Pirfenidone Aurovitas

Package Leaflet: Information for the User

Pirfenidone Aurovitas, 267 mg, Hard Capsules

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.

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.
Idiopathic pulmonary fibrosis is a disease in which the lung tissue becomes scarred and over time becomes fibrotic, leading to difficulty breathing deeply. This makes it difficult for the lungs to work properly. Pirfenidone Aurovitas helps reduce scarring and swelling of 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 while taking pirfenidone, which includes symptoms such as swelling of the face, lips, and/or tongue, and which may have been associated with difficulty breathing or wheezing
• if you are taking a medicine called 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 the above conditions occur, 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 develop (photosensitivity reaction). During treatment with Pirfenidone Aurovitas, avoid exposure to sunlight (including sunlamps). 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, such as tetracycline antibiotics (e.g., doxycycline), which may increase sensitivity to sunlight.
• Tell your doctor if you have kidney problems.
• Tell your doctor if you have mild or moderate liver problems.
• Before starting treatment with Pirfenidone Aurovitas and during treatment, stop smoking. Smoking may reduce the effect 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) in association with Pirfenidone Aurovitas treatment. Stop taking Pirfenidone Aurovitas and seek medical attention immediately if you experience any symptoms related to these severe skin reactions, as described in section 4.

Pirfenidone Aurovitas may cause severe liver problems, and some cases have been fatal. Before starting treatment with Pirfenidone Aurovitas, blood tests will be performed, which will be repeated once a month for the first 6 months of treatment, and then every 3 months for the entire duration of treatment to monitor liver function. It is essential to perform regular blood tests throughout the treatment 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, have recently taken, or 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 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 (OCD))

Medicines that may reduce the effect of Pirfenidone Aurovitas:

• omeprazole (a medicine used to treat conditions such as indigestion and gastroesophageal reflux disease)
• rifampicin (a type of antibiotic)

Pirfenidone Aurovitas with food and drink

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, if you decide to breastfeed during treatment.

Driving and using machines

Do not drive or operate any 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 capsule, 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 the diagnosis and treatment of idiopathic pulmonary fibrosis.
Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
The medicine is usually taken in increasing doses as follows:

• for the first 7 days, take 1 capsule, 3 times a day with food (a total of 801 mg/day)
• from day 8 to 14, take 2 capsules, 3 times a day with food (a total of 1602 mg/day)
• from day 15 (maintenance treatment), take 3 capsules, 3 times a day with food (a total of 2403 mg/day)

The recommended daily maintenance dose of Pirfenidone Aurovitas is 3 capsules, 3 times a day, taken with food, which is a total of 2403 mg/day.
Swallow the capsules whole, with water, during or after a meal to reduce the risk of side effects such as nausea (vomiting) and dizziness. If symptoms persist, consult your doctor.
Dose reduction due to side effects
Your doctor may reduce the dose of Pirfenidone Aurovitas if you experience side effects such as stomach problems, any 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 capsules 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 the missed dose. Maintain at least a 3-hour interval between doses. Do not take more capsules 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, for any reason, you stop taking Pirfenidone Aurovitas for more than 14 consecutive days, your doctor will restart treatment from 1 capsule, 3 times a day, gradually increasing the dose to 3 capsules, 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 or dark urine, which may be accompanied by itching of the skin, pain in the upper right abdomen, loss of appetite, bleeding, or easy bruising, or feeling tired. These may be signs of abnormal liver function and may indicate liver damage, which is an uncommon side effect of Pirfenidone Aurovitas.
• Red, non-raised, or round patches on the torso, often with centrally located blisters, peeling skin, ulcers of 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 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 upset stomach
• 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, 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 Drug Safety, 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.
Reporting side effects will help to gather 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 which is stated on the carton or blister after EXP. The expiry date refers to the last day of that month.
There are no special storage conditions 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 hard capsule contains 267 mg of pirfenidone.
• The other ingredients are: capsule content:lactose monohydrate, croscarmellose sodium, polysorbate 80, magnesium stearate. capsule shell:titanium dioxide (E 171), gelatin, purified water. printing ink:shellac (E 904), iron oxide brown (E 172), iron oxide black (E 172), potassium hydroxide (E 525).

What Pirfenidone Aurovitas looks like and contents of the pack

Hard capsule.
A hard gelatin capsule with a white opaque cap and a white opaque body, size "1", with brown printing "P 267" on the cap, filled with a white or almost white granular powder.

Pack sizes:

Blisters: 63, 252, and 270 hard capsules
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

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

Belgium:
Pirfenidone AB 267 mg hard capsules/gélules/Hartkapseln
Denmark:
Pirfenidon Aurobindo
Netherlands:
Pirfenidon Aurobindo 267 mg, hard capsules
Poland:
Pirfenidone Aurovitas
Portugal:
Pirfenidona Generis

Date of last revision of the leaflet: 04/2024