Pirfenidone Viatris

Package leaflet: Information for the user

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

pirfenidone
Please read all of this leaflet carefully before you start 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 side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet

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

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

Pirfenidone Viatris 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 tissues become inflamed and damaged over time, making it difficult to breathe deeply. This impairs the proper functioning of the lungs. Pirfenidone Viatris helps reduce lung damage and inflammation, and helps improve breathing.

2. What you should know before taking Pirfenidone Viatris

Do not take Pirfenidone Viatris

• 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 Viatris. If in doubt, consult your
doctor or pharmacist.
Warnings and precautions
Talk to your doctor or pharmacist before taking Pirfenidone Viatris

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

Pirfenidone Viatris can cause serious liver problems, which in some cases have been fatal. You will need to have a blood test before starting Pirfenidone Viatris, 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 regular blood tests while taking Pirfenidone Viatris.
Children and adolescents
Do not administer Pirfenidone Viatris to children and adolescents under 18 years of age.
Other medicines and Pirfenidone Viatris
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
This is particularly important if you are taking the following medicines, as they may alter the effect of Pirfenidone Viatris.
Medicines that may increase the side effects of Pirfenidone Viatris:

• enoxacin (a type of antibiotic)
• ciprofloxacin (a type of 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 Viatris:

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

Pirfenidone Viatris with food and drink
Do not drink grapefruit juice while taking this medicine. Grapefruit may interfere with the proper action of Pirfenidone Viatris.
Pregnancy and breastfeeding
As a precautionary measure, it is preferable to avoid using Pirfenidone Viatris 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 Viatris. Since it is not known whether Pirfenidone Viatris passes into breast milk, your doctor will evaluate the risks and benefits of taking this medicine while breastfeeding.
Driving and using machines
Do not drive or operate machinery if you experience dizziness or fatigue after taking Pirfenidone Viatris.
Pirfenidone Viatris contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially 'sodium-free'.

3. How to take Pirfenidone Viatris

Treatment with Pirfenidone Viatris must be initiated and supervised by a physician experienced in the diagnosis and treatment of IPF.
Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The medicine will usually be introduced at 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), 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 daily maintenance dose of Pirfenidone Viatris 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 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 reactions such as stomach problems, skin reactions to sunlight or sunlamps, or significant changes in liver enzymes.
If you take more Pirfenidone Viatris 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 Viatris
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 the daily dose.
If you stop taking Pirfenidone Viatris
In certain specific cases, your doctor may advise you to stop taking Pirfenidone Viatris. If you need to stop treatment with Pirfenidone Viatris for more than 14 consecutive days for any reason, your doctor will restart treatment with a dose of 267 mg three times a day, gradually increasing this 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

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
Stop taking Pirfenidone Viatris and contact your doctor immediately:

• if you experience swelling of the face, lips and/or tongue, itching, hives, breathing difficulties or shortness of breath, or a feeling of fainting, which are symptoms of angioedema, a serious allergic reaction or anaphylaxis.
• if you notice yellowing of the whites of the eyes or skin, or dark urine, possibly accompanied by skin itching, pain in the upper right part of the stomach area (abdomen), loss of appetite, increased tendency to bleed or bruise, or feeling tired. These may be signs of liver function impairment and could indicate liver damage, which is an uncommon side effect of Pirfenidone Viatris.
• if you develop flat, red, circular rashes on the trunk, often with central blisters, skin peeling, or ulcers in the mouth, throat, nose, genitals, or eyes. These severe skin reactions may be preceded by fever and flu-like symptoms. These signs and symptoms may indicate the onset of Stevens-Johnson syndrome or toxic epidermal necrolysis.

Other side effects may include
Talk to your doctor if you notice any side effect.
Very common (may affect more than 1 in 10 people):

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

Common (may affect up to 1 in 10 people):

• bladder infections
• drowsiness
• altered taste
• hot flushes
• stomach problems such as bloating, pain and abdominal discomfort, heartburn, and flatulence
• blood tests may show increased liver enzyme levels
• 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 people):

• 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 Viatris

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after
Exp./EXP. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
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 Viatris contains
The active substance is pirfenidone. Each film-coated tablet contains 267 mg, 534 mg, or
801 mg of pirfenidone.
The other ingredients are:
Tablet core
Microcrystalline cellulose (E460)
Sodium croscarmellose (E468) (see section 2 “Pirfenidone Viatris contains sodium”)
Povidone (E1201)
Anhydrous colloidal silica (E551)
Magnesium stearate (E572)
Tablet coating
Polyvinyl alcohol (E1203)
Titanium dioxide (E171)
Macrogol (E1521)
Talc (E553b)
267 mg film-coated tablet
Yellow iron oxide (E172)
534 mg film-coated tablet
Yellow iron oxide (E172)
Red iron oxide (E172)
801 mg film-coated tablet
Black iron oxide (E172)
Red iron oxide (E172)

Description of the appearance of Pirfenidone Viatris and package contents
267 mg film-coated tablet
Pirfenidone Viatris 267 mg film-coated tablets are yellow, oval, biconvex.
Pirfenidone Viatris is available in blisters containing 63, 90 or 252 film-coated tablets, calendar blister packs containing 63 or 252 film-coated tablets, or unit-dose perforated blisters containing 63 x 1 or 252 x 1 film-coated tablets.
The blister strips for the 267 mg tablets contained in calendar packs are marked with the following symbols and abbreviated day names as a reminder to take a dose three times daily.

MON. TUE. WED. THU. FRI. SAT. SUN.
534 mg film-coated tablet
Pirfenidone Viatris 534 mg film-coated tablets are orange, oval, biconvex.
Pirfenidone Viatris is available in blisters containing 21 or 84 film-coated tablets or unit-dose perforated blisters containing 21 x 1 film-coated tablets.
801 mg film-coated tablet
Pirfenidone Viatris 801 mg film-coated tablets are brown, oval, biconvex.
Pirfenidone Viatris is available in blisters containing 84, 90 or 252 film-coated tablets, calendar blister packs containing 84 film-coated tablets, or unit-dose perforated blisters containing 84 x 1 film-coated tablets.
The blister strips for the 801 mg tablets contained in calendar packs are marked with the following symbols and abbreviated day names as a reminder to take a dose three times daily.

MON. TUE. WED. THU. FRI. SAT. SUN.
It is possible that not all pack sizes are marketed.

Marketing Authorization Holder
Viatris Limited
Damastown Industrial Park
Mulhuddart
Dublin 15
Dublin
Ireland

Manufacturer
Laboratorios Liconsa S.A.
Avda. Miralcampo, 7
Polígono Industrial Miralcampo
19200 Azuqueca de Henares
Guadalajara
Spain

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:
België/Belgique/Belgien Lietuva
Mylan bvba/sprl Mylan Healthcare UAB
Tél/Tel: + 32 (0)2 658 61 00 Tel: +370 5 205 1288
България Luxembourg/Luxemburg
Майлан ЕООД Mylan bvba/sprl
Тел.: +359 2 44 55 400 Tél/Tel: + 32 (0)2 658 61 00
(Belgique/Belgien)
Česká republika Magyarország
Viatris CZ s.r.o. Mylan EPD Kft.
Tel: + 420 222 004 400 Tel.: + 36 1 465 2100
Danmark Malta
Viatris ApS V.J. Salomone Pharma Ltd
Tlf: +45 28 11 69 32 Tel: + 356 21 22 01 74
Deutschland Nederland
Viatris Healthcare GmbH Mylan BV
Tel: +49 800 0700 800 Tel: +31 (0)20 426 3300
Eesti Norge
BGP Products Switzerland GmbH Eesti Viatris AS
filiaal Tlf: + 47 66 75 33 00
Tel: + 372 6363 052
Ελλάδα Österreich
Generics Pharma Hellas ΕΠΕ Arcana Arzneimittel GmbH
Τηλ: +30 210 993 6410 Tel: +43 1 416 2418
España Polska
Viatris Pharmaceuticals, S.L.U. Mylan Healthcare Sp. z o.o.
Tel: + 34 900 102 712 Tel.: + 48 22 546 64 00
France Portugal
Viatris Santé Mylan, Lda.
Tél: +33 4 37 25 75 00 Tel: + 351 214 127 200
Hrvatska România
Viatris Hrvatska d.o.o. BGP Products SRL
Tel: +385 1 23 50 599 Tel: +40 372 579 000
Irlanda Slovenija
Mylan Ireland Limited Viatris d.o.o.
Tel: +353 1 8711600 Tel: + 386 1 23 63 180
Ísland Slovenská republika
Icepharma hf. Viatris Slovakia s.r.o.
Sími: +354 540 8000 Tel: +421 2 32 199 100
Italia Suomi/Finland
Mylan Italia S.r.l. Viatris Oy
Tel: + 39 02 612 46921 Puh/Tel: +358 20 720 9555
Κύπρος Sverige
Varnavas Hadjipanayis Ltd Viatris AB
Τηλ: +357 2220 7700 Tel: +46 (0)8 630 19 00
Latvija United Kingdom (Northern Ireland)
Mylan Healthcare SIA Mylan IRE Healthcare Limited
Tel: +371 676 055 80 Tel: +353 18711600

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