PIRFENIDONE 267 mg Tabletki Powlekane

Treść ulotki

1. Possible side effects
2. How to store Pirfenidone Dr. Reddy’s
3. Contents of the pack and other information

Pirfenidone Dr. Reddy’s 267 mg film-coated tablets
Pirfenidone Dr. Reddy’s 534 mg film-coated tablets
Pirfenidone Dr. Reddy’s 801 mg film-coated tablets
Pirfenidone
Generic medicine

Read this leaflet carefully before you start 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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What is Pirfenidone Dr. Reddy’s and what it is used for
• 2. What you need to know before you take Pirfenidone Dr. Reddy’s
• 3. How to take Pirfenidone Dr. Reddy’s
• 4. Possible side effects
• 5. How to store Pirfenidone Dr. Reddy’s
• 6. Contents of the pack and other information 1What is Pirfenidone Dr. Reddy’s and what it is used for

Pirfenidone Dr. Reddy’s contains the active ingredient pirfenidone and is used for the
treatment of idiopathic pulmonary fibrosis (Idiopathic Pulmonary Fibrosis - IPF) in
adult patients.
IPF is a disease in which the tissues of the lungs become inflamed and damaged over
time, which leads to difficulty breathing deeply. This makes it difficult for the
lungs to function properly. Pirfenidone Dr. Reddy’s helps to reduce damage and
inflammation of the lungs, and helps you breathe better.

2What you need to know before you take Pirfenidone Dr. Reddy’s
Do not take Pirfenidone Dr. Reddy’s

• 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 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 Dr. Reddy’s. If you
are unsure, ask your doctor or pharmacist

Warnings and precautions
Talk to your doctor or pharmacist before taking Pirfenidone Dr. Reddy’s

• you may be more sensitive to sunlight (photosensitivity reaction) while taking Pirfenidone Dr. Reddy’s. Avoid sun exposure (including sunbeds) while taking Pirfenidone Dr. Reddy’s. 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 (such as doxycycline), which can make you more sensitive to sunlight.
• if you have kidney problems, tell your doctor.
• if you have mild to moderate liver problems, tell your doctor.
• stop smoking before and during treatment with Pirfenidone Dr. Reddy’s. Cigarette smoking may reduce the effect of Pirfenidone Dr. Reddy’s.
• Pirfenidone Dr. Reddy’s can cause dizziness and fatigue. Be careful if you need to perform activities that require mental alertness and coordination.
• Pirfenidone Dr. Reddy’s can cause weight loss. Your doctor will monitor your weight while you are taking this medicine.
• cases of Stevens-Johnson syndrome and toxic epidermal necrolysis have been reported in association with treatment with Pirfenidone Dr. Reddy’s. If you notice any of the symptoms related to these severe skin reactions, described in section 4, stop taking Pirfenidone Dr. Reddy’s and see a doctor immediately.

Pirfenidone Dr. Reddy’s can cause serious liver problems which have been fatal in some
cases. You will need to have a blood test before you start taking Pirfenidone Dr. Reddy’s,
monthly for the first 6 months and then every 3 months during the
period you are taking this medicine to check your liver is working properly. It is
important that you have these regular blood tests while you are taking Pirfenidone Dr.
Reddy’s.

Children and adolescents
Do not give Pirfenidone Dr. Reddy’s to children and adolescents under 18 years of age.

Other medicines and Pirfenidone Dr. Reddy’s
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines.
This is particularly important if you are taking the following medicines, as they can
change the effect of Pirfenidone Dr. Reddy’s.
Medicines that can increase the side effects of Pirfenidone Dr. Reddy’s:

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

Medicines that can reduce the effectiveness of Pirfenidone Dr. Reddy’s:

• omeprazole (used to treat conditions such as indigestion, gastro-oesophageal reflux disease)
• rifampicin (a type of antibiotic).

Pirfenidone Dr. Reddy’s with food and drink
Do not drink grapefruit juice while taking this medicine. Grapefruit can interfere with the
correct action of Pirfenidone Dr. Reddy’s.

Pregnancy and breastfeeding
As a precaution, it is preferable to avoid the use of Pirfenidone Dr. Reddy’s if you are
pregnant, or if you suspect you are pregnant or are planning to become pregnant as the
risks to the fetus are unknown.
If you are breastfeeding or planning to breastfeed, ask your doctor or pharmacist
before taking Pirfenidone Dr. Reddy’s. As it is not known whether Pirfenidone Dr. Reddy’s
passes into breast milk, your doctor will consider the risks and benefits of taking this
medicine while breastfeeding if you have decided to breastfeed.

Driving and using machines
Do not drive or use machines if you feel dizzy or tired after taking
Pirfenidone Dr. Reddy’s.

Pirfenidone Dr. Reddy’s contains sodium and lactose
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which is
essentially “sodium-free”.
If you have been diagnosed with intolerance to certain sugars, contact your doctor before
taking this medicine

3How to take Pirfenidone Dr. Reddy’s
Treatment with Pirfenidone Dr. Reddy’s should be started and supervised
by a doctor specialist experienced in the diagnosis and treatment of IPF.
Always take this medicine exactly as your doctor or pharmacist has told you. If you
have any questions, ask your doctor or pharmacist.
The medicine will usually be given to you in increasing doses as follows:

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

The recommended maintenance daily dose of Pirfenidone Dr. Reddy’s is 801 mg (3
yellow tablets or 1 brown tablet) three times a day with food, for a total of 2,403 mg/day.
Swallow the tablet whole with water during or after meals to reduce the risk
of side effects such as nausea (feeling sick) and dizziness. If the
symptoms persist, consult your doctor.

Dose reduction due to side effects
Your doctor may reduce the dose if you experience side effects such as stomach
problems, skin reactions to sunlight or sunbeds, or significant changes in liver
enzymes.

If you take more Pirfenidone Dr. Reddy’s than you should
If you have taken more tablets than you should, contact your doctor, pharmacist or the
nearest emergency room immediately, and take the medicine with you.

If you forget to take Pirfenidone Dr. Reddy’s
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 forgotten dose. There must be at least 3 hours
between doses. Do not take more tablets in a day than prescribed according to your
daily dose.

If you stop taking Pirfenidone Dr. Reddy’s
In some specific cases, your doctor may tell you to stop taking Pirfenidone Dr. Reddy’s.
If for any reason you need to stop treatment for a
period longer than 14 consecutive days, your doctor will restart treatment with 1 dose
of 267 mg 3 times a day, gradually increasing this dose to 801 mg 3
times a day.
If you have any questions about using this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Stop taking Pirfenidone Dr. Reddy’s and contact your doctor immediately:

• if you experience swelling of the face, lips and/or tongue, itching, hives, difficulty breathing or shortness of breath, or a feeling of fainting, which are symptoms of angioedema, a serious allergic reaction or anaphylaxis.
• if you develop yellowing of the whites of your eyes or skin, or dark urine, potentially accompanied by skin itching, pain in the upper right area of the 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 Dr. Reddy’s.
• if reddish, flat or circular patches appear on the trunk, often with blisters in the center, skin peeling, ulcers of the mouth, throat, nose, genitals and eyes. These severe skin rashes may be preceded by fever and flu-like symptoms. These signs and symptoms may indicate the onset of Stevens-Johnson syndrome or toxic epidermal necrolysis.

Other side effects may include
Talk to your doctor if you notice any side effect.

Very common side effects(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 feeling constipated
• diarrhea
• indigestion or stomach discomfort
• weight loss
• decreased appetite
• sleep disorders
• fatigue
• dizziness
• headache
• shortness of breath
• cough
• painful joints/joint pain

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

• bladder infections
• feeling sleepy
• taste alterations
• hot flushes
• stomach problems such as, feeling bloated, pain and abdominal discomfort, heartburn and passing gas
• blood tests may show increased levels of liver enzymes
• skin reactions after exposure to the sun or use of sunbeds
• 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 can cause headache, dizziness, confusion, weakness, muscle cramps or nausea and vomiting.
• blood tests may show a decrease in white blood cells.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this
leaflet. You can also report side effects directly through 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 Dr. Reddy’s

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label of the
bottle, on the blister and on the carton after “Exp.”. The expiry date refers to the last
day of that month.
This medicine does not require any particular storage conditions.
Do not dispose of any medicine in the drain or in household waste. Ask your pharmacist
how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What contains Pirfenidone Dr. Reddy’s

• The active ingredient is pirfenidone
• Pirfenidone Dr. Reddy’s 267 mg film-coated tablets: Each film-coated tablet contains 267 mg of pirfenidone.
• Pirfenidone Dr. Reddy’s 534 mg film-coated tablets: Each film-coated tablet contains 534 mg of pirfenidone
• Pirfenidone Dr. Reddy’s 801 mg film-coated tablets: Each film-coated tablet contains 801 mg of pirfenidone
• The other ingredients are:
• Tablet core: lactose, sodium croscarmellose, anhydrous colloidal silica and magnesium stearate.
• Tablet coating: titanium dioxide (E171), macrogol 3350, talc and polyvinyl alcohol Also for Pirfenidone Dr. Reddy’s 267 mg film-coated tablets: yellow iron oxide (E172). Also for Pirfenidone Dr. Reddy’s 534 mg film-coated tablets: yellow iron oxide (E172) and red iron oxide (E172). Also for Pirfenidone Dr. Reddy’s 801 mg film-coated tablets: red iron oxide (E172) and black iron oxide (E172)

Description of the appearance of Pirfenidone Dr. Reddy’s and contents of the pack

Pirfenidone Dr. Reddy’s 267mg film-coated tablets
The 267 mg film-coated tablets of Pirfenidone Dr. Reddy’s are
yellow, oval, biconvex, film-coated tablets with the inscription
“267”.
Packs
The blister packs contain 63 film-coated tablets (pack of 63
film-coated tablets or a multiple pack containing 1 pack of 21
film-coated tablets and 1 pack of 42 film-coated tablets) or 252
film-coated tablets (pack of 252 film-coated tablets or
multiple pack consisting of 3 packs each containing 84 film-coated
tablets).
The blister foils are marked with the following symbols and abbreviated day names, as a reminder for taking a dose three times a day:

(dawn; morning dose) (sun; midday dose) and (moon; evening dose).
Mon. Tue. Wed. Thu. Fri. Sat. Sun.

Pirfenidone Dr. Reddy’s 534mg film-coated tablets
The 534 mg film-coated tablets of Pirfenidone Dr. Reddy’s are orange in
color, oval, biconvex with the inscription “534 ”
Packs
The blister packs contain 21, 63 or 84 film-coated tablets.
The bottle pack contains a bottle of 90 film-coated tablets.
The blister foils are marked with the following symbols and abbreviated day names, as a reminder for taking a dose three times a day:

(dawn; morning dose) (sun; midday dose) and (moon; evening dose).
Mon. Tue. Wed. Thu. Fri. Sat. Sun

Pirfenidone Dr. Reddy’s 801mg film-coated tablets
The 801 mg film-coated tablets of Pirfenidone Dr. Reddy’s are brown in
color, oval, biconvex with the inscription “801”
Packs
The blister pack contains 84 film-coated tablets.
The blister foils are marked with the following symbols and abbreviated day names,
as a reminder for taking a dose three times a day:

(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 Authorisation Holder and Manufacturer
Dr. Reddy’s S.r.l.
Piazza Santa Maria Beltrade, 1
20123 Milan
Italy
betapharm Arzneimitteln GmbH,
Kobelweg 95,
Augsburg, 86156,
Germany

This medicinal product is authorised in the Member States of the European Economic Area with
the following denominations:
Pirfenidon Reddy 267 mg filmtabletta
Pirfenidon Reddy 534 mg filmtabletta
Pirfenidon Reddy 801 mg filmtabletta
Pirfenidona Dr. Reddys 267 mg comprimidos recubiertos con película EFG
Pirfenidona Dr. Reddys 534 mg comprimidos recubiertos con película EFG
Pirfenidona Dr. Reddys 801 mg comprimidos recubiertos con película EFG
Pirfenidone Dr. Reddy’s
Hungary
Spain
Italy