Pirfenidone Vivanta 267 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Pirfenidone Vivanta 267 mg film-coated tablets EFG

Pirfenidone Vivanta 801 mg film-coated tablets EFG

Read the entire patient information leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only; do not give it to others, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if the adverse effects are not listed in this leaflet. See section 4.

Contents of the patient information leaflet

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

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

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

IPF is a disease in which lung tissues become inflamed and scarred over time, making it difficult to take deep breaths. Under these circumstances, the lungs have difficulty functioning properly. Pirfenidone helps reduce scarring and inflammation in the lungs, helping you breathe better.

2. What you need to know before starting Pirfenidone Vivanta

Do not take Pirfenidone Vivanta

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

Warnings and precautions

Talk to your doctor or pharmacist before starting pirfenidone

• You may experience increased sensitivity to sunlight (photosensitivity reaction) while taking pirfenidone. Avoid sun exposure (including UVA lamps) during treatment with pirfenidone. 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 antibiotics of the tetracycline group (e.g. doxycycline), which 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 pirfenidone. Tobacco may reduce the effect of pirfenidone.
• Pirfenidone may cause dizziness and fatigue. Be cautious when performing activities requiring 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 immediate medical attention if you notice any symptoms related to these serious 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 pirfenidone, once a month for the first 6 months, and then every 3 months thereafter while taking this medicine, to check that your liver is functioning properly. It is important that you have these blood tests performed regularly throughout the duration of your treatment with pirfenidone.

Children and adolescents

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

Other medicines and Pirfenidone Vivanta

Inform 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 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 conditions such as indigestion, gastroesophageal reflux disease),
• rifampicin (a type of antibiotic).

Taking Pirfenidone Vivanta with food and drink

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 using pirfenidone if you are pregnant, planning to become pregnant, or think you might 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 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 physicians experienced in the diagnosis and treatment of IPF.

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

You will normally be given this medicine with a gradually increasing 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),
• from days 8 to 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 onwards (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 daily 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, contact your doctor.

Dose reduction due to side effects

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 Pirfenidona Vivanta than you should

Contact your doctor, pharmacist, or the nearest hospital emergency department immediately if you take more tablets than you should, and bring your medication with you.

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

If you forget to take Pirfenidona 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 must be separated by a minimum interval of 3 hours. Do not take more tablets per day than your prescribed daily dose.

If you stop taking Pirfenidona Vivanta

In certain situations, your doctor may 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 at a dose of 267 mg three times a day and gradually increase it 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 pirfenidone and seek immediate medical attention 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 faint, which are signs of angioedema, a serious allergic reaction or anaphylaxis.
• 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 feeling tired. These could be signs of abnormal liver function and may indicate liver damage, which is an uncommon adverse effect of pirfenidone.
• Red, non-elevated spots, or circular rashes on the trunk, often with central blisters, skin peeling, 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, elevated body temperature, and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).

Other possible adverse effects are

If you experience any adverse effect, consult your doctor.

Very common adverse effects (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 heaviness,
• Weight loss,
• Decreased appetite,
• Difficulty sleeping,
• Fatigue,
• Dizziness,
• Headache,
• Shortness of breath,
• Cough,
• Joint pain.

Common adverse effects (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 adverse effects (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 adverse effect, talk to your doctor, pharmacist, or nurse, even if they are possible adverse effects not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaram.es. By reporting adverse 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 stated on the label of the bottle, on the blister pack, and on the carton, following EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE Point at your pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Pirfenidone Vivanta

Tablets of 267 mg

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

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

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

Tablets of 801 mg

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

The other components are: microcrystalline cellulose, sodium croscarmellose, hydroxypropyl cellulose, anhydrous colloidal 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

Tablets of 267 mg

The film-coated tablets are white, oval-shaped, marked with "M" on one side and "PF1" on the other side.

Packaged in HDPE bottles containing one bottle with 90 tablets or two bottles with 90 tablets each (180 tablets in total).

Pirfenidone Vivanta 267 mg is also available in blister packs containing 21, 42, 84 or 168 film-coated tablets, or in single-dose precut 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.

Tablets of 801 mg

The film-coated tablets are white, oval-shaped, marked with "M" on one side and "PF3" on the other side.

Packaged in HDPE bottles containing one bottle with 90 tablets.

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

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

Only certain pack sizes may be marketed.

Marketing Authorization Holder

Vivanta Generics s.r.o.
Trtinová 260/1, Cakovice
196 00 Prague 9
Czech Republic

Manufacturer Responsible
Pharmadox Healthcare Limited,
KW20A Kordin Industrial Park,
Paola, PLA3000,
Malta
or
MSN Labs Europe Limited,
KW20A Corradino Park,
Paola, PLA3000,
Malta

For further information on this medicinal product, please contact the local representative of the marketing authorization holder:

Local Representative:
Vivanta Generics s.r.o. Spanish Branch
C/Guzmán el Bueno, 133, edificio Britannia
28003 Madrid, Spain

This medicinal product 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 latest review of this leaflet: April 2024

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