Pirfenidone Aurovitas

Package Leaflet: Information for the User

Pirfenidone Aurovitas, 267 mg, tablets

Pirfenidone Aurovitas, 801 mg, tablets

Pirfenidone

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

Table of Contents of the Package Leaflet:

• 1. What is Pirfenidone Aurovitas and what is it used for
• 2. Important information 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 is Pirfenidone Aurovitas and what is it used for

Pirfenidone Aurovitas contains the active substance pirfenidone and is used to treat idiopathic pulmonary fibrosis (IPF) in adults. IPF is a disease in which the lung tissue becomes scarred and over time, this scarring leads to difficulty breathing. Pirfenidone Aurovitas helps reduce scarring and swelling in the lungs and helps improve breathing.

2. Important information before taking Pirfenidone Aurovitas

When not to 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 experienced angioedema (swelling of the face, lips, and/or tongue) while taking pirfenidone
• if you are taking fluvoxamine (used to treat depression and obsessive-compulsive disorder)
• in case of severe or end-stage liver disease
• in case of severe or end-stage kidney disease requiring dialysis

If any of these conditions apply, do not take Pirfenidone Aurovitas. If in doubt, consult your doctor or pharmacist.

Warnings and precautions

Before starting treatment with Pirfenidone Aurovitas, discuss it with your doctor or pharmacist.

• During treatment with Pirfenidone Aurovitas, increased sensitivity to sunlight may occur. Avoid exposure to sunlight (including sunlamps) while taking Pirfenidone Aurovitas. Use sunscreens and cover your arms, legs, and head to minimize exposure to sunlight (see section 4: Possible side effects).
• Do not take other medicines that may increase sensitivity to sunlight, such as tetracycline antibiotics (e.g., doxycycline).
• Tell your doctor about any kidney problems.
• Tell your doctor about any mild or moderate liver problems.
• Stop smoking before starting treatment with Pirfenidone Aurovitas and during treatment. Smoking may reduce the effectiveness of Pirfenidone Aurovitas.
• Pirfenidone Aurovitas may cause dizziness and fatigue. Be careful when performing tasks that require attention and coordination.
• Pirfenidone Aurovitas may cause weight loss. Your doctor will monitor your weight while taking this medicine.
• There have been reports of Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS syndrome) in patients taking Pirfenidone Aurovitas. Stop taking Pirfenidone Aurovitas and seek medical attention immediately if you experience any symptoms of these severe skin reactions, described in section 4.

Pirfenidone Aurovitas may cause severe liver damage, and some cases have been fatal. Before starting treatment with Pirfenidone Aurovitas, blood tests will be performed, which will be repeated every month for the first 6 months of treatment, and then every 3 months during the entire treatment period to monitor liver function. It is essential to perform regular blood tests during the entire treatment period with Pirfenidone Aurovitas.

Children and adolescents

Pirfenidone Aurovitas should not be given to children and adolescents under 18 years of age.

Pirfenidone Aurovitas and other medicines

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take. This is especially important when taking the following medicines, as they may affect the action of Pirfenidone Aurovitas.

• Medicines that may increase the risk of side effects of Pirfenidone Aurovitas:
• enoxacin (a type of antibiotic)
• ciprofloxacin (a type of antibiotic)
• amiodarone (a medicine used to treat certain heart conditions)
• propafenone (a medicine used to treat certain heart conditions)
• fluvoxamine (a medicine used to treat depression and obsessive-compulsive disorder)

Medicines that may reduce the effectiveness of Pirfenidone Aurovitas:

• omeprazole (a medicine used to treat conditions such as heartburn and gastroesophageal reflux disease)

rifampicin (a type of antibiotic)

Pirfenidone Aurovitas with food, drink, and alcohol

Do not drink grapefruit juice while taking this medicine. Grapefruit may interfere with the proper functioning of Pirfenidone Aurovitas.

Pregnancy, breastfeeding, and fertility

As a precaution, it is recommended to avoid taking Pirfenidone Aurovitas if you are pregnant, think you may be pregnant, or plan to have a baby, as the potential risk to the unborn child is unknown. If you are breastfeeding or plan to breastfeed, consult your doctor or pharmacist before taking Pirfenidone Aurovitas. It is not known whether Pirfenidone Aurovitas passes into breast milk, so your doctor will discuss the risks and benefits of taking this medicine while breastfeeding.

Driving and using machines

Do not drive or operate machinery if you experience dizziness or fatigue after taking Pirfenidone Aurovitas.

Pirfenidone Aurovitas contains lactose monohydrate

This medicine contains lactose monohydrate (a type of sugar). If you have been diagnosed with intolerance to some sugars, consult your doctor before taking this medicine.

Pirfenidone Aurovitas contains sodium

Pirfenidone Aurovitas contains less than 1 mmol (23 mg) of sodium per tablet, which means it is essentially sodium-free.

3. How to take Pirfenidone Aurovitas

Treatment with Pirfenidone Aurovitas should be started and supervised by a specialist doctor with experience in diagnosing and treating IPF. Always take this medicine exactly as your doctor or pharmacist has told you. If you are unsure, ask your doctor or pharmacist. The medicine is usually taken in increasing doses as follows:

• for the first 7 days, take a dose of 267 mg (1 yellow tablet) 3 times a day with food (total 801 mg/day)
• from day 8 to 14, take a dose of 534 mg (2 yellow tablets) 3 times a day with food (total 1602 mg/day)
• from day 15 (maintenance treatment), take a dose of 801 mg (3 yellow tablets or 1 pink tablet) 3 times a day with food (total 2403 mg/day)

The recommended daily maintenance dose of Pirfenidone Aurovitas is 801 mg (3 yellow tablets or 1 pink tablet) 3 times a day with food, which is 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 and dizziness. If symptoms persist, consult your doctor.

Reducing the dose due to side effects

Your doctor may reduce the dose of Pirfenidone Aurovitas if you experience side effects such as stomach problems, skin reactions to sunlight or sunlamps, or significant changes in liver enzyme activity.

Taking more than the recommended dose of Pirfenidone Aurovitas

If you have taken more tablets than recommended, contact your doctor, pharmacist, or the nearest hospital emergency department immediately and take the medicine with you.

Missing a dose of Pirfenidone Aurovitas

If you miss a dose, take it as soon as possible. Do not take a double dose to make up for a missed dose. Maintain at least a 3-hour interval between doses. Do not take more tablets in a day than the recommended daily dose.

Stopping treatment with Pirfenidone Aurovitas

In certain situations, your doctor may advise you to stop taking Pirfenidone Aurovitas. If you stop taking Pirfenidone Aurovitas for more than 14 consecutive days, your doctor will restart treatment with a dose of 267 mg 3 times a day, gradually increasing the dose to 801 mg 3 times a day. If you have any further questions about taking this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Pirfenidone Aurovitas can cause side effects, although not everybody gets them. Stop taking Pirfenidone Aurovitas and seek medical attention immediately if you experience any of the following symptoms:

• Swelling of the face, lips, and/or tongue, itching, hives, difficulty breathing or wheezing, or feeling faint. These are symptoms of a severe allergic reaction called angioedema or anaphylaxis.
• Yellowing of the eyes or skin, dark urine, which may be accompanied by itching, pain in the upper right abdomen, loss of appetite, bleeding, or bruising, or feeling tired. These may be symptoms of abnormal liver function and may indicate liver damage, which is an uncommon side effect of Pirfenidone Aurovitas.
• Red, non-raised, or round spots on the torso, often with centrally located blisters, peeling skin, ulcers in the mouth, throat, nose, genitals, and eyes. These severe skin rashes may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome or toxic epidermal necrolysis).
• Widespread rash, high fever, and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).

Other side effects that may occur

Tell your doctor if you experience any side effects. Very common side effects(may affect more than 1 in 10 people):

• infections of the throat or respiratory tract leading to the lungs and/or sinusitis
• nausea
• stomach problems, such as gastroesophageal reflux disease, vomiting, constipation
• diarrhea
• indigestion or stomach upset
• weight loss
• decreased appetite
• sleep disturbances
• fatigue
• dizziness
• headache
• shortness of breath
• cough
• joint pain

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

• urinary tract infections
• drowsiness
• taste disturbances
• hot flushes
• stomach problems, such as bloating, abdominal pain, and discomfort in the abdominal cavity, heartburn, and gas
• blood tests may indicate increased liver enzyme activity
• skin reactions to sunlight or sunlamps
• skin problems, such as itching, redness, dryness, and skin rash
• muscle pain
• feeling weak or lacking 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, disorientation, weakness, muscle cramps, or nausea and vomiting.
• blood tests may show a decrease in white blood cell count.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. Side effects can be reported directly to the Department of Medicinal Product Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store 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 or carton after EXP. The expiry date refers to the last day of the month. There are no special storage instructions for this medicine. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Pirfenidone Aurovitas contains

• The active substance is pirfenidone. Each tablet contains 267 mg or 801 mg of pirfenidone.
• The other ingredients are: lactose monohydrate, sodium croscarmellose, hypromellose 3 mPas (type 2910), iron oxide red (E 172) (for 801 mg dose), iron oxide yellow (E 172) (for 267 mg dose), colloidal silicon dioxide, sodium stearyl fumarate.

What Pirfenidone Aurovitas looks like and contents of the pack

Tablet. Pirfenidone Aurovitas, 267 mg, tablets: [Size: approximately 13.2 x 6.4 mm] Yellow, oval, biconvex tablets without coating with engraved "P" on one side and "267" on the other side. The tablet may be scored. Pirfenidone Aurovitas, 801 mg, tablets: [Size: approximately 20.2 x 9.4 mm] Pink, oval, biconvex tablets without coating with engraved "P" on one side and "801" on the other side. The tablet may be scored.

Pack sizes:

Blisters: 7, 14, 21, 28, 35, 42, 49, 56, 63, 84, 168, and 252 tablets. Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Aurovitas Pharma Polska Sp. z o.o. ul. Sokratesa 13D lokal 27 01-909 Warsaw e-mail: medicalinformation@aurovitas.pl

Manufacturer/Importer:

APL Swift Services (Malta) Ltd. HF26, Hal Far Industrial Estate, Hal Far Birzebbugia, BBG 3000 Malta Generis Farmacêutica, S.A. Rua João de Deus 19, Venda Nova 2700-487 Amadora Portugal Arrow Génériques 26 Avenue Tony Garnier 69007 Lyon France

This medicine is authorized in the Member States of the European Economic Area under the following names:

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

Date of last revision of the package leaflet: 04/2024