 42x1, 84x1,
168x1 film-coated tablets in a unit dose divisible perforated blister.

2-week starter pack:
Each multipack contains a total of 63 film-coated tablets. ( 1 pack

containing 3 blisters of 7 and 1 pack containing 6 blisters of 7 film-coated tablets

or 1 pack containing 3 unit-dose divisible perforated blisters of 7 film-coated tablets

and 1 pack containing 6 unit-dose divisible perforated blisters of 7

film-coated tablets)

Maintenance pack:
Each multipack contains a total of 252 film-coated tablets. ( 3 packs

each containing 12 blisters of 7 film-coated tablets or 3 packs containing

each 12 unit-dose divisible perforated blisters of 7 film-coated tablets)
801 mg tablets
Package contents: 84 film-coated tablets or 84x1 film-coated tablets
in a unit dose divisible perforated blister.

Maintenance pack:
Each multipack contains a total of 252 film-coated tablets. ( 3 packs

each containing 12 blisters of 7 film-coated tablets or 3 packs containing

each 12 unit-dose divisible perforated 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, 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 authorised in the Member States of the European Economic Area with the
following denominations:
CountryInvented Name
Marketing Authorization
Holder
NL Pirfenidone Accord 267 mg/801 mg Filmomhulde tabletten
DE Pirfenidon Accord 267 mg/801 mg Filmtabletten
DK
(RMS)
Pirfenidone Accord

Accord Healthcare B.V.,
NO Pirfenidone Accord NL
SE Pirfenidone Accord
FI Pirfenidone Accord
ES
Pirfenidone Accord 267 mg/801 mg comprimidos recubiertos
con película Accord Healthcare S.L.U,
IT Pirfenidone Accord ES
AT Pirfenidon Accord 267 mg/801 mg Filmtabletten
BE Pirfenidone Accord 267 mg/801 mg Filmtabletten
EE Pirfenidone Accord

Accord Healthcare B.V.,
NL
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
LT

Accord Healthcare S.L.U,
ES
EL PIRFENIDONE/ACCORD
PT Pirfenidone Accord
PL Pirfenidone Accord
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 Polska
Sp. z o.o., PL
HR
IE
Pirfenidone Accord 267 mg/801 mg film-coated tablets Accord Healthcare
Ireland, IE
PIRFENIDONE ACCORD 267mg, comprimé pelliculé
PIRFENIDONE ACCORD 801mg, comprimé pelliculé

Accord Healthcare France
SAS, FR
FR