Pirfenidon Zentiva

Leaflet attached to the packaging: information for the user

Pirfenidon Zentiva, 267 mg, coated tablets

Pirfenidon Zentiva, 801 mg, coated tablets

Pirfenidone

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

You should keep this leaflet, so that you can read it again if you need to.

• In case of any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the 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 packaging 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 swollen and scarred over time, leading to difficulty breathing deeply. This makes it difficult for the lungs to work properly. Pirfenidon Zentiva helps to reduce scarring and swelling of the lungs and helps to breathe better.

2. Important information before taking Pirfenidon Zentiva

When not to take Pirfenidon Zentiva

Warnings and precautions

Before starting treatment with Pirfenidon Zentiva, you should discuss it with your doctor or pharmacist

• During treatment with Pirfenidon Zentiva, increased sensitivity to sunlight may develop (photosensitivity reaction). During treatment with Pirfenidon Zentiva, you should avoid exposure to sunlight (including sunbeds). You should use sunscreens and cover your 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, you should consult a doctor.

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

You should tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you 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

While taking the medicine, you should not drink grapefruit juice. Grapefruit may interfere with the proper functioning of Pirfenidon Zentiva.

Pregnancy and breastfeeding

As a precaution, it is recommended to avoid taking Pirfenidon Zentiva if you are pregnant, plan to become pregnant, or suspect you may be pregnant, as the potential risk to the unborn child is unknown. If you are breastfeeding or plan to breastfeed, you should consult a 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

You should 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, you should consult a 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 according to the doctor's or pharmacist's instructions. In case of doubt, consult a 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 per day)
• from day 8 to 14, take a dose of 534 mg (2 yellow tablets) 3 times a day with food (total 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 (total 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 with food, which is a total of 2,403 mg per day.

Tablets should be swallowed whole, with a glass of 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 The doctor may reduce the dose of the medicine if the patient experiences 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

In case of taking a higher dose than recommended, you should immediately consult a doctor, pharmacist, or the emergency department of the nearest hospital and take the medicine with you.

Missing a dose of Pirfenidon Zentiva

In case of missing a dose, you should take it as soon as possible. Do not take a double dose to make up for the missed dose. You should maintain at least a 3-hour interval between doses. During the day, do not take more tablets than the recommended daily dose.

Stopping treatment with Pirfenidon Zentiva

In certain situations, the treating doctor may advise stopping treatment with Pirfenidon Zentiva. If, for any reason, treatment with Pirfenidon Zentiva is interrupted for more than 14 consecutive days, the 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. In case of any further doubts about taking this medicine, consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. You should stop taking Pirfenidon Zentiva and seek medical attention immediately if you notice any of the following symptoms:

• Facial swelling, lip and/or tongue swelling, 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 circular 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 body temperature, and swollen lymph nodes (DRESS or drug hypersensitivity).

Other side effects that may occur

You should 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 gastroesophageal reflux disease, 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

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 the leaflet, you should 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. Tel.: +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. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Pirfenidon Zentiva

The medicine should be stored out of 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. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Pirfenidon Zentiva contains

267 mg tablet
The active substance of the medicine is pirfenidone. Each coated tablet contains 267 mg of pirfenidone. The other ingredients are: lactose, croscarmellose sodium, colloidal silicon dioxide, magnesium stearate. Tablet coating: polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc, yellow iron oxide (E172).
801 mg tablet
The active substance of the medicine is pirfenidone. Each coated tablet contains 801 mg of pirfenidone. The other ingredients are: lactose, croscarmellose sodium, colloidal silicon dioxide, 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 pack

267 mg tablet
Pirfenidon Zentiva, 267 mg, coated tablets are yellow, oval, biconvex, with the inscription "267". The blister pack contains 63 coated tablets (pack of 63 coated tablets or collective pack containing one pack of 21 coated tablets and one pack of 42 coated tablets) or 252 coated tablets (pack of 252 coated tablets or collective pack containing three packs of 84 coated tablets), in a cardboard box. The blisters in the packaging 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, coated tablets are brown, oval, biconvex, with the inscription "801".

(sunrise; morning dose)
(sun; daytime dose) and
(moon, evening dose)
The blister pack contains 84 coated tablets or 252 coated tablets (pack of 252 coated tablets or collective pack containing three packs of 84 coated tablets), in a cardboard box. The blisters in the packaging 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, please contact the local representative of the marketing authorization holder:

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