Leaflet: Information for the user

Pirfenidone axunio 267 mg film-coated tablets

Pirfenidone axunio 534 mg film-coated tablets

Pirfenidone axunio 801 mg film-coated tablets

pirfenidone

Read this leaflet carefully before you start 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 questions, consult your doctor or pharmacist.

•This medicine has been prescribed for you only and should not be given to other people, even if they have the same symptoms as you, as it may harm them.

•If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

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

2.What you need to know before starting to take Pirfenidone axunio

3.How to take Pirfenidone axunio

4.Possible side effects

5.Storage of Pirfenidone axunio

6.Contents of the pack and additional information

Pirfenidona axunio contains the active ingredient pirfenidona and is used for the treatment of

Idiopathic Pulmonary Fibrosis (IPF) from mild to moderate in adults.

IPF is a disease in which the lung tissues become inflamed and filled with scars over time, making it difficult to breathe deeply. In these circumstances, the lungs have trouble functioning correctly. Pirfenidona axunio helps to reduce lung scarring and inflammation, and helps you breathe better.

Do not take Pirfenidona axunio

• if you are allergic to pirfenidona or any of the other components of this medication
• (listed in section 6)
• if you have previously experienced angioedema with pirfenidona, including symptoms such as facial swelling, lips, and/or tongue that may be associated with difficulty breathing or wheezing
• if you are taking a medication 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 Pirfenidona axunio. If you have any doubts, consult your doctor or pharmacist.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Pirfenidona axunio

• You may be more sensitive to sunlight (phototoxicity) when taking Pirfenidona axunio. Avoid the sun (also UVA lamps) while taking Pirfenidona axunio. Use daily sunscreen and cover your arms, legs, and head to reduce exposure to sunlight (see section 4: Possible side effects).
• Do not take other medications, 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 abstain from smoking before and during treatment with Pirfenidona axunio. Smoking may reduce the effect of Pirfenidona axunio.
• Pirfenidona axunio may cause dizziness and fatigue. Be careful if you have to perform activities that require attention and coordination.
• Pirfenidona axunio may cause weight loss. Your doctor will monitor your weight while you are taking this medication.
• Stevens-Johnson syndrome and toxic epidermal necrolysis have been reported in association with pirfenidona treatment. Stop taking Pirfenidona axunio and seek medical attention immediately if you notice any symptoms related to these severe skin reactions described in section 4.

Pirfenidona axunio may cause severe liver problems. Some cases have been fatal. You will need to have blood tests before starting to take Pirfenidona axunio, once a month for the first 6 months, and then every 3 months while you are taking this medication, to check the proper functioning of your liver. It is essential that you have these blood tests periodically throughout the time you are taking Pirfenidona axunio.

Children and adolescents

Do not administer Pirfenidona axunio to children and adolescents under 18 years old.

Other medications and Pirfenidona axunio

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

This is especially important if you are taking the following medications, as they may alter the effect of Pirfenidona axunio.

The following medications may increase the adverse effects of Pirfenidona axunio:

• enoxacina (a type of antibiotic)
• ciprofloxacino (a type of antibiotic)
• amiodarona (used to treat certain types of cardiomyopathy)
• propafenona (used to treat certain types of cardiomyopathy)
• fluvoxamina (used to treat depression and obsessive-compulsive disorder [OCD]).

(TOC).

The following medications may reduce the efficacy of Pirfenidona axunio:

• omeprazol (used to treat conditions such as indigestion and gastroesophageal reflux disease)
• rifampicina (a type of antibiotic).

Taking Pirfenidona axunio with food and drinks

Do not drink grapefruit juice while taking this medication. Grapefruit juice may make Pirfenidona axunio less effective.

Pregnancy and breastfeeding

As a precaution, it is recommended to avoid using Pirfenidona axunio 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 do so, speak with your doctor or pharmacist before taking Pirfenidona axunio. As it is not known whether Pirfenidona axunio is excreted in breast milk, your doctor will explain the risks and benefits of taking this medication during breastfeeding if you decide to do so.

Driving and operating machinery

Do not drive or operate machinery if you feel dizzy or fatigued after taking Pirfenidona axunio.

Pirfenidona axunio contains sodium

Pirfenidona axunio contains less than 1 mmol of sodium (23 mg) per tablet, which means it is essentially "sodium-free".

Pirfenidona axunio 534 mg film-coated tablets contain azo dyes

Pirfenidona axunio may cause allergic reactions.

The treatment with Pirfenidona axunio should be initiated and supervised by specialist doctors with experience in the diagnosis and treatment of FPI.

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

Normally, you will be administered this medication by gradually increasing the dose as follows:

•During 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 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 daily maintenance dose of Pirfenidona axunio is 801 mg (3 yellow tablets or 1 brown tablet) three times a day with food, a total of 2403 mg/day.

Swallow the tablets whole with water, during or after a meal to reduce the risk of side effects such as nausea (feeling of discomfort) 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 UV-A lamps, or significant changes in liver enzymes.

If you take more Pirfenidona axunio than you should

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

If you forget to take Pirfenidona axunio

If you forget to take a dose, take it as soon as you remember. Do not take a double dose to compensate for the missed doses. Each dose should be separated by a minimum interval of 3 hours. Do not take more tablets per day than correspond to your prescribed daily dose.

If you interrupt treatment with Pirfenidona axunio

In certain situations, your doctor will advise you to stop taking Pirfenidona axunio. If for any reason you stop taking Pirfenidona axunio for more than 14 consecutive days, the 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 doubts about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Stop taking Pirfenidona axunio and inform your doctor immediately

•If you experience swelling of the face, lips, or tongue, itching, hives, difficulty breathing, or wheezing, or a feeling of fainting, which are signs of angioedema, a severe allergic reaction, or anaphylaxis.

•If you notice that your eyes or skin are yellow in color, or your urine is dark, and possibly accompanied by itching of the skin, abdominal pain on the upper right side, loss of appetite, bleeding, or the appearance of bruises more easily than normal, or you feel tired. These could be signs of abnormal liver function and may indicate

liver damage, which is a rare side effect of Pirfenidona axunio.

•If you experience flat red spots, or circular spots on the trunk, often with

central blisters, skin peeling, mouth ulcers, throat, nose, genital, and eye ulcers. These severe skin eruptions may be preceded by fever and symptoms similar to those of the

flu. These signs and symptoms may indicate Stevens-Johnson syndrome or toxic epidermal necrolysis.

Other possible side effects are

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

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

•Throat or respiratory tract infections that reach the lungs and/or sinusitis

•Unpleasant feeling (nausea)

•Stomach problems, such as acid reflux, vomiting, and constipation

•Diarrhea

•Indigestion or stomach heaviness

•Weight loss

•Loss of appetite

•Difficulty sleeping

•Tiredness

•Dizziness

•Headache

•Difficulty breathing

•Cough

•Joint pain

Common(may affect up to 1 in 10 people)

•Urinary tract infections

•Drowsiness

•Alteration of taste

•Headaches

•Stomach problems, such as heaviness, pain, and abdominal discomfort, stomach burning, and flatulence

•Blood tests may indicate an increase in liver enzymes

•Skin reactions after exposure to the sun or the use of UVA lamps

•Skin problems such as itching, irritation, or redness, dryness, rash

•Muscle pain

•Weakness or lack of energy

•Chest pain

•Sunburn.

Rare(may affect up to 1 in 100 people)

•Low sodium levels in the blood. This may cause headache, dizziness, confusion, weakness, muscle cramps, or nausea and vomiting.

•Blood test results may show a decrease in white blood cells.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the national notification system included in theAppendix V. By reporting side effects, you can contribute to providing more information about the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the label of the bottle, on the blister pack, and on the box after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the containers and medications that you no longer need. In this way, you will help protect the environment.

Pirfenidone Axunio Composition

Tablets of 267 mg

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

The other components are: mannitol, sodium croscarmellose, povidone, microcrystalline cellulose,

colloidal anhydrous silica. esterified sodium fumarate.

The film coating consists of: partially hydrolyzed polyvinyl alcohol (E1203), titanium dioxide (E171), macrogol 3350 (E1521), talc (E553b) and yellow iron oxide

(E172).

Tablets of 534 mg

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

The other components are: mannitol, sodium croscarmellose, povidone, microcrystalline cellulose,

colloidal anhydrous silica. esterified sodium fumarate.

The film coating consists of: partially hydrolyzed polyvinyl alcohol (E1203), titanium dioxide (E171), macrogol 3350 (E1521), talc (E553b) and sunset yellow FCF lake (E110).

Tablets of 801 mg

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

The other components are: mannitol, sodium croscarmellose, povidone, microcrystalline cellulose,

colloidal anhydrous silica. esterified sodium fumarate.

The film coating consists of: partially hydrolyzed polyvinyl alcohol (E1203), titanium dioxide (E171), macrogol 3350 (E1521), talc (E553b), red iron oxide (E172) and

black iron oxide (E172).

Appearance of the product and contents of the package

Tablets of 267 mg

Pirfenidone Axunio 267 mg film-coated tablets are yellow film-coated, oval, biconvex tablets with the inscription “LP2” on one side and smooth on the other side.

Pirfenidone Axunio 267 mg film-coated tablets are available in a bottle containing 90 film-coated tablets, in blister packs containing 63 or 252 film-coated tablets and in pre-cut single-dose blister packs containing 63x1 or 252x1 film-coated tablets.

Tablets of 534 mg

Pirfenidone Axunio 534 mg film-coated tablets are orange film-coated, oval, biconvex tablets with the inscription “LP5” on one side and smooth on the other side.

Pirfenidone Axunio 534 mg film-coated tablets are available in blister packs containing 252 film-coated tablets and in pre-cut single-dose blister packs containing 252x1 film-coated tablets.

Tablets of 801 mg

Pirfenidone Axunio 801 mg film-coated tablets are brown film-coated, oval, biconvex tablets with the inscription “LP8” on one side and smooth on the other side.

Pirfenidone Axunio 801 mg film-coated tablets are available in a bottle containing 90 film-coated tablets, in blister packs containing 63, 84 or 252 film-coated tablets and in pre-cut single-dose blister packs containing 63x1, 84x1 or 252x1 film-coated tablets.

Only some package sizes may be marketed.

Marketing Authorization Holder

axunio Pharma GmbH

Van-der-Smissen-Straße 1

22767 Hamburg

Germany

Responsible Person for Manufacturing

Delorbis Pharmaceuticals Ltd.

17 Athinon Str., Ergates Industrial Area

2643 Ergates, Lefkosia

Cyprus

For further information about this medicinal product, please contact the local representative of the marketing authorization holder:

AT/BE/BG/CZ/CY/DE/EE/FR/HR/DK/FI/NO/SE

HU/ IS/LU/LT/LV/MT/PL/PT/RO/ORESEUND PHARMA ApS

SI/SK/UK (NI)Tel: +45 5363 3916

axunio Pharma GmbH

Tel: + 49 (0)40 38 02 32 14

ELES

ELPEN PHARMACEUTICAL CO., INCLaboratorios Rodio, S.L. Tel: +30 210 6039326Tel: +34 639172206

IEIT

ROWA Pharmaceuticals Ltd.Bruno Farmaceutici S.p.A. Tel: +353 27 50077Tel: +39 06 6050601

NL

Prolepha Research B.V. Tel: +31 (0)76 596 4009

Last revision date of this leaflet:

The detailed information on this medicinal product is available on the website of the European Medicines Agency:http://www.ema.europa.eu.