Pirfenidon Stada

Leaflet accompanying the packaging: information for the user

Pirfenidon Stada, 267 mg, coated tablets

Pirfenidon Stada, 534 mg, coated tablets

Pirfenidon Stada, 801 mg, coated tablets

Pirfenidone

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

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor, pharmacist, or nurse.
• -This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.

Table of contents of the 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 packaging 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.
Idiopathic pulmonary fibrosis is a disease in which the lung tissue becomes inflamed and scarred over time, leading to difficulty breathing deeply. This makes it harder for the lungs to work properly. Pirfenidon Stada helps reduce scarring and inflammation of the lungs and helps improve breathing.

2. Important information before taking Pirfenidon Stada

When not to take Pirfenidon Stada

If any of these conditions occur, do not take Pirfenidon Stada. If in doubt, consult your doctor or pharmacist.

Warnings and precautions

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

• While taking Pirfenidon Stada, increased sensitivity to sunlight may develop (photosensitivity reaction). Avoid exposure to sunlight (including sunlamps) while taking Pirfenidon Stada. Use sunscreens and cover your arms, legs, and head to limit sun exposure (see section 4: Possible side effects).
• Do not take other medicines that may increase sensitivity to sunlight, such as tetracycline 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. Smoking may reduce the effectiveness of Pirfenidon Stada.
• Pirfenidon Stada may cause dizziness and fatigue. Be careful when performing tasks that require attention and coordination.
• Pirfenidon Stada may cause weight loss. Your doctor will monitor your weight while taking this medicine.
• 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, described in section 4.

Pirfenidon Stada may cause severe liver damage, and some cases have been fatal. Before starting treatment with Pirfenidon Stada, blood tests will be performed, which will be repeated every month for the first 6 months of treatment, and then every 3 months for the duration of treatment, to monitor liver function. It is essential to perform regular blood tests throughout the treatment with 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, have recently taken, or plan to take.
This is especially important for the following medicines, as they may affect the action of Pirfenidon Stada.
Medicines that may increase the 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 effectiveness of 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 this medicine. Grapefruit may interfere with the proper functioning of Pirfenidon Stada.

Pregnancy and breastfeeding

As a precaution, it is recommended to avoid taking Pirfenidon Stada if you are pregnant, plan to become pregnant, or think you may be pregnant, as the potential risk to the unborn child is unknown.
If you are breastfeeding or plan to breastfeed, consult your doctor or pharmacist before taking Pirfenidon Stada. It is not known whether Pirfenidon Stada passes into human milk, so your doctor will discuss the risks and benefits of taking this medicine while breastfeeding.

Driving and using machines

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

Pirfenidon Stada contains sodium

The medicine contains less than 1 mmol of sodium (23 mg) per tablet, which means it is essentially 'sodium-free'.

Pirfenidon Stada contains lactose

If you have been diagnosed with an intolerance to some 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 doctor with experience in the diagnosis and treatment of idiopathic pulmonary fibrosis.
Always take this medicine exactly as your doctor or pharmacist has told you. If you are unsure, consult your doctor or pharmacist.
The medicine is usually taken 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 (total 801 mg/day);
• from day 8 to 14, take a dose of 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 a dose of 801 mg (3 yellow tablets or 1 brown tablet) 3 times a day with food (total 2403 mg/day).

The recommended daily maintenance dose of Pirfenidon Stada is 801 mg (3 yellow tablets or 1 brown tablet) 3 times a day, taken with food, which is a total of 2403 mg/day.
Reducing the dose due to side effects
Your doctor may reduce the dose of Pirfenidon Stada if you experience side effects such as stomach problems, skin reactions to sunlight or sunlamps, or significant changes in liver enzyme activity.

Method of administration

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

Taking a higher dose of Pirfenidon Stada than recommended

If you have taken more tablets than recommended, contact your doctor, pharmacist, or the emergency department of your nearest hospital immediately and take 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 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 with Pirfenidon Stada

In certain situations, your doctor may advise you to stop taking Pirfenidon Stada.
If treatment with Pirfenidon Stada is interrupted 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.
If you have any further doubts about taking this medicine, consult your doctor or pharmacist.

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

• If you experience swelling of the face, lips, and/or tongue, itching, hives, difficulty breathing, or wheezing, or a feeling of fainting. These are symptoms of a severe allergic reaction called angioedema or anaphylaxis.
• If you experience yellowing of the eyes or skin, or dark urine, which may be accompanied by itching of the skin, pain in the upper right abdomen, loss of appetite, bleeding, or easier bruising than usual, or a feeling of tiredness. These may be symptoms of abnormal liver function and may indicate liver damage, which is an uncommon side effect of Pirfenidon Stada.
• If you experience red, non-raised, or round spots on the torso, often with centrally located blisters, peeling skin, ulcers of the mouth, throat, nose, genitals, and 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 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 reflux, vomiting, constipation
• diarrhea
• indigestion or stomach upset
• 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 flushes
• 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 to sunlight or sunlamps
• skin problems, such as itching, redness, dryness, skin 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 show a decrease in white blood cell count

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
PL-02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help gather more information on the safety of this medicine.

5. How to store Pirfenidon Stada

Keep the 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.
There are no special storage instructions for this medicine.
Medicines should 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 packaging and other information

What Pirfenidon Stada contains

Pirfenidon Stada, 267 mg, 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: polyvinyl alcohol, partially hydrolyzed, titanium dioxide (E 171), macrogol, talc, yellow iron oxide (E 172)

Pirfenidon Stada, 534 mg, 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: polyvinyl alcohol, partially hydrolyzed, titanium dioxide (E 171), macrogol, talc, yellow iron oxide (E 172), red iron oxide (E 172)

Pirfenidon Stada, 801 mg, 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: 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, 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, 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, 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, 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, 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, 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 more detailed information, please contact the representative of the marketing authorization holder:
Stada Pharm Sp. z o.o.
ul. Krakowiaków 44
02-255 Warsaw
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 film-coated tablets
Pirfenidon EG 534 mg film-coated tablets
Pirfenidon EG 801 mg film-coated tablets
Denmark:
Pirfenidone STADA
Finland:
France:
Pirfenidone STADA 267 mg film-coated tablets
Pirfenidone STADA 801 mg film-coated tablets
PIRFENIDONE EG 267 mg, film-coated tablets
PIRFENIDONE EG 801 mg, film-coated tablets
Germany:
Ireland:
Luxembourg:
Netherlands:
Norway:
Poland:
Spain:
Sweden:
Pirfenidon STADA 267 mg film-coated tablets
Pirfenidon STADA 534 mg film-coated tablets
Pirfenidon STADA 801 mg film-coated tablets
Pirfenidone Clonmel 267 mg film-coated tablets
Pirfenidone Clonmel 801 mg film-coated tablets
Pirfenidon EG 267 mg film-coated tablets
Pirfenidon EG 534 mg film-coated tablets
Pirfenidon EG 801 mg film-coated tablets
Pirfenidon CF 267 mg, film-coated tablets
Pirfenidon CF 801 mg, film-coated tablets
Pirfenidone STADA
Pirfenidon STADA
Pirfenidona STADA 267 mg film-coated tablets EFG
Pirfenidona STADA 534 mg film-coated tablets EFG
Pirfenidona STADA 801 mg film-coated tablets EFG
Pirfenidone STADA 267 mg film-coated tablets
Pirfenidone STADA 801 mg film-coated tablets

Date of last revision of the leaflet: