Pirfenidon Stada

Package Leaflet: Information for the User

Pirfenidon Stada, 267 mg, Film-Coated Tablets

Pirfenidon Stada, 534 mg, Film-Coated Tablets

Pirfenidon Stada, 801 mg, Film-Coated Tablets

Pirfenidone

Read the package leaflet carefully before taking the medicine, as it contains important information for you.

• Keep this package leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• -This medicine has been prescribed specifically for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this package leaflet, please inform your doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Package Leaflet

• 1. What is Pirfenidon Stada and what is it used for
• 2. Important information 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 is Pirfenidon Stada and what is it used for

Pirfenidon Stada contains the active substance pirfenidone and is used to treat mild to moderate idiopathic pulmonary fibrosis in adults.

2. Important information before taking Pirfenidon Stada

When not to take Pirfenidon Stada

If any of these conditions apply to you, do not take Pirfenidon Stada. If you are unsure, consult your doctor or pharmacist.

Warnings and precautions

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

• While taking Pirfenidon Stada, you may develop increased sensitivity to sunlight (photosensitivity reaction). Avoid exposure to sunlight (including sunlamps) while taking Pirfenidon Stada. Use sunscreens and cover your arms, legs, and head to minimize sun exposure (see section 4: Possible side effects).
• Do not take other medicines that may increase your sensitivity to sunlight, such as certain antibiotics (e.g., doxycycline).
• Tell your doctor if you have kidney problems.
• Tell your doctor if you have mild or moderate liver problems.
• Stop smoking before starting and during treatment with Pirfenidon Stada, as smoking may reduce the effectiveness of Pirfenidon Stada.
• Pirfenidon Stada may cause dizziness and fatigue. Be cautious when performing tasks that require attention and coordination.
• Pirfenidon Stada may cause weight loss. Your doctor will monitor your weight while taking this medicine.
• In rare cases, Pirfenidon Stada has been associated with Stevens-Johnson syndrome and toxic epidermal necrolysis. Stop taking Pirfenidon Stada and seek medical attention immediately if you experience any symptoms of these severe skin reactions, as described in section 4.

Pirfenidon Stada may cause severe liver damage, and some cases have been fatal. Before starting treatment with Pirfenidon Stada, you will need to have blood tests to check your liver function, which will be repeated monthly for the first 6 months of treatment and then every 3 months for the duration of treatment. It is essential to have regular blood tests while taking Pirfenidon Stada.

Children and adolescents

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

Pirfenidon Stada and other medicines

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take.

• 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)

These medicines may increase the risk of side effects when taken with Pirfenidon Stada.

• Omeprazole (a medicine used to treat conditions such as heartburn and gastroesophageal reflux disease)
• Rifampicin (a type of antibiotic)

Taking Pirfenidon Stada with food and drink

Do not drink grapefruit juice while taking Pirfenidon Stada, as it may interfere with the proper functioning of the medicine.

Pregnancy and breastfeeding

As a precaution, it is recommended to avoid taking Pirfenidon Stada if you are pregnant, planning to become pregnant, or think you may be pregnant, as the potential risk to the unborn child is unknown.

Driving and using machines

Do not drive or operate machinery if you experience dizziness or fatigue after taking Pirfenidon Stada.

Pirfenidon Stada contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet, which is considered to be essentially sodium-free.

Pirfenidon Stada contains lactose

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

3. How to take Pirfenidon Stada

Treatment with Pirfenidon Stada should be started and supervised by a specialist doctor experienced in the diagnosis and treatment of idiopathic pulmonary fibrosis.

This medicine should always be taken exactly as directed by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist.

The usual dose is:

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

The recommended maintenance dose is 801 mg (3 yellow tablets or 1 brown tablet) 3 times a day with food, which is a total of 2403 mg/day.

Method of administration

Pirfenidon Stada should be taken orally. Swallow the tablets whole with water, during or after meals, to reduce the risk of side effects such as nausea and dizziness. If symptoms persist, consult your doctor.

Overdose

If you take more tablets than prescribed, contact your doctor, pharmacist, or the nearest hospital emergency department immediately and take the medicine with you.

Missed dose

If you miss a dose, take it as soon as possible. Do not take a double dose to make up for the 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 treatment

In certain situations, your doctor may advise you to stop taking Pirfenidon Stada. If you stop taking Pirfenidon Stada for more than 14 consecutive days, your doctor will restart treatment with a dose of 267 mg (1 yellow tablet) 3 times a day, gradually increasing the dose to 801 mg (3 yellow tablets or 1 brown tablet) 3 times a day.

4. Possible side effects

Like all medicines, Pirfenidon Stada can cause side effects, although not everybody gets them.

Stop taking Pirfenidon Stada and inform your doctor immediately

Other side effects that may occur

Tell your doctor if you experience any side effects.

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

• infections of the throat or respiratory tract leading to the lungs and/or sinusitis
• nausea
• stomach problems, such as gastroesophageal reflux disease, vomiting, constipation
• diarrhea
• indigestion or upset stomach
• weight loss
• decreased appetite
• sleep disturbances
• fatigue
• dizziness
• headache
• shortness of breath
• cough
• joint pain

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

• urinary tract infections
• drowsiness
• taste disturbances
• hot flashes
• stomach problems, such as bloating, abdominal pain, and discomfort in the abdominal area, heartburn, and gas
• blood tests may indicate increased liver enzyme activity
• skin reactions after sun exposure or sunlamps
• skin problems, such as itching, redness, dryness, rash
• muscle pain
• feeling weak or lacking energy
• chest pain
• sunburn

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

• low sodium levels in the blood. This may cause headache, dizziness, disorientation, weakness, muscle cramps, or nausea and vomiting
• blood tests may indicate a decrease in white blood cell count

Reporting side effects

If you experience any side effects, including those not listed in this package leaflet, please inform your doctor, pharmacist, or nurse.

5. How to store Pirfenidon Stada

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

Do not use this medicine after the expiry date stated on the label, blister, and carton after EXP. The expiry date refers to the last day of the month.

No special precautions for storage are necessary.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. This 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.

The other ingredients are:

• tablet core: lactose monohydrate, croscarmellose sodium, hypromellose, colloidal silicon dioxide, magnesium stearate
• coating: polyvinyl alcohol, partially hydrolyzed, 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.

The other ingredients are:

• tablet core: lactose monohydrate, croscarmellose sodium, hypromellose, colloidal silicon dioxide, magnesium stearate
• coating: polyvinyl alcohol, partially hydrolyzed, 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.

The other ingredients are:

• tablet core: lactose monohydrate, croscarmellose sodium, hypromellose, colloidal silicon dioxide, magnesium stearate
• coating: polyvinyl alcohol, partially hydrolyzed, 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 a smooth surface on the other.

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 a smooth surface on the other.

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 a smooth surface on the other.

Pirfenidon Stada, 267 mg, film-coated tablets

Tablets are available in blisters of aluminum foil and white non-transparent PVC/PVDC or PVC/PVTFE film, containing 63 or 252 tablets in a carton.

Pirfenidon Stada, 534 mg, film-coated tablets

Tablets are available in blisters of aluminum foil and white non-transparent PVC/PVDC or PVC/PVTFE film, containing 21 or 84 tablets in a carton.

Pirfenidon Stada, 801 mg, film-coated tablets

Tablets are available in blisters of aluminum foil and white non-transparent PVC/PVDC or PVC/PVTFE film, containing 84 tablets in a carton.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

STADA Arzneimittel AG

Stadastrasse 2-18

61118 Bad Vilbel

Germany

For further information, please contact the marketing authorization holder:

Stada Pharm Sp. z o.o.

ul. Krakowiaków 44

02-255 Warszawa

Phone: +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

Netherlands

This medicine is authorized 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:

France:

Pirfenidone STADA 267 mg kalvopäällysteiset tabletit

Pirfenidone STADA 801 mg kalvopäällysteiset tabletit

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

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

Date of last revision of the package leaflet: