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 specifically for you. Do not pass it on to others.
The medicine may harm another person, even if their symptoms are the same.
If the patient experiences any side effects, including any possible side effects not listed in this package leaflet, they should tell their doctor or pharmacist.
See section 4.

Package Leaflet Contents:

• 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. Package contents 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, making it difficult to breathe properly. Pirfenidone Sandoz helps reduce scarring and swelling of the lungs and improves breathing.

2. Important information before taking Pirfenidone Sandoz

When not to take Pirfenidone Sandoz

if the patient is allergic to pirfenidone or any of the other ingredients of this medicine (listed in section 6);
if the patient has previously experienced angioedema while taking pirfenidone, including symptoms such as swelling of the face, lips, and/or tongue, and 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 kidney failure requiring dialysis.
If any of these situations apply to the patient, they should not take Pirfenidone Sandoz. In case of doubt, consult a doctor or pharmacist.

Warnings and precautions

Before starting treatment with Pirfenidone Sandoz, the patient should discuss it with their doctor or pharmacist.
During treatment with Pirfenidone Sandoz, the patient may develop increased sensitivity to sunlight (photosensitivity reaction). During treatment with Pirfenidone Sandoz, the patient should avoid exposure to sunlight (including sunlamps). They should use sunscreens and cover their arms, legs, and head to limit exposure to sunlight (see section 4: Possible side effects).
The patient should not take other medicines, such as tetracycline antibiotics (e.g., doxycycline), which may increase sensitivity to sunlight.
The patient should tell their doctor about any kidney problems.
The patient should tell their doctor about any mild or moderate liver problems.
Before starting treatment with Pirfenidone Sandoz and during treatment, the patient should stop smoking. Smoking may reduce the effect of Pirfenidone Sandoz.
Pirfenidone Sandoz may cause dizziness and fatigue. The patient should be careful when performing tasks that require attention and coordination.
Pirfenidone Sandoz may cause weight loss. The doctor will monitor the patient's weight.
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. The patient should stop taking Pirfenidone Sandoz and seek medical attention immediately if they experience any symptoms associated with 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, the patient should have 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

The patient should tell their doctor or pharmacist about all medicines they are taking or have recently taken, as well as any medicines they 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 effect of Pirfenidone Sandoz:
omeprazole (a medicine used to treat conditions such as indigestion and reflux esophagitis)
rifampicin (a type of antibiotic).

Pirfenidone Sandoz with food and drink

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

Pregnancy and breastfeeding

If the patient is pregnant, plans to have a child, or suspects they may be pregnant, as a precautionary measure, they should avoid taking Pirfenidone Sandoz, as the risk to the unborn child is unknown.
If the patient is breastfeeding or plans to breastfeed, they should consult their doctor or pharmacist before taking Pirfenidone Sandoz. It is not known whether Pirfenidone Sandoz passes into breast milk, so the doctor will discuss the risks and benefits of taking this medicine during breastfeeding, if the patient decides to do so.

Driving and using machines

The patient should not drive or operate any machinery if they 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.
This medicine should always be taken exactly as prescribed by the doctor or pharmacist. In case of doubt, consult a 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.
Tablets should be swallowed 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

The doctor may reduce the dose of the medicine if the patient experiences 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 Sandoz

In case of taking more tablets than recommended, the patient should immediately contact their doctor, pharmacist, or the emergency department of the nearest hospital and take the medicine with them.

Missing a dose of Pirfenidone Sandoz

In case of missing a dose, the patient should take it as soon as possible. They should not take a double dose to make up for the missed dose. The patient should maintain at least a 3-hour interval between doses. The patient should not take more tablets in a day than the recommended daily dose.

Stopping treatment with Pirfenidone Sandoz

In certain situations, the treating doctor may advise stopping treatment with Pirfenidone Sandoz. If, for any reason, treatment with Pirfenidone Sandoz is interrupted for a period of more than 14 consecutive days, the 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.
In case of 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.
The patient should stop taking Pirfenidone Sandoz and seek medical attention immediately if they notice 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 easier bruising than usual, or feeling tired. These may be symptoms of abnormal liver function and may indicate liver damage, which is an uncommon side effect of Pirfenidone Sandoz.
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 body temperature, and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).

Other side effects that may occur

The patient should talk to their doctor if they 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 reflux, vomiting, constipation
diarrhea
indigestion or stomach upset
weight loss
decreased appetite
sleep disorders
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 disorders
hot flashes
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 disorders, 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 the patient experiences any side effects, including any possible side effects not listed in this package leaflet, they should tell their doctor, pharmacist, or nurse.
Side effects can be reported directly to the Department of Drug Safety Monitoring 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
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 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. The patient should ask their pharmacist how to dispose of medicines they no longer use. This will help protect the environment.

6. Package contents 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: maize starch, croscarmellose sodium, hydroxypropylcellulose, silicon dioxide, magnesium stearate.
tablet coating (Opadry yellow 85F220100): hypromellose, 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: maize starch, croscarmellose sodium, hydroxypropylcellulose, silicon dioxide, magnesium stearate.
tablet coating (Opadry pink 85F240048): hypromellose, 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 tablets.
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 the patient 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 more information about this medicine, the patient should contact their local representative of the marketing authorization holder:

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