Pirfenidon Zentiva

Package Leaflet: Information for the User

Pirfenidon Zentiva, 267 mg, Film-Coated Tablets

Pirfenidon Zentiva, 801 mg, Film-Coated Tablets

Pirfenidone

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

Keep this package leaflet, you may need to read it again.

• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed to you by a doctor and is intended for your use only. Do not give it to others. The medicine may harm them, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of Contents of the Package Leaflet

• 1. What is Pirfenidon Zentiva and what is it used for
• 2. Important information before taking Pirfenidon Zentiva
• 3. How to take Pirfenidon Zentiva
• 4. Possible side effects
• 5. How to store Pirfenidon Zentiva
• 6. Contents of the package and other information

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

Pirfenidon Zentiva contains the active substance pirfenidone and is used to treat 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 difficult for the lungs to function properly. Pirfenidon Zentiva helps reduce scarring and inflammation of the lungs and helps improve breathing.

2. Important information before taking Pirfenidon Zentiva

When not to take Pirfenidon Zentiva

• if the patient is allergic to pirfenidone or any of the other ingredients of this medicine (listed in section 6)
• if the patient has previously experienced angioedema while taking pirfenidone, including symptoms such as swelling of the face, lips, and/or tongue, and which may have been associated with difficulty breathing 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 kidney failure requiring dialysis. If any of these conditions are present, do not take Pirfenidon Zentiva. In case of doubt, consult a doctor or pharmacist.

Warnings and precautions

Before starting treatment with Pirfenidon Zentiva, discuss it with a doctor or pharmacist

• During treatment with Pirfenidon Zentiva, increased sensitivity to sunlight may develop (photosensitivity reaction). During treatment with Pirfenidon Zentiva, avoid exposure to sunlight (including sunbeds). Use sunscreens and cover arms, legs, and head to minimize exposure to sunlight (see section 4: Possible side effects).

and drink plenty of water to reduce the risk of side effects such as nausea (vomiting) and dizziness. If symptoms persist, consult a doctor.

• Do not take other medicines, such as tetracycline antibiotics (e.g., doxycycline), which may increase sensitivity to sunlight.
• Tell your doctor if you have kidney problems.
• Tell your doctor if you have mild or moderate liver problems.
• Before starting treatment with Pirfenidon Zentiva and during treatment, stop smoking. Smoking may reduce the effect of Pirfenidon Zentiva.
• Pirfenidon Zentiva may cause dizziness and fatigue. Be careful when performing tasks that require attention and coordination.
• Pirfenidon Zentiva may cause weight loss. The doctor will monitor your weight during treatment with this medicine.
• In connection with treatment with Pirfenidon Zentiva, cases of Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS) have been reported. Stop taking Pirfenidon Zentiva and seek medical attention immediately if any symptoms associated with these severe skin reactions occur, as described in section 4. Pirfenidon Zentiva may cause severe liver damage, and some cases have been fatal. Before starting treatment with Pirfenidon Zentiva, blood tests will be performed, which will be repeated once a month for the first 6 months of treatment, and then every 3 months during the entire treatment period to monitor liver function. It is essential to perform regular blood tests throughout the treatment with Pirfenidon Zentiva.

Children and adolescents

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

Pirfenidon Zentiva 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 when taking the following medicines, as they may affect the action of Pirfenidon Zentiva.
Medicines that may increase the side effects of Pirfenidon Zentiva:

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

Taking Pirfenidon Zentiva with food and drink

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

Pregnancy and breastfeeding

As a precautionary measure, it is better to avoid taking Pirfenidon Zentiva 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 Zentiva. It is not known whether Pirfenidon Zentiva passes into breast milk, so your doctor will discuss the risks and benefits of taking this medicine while breastfeeding, if you decide to breastfeed during treatment.

Driving and using machines

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

Pirfenidon Zentiva contains sodium

Pirfenidon Zentiva contains less than 1 mmol (23 mg) of sodium per capsule, which means the medicine is considered "sodium-free".

Pirfenidon Zentiva contains lactose

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

3. How to take Pirfenidon Zentiva

Treatment with Pirfenidon Zentiva should be started and supervised by a specialist doctor with experience in diagnosing and treating idiopathic pulmonary fibrosis.
This medicine should always be taken exactly as prescribed by your doctor or pharmacist. 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 (a total of 801 mg per day)
• from day 8 to 14, take a dose of 534 mg (2 yellow tablets) 3 times a day with food (a total of 1,602 mg per 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 (a total of 2,403 mg per day). The recommended daily maintenance dose of Pirfenidon Zentiva is 801 mg (3 yellow tablets or 1 brown tablet) 3 times a day, taken with food, which is a total of 2,403 mg per day.

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 a doctor.

Reducing the dose due to side effects

Your doctor may reduce the dose of Pirfenidon Zentiva if you experience side effects such as stomach problems, any skin reactions to sunlight or sunbeds, or significant changes in liver enzyme activity.

Taking a higher dose of Pirfenidon Zentiva 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 Zentiva

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 Zentiva

In certain situations, your doctor may advise you to stop taking Pirfenidon Zentiva. If, for any reason, you stop taking Pirfenidon Zentiva for more than 14 consecutive days, your doctor will restart treatment with a dose of 267 mg 3 times a day, gradually increasing the dose to 801 mg 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 Zentiva can cause side effects, although not everybody gets them. Stop taking Pirfenidon Zentiva and seek medical attention immediately if you experience any of the following symptoms:

• 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.
• 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 fatigue. These may be symptoms of abnormal liver function and may indicate liver damage, which is an uncommon side effect of pirfenidone.
• Red, unraised, 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 (Stevens-Johnson syndrome or toxic epidermal necrolysis)
• Widespread rash, high fever, and swollen lymph nodes (DRESS or drug hypersensitivity).

Other side effects that may occur

Talk to 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, constipation, and gas

and drink plenty of water to reduce the risk of side effects such as nausea (vomiting) and dizziness. If symptoms persist, consult a doctor.

• blood tests may indicate increased liver enzyme activity
• skin reactions after exposure to sunlight or sunbeds
• skin problems, such as itching, redness, or dryness of the skin, skin rash
• muscle pain
• feeling of weakness or lack of 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 side effects not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring 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
Side effects can also be reported to the marketing authorization holder or its representative in Poland.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Pirfenidon Zentiva

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and carton after EXP. The expiry date refers to the last day of the month.
There are no special precautions for storing the medicine.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the package and other information

What Pirfenidon Zentiva contains

267 mg tablet
The active substance is pirfenidone. Each film-coated tablet contains 267 mg of pirfenidone.
The other ingredients are: lactose, croscarmellose sodium, colloidal anhydrous silica, magnesium stearate.
Tablet coating: polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc, yellow iron oxide (E172).
801 mg tablet
The active substance is pirfenidone. Each film-coated tablet contains 801 mg of pirfenidone.
The other ingredients are: lactose, croscarmellose sodium, colloidal anhydrous silica, magnesium stearate.
Tablet coating: polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc, red iron oxide (E172) and black iron oxide (E172).

What Pirfenidon Zentiva looks like and contents of the package

267 mg tablet
Pirfenidon Zentiva, 267 mg, film-coated tablets are yellow, oval, biconvex, with the inscription "267".
The package with blisters contains 63 film-coated tablets (package of 63 film-coated tablets or a collective package containing one package of 21 film-coated tablets and one package of 42 film-coated tablets) or 252 film-coated tablets (package of 252 film-coated tablets or a collective package containing three packages of 84 film-coated tablets), in a cardboard box.
The blisters in the package are marked with the following symbols and abbreviations of the days of the week to remind you to take the dose three times a day:
Mon. Tue. Wed. Thu. Fri. Sat. Sun.
801 mg tablet
Pirfenidon Zentiva, 801 mg, film-coated tablets are brown, oval, biconvex, with the inscription "801".

(sunrise; morning dose)
(sun; daytime dose) and
(moon, evening dose)
The package with blisters contains 84 film-coated tablets or 252 film-coated tablets (package of 252 film-coated tablets or a collective package containing three packages of 84 film-coated tablets), in a cardboard box.
The blisters in the package are marked with the following symbols and abbreviations of the days of the week to remind you to take the dose three times a day:
Mon. Tue. Wed. Thu. Fri. Sat. Sun.

(sunrise; morning dose)
(sun; daytime dose) and
(moon, evening dose)
Not all pack sizes may be marketed.

Marketing Authorization Holder:

Zentiva, k.s.,
U kabelovny 130,
Dolní Měcholupy,
102 37 Prague 10,
Czech Republic

Manufacturer

Rontis Hellas Medical and Pharmaceutical Products S.A.
P.O. Box 3012 Larisa Industrial Area,
Larisa, 41004, Greece
PharOS MT Ltd.
HF62X, Hal Far Industrial Estate,
Birzebbugia BBG3000, Malta

For more information, contact the local representative of the Marketing Authorization Holder:

Zentiva Polska Sp. z.o.o.,
ul. Bonifraterska 17
00-203 Warsaw, Poland
phone: +48 22 375 92 00
Date of last revision of the leaflet:March 2024