Pirfenidone Axunio 801 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Pirfenidona axunio 267 mg film-coated tablets

Pirfenidona axunio 534 mg film-coated tablets

Pirfenidona axunio 801 mg film-coated tablets

pirfenidone

Read the entire 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, 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, because it could harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents:

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

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

Pirfenidona axunio 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 scarred over time, making it difficult to breathe deeply. Under these conditions, the lungs have difficulty functioning properly. Pirfenidona axunio helps reduce lung scarring and inflammation, and helps you breathe better.

2. What you need to know before taking Pirfenidona axunio

Do not take Pirfenidona axunio

• 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 Pirfenidona axunio. If you have any doubts, consult your doctor or pharmacist.

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Pirfenidona axunio

• You may become more sensitive to sunlight (photosensitivity reaction) while taking Pirfenidona axunio. Avoid sunlight (including UVA lamps) while taking Pirfenidona axunio. Use sunscreen daily and cover your arms, legs, and head to reduce exposure to sunlight (see section 4: Possible side effects).
• You should 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 Pirfenidona axunio. Tobacco may reduce the effect of Pirfenidona axunio.
• Pirfenidona axunio may cause dizziness and fatigue. Be cautious if you need to perform activities requiring attention and coordination.
• Pirfenidona 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 Pirfenidona axunio and seek immediate medical attention if you notice any symptoms related to these serious skin reactions described in section 4.

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

Children and adolescents

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

Other medicines and Pirfenidona axunio

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 Pirfenidona axunio.

The following medicines may increase the adverse effects of Pirfenidona 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 effectiveness of Pirfenidona axunio:

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

Taking Pirfenidona axunio with food and drink

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

Pregnancy and breastfeeding

As a precautionary measure, it is preferable 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 planning to breastfeed, talk to your doctor or pharmacist before taking Pirfenidona axunio. Since it is not known whether Pirfenidona axunio 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 use of machines

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

Pirfenidona axunio contains sodium

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

Pirfenidona axunio 534 mg film-coated tablets contain azo colourings

Pirfenidona axunio may cause allergic reactions.

3. How to take Pirfenidona axunio

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

Always follow exactly the instructions for administration of this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

This medicine is usually administered by gradually increasing the dose as follows:

• during the first 7 days, take a dose of 267 mg (1 yellow tablet) three times a day with food (a total of 801 mg/day)
• from days 8 to 14, take a dose of 534 mg (2 yellow tablets or 1 orange tablet) three times a day with food (a 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 (a total of 2,403 mg/day).

The recommended maintenance daily dose of Pirfenidona axunio is 801 mg (3 yellow tablets or 1 brown tablet) three times a day with food, 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 Pirfenidona axunio than you should

Contact your doctor, pharmacist, or 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 make up for forgotten doses. Each dose should be separated by a minimum interval of 3 hours. Do not take more tablets in one day than your prescribed daily dose.

If you stop taking Pirfenidona axunio

In certain situations, your doctor may advise you to stop taking Pirfenidona axunio. If for any reason you stop taking Pirfenidona axunio for more than 14 consecutive days, your doctor will restart your treatment with a dose of 267 mg three times a day and gradually increase it up to 801 mg 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 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 yellowing of the eyes or skin, dark urine, and possibly accompanied by itching of the skin, pain in the upper right area of the abdomen, loss of appetite, bleeding or bruising more easily than normal, or feel tired. These could be signs of abnormal liver function and may indicate liver damage, which is an uncommon adverse effect of Pirfenidona axunio.

• If you develop raised red spots, or circular rashes on the trunk, often with central blisters, skin peeling, or ulcers in the mouth, throat, nose, genitals, and eyes. These serious skin rashes may be preceded by fever and flu-like symptoms. These signs and symptoms may indicate Stevens-Johnson syndrome or toxic epidermal necrolysis.

Other possible adverse effects are

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

Very common (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 discomfort
• Weight loss
• Decreased appetite
• Difficulty sleeping
• Fatigue
• Dizziness
• Headache
• Shortness of breath
• Cough
• Joint pain

Common (may affect up to 1 in 10 people)

• Bladder infections
• Drowsiness
• Taste disturbances
• Hot flushes
• Stomach problems such as feeling of fullness, 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 (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 type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the national reporting system included in Appendix V. By reporting adverse 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 stated on the label of the bottle, blister pack, and carton, following EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to properly dispose of any unused medicines and their packaging. This helps protect the environment.

6. Contents of the Pack and Other Information

Composition of Pirfenidone axunio

Tablets 267 mg

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

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

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

Tablets 534 mg

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

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

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

Tablets 801 mg

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

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

The film coating consists of: partially hydrolysed 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 Pack

Tablets 267 mg

Pirfenidone axunio 267 mg film-coated tablets are yellow, film-coated, oval, biconvex tablets, with the imprint “LP2” on one side and plain on the other side.

Pirfenidone axunio 267 mg film-coated tablets are available in bottle packs containing one bottle of 90 film-coated tablets, in blister packs containing 63 or 252 film-coated tablets, and in single-dose perforated blister packs containing 63x1 or 252x1 film-coated tablets.

Tablets 534 mg

Pirfenidone axunio 534 mg film-coated tablets are orange, film-coated, oval, biconvex tablets, with the imprint “LP5” on one side and plain on the other side.

Pirfenidone axunio 534 mg film-coated tablets are available in blister packs containing 252 film-coated tablets and in single-dose perforated blister packs containing 252x1 film-coated tablet.

Tablets 801 mg

Pirfenidone axunio 801 mg film-coated tablets are brown, film-coated, oval, biconvex tablets, with the imprint “LP8” on one side and plain on the other side.

Pirfenidone axunio 801 mg film-coated tablets are available in bottle packs containing one bottle of 90 film-coated tablets, in blister packs containing 63, 84 or 252 film-coated tablets, and in single-dose perforated blister packs containing 63x1, 84x1 or 252x1 film-coated tablet.

Only certain pack sizes may be marketed.

Marketing Authorization Holder

axunio Pharma GmbH
Van-der-Smissen-Straße 1
22767 Hamburg
Germany

Manufacturer Responsible

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

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

ELES
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 the Most Recent Review of this Leaflet:

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