Pirfenidone sandoz
Poland
Table of Contents
Package leaflet: Information for the patient
Pirfenidone Sandoz, 267 mg, film-coated tablets
Pirfenidone Sandoz, 801 mg, film-coated tablets
Pirfenidone
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for the patient.
Keep this leaflet, as you may need to read it again.
If you have any further questions, please ask your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others.
It may harm other people, even if their symptoms are the same.
If you experience any adverse effects, including any possible adverse effects not listed in this
leaflet, tell your doctor or pharmacist.
See section 4.
Contents of the leaflet:
- What Pirfenidone Sandoz is and what it is used for
- What you need to know before taking Pirfenidone Sandoz
- How to take Pirfenidone Sandoz
- Possible side effects
- How to store Pirfenidone Sandoz
- Contents of the pack and other information
1. What Pirfenidone Sandoz is and what it is 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 lung tissue becomes inflamed and over time
forms scar tissue, making deep breathing difficult. This impairs the proper function of the lungs.
Pirfenidone Sandoz helps reduce scarring and inflammation in the lungs and helps improve breathing.
2. Important information before using Pirfenidone Sandoz
When not to use Pirfenidone Sandoz
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 during treatment with 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.
If any of the above situations apply to the patient, Pirfenidone Sandoz must not be used. If in doubt,
consult a doctor or pharmacist.
Warnings and precautions
Talk to your doctor or pharmacist before starting treatment with Pirfenidone Sandoz.
During treatment with Pirfenidone Sandoz, increased sensitivity to sunlight (photosensitivity reaction)
may develop. While taking Pirfenidone Sandoz, avoid exposure to sunlight (including sunbeds). Use
sunscreen and cover 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) that may increase
sensitivity to sunlight.
Inform your doctor if you have kidney problems.
Inform your doctor if you have mild or moderate liver impairment.
Before starting and during treatment with Pirfenidone Sandoz, stop smoking. Smoking may reduce
the effectiveness of Pirfenidone Sandoz.
Pirfenidone Sandoz may cause dizziness and fatigue. Be cautious when performing tasks requiring
alertness and coordination.
Pirfenidone Sandoz may cause weight loss. Your doctor will monitor your body weight during
treatment.
Serious skin reactions such as Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug
reaction with eosinophilia and systemic symptoms (DRESS syndrome) have been reported with
Pirfenidone Sandoz treatment. Stop taking Pirfenidone Sandoz and contact your doctor immediately
if any symptoms related to these serious skin reactions occur, as described in section 4.
Pirfenidone Sandoz may cause severe liver problems, and some cases have resulted in death.
Before starting treatment with Pirfenidone Sandoz, blood tests must be performed 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 Sandoz.
Children and adolescents
Pirfenidone Sandoz must 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 the patient is currently taking or has recently
taken, as well as any medicines the patient plans to take. This is particularly important when taking
the medicines listed below, as they may affect the action of Pirfenidone Sandoz.
Medicines that may increase 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, gastroesophageal reflux disease)
rifampicin (a type of antibiotic).
Pirfenidone Sandoz with food and drink
Do not drink grapefruit juice while taking this medicine. Grapefruit may interfere with the normal
action of Pirfenidone Sandoz.
Pregnancy and breastfeeding
If the patient is pregnant, planning to become pregnant, or suspects she may be pregnant, it is
recommended as a precautionary measure to avoid using Pirfenidone Sandoz, since the risk to the
unborn child is unknown.
If the patient is breastfeeding or planning to breastfeed, consult a doctor or pharmacist before taking
Pirfenidone Sandoz. It is not known whether Pirfenidone Sandoz passes into human breast milk.
Therefore, the doctor will discuss with the patient the risks and benefits of using this medicine during
breastfeeding if she decides to do so.
Driving and using machines
Do not drive or operate any machinery if dizziness or fatigue occurs after taking Pirfenidone Sandoz.
Pirfenidone Sandoz contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per tablet; this means the medicine is
considered "sodium-free".
3. How to use Pirfenidone Sandoz
Treatment with Pirfenidone Sandoz 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 directed by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist.
The medicine is usually administered in gradually 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 dark pink tablet) three times daily with food (total 2403 mg/day).
The recommended maintenance daily dose of Pirfenidone Sandoz is 801 mg (3 yellow tablets or 1 dark pink tablet) taken three times a day 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 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 stomach disturbances, any skin reactions to sunlight or solarium exposure, or significant changes in liver enzyme activity.
Taking more Pirfenidone Sandoz than recommended
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 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 one day than the recommended daily dose.
Stopping treatment with Pirfenidone Sandoz
In certain situations, your treating physician may advise stopping treatment with Pirfenidone Sandoz. If, for any reason, treatment with Pirfenidone Sandoz is interrupted for longer than 14 consecutive days, 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 side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Treatment with Pirfenidone Sandoz should be stopped immediately and medical help should be sought
if the patient experiences any of the following objective or subjective symptoms:
Swelling of the face, lips and (or) tongue, itching, hives, difficulty breathing or wheezing, or a feeling of fainting. 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 itchy skin,
pain in the upper right part of the abdomen, loss of appetite, bleeding or easier than usual
bruising, or a feeling of tiredness. These may be symptoms of impaired liver function and
may indicate liver damage, which is an uncommon side effect of Pirfenidone Sandoz.
Red, flat or round spots on the trunk, often with centrally located blisters, peeling of the skin,
ulceration of 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 body temperature 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 occur in more than 1 in 10 people):
infections of the throat or respiratory tract leading to the lungs and (or) sinusitis
nausea
gastrointestinal disorders such as regurgitation of stomach contents into the oesophagus, vomiting, constipation
diarrhoea
indigestion or upset stomach
weight loss
decreased appetite
sleep disorders
fatigue
dizziness
headache
shortness of breath
cough
joint pain
Common side effects (may occur in up to 1 in 10 people):
urinary tract infections
feeling sleepy
taste disturbances
hot flushes
gastrointestinal disorders such as bloating, abdominal pain and discomfort in the abdominal area, heartburn and flatulence
blood tests may show increased liver enzyme activity
skin reactions after exposure to sunlight or solarium
skin disorders such as itchy skin, redness of the skin, dry skin, skin rash
muscle pain
feeling of weakness or lack of energy
chest pain
sunburn
Uncommon side effects (may occur in up to 1 in 100 people):
low sodium levels in the blood. This may cause headache, dizziness, confusion, weakness, muscle cramps, or nausea and vomiting.
blood tests may show a decreased white blood cell count.
Reporting of side effects
If any side effects occur, including any side effects not listed in this leaflet, tell your doctor, pharmacist or nurse. Side effects can be reported directly to the Department of Monitoring Adverse Drug Reactions at 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 authorisation holder.
By reporting side effects, additional information on the safety of the medicine can be collected.
5. How to store Pirfenidone Sandoz
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the cardboard box and blister pack after EXP. The expiry date refers to the last day of the stated month.
Do not store this medicine 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. These measures 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.
Other ingredients are:
Tablet core: pregelatinized starch, corn, sodium croscarmellose,
hydroxypropylcellulose, silicon dioxide, magnesium stearate.
Tablet coating (Opadry yellow 85F220100): polyvinyl alcohol – partially hydrolysed,
titanium dioxide (E171), macrogol 3350, talc, iron oxide yellow (E172).
Pirfenidone Sandoz, 801 mg, film-coated tablets
The active substance is pirfenidone. Each film-coated tablet contains 801 mg of pirfenidone.
Other ingredients are:
Tablet core: pregelatinized starch, corn, sodium croscarmellose,
hydroxypropylcellulose, silicon dioxide, magnesium stearate.
Tablet coating (Opadry pink 85F240048): polyvinyl alcohol – partially hydrolysed,
titanium dioxide (E171), macrogol 3350, talc, iron oxide yellow (E172), iron oxide red (E172), iron oxide black (E172).
What Pirfenidone Sandoz looks like and contents of the pack
Pirfenidone Sandoz, 267 mg, film-coated tablets
Film-coated 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
Film-coated 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/Aluminium foil blisters in a cardboard 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-Aluminium foil blisters in a cardboard carton:
Blisters containing 84 film-coated tablets.
Single-dose blisters containing 84 x 1 film-coated tablet.
Each blister is marked with the following symbols to remind you to take the dose three times daily:
(sunrise, morning dose) (sun; daytime dose) (moon, evening dose)
Mon. Tue. Wed. Thu. Fri. Sat. Sun.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation 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 authorised for marketing in 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 detailed information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Sandoz Polska Sp. z o.o.
ul. Domaniewska 50 C
02-672 Warszawa
tel. 22 209 70 00