Pirfenidone aurovitas

Patient Information Leaflet

Pirfenidone Aurovitas, 267 mg, tablets
Pirfenidone Aurovitas, 801 mg, tablets
Pirfenidone
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.

• Keep this 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 personally. 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, inform your doctor or pharmacist. See section 4.

Leaflet contents:

1. What Pirfenidone Aurovitas is and what it is used for
2. What you need to know 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 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.
IPF is a disease in which lung tissue becomes inflamed and over time turns into scar tissue, making deep breathing difficult. This impairs proper lung function. Pirfenidone Aurovitas helps reduce scarring and inflammation in the lungs 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 has previously experienced angioedema while taking pirfenidone, with symptoms such as swelling of the face, lips and (or) tongue, which may have been associated with difficulty breathing or wheezing
• if the patient is taking a medicine called fluvoxamine (used to treat depression and obsessive-compulsive disorder)
• in case of severe or end-stage liver failure
• in case of severe or end-stage renal failure requiring dialysis.

If any of the above conditions apply, Pirfenidone Aurovitas must not be used.
If in doubt, consult a doctor or pharmacist.
Warnings and precautions
Before starting treatment with Pirfenidone Aurovitas, discuss it with your doctor or
pharmacist.

• Increased sensitivity to sunlight (photosensitivity reaction) may develop during treatment with Pirfenidone Aurovitas. While taking Pirfenidone Aurovitas, avoid exposure to sunlight (including sunlamps and tanning beds). Use sunscreen and cover arms, legs and head to minimize sun exposure (see section 4: Possible side effects).
• Do not take other medicines such as tetracycline antibiotics (e.g. doxycycline) that 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.
• Stop smoking 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 cause weight loss. Your doctor will monitor your body weight during treatment with this medicine.
• Cases of Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS syndrome) have been reported during treatment with Pirfenidone Aurovitas. Discontinue Pirfenidone Aurovitas and contact your doctor immediately if any of the symptoms associated with these serious skin reactions occur, as described in section 4.

Pirfenidone Aurovitas may cause severe liver function disorders, and some cases have resulted in death. Before starting treatment with Pirfenidone Aurovitas, blood tests should be performed and repeated monthly for the first 6 months of treatment, then every 3 months throughout the treatment period to monitor liver function. It is important to carry out regular blood tests throughout the entire treatment period 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 all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
This is particularly 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, 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 action of Pirfenidone Aurovitas.
Pregnancy, breastfeeding and fertility
As a precaution, it is better to avoid using Pirfenidone Aurovitas if the patient is pregnant, suspects she may be pregnant, or is planning to become pregnant, because 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. Therefore, the doctor will discuss with the patient the risks and benefits of using this medicine during breastfeeding, if the patient decides to breastfeed during treatment.
Driving and operating machinery
Do not drive or operate 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 tablet, meaning 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 IPF.
This medicine should always be used exactly as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
The medicine is usually administered in increasing doses as follows:

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

The recommended maintenance daily dose of Pirfenidone Aurovitas is 801 mg (3 yellow tablets or 1 pink tablet) taken three times daily with food, for a total of 2403 mg/day.
Tablets should be swallowed whole with water, during or after meals, 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 if you experience adverse reactions such as gastrointestinal problems, any skin reactions to sunlight or solarium exposure, or significant changes in liver enzyme activity.
Taking more Pirfenidone Aurovitas than prescribed
If you take more tablets than prescribed, contact your doctor, pharmacist, or the emergency department of your nearest hospital 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 tablets in one day than the prescribed daily dose.
Stopping Pirfenidone Aurovitas
In certain situations, your doctor 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 at a dose of 267 mg three times daily, gradually increasing the dose to 801 mg three times daily.
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 everybody will experience them.
You must immediately stop taking Pirfenidone Aurovitas and seek medical help
if the patient experiences any of the following symptoms:

• Swelling of the face, lips and (or) tongue, itching, urticaria, difficulty breathing, 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 itchy skin, pain in the upper right side of the abdomen, loss of appetite, bleeding or bruising more easily than normal, 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, non-elevated or round spots on the trunk, often with central blisters, peeling skin, and ulcers in the mouth, throat, nose, genital organs or 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 affect 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 affect up to 1 in 10 people):

• urinary tract infections
• feeling sleepy
• taste disturbances
• hot flushes
• stomach problems such as bloating, abdominal pain and discomfort, heartburn and flatulence
• blood tests may show increased liver enzyme activity
• skin reactions after sun exposure or use of sunbeds
• skin problems such as itchy skin, redness of the skin, dry skin, skin rash
• muscle pain
• feeling weak or lack of energy
• chest pain
• sunburn

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

• low blood sodium levels. This may cause headache, dizziness, confusion, weakness, muscle cramps, nausea and vomiting.
• blood tests may show decreased white blood cell count.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed
in this leaflet, tell 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 authorisation holder.
Reporting adverse reactions helps to 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 pack or carton after:
EXP. The expiry date refers to the last day of the stated month.
No special storage instructions apply.
Medicines must 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 package and other information

What Pirfenidone Aurovitas contains

• The active substance is pirfenidone. Each tablet contains 267 mg of pirfenidone. Each tablet contains 801 mg of pirfenidone.
• Other ingredients are: lactose monohydrate, sodium croscarmellose, hypromellose 3 mPas (type 2910), iron oxide red (E 172) (for the 801 mg dose), iron oxide yellow (E 172) (for the 267 mg dose), colloidal anhydrous silica, 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, uncoated tablets with embossed marking „P” on one side and „267” on the other side. The tablet may be speckled.
Pirfenidone Aurovitas, 801 mg, tablets: [Size: approximately 20.2 x 9.4 mm]
Pink, oval, biconvex, uncoated tablets with embossed marking „P” on one side and „801” on the other side. The tablet may be speckled.
Pack sizes:
Blister packs: 7, 14, 21, 28, 35, 42, 49, 56, 63, 84, 168 and 252 tablets.
Perforated single-dose blisters:
267 mg: 252 x 1 tablet
801 mg: 84 x 1 tablet
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer/Importer
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
Arrow Génériques
26 Avenue Tony Garnier
69007 Lyon
France
This medicinal product is authorised in the European Economic Area countries 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