Pirfenidone zentiva
Poland
Table of Contents
Package leaflet: Information for the user
Pirfenidon Zentiva, 267 mg, coated tablets
Pirfenidon Zentiva, 801 mg, coated tablets
Pirfenidonum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for the patient.
Keep this leaflet, as you may need to read it again.
- If you have any questions, please consult your doctor or pharmacist.
- This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
- If any side effects occur in the patient, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.
Table of contents of the leaflet
- What Pirfenidon Zentiva is and what it is used for
- Important information before taking Pirfenidon Zentiva
- How to take Pirfenidon Zentiva
- Possible side effects
- How to store Pirfenidon Zentiva
- 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 swollen and, over time,
develops scarring (fibrosis), leading to difficulty in deep breathing. This impairs proper lung function. Pirfenidon Zentiva helps reduce lung scarring and inflammation and helps improve breathing.
2. Information before using Pirfenidon Zentiva
When not to use 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 previously experienced angioedema (a type of swelling) affecting the face, lips and (or) tongue during treatment with pirfenidone, 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 cases of severe or end-stage liver failure
- in cases of severe or end-stage kidney failure requiring dialysis therapy.
Do not use Pirfenidon Zentiva if any of the above conditions apply.
If in doubt, consult a doctor or pharmacist.
Warnings and precautions
Before starting treatment with Pirfenidon Zentiva, discuss this with your doctor or pharmacist.
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Increased sensitivity to sunlight (photosensitivity reaction) may develop during treatment with Pirfenidon Zentiva. During treatment, avoid exposure to sunlight (including use of sunbeds). Sunscreen and protective clothing covering arms, legs and head should be used to minimize exposure to sunlight (see section 4: Possible side effects).
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Do not take other medicines such as tetracycline antibiotics (e.g. doxycycline) that may increase sensitivity to sunlight.
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Inform your doctor if you have kidney function disorders.
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Inform your doctor if you have mild or moderate liver function disorders.
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Stop smoking before starting and during treatment with Pirfenidon Zentiva. Smoking may reduce the effectiveness of Pirfenidon Zentiva.
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Pirfenidon Zentiva may cause dizziness and fatigue. Exercise caution when performing activities requiring alertness and coordination.
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Pirfenidon Zentiva may cause weight loss. Your doctor will monitor your body weight during treatment.
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Cases of Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS syndrome) have been reported with pirfenidone treatment. Treatment with Pirfenidon Zentiva should be discontinued and immediate medical advice sought if any symptoms of these serious skin reactions occur, as described in section 4. Pirfenidon Zentiva may cause severe liver function disorders, and some cases have been fatal. Blood tests to monitor liver function should be performed before starting Pirfenidon Zentiva and repeated monthly for the first 6 months of treatment, then every 3 months throughout treatment. It is important to have regular blood tests throughout the entire duration of treatment with Pirfenidon Zentiva.
Children and adolescents
Pirfenidon Zentiva must not be given to children and adolescents under 18 years of age.
Pirfenidon Zentiva with other medicines
Inform your doctor or pharmacist about all medicines currently used, recently taken, or planned for use. This is particularly important when taking the following medicines, as they may alter the effect of Pirfenidon Zentiva.
Medicines that may increase 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 during treatment. Grapefruit may interfere with the proper action of Pirfenidon Zentiva.
Pregnancy and breastfeeding
As a precautionary measure, it is advisable to avoid using Pirfenidon Zentiva if the patient is pregnant, planning pregnancy, or suspects she might be pregnant, as the potential risk to the unborn child is unknown.
If the patient is breastfeeding or planning to breastfeed, she should consult her doctor or pharmacist before using Pirfenidon Zentiva. It is not known whether Pirfenidon Zentiva passes into human milk; therefore, the doctor will discuss with the patient the risks and benefits of using this medicine during breastfeeding if she decides to breastfeed while on treatment.
Driving and operating machinery
Do not drive or operate any machinery if dizziness or fatigue occurs after taking Pirfenidon Zentiva.
Pirfenidon Zentiva contains sodium
Pirfenidon Zentiva contains less than 1 mmol (23 mg) of sodium per capsule, meaning the medicine is considered "sodium-free".
Pirfenidon Zentiva contains lactose
If you have an intolerance to certain sugars, consult your doctor before taking this medicine.
3. How to use 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 used exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The medicine is usually administered in gradually increasing doses as follows:
- for the first 7 days, take 267 mg (1 yellow tablet) three times a day with food (total daily dose 801 mg)
- from day 8 to day 14, take 534 mg (2 yellow tablets) three times a day with food (total daily dose 1,602 mg)
- from day 15 onwards (maintenance treatment), take 801 mg (3 yellow tablets or 1 brown tablet) three times a day with food (total daily dose 2,403 mg). The recommended maintenance daily dose of Pirfenidon Zentiva is 801 mg (3 yellow tablets or 1 brown tablet) three times daily with food, for a total daily dose of 2,403 mg.
Tablets should be swallowed whole with water, during or after a meal, 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 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 emergency department of your nearest hospital 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 Pirfenidon Zentiva
In certain circumstances, your treating physician may advise discontinuing 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 three times daily, gradually increasing the dose to 801 mg three 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 should be 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 itching of the 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 roundish spots on the trunk, often with centrally located blisters, peeling of the skin, and ulcers in 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 body temperature, and swollen lymph nodes (DRESS syndrome or drug hypersensitivity).
Other adverse reactions that may occur
Talk to your doctor if you experience any adverse reactions.
Very common adverse reactions (may occur in more than 1 in 10 people):
- throat or respiratory tract infections leading to lung infections 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 tract infections
- feeling sleepy
- taste disturbances
- hot flushes
- stomach problems, such as bloating, abdominal pain, discomfort in the abdominal area, heartburn, feeling of constipation, and flatulence
- blood tests may indicate increased liver enzyme activity
- skin reactions after exposure to sunlight or solarium
- skin problems, such as itching, 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 number of white blood cells.
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 Reactions of Medicinal Products at 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 authorization holder or its representative in Poland.
Reporting adverse reactions helps provide more information on the safety of the medicine.
5. How to store Pirfenidon Zentiva
Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the blister pack and carton after EXP. The expiry date refers to the last day of the specified 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 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 "267" engraved on one side.
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 box.
The blisters are marked with the following symbols and abbreviations of the days of the week to remind you to take the dose three times daily:
(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 "801" engraved on one side.
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 box.
The blisters are marked with the following symbols and abbreviations of the days of the week to remind you to take the dose three times daily:
(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, 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