Pirfenidone stada

Patient Information Leaflet

Pirfenidon Stada, 267 mg, film-coated tablets
Pirfenidon Stada, 534 mg, film-coated tablets
Pirfenidon Stada, 801 mg, film-coated tablets
Pirfenidonum
Please read this leaflet carefully before taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Leaflet Contents

1. What Pirfenidon Stada is and what it is used for
2. What you need to know before taking Pirfenidon Stada
3. How to take Pirfenidon Stada
4. Possible side effects
5. How to store Pirfenidon Stada
6. Contents of the pack and other information

1. What Pirfenidon Stada is and what it is used for

Pirfenidon Stada contains the active substance pirfenidone and is used to treat mild to moderate idiopathic pulmonary fibrosis in adults.
Idiopathic pulmonary fibrosis is a disease in which lung tissue becomes inflamed and, over time, forms scar tissue, making deep breathing difficult. This impairs proper lung function. Pirfenidon Stada helps reduce lung scarring and inflammation and helps improve breathing.

2. Important information before using Pirfenidon Stada

When not to use Pirfenidon Stada

• 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 while taking 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 cases of severe or end-stage liver failure
• in cases of severe or end-stage renal failure requiring dialysis.

Do not use Pirfenidon Stada if any of the above conditions apply. If in doubt, consult a doctor or pharmacist.

Warnings and precautions

Before starting treatment with Pirfenidon Stada, discuss this with your doctor or pharmacist.

• Increased sensitivity to sunlight (photosensitivity reaction) may develop during treatment with Pirfenidon Stada. Avoid exposure to sunlight (including solariums) while taking Pirfenidon Stada. Use sunscreen and cover arms, legs and head to minimize sun exposure (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 disorders.
• Stop smoking before starting and during treatment with Pirfenidon Stada. Smoking may reduce the effectiveness of Pirfenidon Stada.
• Pirfenidon Stada may cause dizziness and fatigue. Exercise caution when performing activities requiring alertness and coordination.
• Pirfenidon Stada may lead to weight loss. Your doctor will monitor your body weight during treatment.
• Cases of Stevens-Johnson syndrome and toxic epidermal necrolysis have been reported during treatment with Pirfenidon Stada. Discontinue Pirfenidon Stada immediately and contact your doctor if any symptoms associated with these serious skin reactions occur, as described in section 4.

Pirfenidon Stada may cause severe liver function disorders, and some cases have resulted in death. Blood tests should be performed before starting treatment with Pirfenidon Stada and repeated monthly for the first 6 months of treatment, then every 3 months throughout the treatment period to monitor liver function. Regular blood tests are essential throughout the entire duration of treatment with Pirfenidon Stada.

Children and adolescents

Pirfenidon Stada must not be given to children and adolescents under 18 years of age.

Pirfenidon Stada and other medicines

Inform 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 Pirfenidon Stada.

Medicines that may increase side effects of Pirfenidon Stada:

• 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 effect of Pirfenidon Stada:

• omeprazole (a medicine used to treat conditions such as indigestion, gastroesophageal reflux disease)
• rifampicin (a type of antibiotic)

Taking Pirfenidon Stada with food and drink

Do not drink grapefruit juice while taking this medicine. Grapefruit may interfere with the proper action of Pirfenidon Stada.

Pregnancy and breastfeeding

As a precautionary measure, it is advisable to avoid using Pirfenidon Stada if you are pregnant, planning pregnancy, or suspect you may be pregnant, as the potential risk to the unborn child is unknown.

If you are breastfeeding or planning to breastfeed, consult your doctor or pharmacist before using Pirfenidon Stada. It is not known whether Pirfenidon Stada passes into human milk. Your doctor will discuss the risks and benefits of using this medicine during breastfeeding if you decide to breastfeed during treatment.

Driving and operating machinery

Do not drive or operate any machinery if dizziness or fatigue occurs after taking Pirfenidon Stada.

Pirfenidon Stada contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e. the medicine is considered "sodium-free".

Pirfenidon Stada contains lactose

If you have been previously diagnosed with intolerance to certain sugars, consult your doctor before taking this medicine.

3. How to take Pirfenidon Stada

Treatment with Pirfenidon Stada 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 according to the recommendations of 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 801 mg/day);
• from day 8 to day 14, take 534 mg (2 yellow tablets or 1 orange tablet) three times a day with food (total 1,602 mg/day);
• from day 15 onwards (maintenance treatment), take 801 mg (3 yellow tablets or 1 brown tablet) three times a day with food (total 2,403 mg/day).

The recommended maintenance daily dose of Pirfenidon Stada is 801 mg (3 yellow tablets or
1 brown tablet) three times a day with food, giving a total of 2,403 mg/day.
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.
Method of administration
Pirfenidon Stada should be taken orally. Tablets should be swallowed whole with water, during or after a meal, to reduce the risk of adverse reactions such as nausea and dizziness. If symptoms persist, consult your doctor.
Taking more than the recommended dose of Pirfenidon Stada
If you take more tablets than recommended, contact your doctor, pharmacist, or the emergency department of your nearest hospital immediately and bring the medicine with you.
Missing a dose of Pirfenidon Stada
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 a day than the recommended daily dose.
Stopping Pirfenidon Stada
In certain situations, your doctor may advise stopping treatment with Pirfenidon Stada.
If treatment with Pirfenidon Stada is interrupted for more than 14 consecutive days for any reason, your doctor will restart treatment with a dose of 267 mg (1 yellow tablet) three times a day, gradually increasing the dose to 801 mg (3 yellow tablets or 1 brown tablet) 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.
You must immediately stop taking Pirfenidon Stada and contact your doctor

• If you experience swelling of the face, lips and (or) tongue, itching, hives, difficulty breathing, wheezing or feeling faint. These are symptoms of a severe allergic reaction called angioedema or anaphylaxis.
• If the patient develops yellowing of the eyes or skin or dark urine, which may be accompanied by itchy skin, pain in the upper right side of the abdomen, loss of appetite, bleeding or bruising more easily than normal, or feeling tired. These may be symptoms of liver dysfunction and may indicate liver damage, which is an uncommon adverse reaction of Pirfenidon Stada.
• If red, flat or raised spots appear on the trunk, often with centrally located blisters, skin peeling, and ulcers in the mouth, throat, nose, genital organs or eyes. These severe skin rashes may be preceded by fever and flu-like symptoms. These symptoms may indicate Stevens-Johnson syndrome or toxic epidermal necrolysis.

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 oesophagus, vomiting, constipation
• diarrhoea
• 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 tract infections (bladder infections)
• feeling sleepy
• taste disturbances
• hot flushes
• stomach problems such as bloating, abdominal pain, discomfort in the abdominal area, heartburn and gas
• blood tests may show increased liver enzyme activity
• skin reactions after sun exposure or use of sunbeds
• skin problems such as itchy skin, redness of the skin, dry skin, skin rash
• muscle pain
• feeling weak or lack of 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, nausea or vomiting.
• blood tests may show a reduced number of white blood cells

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in
this leaflet, tell your doctor, pharmacist or nurse. Adverse reactions
can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
PL-02-222 Warsaw
Tel.: + 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 provide more information on the safety of this medicine.

5. How to store Pirfenidon Stada

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the label of the bottle, blister pack, and
cardboard box following: EXP. The expiry date refers to the last day of the stated month.
No special storage instructions 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. These measures will help protect the environment.

6. Contents of the pack and other information

What Pirfenidon Stada contains
Pirfenidon Stada, 267 mg, film-coated tablets
The active substance is pirfenidone. Each tablet contains 267 mg of pirfenidone.
Other ingredients are:

• Tablet core: lactose monohydrate, sodium croscarmellose, hypromellose, colloidal anhydrous silica, magnesium stearate.
• Coating: partially hydrolysed polyvinyl alcohol, titanium dioxide (E 171), macrogol, talc, yellow iron oxide (E 172).

Pirfenidon Stada, 534 mg, film-coated tablets
The active substance is pirfenidone. Each tablet contains 534 mg of pirfenidone.
Other ingredients are:

• Tablet core: lactose monohydrate, sodium croscarmellose, hypromellose, colloidal anhydrous silica, magnesium stearate.
• Coating: partially hydrolysed polyvinyl alcohol, titanium dioxide (E 171), macrogol, talc, yellow iron oxide (E 172), red iron oxide (E 172).

Pirfenidon Stada, 801 mg, film-coated tablets
The active substance is pirfenidone. Each tablet contains 801 mg of pirfenidone.
Other ingredients are:

• Tablet core: lactose monohydrate, sodium croscarmellose, hypromellose, colloidal anhydrous silica, magnesium stearate.
• Coating: partially hydrolysed polyvinyl alcohol, titanium dioxide (E 171), macrogol, talc, black iron oxide (E 172), red iron oxide (E 172).

What Pirfenidon Stada looks like and contents of the pack
Pirfenidon Stada, 267 mg, film-coated tablets, are yellow, oval, biconvex tablets, approximately 13.3 mm x 6.5 mm in size, with the imprint "L814" on one side and smooth on the other side.
Pirfenidon Stada, 534 mg, film-coated tablets, are orange, oval, biconvex tablets, approximately 16.0 mm x 8.0 mm in size, with the imprint "L813" on one side and smooth on the other side.
Pirfenidon Stada, 801 mg, film-coated tablets, are brown, oval, biconvex tablets, approximately 20.0 mm x 9.2 mm in size, with the imprint "L812" on one side and smooth on the other side.
Pirfenidon Stada, 267 mg, film-coated tablets
Film-coated tablets in blisters made of aluminium foil and white opaque PVC/PVDC or PVC/PVTFE foil, containing 63 or 252 tablets in a cardboard box.
Pirfenidon Stada, 534 mg, film-coated tablets
Film-coated tablets in blisters made of aluminium foil and white opaque PVC/PVDC or PVC/PVTFE foil, containing 21 or 84 tablets in a cardboard box.
Pirfenidon Stada, 801 mg, film-coated tablets
Film-coated tablets in blisters made of aluminium foil and white opaque PVC/PVDC or PVC/PVTFE foil, containing 84 tablets in a cardboard box.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
STADA Arzneimittel AG
Stadastrasse 2-18
61118 Bad Vilbel
Germany
For further information, contact the representative of the Marketing Authorisation Holder:
Stada Pharm Sp. z o.o.
ul. Krakowiaków 44
02-255 Warsaw
Tel. +48 22 737 79 20

Manufacturer/Importer:
STADA Arzneimittel AG
Stadastrasse 2-18,
61118 Bad Vilbel,
Germany
Clonmel Healthcare Limited
3 Waterford Road, E91 D768 Clonmel,
Co. Tipperary,
Ireland
Centrafarm Services B.V.
Van de Reijtstraat 31 E,
4814NE Breda,
The Netherlands

This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Belgium: Pirfenidon EG 267 mg filmomhulde tabletten
Pirfenidon EG 534 mg filmomhulde tabletten
Pirfenidon EG 801 mg filmomhulde tabletten
Denmark: Pirfenidone STADA
Finland: Pirfenidone STADA 267 mg kalvopäällysteiset tabletit
Pirfenidone STADA 801 mg kalvopäällysteiset tabletit
France: PIRFENIDONE EG 267 mg, comprimé pelliculé
PIRFENIDONE EG 801 mg, comprimé pelliculé
Germany: Pirfenidon STADA 267 mg Filmtabletten
Pirfenidon STADA 534 mg Filmtabletten
Pirfenidon STADA 801 mg Filmtabletten
Ireland: Pirfenidone Clonmel 267 mg film-coated tablets
Pirfenidone Clonmel 801 mg film-coated tablets
Luxembourg: Pirfenidon EG 267 mg comprimés pelliculés
Pirfenidon EG 534 mg comprimés pelliculés
Pirfenidon EG 801 mg comprimés pelliculés
The Netherlands: Pirfenidon CF 267 mg, filmomhulde tabletten
Pirfenidon CF 801 mg, filmomhulde tabletten
Norway: Pirfenidone STADA
Poland: Pirfenidon STADA
Spain: Pirfenidona STADA 267 mg comprimidos recubiertos con película EFG
Pirfenidona STADA 534 mg comprimidos recubiertos con película EFG
Pirfenidona STADA 801 mg comprimidos recubiertos con película EFG
Sweden: Pirfenidone STADA 267 mg filmdragerade tabletter
Pirfenidone STADA 801 mg filmdragerade tabletter