Pirfenidone Aurovitas 267 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Pirfenidone Aurovitas 267 mg tablets EFG

Pirfenidone Aurovitas 801 mg 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 you should not give it to other people, 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 they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents:

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

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

Pirfenidona Aurovitas 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 conditions, the lungs have difficulty functioning properly. This medicine helps reduce scarring and inflammation in the lungs, thereby helping you breathe better.

2. What you need to know before taking Pirfenidone Aurovitas

Do not take Pirfenidone Aurovitas

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

Warnings and precautions

Talk to your doctor or pharmacist before starting to take this medicine.

• 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.
• Inform your doctor if you have kidney problems.
• 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 if you need to perform 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 advice 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 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 time you are taking pirfenidone.

Children and adolescents

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

Other medicines and Pirfenidone Aurovitas

Tell 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 and gastroesophageal reflux disease).
• rifampicin (a type of antibiotic).

Taking Pirfenidone Aurovitas with food and drink

Do not drink grapefruit juice while taking this medicine. Grapefruit juice may cause pirfenidone to not work properly.

Pregnancy, breastfeeding, and fertility

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 plan to breastfeed, talk to your doctor or pharmacist before taking this medicine. 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 Aurovitas contains lactose monohydrate

This medicine contains lactose monohydrate (a type of sugar). If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.

Pirfenidone Aurovitas contains sodium

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

3. How to take Pirfenidone Aurovitas

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 for taking this medicine. If you are unsure, 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 yellow tablet) three times daily with food (a total of 801 mg/day).
• From days 8 to 14, take a dose of 534 mg (2 yellow tablets) three times daily with food (a total of 1,602 mg/day).
• From day 15 onwards (maintenance), take a dose of 801 mg (3 yellow tablets or 1 pink tablet) three times daily with food (a total of 2,403 mg/day).

The recommended daily maintenance dose of pirfenidone is 801 mg (3 yellow tablets or 1 pink 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 Aurovitas than you should

Go immediately to your doctor, pharmacist, or the nearest hospital emergency department if you take more tablets than prescribed, 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 medicine and the amount ingested.

If you forget to take Pirfenidone Aurovitas

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 at least a 3-hour interval. Do not take more tablets in one day than your prescribed daily dose.

If you stop taking Pirfenidone Aurovitas

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 daily and gradually increase it to 801 mg three times daily.

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 a feeling of fainting, which are signs of angioedema, a serious allergic reaction or anaphylaxis.
• Yellowing of the eyes or skin, or dark urine, possibly accompanied by itching of the skin, pain in the upper right part of the abdomen, loss of appetite, bleeding or bruising more easily than normal, or feeling tired. These may be signs of abnormal liver function and could indicate liver damage, an uncommon adverse effect of pirfenidone.
• Non-elevated or circular red patches on the trunk, often with central blisters, skin peeling, or ulcers in the mouth, throat, nose, genitals, and eyes. These severe skin rashes are preceded by fever and flu-like symptoms (Stevens-Johnson syndrome or toxic epidermal necrolysis).
• Widespread rash, elevated body temperature, and enlarged lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).

Other possible adverse effects are

If you experience any type of 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.
• Tiredness.
• 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, 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 type of 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: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Pirfenidone Aurovitas

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

Do not use this medicine after the expiry date stated on the blister pack or 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 should not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE Point in your pharmacy. 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 Aurovitas

• The active substance is pirfenidone.

Pirfenidone Aurovitas 267 mg tablets EFG

Each tablet contains 267 mg of pirfenidone.

Pirfenidone Aurovitas 801 mg tablets EFG

Each tablet contains 801 mg of pirfenidone.

• The other components are: lactose monohydrate, sodium croscarmellose, hypromellose 3 mPAS (2910), iron oxide red (E172) (for the 801 mg dose), iron oxide yellow (E172) (for the 267 mg dose), colloidal anhydrous silica, and sodium stearyl fumarate.

Appearance of the product and contents of the pack

Pirfenidone Aurovitas 267 mg tablets EFG [size: approximately 13.2 × 6.4 mm]

Uncoated yellow oval, biconvex tablets, marked with “P” on one side and “267” on the other. The tablet may be mottled.

Pirfenidone Aurovitas 801 mg tablets EFG [size: approximately 20.2 × 9.4 mm]

Uncoated pink oval, biconvex tablets, marked with “P” on one side and “801” on the other. The tablet may be mottled.

Pirfenidone Aurovitas 267 mg and 801 mg tablets EFG are available in blister packs.

Pack sizes:

Blister: 7, 14, 21, 28, 35, 42, 49, 56, 63, 84, 168 and 252 tablets.

Single-dose perforated blister:

267 mg: 252 × 1 tablet.

801 mg: 84 × 1 tablet.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Aurovitas Spain, S.A.U.
Avda. de Burgos, 16-D
28036 Madrid
Spain

Manufacturer:

APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate, Hal Far
Birzebbugia, BBG 3000
Malta

Or

Generis Farmacêutica, S.A.
Rua João de Deus, 19
2700-487 Amadora
Portugal

Or

Arrow Génériques
26 Avenue Tony Garnier
69007 Lyon
France

This medicinal product is authorized in the European Economic Area (EEA) Member States under the following names:

Belgium: Pirfenidon AB 267 mg/801 mg tabletten / comprimés / Tabletten
Germany: Pirfenidon PUREN 267 mg/801 mg Tabletten
Spain: Pirfenidona Aurovitas 267 mg/801 mg comprimidos EFG
France: Pirfenidone Arrow 267 mg/801 mg comprimé
Netherlands: Pirfenidon Aurobindo 267 mg/801 mg, tabletten
Poland: Pirfenidone Aurovitas
Portugal: Pirfenidona Generis

Date of the most recent review of this leaflet: January 2026

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/).