Pirfenidone zentiva

Package leaflet: Information for the user

Pirfenidon Zentiva, 267 mg, film-coated tablets
Pirfenidon Zentiva, 801 mg, film-coated tablets
Pirfenidonum
Read the entire leaflet carefully before using this medicine, as it contains important information for you.
Keep this leaflet as you may need to read it again.

• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm others, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist immediately. See section 4.

Table of contents of the leaflet

1. What Pirfenidon Zentiva is and what it is 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 pack and other information

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

Pirfenidon Zentiva contains the active substance pirfenidone and is used in the treatment of
idiopathic pulmonary fibrosis in adults.
Idiopathic pulmonary fibrosis is a disease in which lung tissue becomes inflamed and, over time,
develops scarring (fibrosis), making deep breathing difficult. This impairs proper lung function.
Pirfenidon Zentiva helps reduce lung scarring and inflammation and helps improve breathing.

2. Important information before using Pirfenidone

Pirfenidone Zentiva When not to use Pirfenidone Zentiva

• 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 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 renal failure requiring dialysis therapy.

Do not use Pirfenidone Zentiva if any of the above conditions apply.
If in doubt, consult a doctor or pharmacist.
Warnings and precautions
Before starting Pirfenidone Zentiva, discuss this with your doctor or pharmacist.

• During treatment with Pirfenidone Zentiva, increased sensitivity to sunlight (photosensitivity reaction) may develop. While taking Pirfenidone Zentiva, avoid exposure to sunlight (including sunlamps and tanning beds). Use sunscreen and cover arms, legs and head to minimize exposure to sunlight (see section 4: Possible side effects).

• Do not take other medicines such as tetracycline antibiotics (e.g. doxycycline) that may cause increased sensitivity to sunlight.

• Inform your doctor if you have kidney function disorders.

• Inform your doctor if you have mild or moderate liver function disorders.

• Before starting and during treatment with Pirfenidone Zentiva, stop smoking. Smoking may reduce the effectiveness of Pirfenidone Zentiva.

• Pirfenidone Zentiva may cause dizziness and fatigue. Exercise caution when performing activities requiring alertness and coordination.

• Pirfenidone Zentiva may cause weight loss. Your doctor will monitor your body weight during treatment.

• Cases of Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS syndrome) have been reported with pirfenidone treatment. Discontinue Pirfenidone Zentiva and seek immediate medical advice if any symptoms related to these serious skin reactions occur, as described in section 4. Pirfenidone Zentiva may cause severe liver function disorders, and some cases have been fatal. Before starting Pirfenidone Zentiva, blood tests should be performed and repeated monthly for the first 6 months of treatment, then every 3 months throughout treatment to monitor liver function. It is important to carry out regular blood tests throughout the entire duration of treatment with Pirfenidone Zentiva. Children and adolescents Pirfenidone Zentiva must not be given to children and adolescents under 18 years of age. Pirfenidone Zentiva with other medicines Inform your doctor or pharmacist about any 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 Pirfenidone Zentiva. Medicines that may increase the adverse effects of Pirfenidone 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 Pirfenidone Zentiva:

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

• rifampicin (a type of antibiotic). Taking Pirfenidone Zentiva with food and drink While taking this medicine, do not drink grapefruit juice. Grapefruit may interfere with the proper action of Pirfenidone Zentiva. Pregnancy and breastfeeding As a precautionary measure, it is better to avoid using Pirfenidone Zentiva if the patient is pregnant, planning pregnancy, or suspects she may be pregnant, as the potential risk to the unborn child is unknown.
  If the patient is breastfeeding or planning to breastfeed, she should consult a doctor or pharmacist before using Pirfenidone Zentiva. It is not known whether Pirfenidone Zentiva passes into human milk; therefore, the doctor will discuss the risks and benefits of using this medicine during breastfeeding if the patient decides to breastfeed during treatment.
  Driving and operating machinery
  Do not drive or operate any machinery if dizziness or fatigue occurs after taking Pirfenidone Zentiva.
  Pirfenidone Zentiva contains sodium
  Pirfenidone Zentiva contains less than 1 mmol (23 mg) of sodium per capsule, meaning the medicine is considered "sodium-free".
  Pirfenidone Zentiva contains lactose
  If you have an intolerance to certain sugars, consult your doctor before taking this medicine.

3. How to take Pirfenidon Zentiva

Treatment with Pirfenidon Zentiva 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 exactly as directed by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist.
The medicine is usually administered in gradually increasing doses as follows:

• for the first 7 days, take a dose of 267 mg (1 yellow tablet) 3 times daily with food (total daily dose 801 mg)
• from day 8 to day 14, take a dose of 534 mg (2 yellow tablets) 3 times daily with food (total daily dose 1,602 mg)
• from day 15 onwards (maintenance treatment), take a dose of 801 mg (3 yellow tablets or 1 brown tablet) 3 times daily with food (total daily dose 2,403 mg). The recommended maintenance dose of Pirfenidon Zentiva is 801 mg (3 yellow tablets or 1 brown tablet) 3 times daily with food, for a total daily dose of 2,403 mg.

Tablets should be swallowed whole with water, during or after meals, to reduce the risk of adverse effects such as nausea and dizziness. If symptoms persist, consult your doctor.
Dose reduction due to adverse reactions
Your doctor may reduce the dose of the medicine if you experience adverse reactions such as gastrointestinal problems, any skin reactions to sunlight or solarium exposure, or significant changes in liver enzyme activity.
Taking more Pirfenidon Zentiva than prescribed
If you take more tablets than prescribed, contact your doctor, pharmacist, or the nearest hospital emergency department immediately and bring 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 a missed dose. Maintain at least a 3-hour interval between doses. Do not take more tablets in one day than the recommended daily dose.
Stopping treatment with Pirfenidon Zentiva
In certain situations, your treating physician may advise stopping treatment with Pirfenidon Zentiva. If treatment with Pirfenidon Zentiva is interrupted for more than 14 consecutive days for any reason, your doctor will restart treatment at a dose of 267 mg 3 times daily, gradually increasing the dose to 801 mg 3 times daily.
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 will experience them.
Treatment with Pirfenidon Zentiva should be stopped immediately and medical help sought if the patient notices any of the following objective or subjective symptoms:

• Swelling of the face, lips and (or) tongue, itching, urticaria, difficulty breathing or wheezing, or feeling faint. 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 itchy skin, pain in the upper right part of the abdomen, loss of appetite, bleeding or bruising more easily than usual, or feeling tired. These may be symptoms of liver dysfunction and may indicate liver damage, which is an uncommon adverse reaction of pirfenidone.
• Reddish, non-elevated or circular skin lesions on the trunk, often with centrally located blisters, skin peeling, and ulceration of the mouth, throat, nose, genital organs 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 enlarged lymph nodes (DRESS syndrome or drug hypersensitivity).

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 infection 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 bladder infections
• feeling sleepy
• taste disturbances
• hot flushes
• stomach problems such as bloating, abdominal pain and discomfort, heartburn, feeling of constipation and gas
• blood tests may indicate increased liver enzyme activity
• skin reactions after sun exposure or use of a solarium
• skin problems such as itchy skin, redness or dryness of the 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 blood sodium levels. This may cause headache, dizziness, confusion, weakness, muscle cramps, or nausea and vomiting.
• Blood tests may show a reduced white blood cell count.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. 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, 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 authorisation holder or its representative in Poland.
Reporting adverse reactions helps to provide more information on the safety of this medicine.

5. How to store Pirfenidon Zentiva

Keep this 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 stated month.
No special storage conditions 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. Such measures will help protect the environment.

6. Contents of the pack and other information

What Pirfenidon Zentiva contains
267 mg tablet
The active substance is pirfenidone. Each coated tablet contains 267 mg of pirfenidone.
The other ingredients are: lactose, sodium croscarmellose, 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 coated tablet contains 801 mg of pirfenidone.
The other ingredients are: lactose, sodium croscarmellose, 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 pack
267 mg tablet
Pirfenidon Zentiva 267 mg, coated tablets are yellow, oval-shaped, biconvex, with the engraved mark "267".
The blister pack contains 63 coated tablets (pack of 63 coated tablets or a multipack containing one pack of 21 coated tablets and one pack of 42 coated tablets) or 252 coated tablets (pack of 252 coated tablets or a multipack containing three packs of 84 coated tablets), in a cardboard carton.
The blisters in the pack 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:

(sunrise; (sun; dose (moon, evening dose)
morning dose) during the day) and
Mon Tue Wed Thu Fri Sat Sun

801 mg tablet
Pirfenidon Zentiva 801 mg, coated tablets are brown, oval-shaped, biconvex, with the engraved mark "801".
The blister pack contains 84 coated tablets or 252 coated tablets (pack of 252 coated tablets or a multipack containing three packs of 84 coated tablets), in a cardboard carton.
The blisters in the pack 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:

(sunrise; (sun; dose (moon, evening dose)
morning dose) during the day) and
Mon Tue Wed Thu Fri Sat Sun

Not all pack sizes may be marketed.

Marketing Authorisation 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 further information, please contact the local representative of the Marketing Authorisation Holder:
Zentiva Polska Sp. z.o.o.,
ul. Bonifraterska 17
00-203 Warsaw, Poland
Tel.: +48 22 375 92 00