Pirfenidone Axunio

Package leaflet: Information for the user

Pirfenidone axunio 267 mg film-coated tablets, 534 mg film-coated tablets, 801 mg film-coated tablets

pirfenidone
Read this leaflet carefully before taking this medicine because it contains
important information for you.

• Keep this leaflet. 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. Do not give it to other people, even if their symptoms are the same as yours, because it may be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4. Contents of this leaflet:
  1. What Pirfenidone axunio is and what it is used for
  2. What you need to know before taking Pirfenidone axunio
  3. How to take Pirfenidone axunio
  4. Possible side effects
  5. How to store Pirfenidone axunio
  6. Contents of the pack and other information

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

Pirfenidone axunio contains the active substance pirfenidone and is used to treat
idiopathic pulmonary fibrosis (Idiopathic Pulmonary Fibrosis - IPF) in adult patients.
IPF is a disease in which lung tissue becomes inflamed and damaged over time,
leading to difficulty in breathing deeply. This makes it hard for the lungs to function properly. Pirfenidone axunio helps reduce lung damage and inflammation, and helps improve breathing.

2. What you should know before taking Pirfenidone axunio

Do not take Pirfenidone 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 experienced 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 conditions apply to you, do not take Pirfenidone axunio. If in doubt,
consult your doctor or pharmacist.
Warnings and precautions
Talk to your doctor or pharmacist before taking Pirfenidone axunio.

• you may become more sensitive to sunlight (photosensitivity reaction) while taking Pirfenidone axunio. Avoid sun exposure (including sunlamps) during treatment with Pirfenidone axunio. Apply 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), which may increase your sensitivity to sunlight.
• if you have kidney problems, inform your doctor.
• if you have mild to moderate liver problems, inform your doctor.
• stop smoking before and during treatment with Pirfenidone axunio. Cigarette smoking may reduce the effect of Pirfenidone axunio.
• Pirfenidone axunio may cause dizziness and fatigue. Be cautious if you need to perform activities requiring mental alertness and coordination.
• Pirfenidone axunio may cause weight loss. Your doctor will monitor your weight during treatment with this medicine.
• cases of Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS) have been reported during treatment with pirfenidone. If you notice any of the symptoms related to these serious skin reactions described in section 4, stop treatment with Pirfenidone axunio and contact a doctor immediately.

Pirfenidone axunio can cause serious liver problems, which in some cases have been fatal. You will need to have a blood test before starting Pirfenidone axunio, monthly for the first 6 months, and then every 3 months during treatment to monitor proper liver function. It is important that you attend these blood tests regularly while taking this medicine.
Children and adolescents
Do not give Pirfenidone axunio to children and adolescents under 18 years of age.
Other medicines and Pirfenidone axunio
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
This section is particularly important if you are taking the following medicines, as they may alter the effect of Pirfenidone axunio.
Medicines that may increase the side effects of Pirfenidone axunio:

• enoxacin (an antibiotic)
• ciprofloxacin (an antibiotic)
• amiodarone (used to treat certain heart conditions)
• propafenone (used to treat certain heart conditions)
• fluvoxamine (used to treat depression and obsessive-compulsive disorder [OCD])

Medicines that may reduce the effectiveness of Pirfenidone axunio:

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

Pirfenidone axunio with food and drink
Do not drink grapefruit juice while taking this medicine. Grapefruit may interfere with the proper action of Pirfenidone axunio.
Pregnancy and breastfeeding
As a precautionary measure, it is preferable to avoid using Pirfenidone axunio during pregnancy, or if you suspect you might be pregnant or are planning a pregnancy, as the potential risks to the fetus are unknown.
If you are breastfeeding or intend to breastfeed, consult your doctor or pharmacist before taking Pirfenidone axunio. Since it is not known whether Pirfenidone axunio passes into breast milk, your doctor will evaluate the risks and benefits of taking this medicine during breastfeeding if you decide to breastfeed.
Driving and using machines
Do not drive or operate machinery if you experience dizziness or fatigue 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 colourings
Pirfenidone axunio may cause allergic reactions.

3. How to take Pirfenidone axunio

Treatment with Pirfenidone axunio should be initiated and supervised by a physician experienced in the diagnosis and treatment of IPF.
Take this medicine exactly as prescribed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The medicine will usually be given to you in gradually increasing doses as follows:

• for the first 7 days, take a dose of 267 mg (1 yellow tablet) three times a day with food (for a 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 (for a total of 1,602 mg/day)
• from day 15 onwards (maintenance phase), take a dose of 801 mg (3 yellow tablets or 1 brown tablet) three times a day with food (for a total of 2,403 mg/day). The recommended maintenance daily dose of Pirfenidone axunio for patients with IPF is 801 mg (3 yellow tablets or 1 brown tablet) three times a day with food, for a total daily dose of 2,403 mg. Swallow the tablet whole with water during or after meals to reduce the risk of adverse effects such as nausea and dizziness. If symptoms persist, consult your doctor.
  Dose reduction due to adverse reactions
  Your doctor may reduce your dose if you experience adverse effects such as stomach problems, skin reactions to sunlight or sunlamps, or significant changes in liver enzymes.

If you take more Pirfenidone axunio than you should
If you have taken more tablets than prescribed, contact your doctor, pharmacist, or nearest emergency department immediately, and bring the 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 the missed dose. There must be at least three hours between doses. Do not take more tablets in one day than prescribed according to your daily dose.

If you stop taking Pirfenidone axunio
In certain specific cases, your doctor may advise you to stop taking Pirfenidone axunio. If for any reason you need to interrupt treatment with Pirfenidone axunio for more than 14 consecutive days, your doctor will restart treatment with a dose of 267 mg three times a day, gradually increasing the dose up to 801 mg three times a day.

If you have any questions about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Stop taking Pirfenidone axunio and contact your doctor immediately if you notice any of the following symptoms or signs:

• Swelling of the face, lips and/or tongue, itching, hives, difficulty breathing or shortness of breath, or a feeling of fainting, which are symptoms of angioedema, a serious allergic reaction or anaphylaxis.
• Yellowing of the whites of the eyes or skin, dark urine, possibly accompanied by skin itching, pain in the upper right part of the stomach area (abdomen), loss of appetite, increased tendency to bleeding or bruising, or feeling tired. These may be signs of impaired liver function and could indicate liver damage, which is an uncommon side effect of Pirfenidone axunio.
• Flat, red, circular rashes on the trunk, often with central blisters, skin peeling, or ulcers in the mouth, throat, nose, genitals, and eyes. These severe skin rashes may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome or toxic epidermal necrolysis).
• Widespread rash, high body temperature, and swollen lymph nodes (drug reaction with eosinophilia and systemic symptoms or drug hypersensitivity syndrome).

Other possible side effects include
Talk to your doctor if you notice any side effect.
Very common (affects more than 1 in 10 patients)

• throat or airway infections reaching the lungs and/or sinusitis
• feeling unwell (nausea)
• stomach problems such as acid reflux, vomiting, and constipation
• diarrhoea
• indigestion or stomach discomfort
• weight loss
• decreased appetite
• sleep disturbances
• fatigue
• dizziness
• headache
• shortness of breath
• cough
• painful joints/joint pain

Common (affects up to 1 in 10 patients)

• bladder infections
• drowsiness
• changes in taste
• hot flushes
• stomach problems such as bloating, abdominal pain and discomfort, heartburn, and flatulence
• blood tests may show increased levels of liver enzymes
• skin reactions after exposure to sunlight or use of sunlamps
• skin problems such as itching, redness, dry skin, rash
• muscle pain
• feeling weak or lacking energy
• chest pain
• sunburn

Uncommon (may affect up to 1 in 100 patients)

• low levels of sodium in the blood, which may cause headache, dizziness, confusion, weakness, muscle cramps, or nausea and vomiting.
• blood tests may show a reduction in white blood cells. Reporting of side effects If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store 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 Scad./EXP. The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Pirfenidone axunio contains
267 mg tablets
The active substance is pirfenidone. Each coated tablet contains 267 mg of pirfenidone.
The other ingredients are: mannitol, croscarmellose sodium, povidone, microcrystalline cellulose,
anhydrous colloidal silica, sodium stearil fumarate.
Tablet coating: partially hydrolysed 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 coated tablet contains 534 mg of pirfenidone.
The other ingredients are: mannitol, croscarmellose sodium, povidone, microcrystalline cellulose,
anhydrous colloidal silica, sodium stearil fumarate.
Tablet coating: partially hydrolysed polyvinyl alcohol (E1203), titanium dioxide (E171),
macrogol 3350 (E1521), talc (E553b) and sunset yellow aluminium lake FCF (E110).
801 mg tablets
The active substance is pirfenidone. Each coated tablet contains 801 mg of pirfenidone.
The other ingredients are: mannitol, croscarmellose sodium, povidone, microcrystalline cellulose,
anhydrous colloidal silica, sodium stearil fumarate.
Tablet coating: partially hydrolysed polyvinyl alcohol (E1203), titanium dioxide (E171),
macrogol 3350 (E1521), talc (E553b), red iron oxide (E172) and black iron oxide (E172).

Description of the appearance of Pirfenidone axunio and package contents
267 mg tablets
Pirfenidone axunio 267 mg film-coated tablets are yellow, oval, biconvex tablets, with the imprint “LP2” on one side and smooth on the other.
Pirfenidone axunio 267 mg film-coated tablets are available in bottles containing one bottle of 90 film-coated tablets, in blisters containing 63 or 252 film-coated tablets, and in unit-dose divisible blisters containing 63x1 or 252x1 film-coated tablet.
534 mg tablets
Pirfenidone axunio 534 mg film-coated tablets are orange, oval, biconvex tablets, with the imprint “LP5” on one side and smooth on the other.
Pirfenidone axunio 534 mg film-coated tablets are available in blisters containing 252 film-coated tablets and in unit-dose divisible blisters containing 252x1 film-coated tablet.
801 mg tablets
Pirfenidone axunio 801 mg film-coated tablets are brown, oval, biconvex tablets, with the imprint “LP8” on one side and smooth on the other.
Pirfenidone axunio 801 mg film-coated tablets are available in bottles containing one bottle of 90 tablets, in blisters containing 63, 84 or 252 film-coated tablets, and in unit-dose divisible blisters containing 63x1, 84x1 or 252x1 film-coated tablet.
Not all pack sizes may be 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

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
AT/BE/BG/CZ/CY/DE/EE/ES/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
EL/IT
ELPEN PHARMACEUTICAL CO., INC Bruno Farmaceutici S.p.A.
Tel: +30 210 6039326 Tel: +39 06 6050601
IE
ROWA Pharmaceuticals Ltd.
Tel: +353 27 50077
NL
Prolepha Research B.V.
Tel: +31 (0)76 596 4009

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