Pirfenidone Sandoz

Package Leaflet: Information for the Patient

Pirfenidone Sandoz, 267 mg, Film-Coated Tablets

Pirfenidone Sandoz, 801 mg, Film-Coated 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.
In case of any doubts, consult a doctor or pharmacist.
This medicine has been prescribed to you by a doctor and should not be given to others.
The medicine may harm another person, even if their symptoms are the same as yours.
If you experience any side effects, including those not listed in this package leaflet, tell your doctor or pharmacist.
See section 4.

Table of Contents of the Package Leaflet:

• 1. What is Pirfenidone Sandoz and what is it used for
• 2. Important information before taking Pirfenidone Sandoz
• 3. How to take Pirfenidone Sandoz
• 4. Possible side effects
• 5. How to store Pirfenidone Sandoz
• 6. Contents of the pack and other information

1. What is Pirfenidone Sandoz and what is it used for

Pirfenidone Sandoz contains the active substance pirfenidone and is used to treat idiopathic pulmonary fibrosis in adults.
Idiopathic pulmonary fibrosis is a disease in which the lung tissue becomes swollen and scarred over time, leading to difficulty breathing deeply. This makes it difficult for the lungs to work properly. Pirfenidone Sandoz helps reduce scarring and swelling of the lungs and helps improve breathing.

2. Important information before taking Pirfenidone Sandoz

When not to take Pirfenidone Sandoz

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 (a condition characterized by swelling of the face, lips, and/or tongue, and difficulty breathing or wheezing) while taking pirfenidone;
if you are 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 kidney failure requiring dialysis.
If any of these situations apply to you, do not take Pirfenidone Sandoz. If in doubt, consult a doctor or pharmacist.

Warnings and precautions

Before starting treatment with Pirfenidone Sandoz, discuss it with your doctor or pharmacist.
During treatment with Pirfenidone Sandoz, you may develop increased sensitivity to sunlight (photosensitivity reaction). While taking Pirfenidone Sandoz, 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 that may increase sensitivity to sunlight, such as tetracycline antibiotics (e.g., doxycycline).
Tell your doctor if you have kidney problems.
Tell your doctor if you have mild or moderate liver problems.
Before starting treatment with Pirfenidone Sandoz and during treatment, stop smoking. Smoking may reduce the effectiveness of Pirfenidone Sandoz.
Pirfenidone Sandoz may cause dizziness and fatigue. Be careful when performing tasks that require attention and coordination.
Pirfenidone Sandoz 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 rash with eosinophilia and systemic symptoms (DRESS syndrome) in patients treated with Pirfenidone Sandoz. Stop taking Pirfenidone Sandoz and seek medical attention immediately if you experience any symptoms related to these severe skin reactions, described in section 4.
Pirfenidone Sandoz may cause severe liver problems, and some cases have been fatal. Before starting treatment with Pirfenidone Sandoz, perform blood tests, which will be repeated every 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 Sandoz.

Children and adolescents

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

Pirfenidone Sandoz 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 Sandoz.
Medicines that may increase the side effects of Pirfenidone Sandoz:
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 Sandoz:
omeprazole (a medicine used to treat conditions such as heartburn and gastroesophageal reflux disease)
rifampicin (a type of antibiotic).

Pirfenidone Sandoz with food and drink

While taking the medicine, do not drink grapefruit juice. Grapefruit may interfere with the proper functioning of Pirfenidone Sandoz.

Pregnancy and breastfeeding

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

Driving and using machines

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

Pirfenidone Sandoz contains sodium

The medicine contains less than 1 mmol of sodium (23 mg) per tablet, which means it is considered "sodium-free"

3. How to take Pirfenidone Sandoz

Treatment with Pirfenidone Sandoz should be started and supervised by a specialist doctor with experience in diagnosing and treating 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 a dose of 267 mg (1 yellow tablet) 3 times a day with food (a total of 801 mg/day);
from day 8 to 14, take a dose of 534 mg (2 yellow tablets) 3 times a day with food (a total of 1602 mg/day);
from day 15 (maintenance treatment), take a dose of 801 mg (3 yellow tablets or 1 dark pink tablet) 3 times a day with food (a total of 2403 mg/day).
The recommended daily maintenance dose of Pirfenidone Sandoz is 801 mg (3 yellow tablets or 1 dark pink tablet) 3 times a day, taken with food, for 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 (vomiting) and dizziness. If symptoms persist, consult a doctor.

Reducing the dose due to side effects

Your doctor may reduce the dose of the medicine 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 Sandoz

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

Missing a dose of Pirfenidone Sandoz

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 Sandoz

In certain situations, your doctor may advise you to stop taking Pirfenidone Sandoz. If, for any reason, you stop taking Pirfenidone Sandoz 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 doubts about taking this medicine, consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, Pirfenidone Sandoz can cause side effects, although not everybody gets them.
Stop taking Pirfenidone Sandoz 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 bruising more easily than usual, or feeling tired. These may be signs of abnormal liver function and may indicate liver damage, which is an uncommon side effect of Pirfenidone Sandoz.
Red, unraised, 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 syndrome or drug hypersensitivity syndrome).

Other side effects that may occur

Talk to 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 acid reflux, 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 after sun exposure or sunlamps
skin problems, such as itching, redness, dryness, 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 those not listed in this package leaflet, tell your doctor, pharmacist, or nurse.
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.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Pirfenidone Sandoz

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after EXP. The expiry date refers to the last day of the month.
Do not store the medicine at temperatures above 30°C.
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 Sandoz contains

Pirfenidone Sandoz, 267 mg, film-coated tablets
The active substance is pirfenidone. Each film-coated tablet contains 267 mg of pirfenidone.
The other ingredients are:
tablet core: corn starch, croscarmellose sodium, hydroxypropyl cellulose, silicon dioxide, magnesium stearate.
tablet coating (Opadry yellow 85F220100): polyvinyl alcohol, partially hydrolyzed, titanium dioxide (E171), macrogol 3350, talc, and yellow iron oxide (E172).
Pirfenidone Sandoz, 801 mg, film-coated tablets
The active substance is pirfenidone. Each film-coated tablet contains 801 mg of pirfenidone.
The other ingredients are:
tablet core: corn starch, croscarmellose sodium, hydroxypropyl cellulose, silicon dioxide, magnesium stearate.
tablet coating (Opadry pink 85F240048): polyvinyl alcohol, partially hydrolyzed, titanium dioxide (E171), macrogol 3350, talc, yellow iron oxide (E172), red iron oxide (E172), and black iron oxide (E172).

What Pirfenidone Sandoz looks like and contents of the pack

Pirfenidone Sandoz, 267 mg, film-coated tablets
The tablets are yellow, oval, biconvex, approximately 1.2 x 0.7 cm in size, with the imprint "SD267" on one side.
Pirfenidone Sandoz, 801 mg, film-coated tablets
The tablets are dark pink, oval, biconvex, approximately 1.8 x 0.9 cm in size, with the imprint "SD801" on one side.
Pirfenidone Sandoz, 267 mg, film-coated tablets
The medicine is available in PVC/PE/PVDC/Aluminum blisters in a carton:
Blisters containing 63 or 252 film-coated tablets.
Single-dose blisters containing 63 x 1 or 252 x 1 film-coated tablet.
Pirfenidone Sandoz, 801 mg, film-coated tablets
The medicine is available in PVC/PE/PVDC-Aluminum blisters in a carton:
Blisters containing 84 film-coated tablets.
Single-dose blisters containing 84 x 1.
Each blister is marked with the following symbols to remind you to take the dose three times a day:

(sunrise, morning dose)
(sun; daytime dose)
(moon, evening dose)
Mon. Tue. Wed. Thu. Fri. Sat. Sun.

Marketing authorization holder and manufacturer

Marketing authorization holder
Sandoz GmbH
Biochemiestrasse 10
A-6250 Kundl
Austria
Manufacturer
Lek Pharmaceuticals d.d.
Verovškova 57
1526 Ljubljana
Slovenia
Lek Pharmaceuticals d.d.
Trimlini 2d
9220 Lendava
Slovenia

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

Denmark
Pirfenidone Sandoz
Belgium
Pirfenidon Sandoz 267 mg filmomhulde tabletten
Pirfenidon Sandoz 801 mg filmomhulde tabletten
Greece
Pirfenidone/Sandoz 267 mg επικαλυμμένα με λεπτό υμένιο δισκία
Spain
Pirfenidona Sandoz 267 mg comprimidos recubiertos con película EFG
Pirfenidona Sandoz 801 mg comprimidos recubiertos con película EFG
Finland
Pirfenidone Sandoz 267 mg tabletti, kalvopäällysteinen
Pirfenidone Sandoz 801 mg tabletti, kalvopäällysteinen
France
PIRFENIDONE SANDOZ 267 mg, comprimé pelliculé
PIRFENIDONE SANDOZ 801 mg, comprimé pelliculé
Hungary
Pirfenidon Sandoz 267 mg filmom obložene tablete
Pirfenidon Sandoz 801 mg filmom obložene tablete
Italy
Pirfenidone Sandoz
Northern Ireland
Pirfenidone Sandoz 267 mg, Filmcoated Tablet
Pirfenidone Sandoz 801 mg, Filmcoated Tablet
Netherlands
Pirfenidon Sandoz 267 mg, filmomhulde tabletten
Pirfenidon Sandoz 801 mg, filmomhulde tabletten
Norway
Pirfenidone Sandoz
Poland
Pirfenidone Sandoz
Portugal
Pirfenidona Sandoz
Sweden
Pirfenidone Sandoz

For further information about this medicine, contact the local representative of the marketing authorization holder:

Sandoz Polska Sp. z o.o.
ul. Domaniewska 50 C
02-672 Warsaw
tel. 22 209 70 00
Date of last revision of the package leaflet:07/2024
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