Package Insert: Information for the Patient

Pirfenidona Tarbis 267 mg Film-Coated Tablets

Pirfenidona Tarbis 801 mg Film-Coated Tablets

Read this package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication 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 package insert. See section 4.

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

2.What you need to know before starting to take Pirfenidona Tarbis

3.How to take Pirfenidona Tarbis

4.Possible adverse effects

5.Storage of Pirfenidona Tarbis

6.Contents of the package and additional information

This medicationcontains the active ingredient pirfenidona and is used for the treatment of Idiopathic Pulmonary Fibrosis (IPF) in adults.

IPF is 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.Pirfenidonahelps to reduce scarring and inflammation of the lungs, and helps you breathe better.

Do not take Pirfenidona Tarbis

• if you are allergic to pirfenidona or any of the other ingredients of 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 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 (photosensitivity 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).

•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.

•Do not smoke before and during treatment with pirfenidona. Smoking 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 medicine.

•Stevens-Johnson syndrome and toxic epidermal necrolysis have been reported in association with pirfenidona treatment. Stop taking pirfenidona and seek medical attention immediately if you notice any of the 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 a blood test before starting to take pirfenidona, once a month for the first 6 months, and then every 3 months while you are taking this medicine, to check the proper functioning of your liver. It is essential that you have these blood tests regularly throughout the time you are taking pirfenidona.

Children and adolescents

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

Other medicines and Pirfenidona Tarbis

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 Tarbis with food and drinks

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

Pregnancy and breastfeeding

As a precaution, it is preferable to avoid the use of 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, speak with 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 medicine 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 Tarbis contains sodium

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

The treatment withpirfenidoneshould be initiated and supervised by specialist doctors with experience in the diagnosis and treatment of FPI.

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:

•for the first 7 days, take a dose of 267 mg (1 white 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 white 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 white tablets or 1 red tablet), 3 times a day with food (a total of 2.403 mg/day).

The recommended daily maintenance dose ofpirfenidoneis 801 mg (3 white tablets or 1 red tablet) three times a day with food, a total of 2403 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 Tarbis 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 Pirfenidone Tarbis

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 Pirfenidone Tarbis

In certain situations, your doctor will advise you to stop takingpirfenidone. If for any reason you stop takingpirfenidonefor 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 takingpirfenidoneand inform your doctor immediately

•If you experience 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.

•If you notice that your eyes or skin are yellow in color, or your urine is dark, and possibly accompanied by itching of the skin, stomach pain, loss of appetite, bleeding, or bruising more easily than normal, or you feel tired. These could be signs of abnormal liver function and may indicate liver damage, which is a rare side effect ofpirfenidone.

•If you experience flat, red patches, or circular patches 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 flu-like symptoms. These signs and symptoms may indicate Stevens-Johnson syndrome or toxic epidermal necrolysis.

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

•Diarrhea

•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 an increase in 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 may cause headache, dizziness, confusion, weakness, muscle cramps, or nausea and vomiting.

•Blood test results may show a decrease in white blood cells.

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 leaflet. You can also report directly through the Spanish System for Pharmacovigilance of Medicines for Human Use website: 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. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. By doing so, you will help protect the environment.

Pirfenidona Tarbis Composition

The active ingredient is pirfenidona.

Each film-coated tablet contains 267 mg of pirfenidona.

Each film-coated tablet contains 801 mg of pirfenidona.

The other components are:microcrystalline cellulose, povidone K-30 (E1201), croscarmellose sodium, anhydrous colloidal silica, magnesium stearate.

The film coating consists of:partially hydrolyzed poly(vinyl alcohol), titanium dioxide (E171), macrogol 3350, talc, iron oxide red (E172) (only for 801 mg film-coated tablets).

Product appearance and packaging contents

Pirfenidona Tarbis 267 mg film-coated tablets EFG

Film-coated tablets, 13.20 x 6.40 mm, white, oval, biconvex, engraved with "P16" on one side and "H" on the other side.

Pirfenidona Tarbis 801 mg film-coated tablets EFG

Film-coated tablets, 20.20 x 9.30 mm, oval, biconvex, red, engraved with "P17" on one side and "H" on the other side.

Packaging with opaque white Alu-PVC/Aclar blister that contains 21, 63, 84, 90, and 252 film-coated tablets and in perforated single-dose blister that contains 21 x 1, 63 x 1, 84 x 1, 90 x 1, and 252 x 1 film-coated tablets.

HDPE bottle with child-resistant closure (polpropylene) that contains 21, 63, 84, 90, and 252 film-coated tablets.

Only some packaging sizes may be commercially available.

Marketing authorization holder

Tarbis Farma S.L.

Gran Vía Carlos III, 94

08028 Barcelona

Spain

Responsible for manufacturing

Amarox Pharma B.V.

Rouboslaan 32

Voorschoten, 2252TR

Netherlands

This medicinal product is authorized in the member states of the European Economic Area with the following names:

GermanyPirfenidon Amarox 267 mg/801 mg Filmtabletten

NetherlandsPirfenidon Amarox 267 mg/801 mg, filmomhulde tabletten

SpainPirfenidona Tarbis 267 mg/801 mg film-coated tablets EFG

Last review date of this leaflet: 02/2024

Further information on this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/