Pirfenidone Teva

Package leaflet: Information for the patient

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

pirfenidone
Generic medicine
Please read all of 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 give it to other people, even if their
symptoms are the same as yours, because it could 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 Teva is and what it is used for
2. What you need to know before taking Pirfenidone Teva
3. How to take Pirfenidone Teva
4. Possible side effects
5. How to store Pirfenidone Teva
6. Contents of the pack and other information

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

Pirfenidone Teva contains the active substance pirfenidone and is used for the treatment of 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 makes it difficult for the lungs to function properly. Pirfenidone Teva helps reduce lung damage and inflammation, and helps improve breathing.

2. What you need to know before taking Pirfenidone Teva

Do not take Pirfenidone Teva
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 Teva. If in doubt, consult your doctor or pharmacist.

Warnings and precautions
Talk to your doctor or pharmacist before taking Pirfenidone Teva
You may become more sensitive to sunlight (photosensitivity reaction) while taking Pirfenidone Teva. Avoid sun exposure (including tanning lamps) during treatment with Pirfenidone Teva. 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 Teva. Cigarette smoking may reduce the effect of Pirfenidone Teva.
Pirfenidone Teva may cause dizziness and fatigue. Be cautious if you perform activities requiring mental alertness and coordination.
Pirfenidone Teva 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 in association with pirfenidone treatment. If you notice any of the symptoms related to these serious skin reactions described in section 4, stop treatment with Pirfenidone Teva and seek immediate medical advice.
Pirfenidone may cause severe liver problems, which in some cases have been fatal. You will need to have a blood test before starting Pirfenidone Teva, 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 Teva.

Children and adolescents
Do not administer Pirfenidone Teva to children and adolescents under 18 years of age.

Other medicines and Pirfenidone Teva
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 Teva.
Medicines that may increase the side effects of Pirfenidone Teva:
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 Teva:
omeprazole (used to treat conditions such as indigestion, gastroesophageal reflux disease)
rifampicin (a type of antibiotic).

Pirfenidone Teva with food and drink
Do not drink grapefruit juice while taking this medicine. Grapefruit may interfere with the proper action of Pirfenidone Teva.

Pregnancy and breastfeeding
As a precautionary measure, it is preferable to avoid using Pirfenidone Teva during pregnancy, or if you suspect you may be pregnant or are planning a pregnancy, as the potential risks to the fetus are unknown.
If you are breastfeeding or intend to breastfeed, consult your doctor or pharmacist before taking Pirfenidone Teva. Since it is not known whether Pirfenidone Teva 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 and do not operate machinery if you experience dizziness or fatigue after taking Pirfenidone Teva.

Pirfenidone Teva contains sodium
Pirfenidone Teva contains less than 1 mmol (23 mg) of sodium per tablet, i.e. it is essentially "sodium-free".

3. How to take Pirfenidone Teva

Treatment with Pirfenidone Teva must be initiated and supervised by a specialist physician experienced in the diagnosis and treatment of IPF.
Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The medicine is usually administered in gradually increasing doses as follows:
for the first 7 days, take a dose of 267 mg (1 yellow tablet) three times daily with food (totaling 801 mg/day)
from day 8 to day 14, take a dose of 534 mg (2 yellow tablets) three times daily with food (totaling 1,602 mg/day)
from day 15 onwards (maintenance phase), take a dose of 801 mg (3 yellow tablets or 1 purple tablet) three times daily with food (totaling 2,403 mg/day).
The recommended daily maintenance dose of Pirfenidone Teva is 801 mg (3 yellow tablets or 1 purple tablet) three times daily with food, totaling 2,403 mg/day.
Swallow the tablet whole with water during or after meals to reduce the risk of adverse effects such as nausea and dizziness. If symptoms persist, consult your doctor.

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

If you take more Pirfenidone Teva 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 Teva
If you forget to take a dose, take it as soon as you remember. Do not take a double dose to make up for the missed dose. There must be at least three hours between doses.
Do not take more tablets in one day than prescribed according to the daily dose.

If you stop taking Pirfenidone Teva
In certain specific cases, your doctor may advise you to stop taking Pirfenidone Teva.
If you need to interrupt treatment with Pirfenidone Teva for more than 14 consecutive days for any reason, your doctor will restart treatment with a dose of 267 mg three times daily, gradually increasing this dose up to 801 mg three times daily.

If you have any doubts 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 Teva 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 wheezing, or a
feeling of fainting, which are symptoms of angioedema, a serious allergic reaction or anaphylaxis.
Yellowing of the whites of the eyes or of the skin, or dark urine, possibly accompanied by itching
of the skin, pain in the upper right part of the stomach area (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 Teva.
Flat or circular reddish skin lesions, often with central blisters, peeling of the skin, mouth, throat,
nose, genital or eye ulcers. 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 possible side effects 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
painful joints/joint pain.
Common side effects (may affect up to 1 in 10 people):
bladder infections
drowsiness
taste disturbances
hot flushes
stomach problems such as bloating sensation, abdominal pain and discomfort, heartburn and
passing wind
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. These 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 get any side effects, including ones not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at
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 Teva

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the bottle label, 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 special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Pirfenidone Teva contains
267 mg tablet
The active substance is pirfenidone. Each film-coated tablet contains 267 mg of
pirfenidone.
The other components are anhydrous colloidal silica, microcrystalline cellulose, sodium croscarmellose,
povidone and magnesium stearate.
The tablet coating consists of: partially hydrolysed polyvinyl alcohol (E1203), titanium dioxide (E171), macrogol 3350 (E1521), talc (E553b), yellow iron oxide (E172) and black iron oxide (E172).
801 mg tablet
The active substance is pirfenidone. Each film-coated tablet contains 801 mg of
pirfenidone.
The other components are anhydrous colloidal silica, microcrystalline cellulose, sodium croscarmellose,
povidone and magnesium stearate.
The tablet coating consists of: partially hydrolysed polyvinyl alcohol (E1203), titanium dioxide (E171), macrogol 3350 (E1521), talc (E553b), yellow iron oxide (E172), black iron oxide (E172) and red iron oxide (E172).
Description of the appearance of Pirfenidone Teva and package contents
Pirfenidone Teva 267 mg film-coated tablets are yellow, oval-shaped, approximately 12.9 x 5.9 mm, with "3610" engraved on one side and "T" on the other.
Bottle packs contain either one bottle with 63 tablets or three bottles each containing 84 tablets (252 tablets in total).
Blister packs contain 63 or 252 film-coated tablets.
Perforated single-dose blister packs contain 63x1 or 252x1 film-coated tablets.
Each 267 mg blister is marked with symbols and abbreviated day names to remind patients to take a dose three times daily:
Pirfenidone Teva 801 mg film-coated tablets are purple, oval-shaped, approximately 20.1 x 9.3 mm, with "3611" engraved on one side and "T" on the other.
Bottle packs contain either one bottle with 84 tablets or three bottles each containing 84 tablets (252 tablets in total).
The blister pack contains 84 film-coated tablets and the multiple pack contains 252 (3x84) film-coated tablets.
The perforated single-dose blister pack contains 84x1 film-coated tablets and the multiple pack contains 252 (3x84x1) film-coated tablets.
Each 801 mg blister is marked with symbols and abbreviated day names to remind patients to take a dose three times daily:
Sunrise symbol (sunrise; morning dose), Sun symbol (daytime; daytime dose), and Moon symbol (moon; evening dose).
Mon. Tue. Wed. Thu. Fri. Sat. Sun.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Teva Italia S.r.l. - Piazzale Luigi Cadorna, 4 - 20123 Milan, Italy
Manufacturer
Actavis Limited, BLB015, BLB016 Bulebel Industrial Estate, ZTN 3000 Zejtun, Malta
This medicinal product is authorised in the European Economic Area Member States
under the following names: