Pirfenidone Sandoz

Package leaflet: Information for the patient

Pirfenidone Sandoz 267 mg film-coated tablets, 801 mg film-coated tablets

Equivalent medicine
Please read 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, because it may be dangerous.
• If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Pirfenidone Sandoz is and what it is used for
2. What you need to know 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 Pirfenidone Sandoz is and what it is used for

Pirfenidone Sandoz contains the active substance pirfenidone and is used for the treatment of idiopathic pulmonary fibrosis (Idiopathic Pulmonary Fibrosis - IPF) in adult patients.
IPF is a disease in which lung tissues become inflamed and damaged over time, leading to difficulty in breathing deeply. This impairs proper lung function. Pirfenidone Sandoz helps reduce lung damage and inflammation, and helps improve breathing.

2. What you should know before taking Pirfenidone Sandoz

Do not take Pirfenidone Sandoz

• if you are allergic to pirfenidone or to any of the other ingredients of this medicine (listed in section 6)
• if you have previously experienced angioedema with pirfenidone, including symptoms such as swelling of the face, lips and/or tongue, which may be associated with difficulty breathing or wheezing
• if you are taking a medicine called fluvoxamine (used to treat depression and obsessive-compulsive disorder [OCD])
• if you have severe or end-stage liver disease
• if you have severe or end-stage kidney disease requiring dialysis.

If any of the above conditions apply to you, do not take Pirfenidone Sandoz. If in doubt, consult your
doctor or pharmacist.
Warnings and precautions
Talk to your doctor or pharmacist before taking Pirfenidone Sandoz.

• you may become more sensitive to sunlight (photosensitivity reaction) while taking Pirfenidone Sandoz. Avoid sun exposure (including sunlamps and tanning beds) during treatment with Pirfenidone Sandoz. Apply sunscreen daily and cover your arms, legs, and head to reduce exposure to sunlight (see section 4: Possible side effects).
• do not take other medicines, such as tetracycline antibiotics (e.g. doxycycline), that may increase your sensitivity to sunlight.
• if you have kidney problems, inform your doctor.
• if you have mild to moderate liver problems, inform your doctor.
• stop smoking before and during treatment with Pirfenidone Sandoz. Cigarette smoking may reduce the effect of Pirfenidone Sandoz.
• Pirfenidone Sandoz may cause dizziness and fatigue. Be cautious if you need to perform activities requiring mental alertness and coordination.
• Pirfenidone Sandoz may cause weight loss. Your doctor will monitor your weight during treatment with this medicine.
• cases of Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS) have been reported during treatment with Pirfenidone Sandoz. If you notice any of the symptoms related to these serious skin reactions described in section 4, stop taking Pirfenidone Sandoz and contact a doctor immediately.

Pirfenidone Sandoz can cause severe liver problems, which in some cases have been fatal.
You will need to have blood tests before starting Pirfenidone Sandoz, monthly for the first 6 months, and then every 3 months during treatment to monitor proper liver function. It is important that you attend these regular blood tests while taking Pirfenidone Sandoz.
Children and adolescents
Do not give Pirfenidone Sandoz to children and adolescents under 18 years of age.
Other medicines and Pirfenidone Sandoz
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
This section is particularly important if you are taking the following medicines, as they may alter the effect of Pirfenidone Sandoz.
Medicines that may increase the side effects of Pirfenidone Sandoz:

• enoxacin (a type of antibiotic)
• ciprofloxacin (a type of antibiotic)
• amiodarone (used to treat certain heart conditions)
• propafenone (used to treat certain heart conditions)
• fluvoxamine (used to treat depression and obsessive-compulsive disorder [OCD]).

Medicines that may reduce the effectiveness of Pirfenidone Sandoz:

• omeprazole (used to treat conditions such as indigestion and gastroesophageal reflux disease)
• rifampicin (a type of antibiotic).

Pirfenidone Sandoz with food and drinks
Do not drink grapefruit juice during treatment with this medicine. Grapefruit may interfere with the proper action of Pirfenidone Sandoz.
Pregnancy and breastfeeding
As a precautionary measure, it is preferable to avoid using Pirfenidone Sandoz during pregnancy, or if you suspect you might be pregnant or are planning a pregnancy, as the risks to the fetus are unknown.
If you are breastfeeding or intend to breastfeed, consult your doctor or pharmacist before taking Pirfenidone Sandoz. Since it is not known whether Pirfenidone Sandoz passes into breast milk, your doctor will evaluate the risks and benefits of taking this medicine during breastfeeding if you decide to breastfeed.
Driving and using machines
Do not drive or operate machinery if you experience dizziness or fatigue after taking Pirfenidone Sandoz.
Pirfenidone Sandoz contains sodium
Pirfenidone Sandoz contains less than 1 mmol of sodium (23 mg) per film-coated tablet, i.e. it is essentially “sodium-free”.

3. How to take Pirfenidone Sandoz

Treatment with Pirfenidone Sandoz must be initiated and supervised by a specialist physician experienced in the diagnosis and treatment of IPF.
Always take this medicine exactly as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The medicine will usually be administered to you in gradually increasing doses as follows:

• for the first 7 days, take one 267 mg dose (1 yellow tablet) three times a day with food (total of 801 mg/day)
• from day 8 to day 14, take one 534 mg dose (2 yellow tablets) three times a day with food (total of 1,602 mg/day)
• from day 15 onwards (maintenance phase), take one 801 mg dose (3 yellow tablets or 1 dark pink tablet) three times a day with food (total of 2,403 mg/day).

The recommended daily maintenance dose of Pirfenidone Sandoz is 801 mg (3 yellow tablets or 1 dark pink tablet) three times a day with food, for a total of 2,403 mg/day.
Swallow the tablet whole with a glass of water during or after meals to reduce the risk of side effects such as nausea (feeling sick) and dizziness. If symptoms persist, consult your doctor.
Dose reduction due to side effects
Your doctor may reduce your dose if you experience side effects such as stomach problems, skin reactions to sunlight or tanning lamps, or significant changes in liver enzymes.
If you take more Pirfenidone Sandoz than you should
If you have taken more tablets than prescribed, contact your doctor, pharmacist, or nearest emergency department immediately, and bring the medicine with you.
If you forget to take Pirfenidone Sandoz
If you forget to take a dose, take it as soon as you remember. Do not take a double dose to make up for a missed dose. There must be at least 3 hours between doses. Do not take more tablets in one day than prescribed according to the daily dose.
If you stop taking Pirfenidone Sandoz
In certain specific cases, your doctor may advise you to stop taking Pirfenidone Sandoz. If you need to interrupt treatment for more than 14 consecutive days for any reason, your doctor will restart treatment with a dose of 267 mg three times a day, gradually increasing this dose up to 801 mg three times a day.
If you have any questions about how to use 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.
Stop taking Pirfenidone Sandoz and contact your doctor immediately if you notice any of the following symptoms or signs:

• Swelling of the face, lips and/or tongue, itching, hives, difficulty breathing or shortness of breath, or feeling faint, which are symptoms of angioedema, a severe allergic reaction or anaphylaxis.
• Yellowing of the whites of the eyes or skin, or dark urine, possibly accompanied by skin itching, pain in the upper right part of the stomach (abdomen), loss of appetite, increased tendency to bleed or bruise, or feeling tired. These may be signs of impaired liver function and could indicate liver damage, which is an uncommon side effect of Pirfenidone Sandoz.
• Flat, red or circular spots on the trunk, often with central blisters, skin peeling, or ulcers in the mouth, throat, nose, genitals, or eyes. These serious 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 may include
Talk to your doctor if you notice any side effect.
Very common side effects (may affect more than 1 in 10 people):

• Throat or airway infections reaching the lungs and/or sinusitis
• Feeling unwell (nausea)
• Stomach problems such as acid reflux, vomiting, and constipation
• Diarrhoea
• Indigestion or stomach discomfort
• Weight loss
• Decreased appetite
• Difficulty sleeping
• Tiredness
• Dizziness
• Headache
• Shortness of breath
• Cough
• Joint pain/joint aches

Common side effects (may affect up to 1 in 10 people):

• Bladder infections
• Drowsiness
• Taste disturbances
• Hot flushes
• Stomach problems such as bloating, pain and abdominal discomfort, heartburn, flatulence
• Blood tests may show increased liver enzyme levels
• Skin reactions after exposure to sunlight or use of sunlamps
• Skin problems such as itching, redness, dry skin, rash
• Muscle pain
• Feeling weak or lacking energy
• Chest pain
• Sunburn

Uncommon side effects (may affect up to 1 in 100 people):

• Low levels of sodium in the blood, which may cause headache, dizziness, confusion, weakness, muscle cramps, or nausea and vomiting
• Blood tests may show a reduction in white blood cells.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

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 carton, on the label of the bottle, and on the blister after Exp. The expiry date refers to the last day of that month.
Do not store this medicine above 30°C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you 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 components are: Tablet core: pregelatinized starch, sodium croscarmellose (E468), hypromellose (E463), silicon dioxide (E551), magnesium stearate (E572).

Tablet coating (Opadry Yellow 85F220100): polyvinyl alcohol – partially hydrolysed (E1203), titanium dioxide (E171), macrogol 3350, talc (E553B) 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 components are: Tablet core: pregelatinized starch, sodium croscarmellose (E468), hypromellose (E463), silicon dioxide (E551), magnesium stearate (E572).

Tablet coating (Opadry Pink 85F240048): polyvinyl alcohol – partially hydrolysed (E1203), titanium dioxide (E171), macrogol 3350, talc (E553B), yellow iron oxide (E172), red iron oxide (E172) and black iron oxide (E172).
Description of the appearance of Pirfenidone Sandoz and contents of the pack
Pirfenidone Sandoz 267 mg film-coated tablets are yellow, oval, approximately 1.2 x 0.7 cm, biconvex, with the imprint “SD267” on one side.
Pirfenidone Sandoz 801 mg film-coated tablets are dark pink, oval, approximately 1.8 x 0.9 cm, biconvex, with the imprint “SD801” on one side.
Pirfenidone Sandoz 267 mg is available in PVC/PE/PVDC-Alu blisters in:

• blister packs containing 63 or 252 film-coated tablets
• divisible unit-dose blister packs containing 63 x 1 or 252 x 1 film-coated tablets

The starter pack for two weeks of treatment:

• Starter packs for 2 weeks of treatment: Multiblister pack containing 63 (1 pack of 21 and 1 pack of 42) film-coated tablets or divisible unit-dose blister in multiblister pack containing 63 (1 pack of 21x1 and 1 pack of 42x1) film-coated tablets
• Maintenance packs: Multiblister pack containing 252 (3 packs of 84) film-coated tablets or divisible unit-dose blister in multiblister pack containing 252 (3 packs of 84x1) film-coated tablets

The 267 mg blister packs containing 63 film-coated tablets, the divisible unit-dose blister packs containing 63x1 film-coated tablets, and the 2-week treatment packs are marked with the following symbols and abbreviated day names to be used as reminders for taking a dose three times daily:

(dawn; morning dose) (sun; midday dose) and (moon; evening dose).
Mon. Tue. Wed. Thu. Fri. Sat. Sun.
Pirfenidone Sandoz 801 mg film-coated tablets are available in PVC/PE/PVDC-Alu blisters in:

• blister packs containing 84 or 252 film-coated tablets
• divisible unit-dose blister packs containing 84x1 or 252x1 film-coated tablets
• maintenance packs: Multiblister pack containing 252 (3 packs of 84) film-coated tablets or divisible unit-dose blister in multiblister pack containing 252 (3 packs of 84x1) film-coated tablets.

The 801 mg blister packs are marked with the following symbols and abbreviated day names to be used as reminders for taking a dose three times daily:

(dawn; morning dose) (sun; midday dose) and (moon; evening dose).
Mon. Tue. Wed. Thu. Fri. Sat. Sun.
Not all pack sizes may be marketed.
Marketing Authorization Holder
Sandoz S.p.A.
Viale Luigi Sturzo 43
20154 Milan
Italy
Manufacturer
Lek Pharmaceuticals d.d.
Verovskova ulica 57
1526 Ljubljana
Slovenia
Lek Pharmaceuticals d.d.
Trimlini 2d
9220 Lendava
Slovenia
This medicinal product is authorized in the European Economic Area and the United Kingdom under the following names:
Croatia Pirfenidon Sandoz 267 mg filmom obložene tablete
Pirfenidon Sandoz 801 mg filmom obložene tablete
Denmark Pirfenidone Sandoz
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
Greece Pirfenidone/Sandoz 267 mg επικαλυμμένα με λεπτό υμένιο δισκία
Italy Pirfenidone Sandoz
Norway Pirfenidone Sandoz
Netherlands Pirfenidon Sandoz 267 mg, filmomhulde tabletten
Pirfenidon Sandoz 801 mg, filmomhulde tabletten
Poland Pirfenidone Sandoz
Portugal Pirfenidona Sandoz
Spain Pirfenidona Sandoz 267 mg comprimidos recubiertos con película EFG
Pirfenidona Sandoz 801 mg comprimidos recubiertos con película EFG
Sweden Pirfenidone Sandoz