Leaflet: information for the user

Pirfenidona Aurovitas 267 mg EFG tablets

Pirfenidona Aurovitas 801 mg EFG tablets

Read this 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, 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 or pharmacist, even if they are not listed in this leaflet. See section 4.

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

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

3.How to take Pirfenidona Aurovitas

4.Possible side effects

5.Storage of Pirfenidona Aurovitas

6.Contents of the pack and additional information

Pirfenidona Aurovitascontains 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. This medication helps to reduce scarring and inflammation of the lungs, and helps you breathe better.

Do not take Pirfenidona Aurovitas

•If you areallergic to pirfenidonaor to any of the other components of this medication (listed in section 6).

•If you have previously had angioedema with pirfenidona, which includes 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 this medication. If you have any doubts, consult your doctor or pharmacist.

Warnings and precautions

Consult your doctor orpharmacist before starting to takethis medication.

•You may be more sensitive to sunlight (photosensitivity reaction) when taking pirfenidona. Avoid the sun (also UVA lamps) while taking pirfenidona. Use daily sunscreen and cover your arms, legs, and head to reduce exposure to sunlight (see section 4: Possible side effects).

•Do 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 must abstain from 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 consult your doctor immediately if you observe 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 a blood test 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 Aurovitas

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 ofpirfenidona.

The following medications may increase the side effects ofpirfenidona:

•Enoxacine (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 ofpirfenidona:

•Omeprazole (used to treat conditions such as indigestion and gastroesophageal reflux disease).

•Rifampicin (a type of antibiotic).

Taking Pirfenidona Aurovitas with food and drinks

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

Pregnancy, breastfeeding, and fertility

As a precaution, it is preferable to avoid the use ofpirfenidonaif 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, speak with your doctor or pharmacist before takingthis medication. As it is not known whetherpirfenidonais 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 Aurovitas contains lactose monohydrate

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

Pirfenidona Aurovitas contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per tablet; that is, it is essentially “sodium-free”.

The treatment withpirfenidonashould 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 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 pink tablet), 3 times a day with food (a total of 2.403 mg/day).

The recommended daily maintenance dose ofpirfenidonais 801 mg (3 yellow tablets or 1 pink 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 lamps, or significant changes in liver enzymes.

If you take more Pirfenidona Aurovitas than you should

Go to your doctor, pharmacist, or the nearest hospital emergency service 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, phone91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Pirfenidona Aurovitas

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 Aurovitas

In certain situations, your doctor will advise you to stop takingpirfenidona. If for any reason you stop takingpirfenidonafor more than 14 consecutive days, the doctor will resume 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 medicinecan 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.

•Yellowing of the eyes or skin, or dark urine, possibly accompanied by itching of the skin, stomach pain in the upper right area, loss of appetite, bleeding, or the formation of bruises more easily than usual, or a feeling of fatigue. These may be signs of abnormal liver function and could indicate liver damage, a rare side effect of pirfenidone.

•Flat, reddish patches, or circular on the trunk, often with central blisters, skin peeling, ulcers in the mouth, throat, nose, genitals, and eyes. These severe skin eruptions are preceded by fever and flu-like symptoms (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.

•Diarrhea.

•Indigestion or stomach heaviness.

•Weight loss.

•Loss of appetite.

•Difficulty sleeping.

•Fatigue.

•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.

•Seizures.

•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 the 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 headache, dizziness, confusion, 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 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 blister or the box after CAD. The expiration date is the last day of the month indicated.

This medication does not require special conditions for conservation.

Medicines should not be thrown down the drains or in the trash. Dispose of the packaging and medicines you no longer need at the SIGRE collection point of the pharmacy. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

Composition of Pirfenidona Aurovitas

-The active ingredient is pirfenidone.

Pirfenidona Aurovitas 267 mg tablets EFG

Each tablet contains 267 mg of pirfenidone.

Pirfenidona Aurovitas 801 mg tablets EFG

Each tablet contains 801 mg of pirfenidone.

-The other components are:lactose monohydrate, croscarmellose sodium, 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 stearate and sodium fumarate.

Appearance of the product and contents of the package

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

Uncoated yellow-colored, oval, biconvex tablets with the mark “P” on one face and “267” on the other. The tablet may be speckled.

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

Uncoated pink-colored, oval, biconvex tablets with the mark “P” on one face and “801” on the other. The tablet may be speckled.

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

Package sizes:

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

Only some package sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Responsible 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 medicine is authorized in the member states of the European Economic Area with the following names:

Bélgica:Pirfenidon AB 267 mg/801 mg tablets / tablets / tablets

Germany:Pirfenidon PUREN 267 mg/801 mg Tablets

Spain:Pirfenidona Aurovitas 267 mg/801 mg tablets EFG

France:Pirfenidone Arrow 267 mg/801 mg tablet

Netherlands:Pirfenidon Aurobindo 267 mg/801 mg, tablets

Poland:Pirfenidone Aurovitas

Portugal:Pirfenidona Generis

Last review date of this leaflet:July 2024

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