PIRFENIDONE DR. REDDY'S 267 mg FILM-COATED TABLETS

2. What you need to know before taking Pirfenidone Dr. Reddys

Do not take Pirfenidone Dr. Reddys

• if you are allergic to pirfenidone or any of the other components 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 pirfenidone. If you have any doubts, consult your doctor or pharmacist.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Pirfenidone Dr. Reddys

• You may be more sensitive to sunlight (photosensitivity reaction) when taking pirfenidone. Avoid the sun (also UVA lamps) while taking Pirfenidone Dr. Reddys. Use a daily sunscreen 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 should inform your doctor if you have kidney problems.
• You should 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 Dr. Reddys may cause dizziness and fatigue. Be careful if you need to perform activities that require attention and coordination.
• Pirfenidone Dr. Reddys 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 medical attention immediately if you notice any 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 Dr. Reddys, once a month for the first 6 months, and then every 3 months while taking this medicine, to check your liver function. It is essential 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 Dr. Reddys

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, esophageal reflux disease)
• rifampicin (a type of antibiotic).

Taking Pirfenidone Dr. Reddys 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 precaution, it is recommended to avoid the use of pirfenidone if you are pregnant, 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 planning to breastfeed, consult 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. Reddys contains sodium

Pirfenidone Dr. Reddys contains less than 1 mmol of sodium (23 mg) per tablet, i.e., it is essentially "sodium-free".

3. How to take Pirfenidone Dr. Reddys

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 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)

? from day 8 to 14, take a dose of 534 mg (2 yellow tablets or 1 orange tablet), 3 times a day with food (a total of 1,602 mg/day)

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

The recommended maintenance dose of Pirfenidone Dr. Reddys is 3 tablets 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 unwell) 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 Dr. Reddys 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 bring your medication with you.

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

If you forget to take Pirfenidone Dr. Reddys

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 Dr. Reddys

In certain situations, your doctor will advise you to stop taking Pirfenidone Dr. Reddys. If you stop taking Pirfenidone Dr. Reddys for more than 14 consecutive days for any reason, your doctor will restart your treatment with 1 tablet 3 times a day and gradually increase it to 3 tablets 3 times a day.

If you have any other doubts 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 Dr. Reddys and seek medical attention immediately 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 of fainting, which are signs of angioedema, a severe allergic reaction 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 (stomach), loss of appetite, bleeding or bruising more easily than usual, or feeling of tiredness. These could be signs of abnormal liver function and may indicate liver damage, which is a rare side effect of Pirfenidone Dr. Reddys.
• Red patches 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 are often preceded by fever or flu-like symptoms (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 unwell (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 bloating
• 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 cell count.

Reporting side effects

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

5. Storage of Pirfenidone Dr. Reddys

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

Do not use this medicine after the expiration date that appears on the bottle, blister pack, and carton after EXP. The expiration 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. Ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Package contents and additional information

Composition of Pirfenidone Dr. Reddys

267 mg tablet

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

The other ingredients 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 ingredients 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

Pirfenidone Dr. Reddys 801 mg film-coated tablets are brown, oval, biconvex, film-coated tablets, engraved with “801”.

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

The other ingredients 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 package contents

267 mg tablet

Pirfenidone Dr. Reddys 267 mg film-coated tablets EFG are yellow, oval, biconvex, film-coated tablets, engraved with “267”.

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

534 mg tablet

Pirfenidone Dr. Reddys 534 mg film-coated tablets are orange, oval, biconvex, film-coated tablets, engraved with “534”.

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

The bottle pack contains 90 film-coated tablets.

801 mg tablet

The film-coated tablets of Pirfenidone Dr. Reddys 801 mg are brown, oval, biconvex, film-coated tablets, engraved with “801”.

The blister pack contains 84 film-coated tablets.

It is possible that only some 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)

Phone: 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 medicine is authorized in the Member States of the European Economic Area under the following names:

Date of the last revision of this leaflet:April 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.