Package leaflet: Information for the user

Pirfenidone Aurovitas, 267 mg, hard capsules
Pirfenidonum
Read the entire leaflet carefully before using this medicine, as it contains
important information for the patient.

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 a specific individual. Do not share it with others. This medicine may harm other people, even if their symptoms are the same.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Leaflet contents:

What Pirfenidone Aurovitas is and what it is used for
Important information before taking Pirfenidone Aurovitas
How to take Pirfenidone Aurovitas
Possible side effects
How to store Pirfenidone Aurovitas
Contents of the pack and other information

1. What Pirfenidone Aurovitas is and what it is 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 lung tissue becomes inflamed and, over time,
develops scarring (fibrosis), making deep breathing difficult. This impairs proper lung function.
Pirfenidone Aurovitas helps reduce lung scarring and inflammation and helps improve breathing.

2. Important information before using Pirfenidone Aurovitas

When not to use Pirfenidone Aurovitas:

if the patient is allergic to pirfenidone or to any of the other ingredients of this medicine (listed in section 6)
if the patient previously experienced angioedema while taking pirfenidone, including symptoms such as swelling of the face, lips and (or) tongue, which may have been associated with breathing difficulties or wheezing
if the patient is taking a medicine called fluvoxamine (used to treat depression and obsessive-compulsive disorder)
in cases of severe or end-stage liver failure
in cases of severe or end-stage renal failure requiring dialysis.

Do not use Pirfenidone Aurovitas if any of the above conditions apply.
If in doubt, consult a doctor or pharmacist.
Warnings and precautions
Before starting Pirfenidone Aurovitas, discuss this with your doctor or
pharmacist.

Increased sensitivity to sunlight (photosensitivity reaction) may develop during treatment with Pirfenidone Aurovitas. Exposure to sunlight (including sunbeds) should be avoided while taking Pirfenidone Aurovitas. Sunscreen should be used and arms, legs and head covered to minimise 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.
Inform your doctor if you have kidney function disorders.
Inform your doctor if you have mild or moderate liver function disorders.
Smoking should be discontinued before starting and during treatment with Pirfenidone Aurovitas. Smoking may reduce the effectiveness of Pirfenidone Aurovitas.
Pirfenidone Aurovitas may cause dizziness and fatigue. Exercise caution when performing activities requiring alertness and coordination.
Pirfenidone Aurovitas may lead to weight loss. Your doctor will monitor your body weight during treatment.
Severe skin reactions such as Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS) have been reported with Pirfenidone Aurovitas treatment. Discontinue Pirfenidone Aurovitas and contact your doctor immediately if you experience any symptoms associated with these serious skin reactions, as described in section 4.

Pirfenidone Aurovitas may cause severe liver function disorders, some of which have resulted in death. Blood tests should be performed before starting Pirfenidone Aurovitas and repeated monthly for the first 6 months of treatment, then every 3 months throughout treatment to monitor liver function. It is important to have regular blood tests throughout the entire duration of treatment with Pirfenidone Aurovitas.
Children and adolescents
Pirfenidone Aurovitas must not be given to children and adolescents under 18 years of age.
Pirfenidone Aurovitas and other medicines
Tell your doctor or pharmacist about any medicines you are currently taking, have recently taken, or plan to take.
This is particularly important when taking the following medicines, as they may alter the effect of Pirfenidone Aurovitas.
Medicines which 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 which may reduce the effect of Pirfenidone Aurovitas:

omeprazole (a medicine used to treat conditions such as indigestion, gastro-oesophageal 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 precautionary measure, it is better to avoid using Pirfenidone Aurovitas if the patient is pregnant, suspects she may be pregnant, or is planning to have a child, as the potential risk to the unborn child is unknown.
If the patient is breastfeeding or planning to breastfeed, she should consult her doctor or pharmacist before using Pirfenidone Aurovitas. It is not known whether Pirfenidone Aurovitas passes into human milk, so the doctor will discuss the risks and benefits of using this medicine during breastfeeding if the patient decides to breastfeed during treatment.
Driving and using machines
Do not drive or operate any machinery if dizziness or fatigue occurs after taking Pirfenidone Aurovitas.
Pirfenidone Aurovitas contains lactose monohydrate
This medicine contains lactose monohydrate (a type of sugar). If the patient has been previously diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.
Pirfenidone Aurovitas contains sodium
Pirfenidone Aurovitas contains less than 1 mmol (23 mg) of sodium per capsule, i.e. the medicine is considered "sodium-free".

3. How to use Pirfenidone Aurovitas

Treatment with Pirfenidone Aurovitas should be initiated and supervised by a specialist physician experienced in the diagnosis and treatment of idiopathic pulmonary fibrosis.
This medicine should always be used exactly as prescribed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
The medicine is usually taken in gradually increasing doses as follows:

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

The recommended maintenance daily dose of Pirfenidone Aurovitas is 3 capsules taken three times a day with food, for a total of 2403 mg/day.
Capsules should be swallowed whole with water, during or after a meal, to reduce the risk of adverse effects such as nausea and dizziness. If symptoms persist, consult your doctor.
Dose reduction due to adverse reactions
Your doctor may reduce the dose of the medicine if you experience adverse reactions such as gastrointestinal problems, any skin reactions to sunlight or sunbeds, or significant changes in liver enzyme activity.
Taking more Pirfenidone Aurovitas than recommended
If you take more capsules than recommended, contact your doctor, pharmacist, or the nearest hospital emergency department immediately and bring 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 capsules in one day than the recommended daily dose.
Stopping Pirfenidone Aurovitas
In certain situations, your treating physician may advise stopping treatment with Pirfenidone Aurovitas. If treatment with Pirfenidone Aurovitas is interrupted for more than 14 consecutive days for any reason, your doctor will restart treatment with 1 capsule three times a day, gradually increasing the dose to 3 capsules three times a day.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although not everyone will experience them.
Treatment with Pirfenidone Aurovitas must be stopped immediately and medical help sought
if the patient experiences any of the following signs or symptoms:

Swelling of the face, lips and (or) tongue, itching, urticaria, difficulty breathing or wheezing, or feeling faint. These are symptoms of a severe allergic reaction known as 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 part of the abdomen, loss of appetite, bleeding or bruising more easily than usual, or feeling tired. These may be symptoms of liver dysfunction and could indicate liver damage, which is an uncommon adverse reaction of Pirfenidone Aurovitas.
Red, raised or round spots on the trunk, often with centrally located blisters, peeling of the skin, and ulcers in the mouth, throat, nose, genital organs, 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 adverse reactions that may occur
Talk to your doctor if the patient experiences any adverse reactions.
Very common adverse reactions (may occur in more than 1 in 10 people):

throat or respiratory tract infections leading to lung infection and (or) sinusitis
nausea
stomach problems such as regurgitation of stomach contents into the oesophagus, vomiting, constipation
diarrhoea
indigestion or upset stomach
weight loss
decreased appetite
sleep disturbances
fatigue
dizziness
headache
shortness of breath
cough
joint pain

Common adverse reactions (may occur in up to 1 in 10 people):

urinary bladder infections
feeling drowsy
taste disturbances
hot flushes
stomach problems such as bloating, abdominal pain, discomfort in the abdominal area, heartburn, and gas
blood tests may indicate increased liver enzyme activity
skin reactions after exposure to sunlight or solarium
skin problems such as itchy skin, redness of the skin, dry skin, skin rash
muscle pain
feeling weak or lacking energy
chest pain
sunburn

Uncommon adverse reactions (may occur in up to 1 in 100 people):

low sodium concentration in the blood. This may cause headache, dizziness, confusion, weakness, muscle cramps, or nausea and vomiting.
blood tests may show a reduced number of white blood cells.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed
in this leaflet, inform your doctor or pharmacist. Adverse reactions can
be reported directly to the Department of Monitoring Adverse Drug Reactions of the 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps 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 carton or blister after:
EXP. The expiry date refers to the last day of the stated month.
No special storage instructions apply.
Medicines should not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer required. These measures 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 contents: monohydrate lactose, sodium croscarmellose, polysorbate 80, magnesium stearate.
Capsule shell: titanium dioxide (E 171), gelatin, purified water.
Printing ink: shellac (E 904), brown iron oxide (E 172), black iron oxide (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”, printed in brown ink with “P 267” on the cap, filled with white or almost white granular powder.
Pack sizes:
Blister packs: 63, 252 and 270 hard capsules.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Aurovitas Pharma Polska Sp. z o.o.
Sokratesa 13D, local 27
01-909 Warsaw
e-mail: [email protected]

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 medicinal product is authorised in the European Economic Area countries 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