Product Information for the Patient

Pirfenidona Vivanta 267 mg Film-Coated Tablets

Pirfenidona Vivanta 801 mg Film-Coated Tablets

Read this entire product information carefully before starting to take this medicine because it contains important information for you.

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

5Storage of Pirfenidona Vivanta

6.Contents of the package and additional information

This medication contains the active ingredient pirfenidona and is used for the treatment of Idiopathic Pulmonary Fibrosis (IPF).

IPF is a disease in which the lung tissues become swollen and filled with scars over time, making it difficult to breathe deeply. In these circumstances, the lungs have trouble functioning correctly. Pirfenidona helps to reduce lung scars and swelling, and helps you breathe better.

Do not take Pirfenidona Vivanta

• if you are allergic to pirfenidona or any of the other components of this medication (listed in section 6),
• if you have previously had angioedema with pirfenidona, 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 medication 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 pirfenidona. If you have any doubts, consult your doctor or pharmacist.

Warnings and precautions

Consult your doctor or pharmacist before starting to take pirfenidona

• You may be more sensitive to sunlight (phototoxicity reaction) when taking pirfenidona. Avoid the sun (also UVA lamps) while taking pirfenidona. Use daily sun protection cream and cover your arms, legs, and head to reduce exposure to sunlight (see section 4: Possible side effects).
• You should not take other medications, such as tetracycline antibiotics (e.g. doxycycline), that 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 should avoid smoking before and during treatment with pirfenidona. Tobacco may reduce the effect of pirfenidona.
• Pirfenidona may cause dizziness and fatigue. Be careful if you have to perform activities that require attention and coordination.
• Pirfenidona may cause weight loss. Your doctor will monitor your weight while you are taking this medication.
• Severe skin reactions, such as Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported in association with pirfenidona treatment. Stop taking pirfenidona and seek medical attention immediately if you notice any symptoms related to these severe skin reactions described in section 4.

Pirfenidona may cause severe liver problems. Some cases have been fatal. You will need to have blood tests before starting to take pirfenidona, once a month for the first 6 months, and then every 3 months while taking this medication, to check the proper functioning of your liver. It is essential that you have these blood tests periodically throughout the time you are taking pirfenidona.

Children and adolescents

Do not administer pirfenidona to children and adolescents under 18 years old.

Other medications and Pirfenidona Vivanta

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

This is especially important if you are taking the following medications, as they may alter the effect of pirfenidona.

The following medications may increase the side effects of pirfenidona:

• enoxacina (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 medications may reduce the effectiveness of pirfenidona:

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

Taking Pirfenidona Vivanta with food and drinks

Do not drink grapefruit juice while taking this medication. Grapefruit juice may make pirfenidona not work correctly.

Pregnancy and breastfeeding

As a precaution, it is recommended to avoid using pirfenidona if you are pregnant, planning to become pregnant, or think you may be pregnant, as the potential risks to the fetus are unknown.

If you are breastfeeding or plan to do so, talk to your doctor or pharmacist before taking pirfenidona. As it is not known whether pirfenidona is excreted in breast milk, your doctor will explain the risks and benefits of taking this medication during breastfeeding if you decide to do so.

Driving and operating machinery

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

Pirfenidona Vivanta contains sodium

This medication contains less than 23 mg of sodium (1 mmol) per tablet, i.e., it is essentially "sodium-free".

Pirfenidona treatment should be initiated and supervised by specialist doctors with experience in diagnosing and treating FPI.

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

This medication is usually administered by gradually increasing the dose as follows:

• During 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 daily maintenance dose of pirfenidona is 801 mg (3 tablets of 267 mg or 1 tablet of 801 mg) three times a day with food, 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 of discomfort) and dizziness. If symptoms persist, consult 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 UV-A lamps, or significant changes in liver enzymes.

If you take more Pirfenidona Vivanta than you should

Go to 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 Toxicological Information Service, phone: 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 compensate for the missed doses. Each dose should be separated by a minimum interval of 3 hours. Do not take more tablets per day than correspond to your prescribed daily dose.

If you interrupt treatment with Pirfenidona Vivanta

In certain situations, your doctor will advise you to stop taking pirfenidona. If for any reason you stop taking pirfenidona for more than 14 consecutive days, the 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 other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine may cause side effects, although not everyone will experience 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 a 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, abdominal pain on the upper right side, 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 a rare side effect of pirfenidone.
• Flat, red patches, or circular patches on the trunk, often with central blisters, skin peeling, ulcers in the mouth, throat, nose, genitals, and eyes. These severe skin eruptions may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome or toxic epidermal necrolysis).
• Generalized rash, elevated body temperature, and enlargement of lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).

Other possible side effects are

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

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

• Throat or respiratory tract infections that reach the lungs and/or sinusitis,
• Unpleasant feeling (nausea),
• Stomach problems, such as acid reflux, vomiting, and constipation,
• Dysentery,
• Indigestion or stomach heaviness,
• Weight loss,
• Loss of appetite,
• Difficulty sleeping,
• Tiredness,
• Dizziness,
• Headache,
• Difficulty breathing,
• Cough,
• Joint pain.

Frequent side effects(may affect up to 1 in 10 people):

• Urinary tract infections,
• Drowsiness,
• Alteration of taste,
• Headaches,
• Stomach problems, such as feeling heavy, pain, and abdominal discomfort, stomach burning, and flatulence
• Blood tests may indicate elevated liver enzymes,
• Skin reactions after exposure to the sun or use of UVA lamps,
• Cutaneous problems such as itching, irritation, or redness, dryness, rash,
• Muscle pain,
• Weakness or lack of energy,
• Chest pain,
• Sunburn.

Rare side effects(may affect up to 1 in 100 people):

• Low sodium levels in the blood. This can cause headache, dizziness, confusion, muscle cramps, nausea, and vomiting.
• Lab test results may show a decrease in white blood cells.

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the label of the bottle, on the blister pack, and on the box after CAD. The expiration date is the last day of the month indicated.

This medication does not require special conditions for conservation.

Medications should not be disposed of through drains or in the trash. Dispose of the containers and medications you no longer need at the SIGRE collection point at the pharmacy.Ask your pharmacist how to dispose of the containers and medications you no longer need if you are unsure. By doing so, you will help protect the environment.

Pirfenidone Vivanta Composition

267 mg Film-Coated Tablets

The active ingredient 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.

801 mg Film-Coated Tablets

The active ingredient 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 Package

267 mg Film-Coated 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.

Presented in an HDPE bottle with a bottle 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 pre-cut blister packs of 63 x 1 and 252 x 1 film-coated tablets.

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

801 mg Film-Coated 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.

Presented in an HDPE bottle with a bottle containing 90 tablets.

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

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

Only some pack sizes may be marketed.

Marketing Authorization Holder

Vivanta Generics s.r.o.

Trtinová 260/1, Cakovice

196 00 Prague 9

Czech Republic

Responsible Person

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 authorization holder:

Local Representative:

Vivanta Generics s.r.o. subsidiary in Spain

C/Guzmán el Bueno, 133, edificio Britannia

28003 Madrid

This medicine is authorized in the member states of the European Economic Area with 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

SpainPirfenidona 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

Last review date of this leaflet: April 2024

The detailed information about this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/).