Pirfenidon Cipla

Package Leaflet: Information for the User

Pirfenidon Cipla, 267 mg, Film-Coated Tablets

Pirfenidon Cipla, 801 mg, Film-Coated Tablets

Pirfenidone

Read All of This Leaflet Carefully Before You Start Taking This Medicine Because It Contains Important Information for You.

• You should keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Pack and Other Information

• 1. What is Pirfenidon Cipla and What is it Used For
• 2. Before You Take 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 is Pirfenidon Cipla and What is it Used For

Pirfenidon Cipla contains the active substance pirfenidone and is used to treat idiopathic pulmonary fibrosis in adults.
Idiopathic pulmonary fibrosis is a condition in which the tissue in the lungs becomes swollen and scarred over time, leading to difficulty breathing deeply. This makes it difficult for the lungs to work properly. Pirfenidon Cipla helps reduce scarring and swelling in the lungs and helps improve breathing.

2. Before You Take Pirfenidon Cipla

When Not to Take Pirfenidon Cipla

• if you are allergic to pirfenidone or any of the other ingredients of this medicine (listed in section 6)
• if you have previously experienced angioedema while taking pirfenidone, with symptoms such as swelling of the face, lips, and/or tongue, and which may have been associated with difficulty breathing or wheezing
• if you are taking a medicine called fluvoxamine (used to treat depression and obsessive-compulsive disorder)
• in cases of severe or end-stage liver disease
• in cases of severe or end-stage kidney disease requiring dialysis therapy.

If any of the above conditions occur, do not take Pirfenidon Cipla.
In case of doubt, consult your doctor or pharmacist.

Warnings and Precautions

Before starting treatment with Pirfenidon Cipla, discuss it with your doctor or pharmacist.

• During treatment with Pirfenidon Cipla, increased sensitivity to sunlight (photosensitivity reaction) may develop. While taking this medicine, avoid exposure to sunlight (including sunlamps). Use sunscreens and cover your 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), 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 Cipla and during treatment, stop smoking. Smoking may reduce the effect of Pirfenidon Cipla.
• Pirfenidon Cipla may cause dizziness and fatigue. Be careful when performing tasks that require attention and coordination.
• Pirfenidon Cipla may cause weight loss. Your doctor will monitor your weight while taking this medicine.
• There have been reports of Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug rash with eosinophilia and systemic symptoms (DRESS) in association with Pirfenidon Cipla treatment. Stop taking this medicine and seek medical attention immediately if you experience any symptoms related to these severe skin reactions, as described in section 4.

Pirfenidon Cipla may cause severe liver problems, and some cases have been fatal. Before starting treatment with Pirfenidon Cipla, blood tests will be performed, 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 perform regular blood tests throughout the treatment with Pirfenidon Cipla.

Children and Adolescents

Pirfenidon Cipla should 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 taking, have recently taken, or might take.
This is especially important if you are taking any of the following medicines, as they may affect the way Pirfenidon Cipla works:

• 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 heartburn and gastroesophageal reflux disease)
• rifampicin (a type of antibiotic).

Taking Pirfenidon Cipla with Food and Drink

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

Pregnancy and Breast-Feeding

As a precaution, it is recommended to avoid taking Pirfenidon Cipla 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 breast-feeding or plan to breast-feed, consult your doctor or pharmacist before taking Pirfenidon Cipla. It is not known whether Pirfenidon Cipla passes into human breast milk; therefore, your doctor will discuss the risks and benefits of taking this medicine while breast-feeding, if you decide to breast-feed during treatment.

Driving and Using Machines

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

Pirfenidon Cipla Contains Sodium

This medicine contains less than 1 mmol sodium (23 mg) per tablet, which is essentially 'sodium-free'.

3. How to Take Pirfenidon Cipla

Treatment with Pirfenidon Cipla should be initiated and supervised by a specialist doctor with experience in the diagnosis and treatment of idiopathic pulmonary fibrosis.
Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask 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 (total 801 mg/day);
• from day 8 to 14, take a dose of 534 mg (2 yellow tablets) 3 times a day with food (total 1602 mg/day); The 534 mg dose is achieved by taking 2 yellow tablets (each 267 mg).
• from day 15 (maintenance treatment), take a dose of 801 mg (3 yellow tablets or 1 pink tablet), 3 times a day with food (total 2403 mg/day).

The recommended maintenance dose of Pirfenidon Cipla is 801 mg (3 yellow tablets or 1 pink tablet) 3 times a day with food, which is a total of 2403 mg/day.
Swallow the tablets whole with water, during or after meals to reduce the risk of side effects such as nausea (vomiting) and dizziness. If symptoms persist, consult your doctor.

Reducing the Dose Due to Side Effects

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

Taking More Than the Recommended Dose of Pirfenidon Cipla

If you have taken more tablets than recommended, contact your doctor, pharmacist, or the nearest hospital emergency department immediately and take the medicine with you.

Missing a Dose of Pirfenidon Cipla

If you miss a dose, take it as soon as you remember. 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 a day than the recommended daily dose.

Stopping Treatment with Pirfenidon Cipla

In certain situations, your doctor may advise you to stop taking Pirfenidon Cipla. If it is necessary to stop taking this medicine for a period of 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 questions about taking this medicine, ask your doctor or pharmacist.

4. Possible Side Effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking Pirfenidon Cipla and seek medical attention immediately if you notice 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 tiredness. These may be signs of abnormal liver function and may indicate liver damage, which is an uncommon side effect of Pirfenidon Cipla.
• Red, unraised, or round patches 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 enlarged lymph nodes (DRESS or drug hypersensitivity syndrome).

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
• blood tests may indicate increased liver enzyme activity
• skin reactions to sunlight or sunlamps
• skin problems, such as itching, redness, dryness, rash
• muscle pain
• feeling weak or lacking 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, talk to your doctor or pharmacist. You can also report side effects directly to the
Department of Medicinal Product Monitoring
Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
PL-02 222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
You can also report side effects to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this 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 which is stated on the label and carton after EXP. The expiry date refers to the last day of that month.
There are no special storage instructions 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. This 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 film-coated tablet contains 267 mg of pirfenidone.
• 801 mg tablet: Each film-coated tablet contains 801 mg of pirfenidone.
• The other ingredients are:
• tablet core: colloidal anhydrous silica, hypromellose, mannitol, sodium carboxymethylcellulose type A, and sodium stearyl fumarate.
• tablet coating: macrogol, polyvinyl alcohol (partially hydrolyzed), talc, titanium dioxide (E171). The 267 mg film-coated tablet also contains yellow iron oxide (E172). The 801 mg film-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, film-coated tablets are yellow to light yellow, biconvex, oval, with beveled edges, and smooth on both sides. The tablet dimensions are approximately 14 mm x 7 mm.
Starter pack for 2 weeks: a multipack containing 63 film-coated tablets (consisting of 1 pack of 21 film-coated tablets and 1 pack of 42 film-coated tablets).
84 film-coated tablets.
Maintenance pack: a multipack containing 252 film-coated tablets (3 packs, each containing 84 film-coated tablets).
801 mg tablet
Pirfenidon Cipla, 801 mg, film-coated tablets are pink to light pink, biconvex, capsule-shaped, and smooth on both sides. The tablet dimensions are approximately 20 mm x 9 mm.
84 film-coated tablets.
Maintenance pack: a multipack containing 252 film-coated tablets (3 packs, each containing 84 film-coated tablets).
The blisters are marked with the following symbols and abbreviations for the days of the week, which remind you to take a dose three times a day:

(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 Authorization 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 Authorized in the Member States of the EEA Under the Following Names:

Date of Last Revision of the Leaflet: