Pirfenidone Dr. Reddy's

Package leaflet: Information for the user

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
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 further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as yours, because it may be harmful to them.
• If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet. See section 4.

Contents of this leaflet:

1. What Pirfenidone Dr. Reddy’s is and what it is used for
2. What you need to know before taking 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 1 What Pirfenidone Dr. Reddy’s is and what it is used for

Pirfenidone Dr. Reddy’s 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 tissue becomes inflamed and damaged over time, leading to difficulty breathing deeply. This makes it difficult for the lungs to function properly. Pirfenidone Dr. Reddy’s helps reduce lung damage and inflammation, and helps you breathe better.
2 What you need to know before taking Pirfenidone Dr. Reddy’s
Do not take Pirfenidone Dr. Reddy’s

• 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, do not take Pirfenidone Dr. Reddy’s. If in doubt, consult your doctor or pharmacist.
Warnings and precautions
Talk to your doctor or pharmacist before taking Pirfenidone Dr. Reddy’s

• you may become more sensitive to sunlight (photosensitivity reaction) while taking Pirfenidone Dr. Reddy’s. Avoid sun exposure (including tanning lamps) during treatment with 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 (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 Dr. Reddy’s. Cigarette smoking may reduce the effect of Pirfenidone Dr. Reddy’s.
• Pirfenidone Dr. Reddy’s may cause dizziness and fatigue. Be cautious if you need to perform activities requiring mental alertness and coordination.
• Pirfenidone Dr. Reddy’s may cause weight loss. Your doctor will monitor your weight during treatment with 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 symptoms of these serious skin reactions described in section 4, stop treatment with Pirfenidone Dr. Reddy’s and contact a doctor immediately.

Pirfenidone Dr. Reddy’s can cause serious liver problems, which in some cases have been fatal. You will need to have a blood test before starting Pirfenidone Dr. Reddy’s, 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 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 section is particularly important if you are taking the following medicines, as they may alter the effect of Pirfenidone Dr. Reddy’s.
Medicines that may increase the side effects of Pirfenidone Dr. Reddy’s:

• 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 Dr. Reddy’s:

• omeprazole (used to treat conditions such as indigestion, gastroesophageal 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 may interfere with the proper action of Pirfenidone Dr. Reddy’s.
Pregnancy and breastfeeding
As a precautionary measure, it is preferable to avoid using Pirfenidone Dr. Reddy’s if you are pregnant, suspect you may be pregnant, or are planning a pregnancy, as the risks to the unborn baby are unknown.
If you are breastfeeding or intend to breastfeed, consult your doctor or pharmacist before taking Pirfenidone Dr. Reddy’s. Since it is not known whether Pirfenidone Dr. Reddy’s 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 Dr. Reddy’s.
Pirfenidone Dr. Reddy’s contains sodium and lactose
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially “sodium-free”.
If your doctor has diagnosed you with an intolerance to certain sugars, contact him or her before taking this medicine.
3 How to take Pirfenidone Dr. Reddy’s
Treatment with Pirfenidone Dr. Reddy’s should be initiated and supervised by a specialist doctor experienced in the diagnosis and treatment of IPF.
Always take this medicine exactly as your doctor or pharmacist has told you. If in doubt, consult your doctor or pharmacist.
The medicine is usually started with gradually increasing doses as follows:

• for the first 7 days, take 1 dose of 267 mg (1 yellow tablet), 3 times a day with food (total 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 (total 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 (total 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 whole tablet with water during or after meals to reduce the risk of side effects such as nausea (feeling unwell) 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 Dr. Reddy’s 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 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 the 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 Dr. Reddy’s
In certain specific cases, your doctor may advise you to stop taking Pirfenidone Dr. Reddy’s. If for any reason you need to stop treatment for more than 14 consecutive days, your doctor will restart treatment with a dose of 267 mg 3 times a day, gradually increasing the dose up to 801 mg 3 times a day.
If you have any doubts about how to use this medicine, talk to 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 Dr. Reddy’s and contact your doctor immediately:

• if you experience swelling of the face, lips and/or tongue, itching, hives, breathing difficulties or shortness of breath, or a feeling of fainting, which are symptoms of angioedema, a severe allergic reaction or anaphylaxis.
• if you develop 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 area (abdomen), loss of appetite, increased tendency to bleeding or bruising, 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 flat, red, circular rashes appear on the trunk, often with central blisters, skin peeling, or mouth, throat, nose, genital or eye ulcers. These serious 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 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 feeling constipated
• diarrhoea
• indigestion or stomach discomfort
• weight loss
• reduced appetite
• sleep disturbances
• fatigue
• dizziness
• headache
• shortness of breath
• cough
• painful joints/joint pain

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

• bladder infections
• feeling sleepy
• taste disturbances
• hot flushes
• stomach problems such as bloating sensation, pain and abdominal discomfort, heartburn and 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 get 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 Dr. Reddy’s

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the
bottle, blister pack, and carton following “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 you no longer use. This will help protect the environment.

6. Package contents and other information

What Pirfenidone Dr. Reddy’s contains

• The active substance 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 components are:
  • Tablet core: lactose, sodium croscarmellose, anhydrous colloidal silica and magnesium stearate.
  • Tablet coating: titanium dioxide (E171), macrogol 3350, talc and polyvinyl alcohol.
  • Additionally for Pirfenidone Dr. Reddy’s 267 mg film-coated tablets: yellow iron oxide (E172).
  • Additionally for Pirfenidone Dr. Reddy’s 534 mg film-coated tablets: yellow iron oxide (E172) and red iron oxide (E172).
  • Additionally 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 267 mg film-coated tablets
Pirfenidone Dr. Reddy’s 267 mg film-coated tablets are yellow, oval-shaped, biconvex tablets, film-coated, with the imprint “267”.
Packs
Blister packs contain 63 film-coated tablets (pack of 63 film-coated tablets or 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 to take a dose three times daily:

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

Pirfenidone Dr. Reddy’s 534 mg film-coated tablets
Pirfenidone Dr. Reddy’s 534 mg film-coated tablets are orange, oval-shaped, biconvex tablets, film-coated, with the imprint “534”.
Packs
Blister packs contain 21, 63 or 84 film-coated tablets.
The bottle pack contains one bottle with 90 film-coated tablets.
The blister foils are marked with the following symbols and abbreviated day names as a reminder to take a dose three times daily:

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

Pirfenidone Dr. Reddy’s 801 mg film-coated tablets
Pirfenidone Dr. Reddy’s 801 mg film-coated tablets are brown, oval-shaped, biconvex tablets, film-coated, with the imprint “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 to take 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 Authorisation Holder and Manufacturer
Dr. Reddy’s S.r.l.
Piazza Santa Maria Beltrade, 1
20123 Milano
Italy

betapharm Arzneimitteln GmbH,
Kobelweg 95,
Augsburg, 86156,
Germany

This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Hungary: Pirfenidon Reddy 267 mg filmtabletta
Pirfenidon Reddy 534 mg filmtabletta
Pirfenidon Reddy 801 mg filmtabletta
Spain: 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
Italy: Pirfenidone Dr. Reddy’s