Pirfenidone Tarbis 801 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Pirfenidone Tarbis 267 mg film-coated tablets EFG

Pirfenidone Tarbis 801 mg film-coated tablets EFG

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

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

Leaflet contents:

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

1. What Pirfenidona Tarbis 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) in adults.

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

2. What you need to know before taking Pirfenidone Tarbis

Do not take Pirfenidone Tarbis

• if you are allergic to pirfenidone or to any of the other ingredients of this medicine (listed in section 6)
• if you have previously experienced 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 become more sensitive to sunlight (photosensitivity reaction) while taking pirfenidone. Avoid sunlight (including UV lamps) while taking pirfenidone. Use 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 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 and toxic epidermal necrolysis 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 monitor your liver function. 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 this medicine to children and adolescents under 18 years of age.

Other medicines and Pirfenidone Tarbis

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 heart conditions)
• propafenone (used to treat certain heart conditions)
• 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 and gastroesophageal reflux disease)
• rifampicin (a type of antibiotic).

Taking Pirfenidone Tarbis 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 may 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 use of machines

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

Pirfenidone Tarbis contains sodium

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

3. How to take Pirfenidone Tarbis

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

Always follow exactly the instructions 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:

• during the first 7 days, take a dose of 267 mg (1 white tablet) three times a day with food (a total of 801 mg/day)
• from days 8 to 14, take a dose of 534 mg (2 white tablets) three times a day with food (a total of 1,602 mg/day)
• from day 15 onwards (maintenance), take a dose of 801 mg (3 white tablets or 1 red tablet) three times a day with food (a total of 2,403 mg/day).

The recommended daily maintenance dose of pirfenidone is 801 mg (3 white tablets or 1 red tablet) three times a day with meals, 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 your 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 Tarbis 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, contact your doctor or pharmacist immediately or call the Toxicology Information Service at 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 make up for forgotten doses. Each dose should be separated by a minimum interval of 3 hours. Do not take more tablets per day than prescribed in your daily dose.

If you stop taking Pirfenidone Tarbis

In certain situations, your doctor may advise you to stop taking pirfenidone. If you stop taking pirfenidone for more than 14 consecutive days for any reason, your doctor will restart your treatment at a dose of 267 mg three times a day and gradually increase it up 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 experiences them.

Stop taking pirfenidone and contact 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 yellowing of the eyes or skin, dark urine, possibly accompanied by itching of the skin, pain in the upper right part of the stomach (abdomen), loss of appetite, bleeding or bruising more easily than normal, or feel tired. These could be signs of abnormal liver function and may indicate liver damage, which is an uncommon adverse effect of pirfenidone.
• If you develop red, non-elevated spots or circular rashes on the trunk, often with central blisters, skin peeling, or ulcers in the mouth, throat, nose, genitals, and eyes. These severe skin rashes may be preceded by fever and flu-like symptoms. These signs and symptoms may indicate Stevens-Johnson syndrome or toxic epidermal necrolysis.

Other possible adverse effects

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
• Difficulty breathing
• Cough
• Joint pain

Common adverse effects (may affect up to 1 in 10 people):

• Bladder infections
• Drowsiness
• Taste disturbance
• Hot flushes
• Stomach problems, such as feeling of fullness, abdominal pain and discomfort, stomach burning, 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 or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines website: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Pirfenidone Tarbis

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 after 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 unused medicines and their containers at a SIGRE Point in your pharmacy. If in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the container and other information

Composition of Pirfenidone Tarbis

The active substance is pirfenidone.

Each film-coated tablet contains 267 mg of pirfenidone.

Each film-coated tablet contains 801 mg of pirfenidone.

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

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

Appearance of the product and contents of the container

Pirfenidone Tarbis 267 mg film-coated tablets EFG

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

Pirfenidone Tarbis 801 mg film-coated tablets EFG

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

Pack with white opaque Alu-PVC/Aclar blister containing 21, 63, 84, 90 and 252 film-coated tablets, and unit-dose perforated blisters containing 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 (polypropylene) containing 21, 63, 84, 90 and 252 film-coated tablets.

Only certain pack sizes may be marketed.

Marketing Authorisation Holder

Tarbis Farma S.L.

Gran Vía Carlos III, 94

08028 Barcelona

Spain

Manufacturer

Amarox Pharma B.V.

Rouboslaan 32

Voorschoten, 2252TR

The Netherlands

This medicinal product is authorised in the European Economic Area member states under the following names:

Germany Pirfenidon Amarox 267 mg/801 mg Filmtabletten

Netherlands Pirfenidon Amarox 267 mg/801 mg, filmomhulde tabletten

Spain Pirfenidona Tarbis 267 mg/801 mg comprimidos recubiertos con película EFG

Date of the latest revision of this leaflet: 02/2024

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