Pirfenidone accord

Patient Information Leaflet

Pirfenidone Accord, 267 mg, film-coated tablets
Pirfenidone Accord, 801 mg, film-coated tablets
Pirfenidone
Please read carefully all the information in this leaflet before taking the medicine, as it contains
important information for the patient.
Keep this leaflet so that you can read it again if necessary.

• If you have any questions, please consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If you experience any adverse reactions, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of 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

Pirfenidone Accord contains the active substance pirfenidone and is used to treat
idiopathic pulmonary fibrosis (IPF) in adults.
Idiopathic pulmonary fibrosis is a disease in which lung tissue becomes inflamed and, over time,
develops scarring, making deep breathing difficult. This impairs proper lung function. Pirfenidone Accord helps reduce lung scarring and inflammation and makes breathing easier.

2. Important information before using Pirfenidone Accord

When not to use Pirfenidone Accord

• if the patient is allergic to pirfenidone or any of the other ingredients of this medicine (listed in section 6)
• if the patient previously experienced angioedema during treatment with pirfenidone, including symptoms such as swelling of the face, lips and (or) tongue, which may have been associated with breathing difficulties or wheezing
• if the patient is taking a medicine called fluvoxamine (used to treat depression and obsessive-compulsive disorder)
• in case of severe or end-stage liver failure
• in case of severe or end-stage renal failure requiring dialysis therapy.

Do not use Pirfenidone Accord if any of the above conditions apply.
If in doubt, consult a doctor or pharmacist.
Warnings and precautions
Talk to your doctor or pharmacist before starting Pirfenidone Accord if:

• Increased sensitivity to sunlight (photosensitivity reaction) may develop during treatment with Pirfenidone Accord. Exposure to sunlight (including sunlamps and tanning beds) should be avoided while taking Pirfenidone Accord. Sunscreen should be used and arms, legs and head covered to minimize exposure to sunlight (see section 4: Possible side effects).
• Do not use other medicines such as tetracycline antibiotics (e.g. doxycycline) that may increase sensitivity to sunlight.
• Inform your doctor if you have kidney function disorders.
• Inform your doctor if you have mild or moderate liver function impairment.
• Smoking should be discontinued before starting and during treatment with Pirfenidone Accord. Smoking may reduce the effectiveness of Pirfenidone Accord.
• Pirfenidone Accord may cause dizziness and fatigue. Exercise caution when performing activities requiring alertness and coordination.
• Pirfenidone Accord may lead to weight loss. Your doctor will monitor your body 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. Treatment with Pirfenidone Accord must be discontinued and immediate medical advice sought if any symptoms associated with these serious skin reactions occur, as described in section 4.

Pirfenidone Accord may cause severe liver function disorders, some of which have been fatal. Blood tests should be performed before starting Pirfenidone Accord and repeated monthly for the first 6 months of treatment, then every 3 months throughout the treatment period to monitor liver function. It is important to have regular blood tests throughout the entire duration of treatment with Pirfenidone Accord.
Children and adolescents
Pirfenidone Accord should not be given to children and adolescents under 18 years of age.
Pirfenidone Accord and other medicines
Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take.
This is particularly important when 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 (a medicine used to treat certain heart conditions)
• propafenone (a medicine used to treat certain heart conditions)
• fluvoxamine (a medicine used to treat depression and obsessive-compulsive disorder).

Medicines that may reduce the effectiveness of Pirfenidone Accord:

• omeprazole (a medicine 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 better to avoid using Pirfenidone Accord if the patient is pregnant, planning pregnancy, or suspects she may be pregnant, as the potential risk to the unborn child is unknown.
If the patient is breastfeeding or planning to breastfeed, she should consult her doctor or pharmacist before using Pirfenidone Accord. It is not known whether Pirfenidone Accord passes into human milk; therefore, the doctor will discuss with the patient the risks and benefits of using this medicine during breastfeeding if she decides to breastfeed during treatment.
Driving and using machines
Do not drive or operate any machinery if dizziness or fatigue occurs after taking Pirfenidone Accord.
Pirfenidone Accord contains lactose
Pirfenidone Accord contains lactose. If the patient has been previously diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.
Pirfenidone Accord contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. the medicine is considered "sodium-free".

3. How to take Pirfenidone Accord

Treatment with Pirfenidone Accord should be initiated and supervised by a specialist physician experienced in the diagnosis and treatment of idiopathic pulmonary fibrosis.
This medicine should always be taken exactly as prescribed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
The medicine is usually taken in increasing doses as follows:

• for the first 7 days, take 267 mg (1 yellow tablet) three times a day with food (total daily dose 801 mg);
• from day 8 to day 14, take 534 mg (2 yellow tablets) three times a day with food (total daily dose 1602 mg);
• from day 15 onwards (maintenance treatment), take 801 mg (3 yellow tablets or 1 brown tablet) three times a day with food (total daily dose 2403 mg).

The recommended maintenance dose of Pirfenidone Accord is 801 mg (3 yellow tablets or 1 brown tablet) three times a day with food, for a total daily dose of 2403 mg.
Tablets should be swallowed 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 the dose if you experience adverse reactions such as gastrointestinal problems, any skin reactions to sunlight or solarium exposure, or significant changes in liver enzyme activity.
Taking more Pirfenidone Accord than prescribed
If you take more tablets than prescribed, contact your doctor, pharmacist, or the emergency department of your nearest hospital immediately and bring the medicine with you.
Missing a dose of Pirfenidone Accord
If you miss a dose, take it as soon as possible. Do not take a double dose to make up for a missed dose. Maintain at least a 3-hour interval between doses. Do not take more tablets in one day than the recommended daily dose.
Stopping Pirfenidone Accord
In certain situations, your treating physician may advise stopping Pirfenidone Accord. If treatment with Pirfenidone Accord is interrupted for more than 14 consecutive days for any reason, your doctor will restart treatment at a dose of 267 mg three times a day, gradually increasing the dose to 801 mg three times a day.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
Treatment with Pirfenidone Accord must be stopped immediately and medical help should be sought if the patient notices any of the following subjective or objective symptoms:

• Swelling of the face, lips and (or) tongue, itching, urticaria, difficulty breathing or wheezing, or feeling faint. These are symptoms of a severe allergic reaction called angioedema or anaphylaxis.
• Yellowing of the eyes or skin, or dark urine, which may be accompanied by itching of the skin, pain in the upper right part of the abdomen, loss of appetite, bleeding or bruising more easily than usual, or feeling tired. These may be symptoms of liver dysfunction and may indicate liver damage, which is an uncommon adverse reaction of Pirfenidone Accord.
• Reddish, non-elevated or round spots on the trunk, often with centrally located blisters, peeling skin, and ulcers in the mouth, throat, nose, genital organs, 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 fever, and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).

Other adverse reactions that may occur
Talk to your doctor if the patient experiences any adverse reactions.
Very common adverse reactions (may occur in more than 1 in 10 people):

• throat or respiratory tract infections leading to lung infections and (or) sinusitis
• nausea
• stomach problems such as regurgitation of stomach contents into the esophagus, vomiting, constipation
• diarrhea
• indigestion or upset stomach
• weight loss
• decreased appetite
• sleep disturbances
• fatigue
• dizziness
• headache
• shortness of breath
• cough
• joint pain

Common adverse reactions (may occur in up to 1 in 10 people):

• urinary bladder infections
• feeling sleepy
• taste disturbances
• hot flushes
• stomach problems such as bloating, abdominal pain, discomfort in the abdominal cavity, heartburn, feeling of constipation, and gas
• blood tests may indicate increased liver enzyme activity
• skin reactions after sun exposure or use of tanning beds
• skin problems such as itchy skin, redness of the skin, dry skin, skin rash
• muscle pain
• feeling weak or lacking energy
• chest pain
• sunburn

Uncommon adverse reactions (may occur in 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 tests may show a reduced number of white blood cells.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of this medicine.

5. How to store Pirfenidone Accord

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister pack following: EXP.
The expiry date refers to the last day of the stated month.
No special storage conditions are required for this medicine.
Medicines must 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 other information

What Pirfenidone Accord contains
267 mg tablet
The active substance is pirfenidone. Each coated tablet contains 267 mg of pirfenidone.
The other ingredients are: monohydrate lactose, copovidone, sodium croscarmellose, magnesium stearate.
The tablet coating contains: polyvinyl alcohol, titanium dioxide (E 171), macrogol 4000, talc,
yellow iron oxide (E 172).

801 mg tablet
The active substance is pirfenidone. Each coated tablet contains 801 mg of pirfenidone.
The other ingredients are: monohydrate lactose, copovidone, sodium croscarmellose, magnesium stearate.
The tablet coating contains: polyvinyl alcohol, titanium dioxide (E 171), macrogol 4000, talc,
black iron oxide (E 172), red iron oxide (E 172).

What Pirfenidone Accord looks like and contents of the pack
267 mg tablet
Pirfenidone Accord 267 mg, coated tablets are yellow, oval-shaped, measuring 13 mm x 7 mm,
biconvex with bevelled edges, embossed with the code "D1" on one side and smooth on the other.

801 mg tablet
Pirfenidone Accord 801 mg, coated tablets are brown, oval-shaped, measuring 21 mm x 10 mm,
biconvex with bevelled edges, embossed with the code "D2" on one side and smooth on the other.

Pirfenidone Accord, coated tablets are packaged in blisters made of
PVC/PE/PCTFE/Aluminium and in single-dose perforated blisters made of
PVC/PE/PCTFE/Aluminium.

267 mg tablets
Pack sizes: 21, 42, 84, 168 coated tablets or 21 x 1, 42 x 1, 84 x 1, 168 x 1 coated tablet.

Starting pack for a 2-week treatment:
Each outer pack contains a total of 63 coated tablets (1 pack containing
1 blister with 21 coated tablets and 1 pack containing 2 blisters with 21 coated tablets each,
or 1 pack containing 21 x 1 coated tablet and 1 pack containing 42 x 1 coated tablet
in single-dose perforated blisters).

Maintenance treatment pack:
Each outer pack contains a total of 252 coated tablets (3 packs, each containing
4 blisters with 21 coated tablets, or 3 packs, each containing 84 x 1 coated tablet
in single-dose perforated blisters).

801 mg tablets
Pack sizes: 84 coated tablets or 84 x 1 coated tablet.

Maintenance treatment pack:
Each outer pack contains a total of 252 coated tablets (3 packs, each containing
4 blisters with 21 coated tablets, or 3 packs, each containing 84 x 1 coated tablet
in single-dose perforated blisters).

Not all pack sizes may be marketed.

Marketing Authorisation Holder
Accord Healthcare Polska Sp. z o.o.
Taśmowa 7 Street
02-677 Warsaw
Tel: +48 22 577 28 00

Manufacturer/Importer
Accord Healthcare Polska Sp. z o.o.
Lutomierska 50
95-200 Pabianice
Laboratori Fundació Dau,
C/ C, 12-14 Pol. Ind. Zona Franca,
Barcelona 08040,
Spain
Accord Healthcare B.V.
Winthontlaan 200
Utrecht, 3526 KV,
The Netherlands
Pharmadox Healthcare Limited,
KW20A Kordin Industrial Park, Paola, PLA 3000
Malta
Accord Healthcare Single Member S.A.
64th Km National Road Athens,
32009 Lamia, Schimatari
Greece

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