PIRFENIDONE VIVANTA 801 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Pirfenidone Vivanta 267 mg film-coated tablets EFG

Pirfenidone Vivanta 801 mg film-coated tablets EFG

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 further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Pirfenidone Vivanta and what is it used for
2. What you need to know before you take Pirfenidone Vivanta
3. How to take Pirfenidone Vivanta
4. Possible side effects

5 Storage of Pirfenidone Vivanta

1. Contents of the pack and further information

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

This medicinal product contains the active substance pirfenidone and is used for the treatment of Idiopathic Pulmonary Fibrosis (IPF).

IPF is a disease in which the lung tissue becomes thickened and scarred over time, making it difficult to breathe deeply. In these circumstances, the lungs have difficulty functioning properly. Pirfenidone helps reduce scarring and swelling of the lungs, and helps you breathe better.

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

Do not take Pirfenidone Vivanta

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take pirfenidone

• You may have increased sensitivity to sunlight (photosensitivity reaction) when taking pirfenidone. Avoid the sun (also UVA lamps) while taking pirfenidone. 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 tetracycline antibiotics (e.g., doxycycline), that may increase your sensitivity to sunlight.
• You should inform your doctor if you have kidney problems.
• You should inform your doctor if you have mild to moderate liver problems.
• You should avoid smoking before and during treatment with pirfenidone. Tobacco can reduce the effect of pirfenidone.
• Pirfenidone may cause dizziness and fatigue. Be careful if you need to perform activities that require attention and coordination.
• Pirfenidone may cause weight loss. Your doctor will monitor your weight while you are taking this medicine.
• Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS) have been reported in association with pirfenidone treatment. Stop taking pirfenidone and seek medical attention immediately if you notice any of the symptoms related to these severe skin reactions described in section 4.

Pirfenidone may cause serious liver problems. Some cases have been fatal. You will need to have a blood test before starting to take pirfenidone, once a month for the first 6 months, and then every 3 months while taking this medicine, to check your liver function. It is essential that you have these blood tests periodically throughout the time you are taking pirfenidone.

Children and adolescents

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

Other medicines and Pirfenidone Vivanta

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.

The following medicines may increase the side effects of pirfenidone:

• 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 pirfenidone:

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

Taking Pirfenidone Vivanta with food and drinks

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

Pregnancy and breastfeeding

As a precautionary measure, it is preferable to avoid the use of pirfenidone 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 breastfeeding or plan to breastfeed, consult your doctor or pharmacist before taking pirfenidone. Since it is not known whether pirfenidone 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 using machines

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

Pirfenidone Vivanta contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per tablet, i.e., essentially “sodium-free”.

3. How to take Pirfenidone Vivanta

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

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

Normally, you will be given this medicine by gradually increasing the dose as follows:

• for the first 7 days, take a dose of 267 mg (1 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 tablets of 267 mg), 3 times a day with food (a total of 1,602 mg/day),
• from day 15 (maintenance), take a dose of 801 mg (3 tablets of 267 mg or 1 tablet of 801 mg), 3 times a day with food (a total of 2,403 mg/day).

The recommended maintenance dose of pirfenidone is 801 mg (3 tablets of 267 mg or 1 tablet of 801 mg) 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, 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 Vivanta than you should

Go to your doctor, pharmacist, or the emergency department of the nearest hospital immediately if you take more tablets than you should, and take your medicine with you.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Pirfenidone Vivanta

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 Vivanta

In certain situations, your doctor will advise you to stop taking pirfenidone. If for any reason you stop taking pirfenidone 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 product, 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 and seek medical attention immediately if you notice any of the following symptoms or signs:

• Swelling of the face, lips, or tongue, itching, hives, difficulty breathing or wheezing, or feeling of fainting, which are signs of angioedema, a severe allergic reaction or anaphylaxis.
• Yellow eyes or skin, or dark urine, and possibly accompanied by itching of the skin, pain in the upper right side of the abdomen, loss of appetite, bleeding or bruising more easily than usual, or feeling tired. These could be signs of abnormal liver function and may indicate liver damage, which is a rare side effect of pirfenidone.
• Red patches without relief, or circular patches on the trunk, often with central blisters, skin peeling, ulcers in the mouth, throat, nose, genitals, and eyes. These severe skin rashes can be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome or toxic epidermal necrolysis).
• Widespread rash, high body temperature, and enlarged lymph nodes (DRESS or drug hypersensitivity syndrome).

Other possible side effects are

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

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

• infections of the throat or respiratory tract that reach the lungs and/or sinusitis,
• feeling unwell (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 side effects(may affect up to 1 in 10 people):

• bladder infections,
• drowsiness,
• altered taste,
• hot flashes,
• stomach problems, such as heaviness, pain, and discomfort, heartburn, and flatulence
• blood tests may indicate increased liver enzymes,
• skin reactions after sun exposure 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 side effects(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 cell count.

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines Surveillance System for Human Use: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Pirfenidone Vivanta

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 is the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicine in the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Contents of the pack and further information

Composition of Pirfenidone Vivanta

267 mg tablets

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

The other ingredients are: microcrystalline cellulose, sodium croscarmellose, hydroxypropyl cellulose, colloidal anhydrous silica, and magnesium stearate.

The coating material consists of: partially hydrolyzed polyvinyl alcohol, titanium dioxide, macrogol 4000, and talc.

801 mg tablets

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

The other ingredients are: microcrystalline cellulose, sodium croscarmellose, hydroxypropyl cellulose, colloidal anhydrous silica, and magnesium stearate.

The coating material consists of: partially hydrolyzed polyvinyl alcohol, titanium dioxide, macrogol 4000, and talc.

Appearance of the product and contents of the pack

267 mg tablets

The film-coated tablets are white, oval-shaped, engraved with “M” on one side of the tablet and with “PF1” on the other side.

Available in HDPE bottles containing 90 tablets or two bottles with 90 tablets each (180 tablets in total).

Pirfenidone Vivanta 267 mg is available in blister packs containing 21, 42, 84, or 168 film-coated tablets or in single-dose blister packs of 63 x 1 and 252 x 1 film-coated tablets.

Multiple packs contain 63 (starter pack for 2 weeks of treatment 21 + 42) or 252 (maintenance pack 3 x 84) film-coated tablets.

801 mg tablets

The film-coated tablets are white, oval-shaped, engraved with “M” on one side of the tablet and with “PF3” on the other side.

Available in HDPE bottles containing 90 tablets.

Pirfenidone Vivanta 801 mg is available in blister packs containing 84 film-coated tablets or in single-dose blister packs of 84 x 1 film-coated tablets.

The multiple pack contains 252 (maintenance pack 3 x 84) film-coated tablets.

Not all pack sizes may be marketed.

Marketing authorisation holder

Vivanta Generics s.r.o.

Trtinová 260/1, Cakovice

196 00 Praga 9

Czech Republic

Manufacturer

Pharmadox Healthcare Limited,

KW20A Kordin Industrial Park,

Paola, PLA3000,

Malta

Or

MSN Labs Europe Limited,

KW20A Corradino Park,

Paola, PLA3000,

Malta

You can request more information about this medicine by contacting the local representative of the marketing authorisation holder:

Local representative:

Vivanta Generics s.r.o., branch in Spain

C/Guzmán el Bueno, 133, Britannia building

28003 Madrid

This medicine is authorised in the Member States of the European Economic Area under the following names:

Cyprus: Pirfenidon MSN 267 mg, film-coated tablets

Pirfenidon MSN 801 mg, film-coated tablets

Denmark: Pirfenidone Vivanta

Finland: Pirfenidone Vivanta 267 mg kalvopäällysteiset tabletit

Pirfenidone Vivanta 801 mg kalvopäällysteiset tabletit

Spain: Pirfenidona Vivanta 267 mg comprimidos recubiertos con película EFG

Pirfenidona Vivanta 801 mg comprimidos recubiertos con película EFG

Portugal: Pirfenidona Vivanta

Germany: Pirfenidon Vivanta 267 mg Filmtabletten

Pirfenidon Vivanta 801 mg Filmtabletten

Netherlands: Pirfenidon Vivanta 267 mg filmomhulde tabletten

Pirfenidon Vivanta 801 mg filmomhulde tabletten

Norway: Pirfenidone Vivanta

Sweden: Pirfenidone Vivanta 267 mg filmdragerad tablet

Pirfenidone Vivanta 801 mg filmdragerad tablet

Date of last revision of this leaflet: April 2024

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/).