PIRFENIDONE CIPLA 267 MG FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Pirfenidone Cipla 267 mg film-coated tablets EFG

Pirfenidone Cipla 801 mg film-coated tablets EFG

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• 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

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

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

Pirfenidone Cipla contains the active substance pirfenidone and is used to treat Idiopathic Pulmonary Fibrosis (IPF) in adults.

IPF is a disease in which the tissue of the lungs becomes swollen and scarred over time, making it difficult to breathe deeply. In these circumstances, the lungs have difficulty functioning properly. This medication helps reduce scarring and swelling of the lungs, and helps you breathe better.

2. What you need to know before you take Pirfenidone Cipla

Do not take Pirfenidone Cipla

• If you are allergic to pirfenidone or any of the other ingredients of this medicine (listed in section 6).
• If you have previously had angioedema with pirfenidone, including symptoms such as swelling of the face, lips and/or tongue that may be associated with difficulty breathing or wheezing.
• If you are taking a medicine called fluvoxamine (used to treat depression and obsessive-compulsive disorder [OCD]).
• If you have severe or terminal liver disease.
• If you have severe or terminal kidney disease that requires dialysis.

If any of the above applies to you, do not take this medicine. If you are in doubt, consult your doctor or pharmacist.

Warnings and precautions

Consult your doctor or pharmacist before starting to take this medicine.

• You may have increased sensitivity to sunlight (photosensitivity reaction) when taking pirfenidone. Avoid the sun (also UVA lamps) while taking pirfenidone. Use a sun protection cream daily and cover your arms, legs, and head to reduce exposure to sunlight (see section 4: Possible side effects).
• Do not take other medicines, such as tetracycline antibiotics (e.g., doxycycline), that may increase your sensitivity to sunlight.
• You must inform your doctor if you have kidney problems.
• You must inform your doctor if you have mild to moderate liver problems.
• You should avoid smoking before and during treatment with pirfenidone. Tobacco can reduce the effect of pirfenidone.
• Pirfenidone may cause dizziness and fatigue. Be careful if you need to perform activities that require attention and coordination.
• Pirfenidone may cause weight loss. Your doctor will monitor your weight while you are taking this medicine.
• Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS) have been reported in association with pirfenidone treatment. Stop taking pirfenidone and seek immediate medical attention if you notice any of the symptoms related to these severe skin reactions described in section 4.

Pirfenidone may cause serious liver problems. Some cases have been fatal. You will need to have a blood test before starting to take pirfenidone, once a month for the first 6 months, and then every 3 months while taking this medicine, to check your liver is working properly. It is important that you have these blood tests periodically throughout the time you are taking pirfenidone.

Children and adolescents

Do not give pirfenidone to children and adolescents under 18 years of age.

Other medicines and Pirfenidone Cipla

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

This is especially important if you are taking the following medicines, as they may alter the effect of pirfenidone.

The following medicines may increase the side effects of pirfenidone:

• enoxacin (a type of antibiotic).
• ciprofloxacin (a type of antibiotic).
• amiodarone (used to treat certain types of heart disease).
• propafenone (used to treat certain types of heart disease).
• fluvoxamine (used to treat depression and obsessive-compulsive disorder [OCD]).

The following medicines may reduce the effectiveness of pirfenidone:

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

Taking Pirfenidone Cipla with food and drinks

Do not drink grapefruit juice while taking this medicine. Grapefruit juice may make pirfenidone not work properly.

Pregnancy and breastfeeding

As a precautionary measure, it is preferable to avoid the use of pirfenidone if you are pregnant, are planning to become pregnant, or think you may be pregnant, as the potential risks to the fetus are not known.

If you are breastfeeding or plan to breastfeed, talk to your doctor or pharmacist before taking this medicine. Since it is not known whether pirfenidone is excreted in breast milk, your doctor will explain the risks and benefits of taking this medicine during breastfeeding if you decide to do so.

Driving and using machines

Do not drive or use machines if you feel dizzy or tired after taking pirfenidone.

Pirfenidone Cipla contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; this is essentially "sodium-free".

3. How to take Pirfenidone Cipla

Treatment with pirfenidone should be initiated and supervised by specialist doctors with experience in the diagnosis and treatment of IPF.

Follow the instructions for administration of this medicine exactly as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Normally, you will be given this medicine by gradually increasing the dose as follows:

• For the first 7 days, take a dose of 267 mg (1 yellow tablet), 3 times a day with food (a total of 801 mg/day).
• Between days 8 and 14, take a dose of 534 mg (2 yellow tablets), 3 times a day with food (a total of 1,602 mg/day). A dose of 534 mg will be obtained through the administration of 2 yellow tablets (267 mg).
• From day 15 (maintenance), take a dose of 801 mg (3 yellow tablets or 1 pink tablet), 3 times a day with food (a total of 2,403 mg/day).

The recommended maintenance dose of pirfenidone is 801 mg (3 yellow tablets or 1 pink tablet) three times a day with food, a total of 2,403 mg/day.

Swallow the tablets whole with water, during or after a meal to reduce the risk of side effects such as nausea (feeling sick) and dizziness. If symptoms persist, consult your doctor.

Dose reduction due to side effects

Your doctor may decide to reduce the dose if you experience side effects such as stomach problems, skin reactions to sunlight or UVA lamps, or significant changes in liver enzymes.

If you take more Pirfenidone Cipla than you should

Go to your doctor, pharmacist, or the emergency department of the nearest hospital immediately if you take more tablets than you should, and take your medicine with you.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, telephone 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Pirfenidone Cipla

If you forget to take a dose, take it as soon as you remember. Do not take a double dose to make up for forgotten doses. Each dose should be separated by an interval of at least 3 hours. Do not take more tablets per day than your prescribed daily dose.

If you stop taking Pirfenidone Cipla

In certain situations, your doctor will advise you to stop taking pirfenidone. If for any reason you stop taking pirfenidone for more than 14 consecutive days, your doctor will restart your treatment with a dose of 267 mg 3 times a day and gradually increase it to 801 mg 3 times a day.

If you have any other questions about the use of 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 pirfenidone and seek immediate medical attention if you experience any of the following symptoms or signs:

• Swelling of the face, lips and/or tongue, itching, hives, difficulty breathing or wheezing, or feeling of fainting, which are signs of angioedema, a severe allergic reaction or anaphylaxis.
• You have yellow eyes or skin or dark urine, and possibly accompanied by itching of the skin, pain in the upper right side of the abdomen (stomach), loss of appetite, bleeding or bruising more easily than normal, or feeling tired. These could be signs of abnormal liver function and may indicate liver damage, which is a rare side effect of pirfenidone.
• Red patches without relief, or circular patches on the trunk, often with central blisters, skin peeling, ulcers in the mouth, throat, nose, genitals, and eyes. These severe skin rashes may be preceded by fever and symptoms similar to those of the flu (Stevens-Johnson syndrome or toxic epidermal necrolysis).
• Widespread skin rash, high body temperature, and swollen lymph nodes (DRESS or drug hypersensitivity syndrome).

Other possible side effects are

If you experience any type of side effect, consult your doctor.

Very common side effects(may affect more than 1 in 10 people):

• infections of the throat or respiratory tract that reach the lungs and/or sinusitis.
• feeling sick (nausea).
• stomach problems, such as acid reflux, vomiting, and constipation.
• diarrhea.
• indigestion or stomach heaviness.
• weight loss.
• decreased appetite.
• difficulty sleeping.
• fatigue.
• dizziness.
• headache.
• difficulty breathing.
• cough.
• joint pain.

Common side effects(may affect up to 1 in 10 people):

• bladder infections.
• drowsiness.
• altered taste.
• hot flashes.
• stomach problems, such as feeling full, stomach pain, and discomfort, heartburn, and flatulence.
• blood tests may indicate increased liver enzymes.
• skin reactions after exposure to sunlight or UVA lamps.
• skin problems such as itching, irritation, or redness, dryness, rash.
• muscle pain.
• weakness or lack of energy.
• chest pain.
• sunburn.

Uncommon side effects(may affect up to 1 in 100 people):

• low sodium levels in the blood. This can cause headache, dizziness, confusion, weakness, muscle cramps, or nausea and vomiting.
• blood test results may show decreased white blood cells.

Reporting of side effects

If you experience any side effect, consult your doctor or pharmacist, even if it is possible side effects not listed in this leaflet. You can also report them directly through the Spanish Medicines Monitoring System for Human Use: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Pirfenidone Cipla

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date that appears on the blister or carton after "EXP". The expiry date is the last day of the month indicated.

This medicine does not require special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicine in the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Contents of the pack and other information

Composition of Pirfenidone Cipla

• The active substance is pirfenidone.

• 267 mg tablets:Each film-coated tablet contains 267 mg of pirfenidone.
• 801 mg tablets:Each film-coated tablet contains 801 mg of pirfenidone.

• Other ingredients are:

• Core of the tablet:anhydrous colloidal silica (E551), hypromellose (E464), mannitol (E421), sodium carboxymethyl starch (Type A), and sodium stearyl fumarate.
• Coating material:macrogol (E1521), poly(vinyl alcohol) (E1203), talc (E553b), titanium dioxide (E171).

267 mg film-coated tablets also contain yellow iron oxide (E172).

801 mg film-coated tablets also contain red iron oxide (E172).

Appearance of the product and pack contents

267 mg tablets

Pirfenidone Cipla 267 mg film-coated tablets EFG are light yellow to yellow, biconvex, film-coated, oval-shaped tablets with a beveled edge and smooth on both sides. The tablet size is approximately 14 mm × 7 mm.

Starting treatment pack of 2 weeks: the multipack contains 63 film-coated tablets (1 pack of 21 and 1 pack of 42).

63 film-coated tablets (3 blisters of 21).

84 film-coated tablets.

Maintenance pack: the multipack contains 252 film-coated tablets (3 packs of 84).

801 mg tablets

Pirfenidone Cipla 801 mg film-coated tablets EFG are light pink to pink, biconvex, film-coated, capsule-shaped tablets and smooth on both sides. The tablet size is approximately 20 mm × 9 mm.

84 film-coated tablets.

Maintenance pack: the multipack contains 252 film-coated tablets (3 packs of 84).

Each of the blister strips is marked with the following symbols and abbreviations, as a reminder to take a dose three times a day:

(dawn; morning dose) (sun; afternoon dose) and (moon; night dose).

Mon., Tue., Wed., Thu., Fri., Sat., Sun.

Some pack sizes may only be marketed.

Marketing authorisation holder and manufacturer

Cipla Europe NV

De Keyserlei 58-60, Box 19

2018, Antwerp

Belgium

Local representative

Cipla Europe NV, branch in Spain

C/Guzmán el Bueno 133, Edificio Britannia

28003, Madrid

Spain

This medicine is authorised in the Member States of the European Economic Area under the following names:

Sweden: Pirfenidon Cipla

Belgium: Pirfenidon Cipla

Germany: Pirfenidon Cipla

Spain: Pirfenidona Cipla 267 mg film-coated tablets EFG

Pirfenidona Cipla 801 mg film-coated tablets EFG

Norway: Pirfenidon Cipla

France: Pirfenidone Cipla

Italy: Pirfenidone Cipla

Poland: Pirfenidon Cipla

Ireland: Pirfenidone Cipla

Finland: Pirfenidon Cipla

Date of last revision of this leaflet: March 2024

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/).