PIRFENIDONE CIPLA

Package leaflet: Information for the user

Pirfenidon Cipla, 267 mg, film-coated tablets
Pirfenidon Cipla, 801 mg, film-coated tablets
Pirfenidonum
Please read all of this leaflet carefully before taking this medicine because it contains
important information for you.

• Keep this leaflet as you may need to read it again.
• If you have any further questions, please ask 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 you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of the leaflet

1. What Pirfenidon Cipla is and what it is used for
2. What you need to know before taking Pirfenidon Cipla
3. How to take Pirfenidon Cipla
4. Possible side effects
5. How to store Pirfenidon Cipla
6. Contents of the pack and other information

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

Pirfenidon Cipla 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 the proper function of the lungs. Pirfenidon Cipla helps reduce scarring and inflammation in the lungs and helps improve breathing.

2. Important information before using Pirfenidon Cipla

When not to use Pirfenidon Cipla

• 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 with symptoms such as swelling of 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 case of severe or end-stage liver failure
• in case of severe or end-stage renal failure requiring dialysis therapy.

Do not use Pirfenidon Cipla if any of the above conditions apply.
If in doubt, consult a doctor or pharmacist.
Warnings and precautions
Talk to your doctor or pharmacist before starting treatment with Pirfenidon Cipla.

• Increased sensitivity to sunlight (photosensitivity reaction) may develop during treatment with Pirfenidon Cipla. Exposure to sunlight (including use of sunlamps or tanning beds) should be avoided during treatment. Sunscreen and protective clothing covering arms, legs and head should be used to minimize exposure to sunlight (see section 4: Possible side effects).
• Do not use other medicines such as tetracycline antibiotics (e.g. doxycycline) that may increase sensitivity to sunlight.
• Inform your doctor if you have kidney function disorders.
• Inform your doctor if you have mild or moderate liver function impairment.
• Smoking should be discontinued before and during treatment with Pirfenidon Cipla. Smoking may reduce the effectiveness of Pirfenidon Cipla.
• Pirfenidon Cipla may cause dizziness and fatigue. Exercise caution when performing activities requiring alertness and coordination.
• Pirfenidon Cipla may lead to 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 during treatment with Pirfenidon Cipla. Treatment should be discontinued immediately and medical advice sought if any symptoms associated with these serious skin reactions occur (as described in section 4).

Pirfenidon Cipla may cause severe liver function disorders, and some cases have resulted in death. Blood tests should be performed before starting treatment and repeated monthly for the first 6 months of treatment, then every 3 months throughout the duration of treatment to monitor liver function. It is essential to undergo regular blood tests for the entire duration of treatment with Pirfenidon Cipla.
Children and adolescents
Pirfenidon Cipla must not be given to children and adolescents under 18 years of age.
Pirfenidon Cipla and other medicines
Tell your doctor or pharmacist about all 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 effects of Pirfenidon Cipla.
Medicines that may increase adverse effects of Pirfenidon Cipla:

• 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 Cipla:

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

Taking Pirfenidon Cipla with food and drink
Do not drink grapefruit juice during treatment. Grapefruit may interfere with the proper action of Pirfenidon Cipla.
Pregnancy and breastfeeding
As a precautionary measure, it is better to avoid using Pirfenidon Cipla if you are pregnant, planning pregnancy, or suspect you may be pregnant, as the potential risk to the unborn child is unknown.
If you are breastfeeding or planning to breastfeed, consult your doctor or pharmacist before using Pirfenidon Cipla. It is not known whether Pirfenidon Cipla passes into human milk. Your doctor will discuss the risks and benefits of using this medicine during breastfeeding if you decide to breastfeed while being treated.
Driving and operating machinery
Do not drive or operate any machinery if dizziness or fatigue occurs after taking Pirfenidon Cipla.
Pirfenidon Cipla contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per tablet; i.e., this medicine is considered "sodium-free".

3. How to use Pirfenidon Cipla

Treatment with Pirfenidon Cipla 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 recommended by your doctor or pharmacist. If in doubt, 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 801 mg/day);
• from day 8 to day 14, take 534 mg (2 yellow tablets) three times a day with food (total 1602 mg/day); the 534 mg dose is achieved by administering 2 yellow tablets (each 267 mg);
• from day 15 onwards (maintenance treatment), take 801 mg (3 yellow tablets or 1 pink tablet) three times a day with food (total 2403 mg/day).

The recommended daily maintenance dose of Pirfenidon Cipla is 801 mg (3 yellow tablets or 1 pink tablet) taken three times a day with food, for a total daily dose of 2403 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 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 Cipla than recommended
If you take more tablets than recommended, contact your doctor, pharmacist, or the emergency department of your nearest hospital immediately and bring the medicine with you.
Missed dose of Pirfenidon Cipla
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 Cipla
In certain situations, your treating physician may advise stopping treatment with Pirfenidon Cipla. If for any reason treatment must be interrupted for longer than 14 consecutive days, your doctor will restart therapy at a dose of 267 mg three times a day, gradually increasing the dose to 801 mg three times a day.
If you have any further doubts regarding 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 everybody gets them.
Treatment with Pirfenidon Cipla must be stopped immediately and medical help sought
if the patient experiences 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, possibly 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 Pirfenidon Cipla.
• Red, non-elevated or round 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 fever, and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).

Other possible adverse reactions
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 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 disorders
• 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 and discomfort, heartburn, feeling of constipation, and flatulence
• blood tests may show increased liver enzyme activity
• skin reactions after sun exposure or use of a solarium
• skin problems, such as itching, redness, dryness of the skin, skin rash
• muscle pain
• feeling of weakness 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 decreased white blood cell count.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to:
Department for Monitoring of Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
PL-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.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Pirfenidon Cipla

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label of the bottle and the carton
after: EXP. The expiry date refers to the last day of the stated month.
No special storage conditions apply 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. These measures will help protect the environment.

6. Contents of the pack and other information

What Pirfenidon Cipla contains

• The active substance is pirfenidone.
• 267 mg tablet: Each coated tablet contains 267 mg of pirfenidone.
• 801 mg tablet: Each coated tablet contains 801 mg of pirfenidone.
• The other ingredients are:
• Tablet core: colloidal anhydrous silica, hypromellose, mannitol, sodium carboxymethyl starch - type A, and sodium stearyl fumarate.
• Tablet coating: macrogol, polyvinyl alcohol (partially hydrolysed), talc, titanium dioxide (E171). The 267 mg coated tablet also contains yellow iron oxide (E172). The 801 mg coated tablet also contains red iron oxide (E172).

What Pirfenidon Cipla looks like and contents of the pack
267 mg tablet
Pirfenidon Cipla, 267 mg, coated tablets are coated, light yellow to yellow in colour, biconvex, oval-shaped with bevelled edges, smooth on both sides. The tablet measures approximately 14 mm x 7 mm.
Starter pack for 2 weeks: a carton containing 63 coated tablets (comprising 1 pack of 21 coated tablets and 1 pack of 42 coated tablets).
84 coated tablets.
Maintenance pack: a carton containing 252 coated tablets (3 packs, each containing 84 coated tablets).
801 mg tablet
Pirfenidon Cipla, 801 mg, coated tablets are coated, light pink to pink in colour, biconvex, capsule-shaped, smooth on both sides. The tablet measures approximately 20 mm x 9 mm.
84 coated tablets.
Maintenance pack: a carton containing 252 coated tablets (3 packs, each containing 84 coated tablets).
The blisters are marked with the following symbols and abbreviations for the days of the week, reminding you to take the dose three times daily:

(sunrise, morning dose) (sun, daytime dose) and (moon, evening dose).
Mon Tue Wed Thu Fri Sat Sun
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Cipla Europe NV
De Keyserlei 58-60,
Box-19, 2018
Antwerp
Belgium
tel: +32(0)32910101/ +32(0) 32910199
Importer
Cipla Europe NV
De Keyserlei 58-60, Box-19, 2018 Antwerp,
Belgium
This medicinal product is authorised for sale in the EEA Member States under the following names: