Pirfenidone Dr. Reddy's 267 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

Pirfenidone Dr. Reddy's 267 mg film-coated tablets EFG

Pirfenidone Dr. Reddy's 534 mg film-coated tablets EFG

Pirfenidone Dr. Reddy's 801 mg film-coated tablets EFG

Read the entire leaflet carefully before you start taking 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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet contents:

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

1. What is Pirfenidone Dr. Reddy's and what is it used for?

This medicine contains the active substance pirfenidone and is used for the treatment of mild to moderate Idiopathic Pulmonary Fibrosis (IPF) in adults.

IPF is a disease in which lung tissues become inflamed and progressively scarred over time, making it difficult to take deep breaths. Under these circumstances, the lungs have difficulty functioning properly. Pirfenidone Dr. Reddy's helps reduce scarring and inflammation in the lungs and helps you breathe better.

2. What you need to know before taking Pirfenidone Dr. Reddy's

Do not take Pirfenidone Dr. Reddy's

• if you are allergic to pirfenidone or to 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, which 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 end-stage liver disease
• if you have severe or end-stage kidney disease requiring dialysis.

If any of the above apply to you, do not take pirfenidone. If you have any doubts, consult your doctor or pharmacist.

Warnings and precautions

Talk to your doctor or pharmacist before starting Pirfenidone Dr. Reddy's

• You may become more sensitive to sunlight (photosensitivity reaction) while taking pirfenidone. Avoid sunlight (including UV lamps) while taking Pirfenidone Dr. Reddy's. Use sunscreen daily and cover your arms, legs, and head to reduce sun exposure (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 must refrain from smoking before and during treatment with pirfenidone. Tobacco may reduce the effect of pirfenidone.
• Pirfenidone Dr. Reddy's may cause dizziness and fatigue. Be cautious when performing activities requiring attention and coordination.
• Pirfenidone Dr. Reddy's may cause weight loss. Your doctor will monitor your weight while you are taking this medicine.
• Cases of 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 symptoms related to these serious 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 Pirfenidone Dr. Reddy's, once a month for the first 6 months, and then every 3 months while taking this medicine, to check that your liver is functioning properly. It is important that you have these blood tests performed regularly 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 Dr. Reddy's

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to 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 conditions such as indigestion and gastroesophageal reflux disease)
• rifampicin (a type of antibiotic).

Taking Pirfenidone Dr. Reddy's with food and drinks

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

Pregnancy and breastfeeding

As a precautionary measure, it is preferable to avoid using pirfenidone if you are pregnant, planning to become pregnant, or think you may be pregnant, as the potential risks to the fetus are unknown.

If you are breastfeeding or plan to breastfeed, talk to your doctor or pharmacist before taking pirfenidone. 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 operate machinery if you feel dizzy or tired after taking pirfenidone.

Pirfenidone Dr. Reddy's contains sodium

Pirfenidone Dr. Reddy's contains less than 1 mmol of sodium (23 mg) per tablet, i.e., essentially "sodium-free".

3. How to take Pirfenidone Dr. Reddy's

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

Always follow exactly the dosing instructions for this medicine as provided by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

You will normally be given this medicine with a gradually increasing dose as follows:

? for the first 7 days, take a dose of 267 mg (1 yellow tablet) three times a day with food (total of 801 mg/day)

? from day 8 to day 14, take a dose of 534 mg (2 yellow tablets or 1 orange tablet) three times a day with food (total of 1,602 mg/day)

? from day 15 onwards (maintenance), take a dose of 801 mg (3 yellow tablets or 1 brown tablet) three times a day with food (total of 2,403 mg/day).

The recommended daily maintenance dose of Pirfenidone Dr. Reddy's is 3 tablets three times a day with meals, for 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 unwell) and dizziness. If symptoms persist, contact your doctor.

Dose reduction due to side effects

Your doctor may decide to reduce your 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 Dr. Reddy's than you should

Contact your doctor, pharmacist, or the nearest hospital emergency department immediately if you take more tablets than you should, and bring your medication with you.

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

If you forget to take Pirfenidone Dr. Reddy's

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 at least 3 hours. Do not take more tablets per day than your prescribed daily dose.

If you stop taking Pirfenidone Dr. Reddy's

In certain situations, your doctor may advise you to stop taking Pirfenidone Dr. Reddy's. If you stop taking Pirfenidone Dr. Reddy's for any reason for more than 14 consecutive days, your doctor will restart your treatment at 1 tablet three times a day and gradually increase the dose up to 3 tablets three times a day.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

Stop taking Pirfenidone Dr. Reddys and seek immediate medical attention if you notice any of the following symptoms or signs:

• Swelling of the face, lips, or tongue, itching, hives, difficulty breathing or wheezing, or feeling faint, which are signs of angioedema, a serious allergic reaction or anaphylaxis.
• Yellowing of the eyes or skin, or dark urine, possibly accompanied by skin itching, pain in the upper right part of the stomach area (abdomen), 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 an uncommon adverse effect of Pirfenidone Dr. Reddys.
• Reddish, non-elevated or circular patches on the trunk, often with central blisters, skin peeling, ulcers in the mouth, throat, nose, genitals, and eyes. These serious skin rashes are often preceded by fever or flu-like symptoms (Stevens-Johnson syndrome or toxic epidermal necrolysis).
  • Widespread skin rash, high body temperature, and enlarged lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).

Other possible adverse effects are

If you experience any adverse effect, consult your doctor.

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

• Throat or respiratory tract infections reaching the lungs and/or sinusitis
• Feeling unwell (nausea)
• Stomach problems, such as acid reflux, vomiting, and constipation
• Diarrhea
• Indigestion or stomach heaviness
• Weight loss
• Decreased appetite
• Difficulty sleeping
• Tiredness
• Dizziness
• Headache
• Difficulty breathing
• Cough
• Joint pain

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

• Bladder infections
• Drowsiness
• Altered taste
• Hot flushes
• Stomach problems, such as feeling of heaviness, pain and abdominal discomfort, heartburn, and flatulence
• Blood tests may show increased liver enzymes
• Skin reactions after exposure to sunlight or use of UVA lamps
• Skin problems such as itching, irritation or redness, dryness, rash
• Muscle pain
• Weakness or lack of energy
• Chest pain
• Sunburn

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

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

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Pirfenidone Dr. Reddy's

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

Do not use this medicine after the expiry date stated on the bottle, blister pack, and carton after EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to properly dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Pirfenidone Dr. Reddy's

267 mg tablet

The active substance is pirfenidone. Each film-coated tablet contains 267 mg of pirfenidone.

The other components are: lactose, sodium croscarmellose, anhydrous colloidal silica, magnesium stearate.

The film coating consists of: polyvinyl alcohol, titanium dioxide (E171), macrogol, talc, yellow iron oxide (E172).

534 mg tablet

The active substance is pirfenidone. Each film-coated tablet contains 534 mg of pirfenidone.

The other components are: lactose, sodium croscarmellose, anhydrous colloidal silica, magnesium stearate.

The film coating consists of: polyvinyl alcohol, titanium dioxide (E171), macrogol, talc, yellow iron oxide (E172) and red iron oxide (E172).

801 mg tablet

The active substance is pirfenidone. Each film-coated tablet contains 801 mg of pirfenidone.

The other components are: lactose, sodium croscarmellose, anhydrous colloidal silica, magnesium stearate.

The film coating consists of: polyvinyl alcohol, titanium dioxide (E171), macrogol, talc, red iron oxide (E172) and black iron oxide (E172).

Appearance of the product and contents of the pack

267 mg tablet

Pirfenidone Dr. Reddy's 267 mg film-coated tablets EFG are yellow, oval-shaped, biconvex, film-coated tablets, engraved with "267".

Blister packs contain 63 film-coated tablets (pack of 63 film-coated tablets or multiple pack composed of 1 pack containing 21 film-coated tablets and 1 pack containing 42 film-coated tablets) or 252 film-coated tablets (pack of 252 film-coated tablets or multiple pack with 3 packs, each containing 84 film-coated tablets).

534 mg tablet

Pirfenidone Dr. Reddy's 534 mg film-coated tablets are orange, oval-shaped, biconvex, film-coated tablets, engraved with "534".

Blister packs contain 21, 63 or 84 film-coated tablets.

The bottle pack contains 90 film-coated tablets.

801 mg tablet

Pirfenidone Dr. Reddy's 801 mg film-coated tablets are brown, oval-shaped, biconvex, film-coated tablets, engraved with "801".

The blister pack contains 84 film-coated tablets.

It is possible that only certain pack sizes are marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Reddy Pharma Iberia, S.A.

Avda. Josep Tarradellas nº 38

08029 Barcelona (Spain)

Telephone: 93.355.49.16

Fax: 93.355.49.61

Manufacturer

betapharm Arzneimittel GmbH

Kobelweg 95

86156 Augsburg

Germany

or

PharOS MT Ltd.

HF62X, Hal Far Industrial Estate,

Birzebbugia BBG3000

Malta

or

Rontis Hellas Medical and Pharmaceutical Products S.A.

Larissa Industrial Area, P.O. BOX 3012,

Larissa, 41500

Greece

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Date of the most recent review of this leaflet: April 2024

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