Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - pirfenidone

Document Subject

Generated Narrative: MedicinalProductDefinition mp36a6a5465117f75ed9e0484773e74fde

identifier: http://ema.europa.eu/identifier/EU/1/22/1707/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Pirfenidone Viatris 267 mg film-coated tablets

type: Full name

part

part: nan

type: Invented name part

part

part: nan

type: Scientific name part

part

part: nan

type: Strength part

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part: nan

type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-36a6a5465117f75ed9e0484773e74fde

identifier: http://ema.europa.eu/identifier/EU/1/22/1707/001

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - pirfenidone

Attesters

What is in this leaflet

1. What Pirfenidone Viatris is and what it is used for
2. What you need to know before you take 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

Pirfenidone Viatris contains the active substance pirfenidone and it is used for the treatment of Idiopathic Pulmonary Fibrosis (IPF) in adults.

IPF is a condition in which the tissues in your lungs become swollen and scarred over time, and as a result makes it difficult to breathe deeply. This makes it hard for your lungs to work properly. Pirfenidone Viatris helps to reduce scarring and swelling in the lungs, and helps you breathe better.

Do not take Pirfenidone Viatris

• if you are allergic to pirfenidone or 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 affects you, do not take Pirfenidone Viatris. If you are unsure ask 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) when taking Pirfenidone Viatris.
• Avoid the sun (including sunlamps) whilst taking Pirfenidone Viatris. Wear sunblock 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 (such as doxycycline), which may make you more sensitive to sunlight.
• You should tell your doctor if you suffer from kidney problems.
• You should tell your doctor if you suffer from mild to moderate liver problems.
• You should stop smoking before and during treatment with Pirfenidone Viatris. Cigarette smoking can reduce the effect of Pirfenidone Viatris.
• Pirfenidone Viatris may cause dizziness and tiredness. Be careful if you have to take part in activities where you have to be alert and co-ordinated.
• Pirfenidone Viatris can cause weight loss. Your doctor will monitor your weight whilst you are taking this medicine.
• Stevens-Johnson syndrome and toxic epidermal necrolysis have been reported in association with pirfenidone treatment. Stop using Pirfenidone Viatris and seek medical attention immediately if you notice any of the symptoms related to these serious skin reactions described in section 4. Pirfenidone Viatris may cause serious liver problems and some cases have been fatal. You will need a blood test before you start taking Pirfenidone Viatris and at monthly intervals for the first 6 months and then every 3 months thereafter whilst you are taking this medicine to check whether your liver is working properly. It is important that you have these regular blood tests for as long as you are taking Pirfenidone Viatris

Children and adolescents Do not give Pirfenidone Viatris to children and adolescents under the age of 18. Other medicines and Pirfenidone Viatris 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 change the effect of Pirfenidone Viatris.

Medicines that may increase side effects of Pirfenidone Viatris:

• enoxacin (a type of antibiotic)
• ciprofloxacin (a type of antibiotic)
• amiodarone (used to treat some types of heart disease)
• propafenone (used to treat some types of heart disease)
• fluvoxamine (used to treat depression and obsessive compulsive disorder (OCD)).

Medicines that may reduce how well Pirfenidone Viatris works:

• omeprazole (used in the treatment of conditions such as indigestion, gastroesophageal reflux disease)
• rifampicin (a type of antibiotic).

Pirfenidone Viatris with food and drink Do not drink grapefruit juice whilst taking this medicine. Grapefruit may prevent Pirfenidone Viatris from working properly.

Pregnancy and breast-feeding As a precautionary measure, it is preferable to avoid the use of Pirfenidone Viatris if you are pregnant, planning to become pregnant or think you might be pregnant as the potential risks to the unborn child are unknown.

If you are breast-feeding or plan to breast-feed speak to your doctor or pharmacist before taking Pirfenidone Viatris. As it is unknown whether Pirfenidone Viatris passes into breast milk, your doctor will discuss the risks and benefits of taking this medicine while breast-feeding if you decide to do so.

Driving and using machines Do not drive or use machines if you feel dizzy or tired after taking Pirfenidone Viatris.

Pirfenidone Viatris contains sodium This medicine contains less than 1 mmol (23 mg) sodium per tablet, that is to say essentially 'sodium- free'.

Treatment with Pirfenidone Viatris should be started and overseen by a specialist doctor experienced in the diagnosis and treatment of IPF.

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Your medicine will usually be given to you in increasing doses 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
• from day 8 to 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 onwards (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 daily 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 tablets whole with a drink of water, during or after a meal to reduce the risk of side effects such as nausea (feeling sick) and dizziness. If symptoms continue, see your doctor.

Dose reduction due to side effects Your doctor may reduce your dose if you suffer from side effects such as, stomach problems, any skin reactions to sunlight or sun lamps, or significant changes to your liver enzymes.

If you take more Pirfenidone Viatris than you should Contact your doctor, pharmacist or nearest hospital casualty department immediately if you have taken more tablets than you should, and take your medicine with you.

If you forget to take Pirfenidone Viatris If you forget a dose, take it as soon as you remember. Do not take a double dose to make up for a forgotten dose. Each dose should be separated by at least 3 hours. Do not take more tablets each day than your prescribed daily dose.

If you stop taking Pirfenidone Viatris In some situations, your doctor may advise you to stop taking Pirfenidone Viatris. If for any reason you have to stop taking Pirfenidone Viatris for more than 14 consecutive days, your doctor will restart your treatment with dose of 267 mg 3 times a day, gradually increasing this to a dose of 801 mg 3 times a day. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Stop taking Pirfenidone Viatris and tell your doctor immediately

• If you experience swelling of the face, lips and/or tongue, itching, hives, difficulty breathing or wheezing, or feeling faint, which are signs of angioedema, a serious allergic reaction or anaphylaxis.
• If you experience yellowing of the eyes or skin, or dark urine, potentially accompanied by itching of the skin, pain on the upper right side of your stomach area (abdomen), loss of appetite, bleeding or bruising more easily than normal, or feeling tired. These may be signs of abnormal liver function and could indicate liver injury, which is an uncommon side effect of Pirfenidone Viatris.
• If you experience reddish non-elevated, or circular patches on the trunk, often with central blisters, skin peeling, ulcers of mouth, throat, nose, genitals and eyes. These serious skin rashes can be preceded by fever and flu-like symptoms. These signs and symptoms may indicate Stevens-Johnson syndrome or toxic epidermal necrolysis.

Other side effects may include Talk to your doctor if you get any side effects.

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

• infections of the throat or the airways going into the lungs and/or sinusitis
• feeling sick (nausea)
• stomach problems such as acid reflux, vomiting and feeling constipated
• tiredness
• diarrhoea
• indigestion or stomach upset
• weight loss
• decreased appetite
• difficulty sleeping
• headache
• dizziness
• shortness of breath
• cough
• aching joints/joint pains.

Common (may affect up to 1 in 10 people)

• bladder infections
• feeling sleepy
• changes in taste
• hot flushes
• stomach problems such as feeling bloated, abdominal pain and discomfort, heart burn and passing wind
• blood tests may show increased levels of liver enzymes
• skin reactions after going out in the sun or using sunlamps
• skin problems such as itchy skin, skin redness or red skin, dry skin, skin rash
• muscle pain
• feeling weak or feeling low in 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 tests may show decrease in white blood cells.

Reporting of side effects If you get any side effects, talk to your doctor or pharmacist This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

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 carton and blister after EXP. The expiry date refers to the last day of that month.

This medicinal product does not require any special storage conditions.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

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 Cellulose, microcrystalline (E 460) Croscarmellose sodium (E 468) (see section 2, Pirfenidone Viatris contains sodium ) Povidone (E 1201) Silica, colloidal anhydrous (E 551) Magnesium stearate (E 572)

Film coat Poly (vinyl alcohol) (E 1203) Titanium dioxide (E 171) Macrogol (E 1521) Talc (E 553b)

267 mg film-coated tablet Iron oxide yellow (E 172)

534 mg film-coated tablet Iron oxide yellow (E 172) Iron oxide red (E 172) 801 mg film-coated tablet Ferric oxide black (E 172) Iron oxide red (E 172)

What Pirfenidone Viatris looks like and contents of the pack

267 mg film-coated tablet Pirfenidone Viatris 267 mg film-coated tablets are yellow, oval, biconvex film-coated tablets. Pirfenidone Viatris is available in blister packs containing 63, 90 or 252 film-coated tablets, calendar packs containing 63 or 252 film-coated tablets or perforated unit dose blister packs containing 63 x 1 or 252 x 1 film-coated tablets.

The 267 mg blisters strips contained in the calendar packs are each marked with the following symbols and abbreviated names of the day as a reminder to take a dose three times a day:

MON. TUE. WED. THU. FRI. SAT. SUN.

534 mg film-coated tablet Pirfenidone Viatris 534 mg film-coated tablets are orange, oval, biconvex film-coated tablets. Pirfenidone Viatris is available in blister packs containing 21 or 84 film-coated tablets or perforated unit dose blister packs containing 21 x 1 film-coated tablets.

801 mg film-coated tablet Pirfenidone Viatris 801 mg film-coated tablets are brown, oval, biconvex film-coated tablets. Pirfenidone Viatris is available in blister packs containing 84, 90 or 252 film-coated tablets, calendar packs containing 84 film-coated tablets or perforated unit dose blister packs containing 84 x 1 film-coated tablets.

The 801 mg blisters strips contained in the calendar packs are each marked with the following symbols and abbreviated names of the day as a reminder to take a dose three times a day:

MON. TUE. WED. THU. FRI. SAT. SUN.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Viatris Limited Damastown Industrial Park Mulhuddart Dublin Dublin Ireland

Manufacturer

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

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

Belgi /Belgique/Belgien Mylan bvba/sprl T l/Tel: + 32 (0)2 658 61 Lietuva Mylan Healthcare UAB Tel: +370 5 205 1

.: +359 2 44 55 Luxembourg/Luxemburg Mylan bvba/sprl T l/Tel: + 32 (0)2 658 61 (Belgique/Belgien)

esk republika Viatris CZ s.r.o. Tel: + 420 222 004 Magyarorsz g Mylan EPD Kft. Tel.: + 36 1 465 2Danmark Viatris ApS Tlf: +45 28 11 69 Malta V.J. Salomone Pharma Ltd Tel: + 356 21 22 01 Deutschland Viatris Healthcare GmbH Tel: +49 800 0700 Nederland Mylan BV Tel: +31 (0)20 426 3Eesti BGP Products Switzerland GmbH Eesti filiaal Tel: + 372 6363 Norge Viatris AS Tlf: + 47 66 75 33
Generics Pharma Hellas
: +30 210 993 6 sterreich Arcana Arzneimittel GmbH Tel: +43 1 416 2Espa a Viatris Pharmaceuticals, S.L.U. Tel: + 34 900 102 Polska Mylan Healthcare Sp. z o.o. Tel.: + 48 22 546 64 France Viatris Sant
T l: +33 4 37 25 75 Portugal Mylan, Lda. Tel: + 351 214 127 Hrvatska Viatris Hrvatska d.o.o. Tel: +385 1 23 50 Rom nia BGP Products SRL Tel: +40 372 579 Ireland Mylan Ireland Limited Tel: +353 1 8711Slovenija Viatris d.o.o. Tel: + 386 1 23 63 sland Icepharma hf. S mi: +354 540 8Slovensk republika Viatris Slovakia s.r.o. Tel: +421 2 32 199 Italia Mylan Italia S.r.l. Tel: + 39 02 612 46Suomi/Finland Viatris Oy Puh/Tel: +358 20 720 9
Varnavas Hadjipanayis Ltd : +357 2220 7Sverige Viatris AB Tel: +46 (0)8 630 19 Latvija Mylan Healthcare SIA Tel: +371 676 055 United Kingdom (Northern Ireland) Mylan IRE Healthcare Limited Tel: +353 18711This leaflet was last revised in.

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site: