PIRFENIDONE AXUNIO 801 mg FILM-COATED TABLETS

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

Do not take Pirfenidone axunio

• 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 Pirfenidone axunio. If you are in doubt, consult your doctor or pharmacist.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Pirfenidone axunio

• You may have increased sensitivity to sunlight (photosensitivity reaction) when taking Pirfenidone axunio. Avoid the sun (also UVA lamps) while taking Pirfenidone axunio. Use a 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 antibiotics of the tetracycline group (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 liver problems of mild to moderate severity.
• You must refrain from smoking before and during treatment with Pirfenidone axunio. Tobacco can reduce the effect of Pirfenidone axunio.
• Pirfenidone axunio may cause dizziness and fatigue. Be careful if you need to perform activities that require attention and coordination.
• Pirfenidone axunio may cause weight loss. Your doctor will monitor your weight while you are taking this medicine.
• Stevens-Johnson syndrome and toxic epidermal necrolysis have been reported in association with pirfenidone treatment. Stop taking Pirfenidone axunio and seek immediate medical attention if you notice any symptoms related to these severe skin reactions described in section 4.

Pirfenidone axunio may cause serious liver problems. Some cases have been fatal. You will need to have a blood test before starting to take Pirfenidone axunio, 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 regularly while taking Pirfenidone axunio.

Children and adolescents

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

Other medicines and Pirfenidone axunio

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 axunio.

The following medicines may increase the adverse effects of Pirfenidone axunio:

• 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 efficacy of Pirfenidone axunio:

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

Taking Pirfenidone axunio with food and drinks

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

Pregnancy and breast-feeding

As a precautionary measure, it is preferable to avoid the use of Pirfenidone axunio 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 breast-feeding or plan to breast-feed, consult your doctor or pharmacist before taking Pirfenidone axunio. Since it is not known whether Pirfenidone axunio is excreted in breast milk, your doctor will explain the risks and benefits of taking this medicine during breast-feeding 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 axunio.

Pirfenidone axunio contains sodium

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

Pirfenidone axunio 534 mg film-coated tablets contain azo dyes

Pirfenidone axunio may cause allergic reactions.

3. How to take Pirfenidone axunio

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

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

Normally, you will be given this medicine with a gradual increase in 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 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 axunio is 801 mg (3 yellow tablets or 1 brown 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

It is possible that 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 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 take your medicine with you.

If you forget to take Pirfenidone axunio

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 axunio

In certain situations, your doctor will advise you to stop taking Pirfenidone axunio. If for any reason you stop taking Pirfenidone axunio 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 further questions on 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 axunio and inform your doctor immediately

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

• If you notice that 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 usual, or you feel tired. These could be signs of abnormal liver function and may indicate liver damage, which is a rare side effect of Pirfenidone axunio.

If you experience red patches without relief, or circular patches on the trunk, often with blisters in the center, 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. These signs and symptoms may indicate Stevens-Johnson syndrome or toxic epidermal necrolysis.

Other possible side effects are

If you experience any side effects, talk to your doctor.

Very common(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(may affect up to 1 in 10 people)

• bladder infections
• drowsiness
• altered taste
• hot flushes
• stomach problems, such as feeling heavy, pain, and discomfort in the abdomen, 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(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 effects, talk to your doctor or pharmacist, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Pirfenidone axunio

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 of the bottle, on the blister, and on the carton after EXP. The expiry date refers to the last day of the month shown.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

Composition of Pirfenidone axunio

267 mg tablets

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

The other ingredients are: mannitol, sodium croscarmellose, povidone, microcrystalline cellulose, colloidal anhydrous silica, sodium stearyl fumarate.

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

534 mg tablets

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

The other ingredients are: mannitol, sodium croscarmellose, povidone, microcrystalline cellulose, colloidal anhydrous silica, sodium stearyl fumarate.

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

801 mg tablets

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

The other ingredients are: mannitol, sodium croscarmellose, povidone, microcrystalline cellulose, colloidal anhydrous silica, sodium stearyl 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 pack contents

267 mg tablets

Pirfenidone axunio 267 mg film-coated tablets are yellow film-coated tablets, oval, biconvex, 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 unit dose blister packs containing 63x1 or 252x1 film-coated tablet.

534 mg tablets

Pirfenidone axunio 534 mg film-coated tablets are orange film-coated tablets, oval, biconvex, 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 unit dose blister packs containing 252x1 film-coated tablet.

801 mg tablets

Pirfenidone axunio 801 mg film-coated tablets are brown film-coated tablets, oval, biconvex, 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 unit dose blister packs containing 63x1, 84x1, or 252x1 film-coated tablet.

It is possible that not all pack sizes are marketed.

Marketing authorisation holder

axunio Pharma GmbH

Van-der-Smissen-Straße 1

22767 Hamburg

Germany

Manufacturer

Delorbis Pharmaceuticals Ltd.

17 Athinon Str., Ergates Industrial Area

2643 Ergates, Lefkosia

Cyprus

You can request more information about this medicine from the local representative of the marketing authorisation 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

EL/ES

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

IE/IT

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

NL

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

Date of last revision of this leaflet:

Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu.