PIRFENIDONE AUROVITAS 267 mg TABLETS

2. What you need to know before you take Pirfenidone Aurovitas

Do not take Pirfenidone Aurovitas

• If you are allergic to pirfenidone or any of the other ingredients of this medicine (listed in section 6).
• If you have previously had angioedema with pirfenidone, 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 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 this medicine. If you are in doubt, consult your doctor or pharmacist.

Warnings and precautions

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

• You may have increased sensitivity to sunlight (photosensitivity reaction) when taking pirfenidone. Avoid the sun (also UVA lamps) while taking pirfenidone. Use a daily sunscreen 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 should avoid smoking before and during treatment with pirfenidone. Smoking may reduce the effect of pirfenidone.
• Pirfenidone may cause dizziness and fatigue. Be careful if you need to perform activities that require 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 consult a doctor immediately if you observe any of the symptoms related to these severe 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 to take pirfenidone, once a month for the first 6 months, and then every 3 months while taking this medicine, to check your liver function. It is essential that you have these blood tests periodically 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 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 disorders such as indigestion, gastroesophageal reflux disease).
• rifampicin (a type of antibiotic).

Taking Pirfenidone Aurovitas with food and drinks

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

Pregnancy, breastfeeding, and fertility

As a precautionary measure, it is preferable to avoid the use of pirfenidone if you are pregnant, planning to become pregnant, or think you may be pregnant, as the potential risks to the fetus are not known.

If you are breastfeeding or planning 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 using 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 told you that you have an intolerance to some sugars, consult with them before taking this medicine.

Pirfenidone Aurovitas contains sodium

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

3. How to take Pirfenidone Aurovitas

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

Follow the instructions for administration of this medicine exactly as indicated by your doctor or pharmacist. If you are in doubt, consult your doctor or pharmacist again.

Normally, you will be given this medicine 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 maintenance dose of pirfenidone is 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 unwell) and dizziness. If symptoms persist, consult your doctor.

Dose reduction 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 UVA lamps, or significant changes in liver enzymes.

If you take more Pirfenidone Aurovitas than you should

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

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 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 an interval of at least 3 hours. Do not take more tablets per day than your prescribed daily dose.

If you stop taking Pirfenidone Aurovitas

In certain situations, your doctor will 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 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 questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets 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 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, pain in the upper right part of the abdomen (stomach), loss of appetite, bleeding or bruising more easily than normal, or feeling of tiredness. These may be signs of abnormal liver function and could indicate liver damage, a rare side effect of pirfenidone.
• Red patches, not raised, or circular on the trunk, often with central blisters, skin peeling, 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, high body temperature, and swollen lymph nodes (DRESS or drug hypersensitivity syndrome).

Other possible side effects are

If you experience any type of side effect, consult your doctor.

Very common side effects(may affect more than 1 in 10 people):

• infections of the throat or respiratory tract that reach 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 side effects(may affect up to 1 in 10 people):

• bladder infections.
• drowsiness.
• altered taste.
• hot flashes.
• stomach problems, such as feeling heavy, pain, and discomfort in the abdomen, heartburn, and gas.
• blood tests may indicate increased liver enzymes.
• skin reactions after sun exposure 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 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 decreased white blood cells.

Reporting of side effects

If you experience any side effects, consult your doctor or pharmacist, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines and Healthcare Products Agency (AEMPS) website (http://www.aemps.gob.es/). By reporting side 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 that appears on the blister or carton after EXP. The expiry date is the last day of the month indicated.

This medicine does not require special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicine in the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Contents of the pack and further information

Composition of Pirfenidone Aurovitas

• The active substance is pirfenidone.

Pirfenidone Aurovitas 267 mg film-coated tablets

Each tablet contains 267 mg of pirfenidone.

Pirfenidone Aurovitas 801 mg film-coated tablets

Each tablet contains 801 mg of pirfenidone.

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

Appearance of the product and pack contents

Pirfenidone Aurovitas 267 mg film-coated tablets[size: 13.2 × 6.4 mm, approximately]

Yellow, oval, biconvex film-coated tablets, marked with "P" on one side and "267" on the other. The tablet may be speckled.

Pirfenidone Aurovitas 801 mg film-coated tablets[size: 20.2 × 9.4 mm, approximately]

Pink, oval, biconvex film-coated tablets, marked with "P" on one side and "801" on the other. The tablet may be speckled.

Pirfenidone Aurovitas 267 and 801 mg film-coated tablets are available in blister packs.

Pack sizes:

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

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation holder:

Aurovitas Spain, S.A.U.

Avenida 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 medicine is authorised in the Member States of the European Economic Area under the following names:

Belgium: Pirfenidon AB 267 mg/801 mg tablets / comprimés / Tabletten

Germany: Pirfenidon PUREN 267 mg/801 mg Tabletten

Spain: Pirfenidona Aurovitas 267 mg/801 mg film-coated tablets

France: Pirfenidone Arrow 267 mg/801 mg comprimé

Netherlands: Pirfenidon Aurobindo 267 mg/801 mg, tabletten

Poland: Pirfenidone Aurovitas

Portugal: Pirfenidona Generis

Date of last revision of this leaflet:July 2024

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS) (http://www.aemps.gob.es/).