Package Insert: Information for the Patient

Pirfenidona Zentiva 267 mg Film-Coated Tablets

Pirfenidona Zentiva 801 mg Film-Coated Tablets

Read this package insert carefully before you start taking this medicine, because it contains important information for you.

• Keep this package insert, 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, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this package insert. See section 4.

Pirfenidona Zentiva contains the active ingredient pirfenidona and is used for the treatment of Idiopathic Pulmonary Fibrosis (IPF) in adults.

IPFis a disease in which the tissues of the lungs become inflamed 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 the scarring and inflammation of the lungs, and helps you breathe better.

Do not take Pirfenidona Zentiva

• if you are allergic to pirfenidona or any of the other ingredients in this medicine(listed in section 6)
• if you have 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 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 pirfenidona. If you are unsure, consult your doctor or pharmacist.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to take pirfenidona.

• You may be more sensitive to sunlight (photosensitivity reaction) when taking pirfenidona. Avoid the sun (also UVA lamps) while taking this medicine. Use daily sun protection cream 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.
• Inform your doctor if you have kidney problems.
• Inform your doctor if you have mild to moderate liver problems.
• Avoid smoking before and during treatment with pirfenidona. Smoking may reduce the effect of this medicine.
• 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 medicine.
• 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 using this medicine and seek medical attention immediately if you notice any of the symptoms related to 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 this medicine, once a month for the first 6 months, and then every 3 months while taking this medicine, to check the proper functioning of your liver. It is essential to have these blood tests regularly throughout the time you are taking pirfenidona.

Children and adolescents

The administration of pirfenidona is not recommended in children and adolescents under 18 years.

Other medicines and Pirfenidona Zentiva

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

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

The following medicines 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 medicines 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 Zentiva with food and drinks

Do not drink grapefruit juice while taking this medicine. Grapefruit juice may make this medicine not work properly.

Pregnancy and breastfeeding

As a precaution, it is recommended to avoid using this medicine 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 breastfeed, talk to your doctor or pharmacist before taking this medicine. As it is not known whether pirfenidona 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 operating machines

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

Pirfenidona Zentiva contains lactose and sodium

This medicine contains lactose. If your doctor has told you that you have a certain sugar intolerance, consult with them before taking this medicine.

This medicine contains less than 1mmol of sodium (23 mg) per tablet; this is essentially "sodium-free".

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

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

Normally, you will be administered this medication by gradually increasing the dose as follows:

• During 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)
• Between days 8 and 14, take a dose of 534 mg (2 yellow tablets), 3 times a day with food (a total of 1.602 mg/day)
• From day 15 (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 daily maintenance dose of pirfenidone is 801 mg (3 yellow tablets or 1 brown tablet) 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.

Reduction of the dose 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 Pirfenidone Zentiva 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.

You can also call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Pirfenidone Zentiva

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 the treatment withPirfenidone Zentiva

In certain situations, your doctor will advise you to stop taking pirfenidone. If for any reason you stop taking this medication 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 can 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, rashes, 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, stomach pain, 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 this medicine.
• Flat, circular, non-elevated red spots on the trunk, often with central blisters, skin peeling, mouth ulcers, throat, nose, genital, and eye ulcers. These severe skin eruptions may be preceded by fever and symptoms similar to the flu (Stevens-Johnson syndrome or toxic epidermal necrolysis).
• Generalized rash, elevated body temperature, and enlarged 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
• Changes in taste
• Headaches
• Stomach problems such as bloating, abdominal pain, and discomfort, stomach burning, and flatulence
• Blood tests may indicate elevated liver enzymes
• Skin reactions after exposure to the sun 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.

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

• Low sodium levels in the blood. This can cause headaches, dizziness, confusion, muscle cramps, nausea, and vomiting.
• Lab test results may show decreased white blood cell counts.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, 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 Pharmacovigilance of Medicines for Human Use:https://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, blister pack, and box after “CAD”/”EXP”. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of through drains or in the trash.Deposit the packaging and medications you no longer need at the SIGRE point of your pharmacy.If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Pirfenidona Zentiva

Tablets of 267 mg

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

The other components are: lactose, sodium croscarmellose, anhydrous colloidal silica, magnesium stearate.

The film coating consists of: polyvinyl alcohol, titanium dioxide (E171), macrogol, talc, yellow iron oxide (E172).

Tablets of 801 mg

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

The other components are: lactose, sodium croscarmellose, anhydrous colloidal silica, magnesium stearate.

The film coating consists of: polyvinyl alcohol, titanium dioxide (E171), macrogol, talc, red iron oxide (E172) and black iron oxide (E172).

Appearance of the product and contents of the package

Tablets of 267mg

Pirfenidona Zentiva 267mg film-coated tablets are yellow, oval, biconvex, film-coated tablets, printed with “267”.

The blisters contain 63 film-coated tablets (blisters of 63 film-coated tablets or composite blister pack consisting of 1 blister containing 21 film-coated tablets and 1 blister containing 42 film-coated tablets) or 252 film-coated tablets (blisters of 252 film-coated tablets or composite blister pack consisting of 3 blisters, each containing 84 film-coated tablets).

Tablets of 801 mg

Pirfenidona Zentiva 801 mg film-coated tablets are brown, oval, biconvex, film-coated tablets, printed with “801”.

The blisters contain 84 film-coated tablets or 252 film-coated tablets (blisters of 252 film-coated tablets or composite blister pack consisting of 3 blisters of 84 film-coated tablets each).

Only some package sizes may be marketed.

Marketing authorization holder and manufacturer responsible

Marketing authorization holder

Zentiva, k.s.

U kabelovny 130,

Dolni Mecholupy, 102 37

Prague 10,

Czech Republic

Manufacturer responsible

Rontis Hellas Medical and Pharmaceutical

Products S.A.

P.O. Box 3012 Larisa Industrial Area,

Larisa, 41004, Greece

or

For more information about this medicine, please contact the local representative of the marketing authorization holder:

Zentiva Spain S.L.U.

Avenida de Europa, 19, Edificio 3, Planta 1.

28224 Pozuelo de Alarcón, Madrid

Spain

This medicine is authorized in the Member States of the European Economic Area with the following names:

Last review date of this leaflet:August 2023

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