Pirfenidona Dr. Reddys 267 mg Film-Coated Tablets

Pirfenidona Dr. Reddys 534 mg Film-Coated Tablets

Pirfenidona Dr. Reddys 801 mg Film-Coated Tablets

Read this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, as 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 others, even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1.What is Pirfenidona Dr. Reddys and what it is used for

2.What you need to know before starting to take Pirfenidona Dr. Reddys

3.How to take Pirfenidona Dr. Reddys

4.Possible side effects

5.Storage of Pirfenidona Dr. Reddys

6.Contents of the pack and additional information

This medication contains the active ingredient pirfenidona and is used for the treatment of mild to moderate Idiopathic Pulmonary Fibrosis (IPF) in adults.

IPF is a disease in which the lung tissues become inflamed and filled with scars over time, making it difficult to breathe deeply. In these circumstances, the lungs have trouble functioning correctly. Pirfenidona Dr. Reddys helps to reduce lung scarring and inflammation, and helps you breathe better.

Do not take Pirfenidona Dr. Reddys

•if you are allergic to pirfenidona or any of the other ingredients of this medication (listed in section 6)

•if you have had previously angioedema with pirfenidona, including symptoms such as swelling of the face, lips, and/or tongue that may be associated with difficulty breathing or wheezing

•if you are taking a medication called fluvoxamine (used to treat depression and obsessive-compulsive disorder [OCD])

•if you have severe or terminal liver disease

•if you have severe or terminal kidney disease that requires dialysis.

If any of the above applies to your case, do not take pirfenidona. If you have any doubts, consult your doctor or pharmacist.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Pirfenidona Dr. Reddys

•You may be more sensitive to sunlight (photosensitivity reaction) when taking pirfenidona. Avoid the sun (also UVA lamps) while taking Pirfenidona Dr. Reddys. Use daily sunscreen and cover your arms, legs, and head to reduce exposure to sunlight (see section 4: Possible side effects).

•Do not take other medications, such as tetracycline antibiotics (e.g. doxycycline), that may increase your sensitivity to sunlight.

•Inform your doctor if you have kidney problems.

•Inform your doctor if you have mild to moderate liver problems.

•Abstain from smoking before and during treatment with pirfenidona. Smoking may reduce the effect of pirfenidona.

•Pirfenidona Dr. Reddys may cause dizziness and fatigue. Be careful if you have to perform activities that require attention and coordination.

•Pirfenidona Dr. Reddys may cause weight loss. Your doctor will monitor your weight while you are taking this medication.

•Severe skin reactions such as Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS) have been reported in association with pirfenidona treatment. Stop taking pirfenidona and seek medical attention immediately if you notice any symptoms related to these severe skin reactions described in section 4.

Pirfenidona may cause severe liver problems. Some cases have been fatal. You will need to have a blood test before starting to take Pirfenidona Dr. Reddys, once a month for the first 6 months, and then every 3 months while you are taking this medication, to check the proper functioning of your liver. It is essential that you have these blood tests regularly throughout the time you are taking pirfenidona.

Children and adolescents

Do not administer pirfenidona to children and adolescents under 18 years old.

Other medications and Pirfenidona Dr. Reddys

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

This is especially important if you are taking the following medications, as they may alter the effect of pirfenidona.

The following medications may increase the side effects of pirfenidona:

•enoxacina (a type of antibiotic)

•ciprofloxacin (a type of antibiotic)

•amiodarone (used to treat certain types of heart disease)

•propafenone (used to treat certain types of heart disease)

•fluvoxamine (used to treat depression and obsessive-compulsive disorder [OCD]).

The following medications may reduce the effectiveness of pirfenidona:

•omeprazole (used to treat conditions such as indigestion and gastroesophageal reflux disease)

•rifampicin (a type of antibiotic).

Taking Pirfenidona Dr. Reddys with food and drinks

Do not drink grapefruit juice while taking this medication. Grapefruit juice may make pirfenidona not work correctly.

Pregnancy and breastfeeding

As a precaution, it is recommended to avoid using pirfenidona if you are pregnant, planning to become pregnant, or think you may be pregnant, as the potential risks to the fetus are unknown.

If you are breastfeeding or plan to do so, speak with your doctor or pharmacist before taking pirfenidona. As it is not known whether pirfenidona is excreted in breast milk, your doctor will explain the risks and benefits of taking this medication during breastfeeding if you decide to do so.

Driving and operating machinery

Do not drive or operate machinery if you feel dizzy or fatigued after taking pirfenidona.

Pirfenidona Dr. Reddys contains sodium

Pirfenidona Dr. Reddys contains less than 1 mmol of sodium (23 mg) per tablet, that is, it is essentially "sodium-free".

The treatment with pirfenidone should be initiated and supervised by specialist doctors with experience in the diagnosis and treatment of IPF.

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Normally, you will be administered this medication by gradually increasing the dose as follows:

?for the first 7 days, take a dose of 267 mg (1 yellow tablet), 3 times a day with food (a total of 801 mg/day)

?from day 8 to 14, take a dose of 534 mg (2 yellow tablets or 1 orange tablet), 3 times a day with food (a total of 1.602 mg/day)

?from day 15 (maintenance), take a dose of 801 mg (3 yellow tablets or 1 brown tablet), 3 times a day with food (a total of 2.403 mg/day).

The recommended daily maintenance dose of Pirfenidone Dr. Reddys is 3 tablets three times a day with food, a total of 2403 mg/day.

Swallow the tablets whole with water, during or after a meal to reduce the risk of side effects such as nausea (feeling of discomfort) and dizziness. If symptoms persist, consult your doctor.

Reduction of the dose due to side effects

Your doctor may decide to reduce the dose if you experience side effects such as stomach problems, skin reactions to sunlight or UV-A lamps, or significant changes in liver enzymes.

If you take more Pirfenidone Dr. Reddys than you should

Go to your doctor, pharmacist, or the nearest hospital emergency department immediately if you take more tablets than you should, and bring your medication with you.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested

If you forget to take Pirfenidone Dr. Reddys

If you forget to take a dose, take it as soon as you remember. Do not take a double dose to compensate for the missed doses. Each dose should be separated by a minimum interval of 3 hours. Do not take more tablets per day than correspond to your prescribed daily dose.

If you interrupt treatment with Pirfenidone Dr. Reddys

In certain situations, your doctor will advise you to stop taking Pirfenidone Dr. Reddys. If for any reason you stop taking Pirfenidone Dr. Reddys for more than 14 consecutive days, the doctor will restart your treatment with 1 tablet 3 times a day and gradually increase it to 3 tablets 3 times a day.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Stop taking Pirfenidona Dr. Reddys and seek medical attention immediately if you notice any of the following symptoms or signs:

•Swelling of the face, lips, or tongue, itching, hives, difficulty breathing, or wheezing, or a feeling of fainting, which are signs of angioedema, a severe allergic reaction, or anaphylaxis.

•Yellowing of the eyes or skin, or dark urine, possibly accompanied by itching of the skin, stomach pain in the upper right area, loss of appetite, bleeding, or the formation of bruises more easily than normal, or a feeling of fatigue. These may be signs of abnormal liver function and may indicate liver damage, which is a rare side effect of Pirfenidona Dr. Reddys.

•Flat, circular patches on the trunk, often with central blisters, skin peeling, mouth ulcers, throat, nose, genital, and eye ulcers. These severe skin eruptions are often preceded by fever or flu-like symptoms (Stevens-Johnson syndrome or toxic epidermal necrolysis).

• Generalized skin rash, elevated body temperature, and enlarged lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).

Other possible side effects are

Consult your doctor if you experience any type of side effect.

Frequent side effects(may affect more than 1 in 10 people):

•Throat or respiratory tract infections that reach the lungs and/or sinusitis

•Unpleasant feeling (nausea)

•Stomach problems, such as acid reflux, vomiting, and constipation

•Diarrhea

•Indigestion or stomach heaviness

•Weight loss

•Loss of appetite

•Difficulty sleeping

•Fatigue

•Dizziness

•Headache

•Difficulty breathing

•Cough

•Joint pain.

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

•Urinary tract infections

•Drowsiness

•Alteration of taste

•Headaches

•Stomach problems, such as feeling heavy, pain, and abdominal discomfort, stomach burning, and flatulence

•Blood tests may indicate an increase in liver enzymes

•Skin reactions after exposure to the sun or the use of UVA lamps

•Skin problems such as itching, irritation, or redness, dryness, rash

•Muscle pain

•Weakness or lack of energy

•Chest pain

•Sunburn.

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

•Low sodium levels in the blood. This can cause headaches, dizziness, confusion, weakness, muscle cramps, nausea, and vomiting.

•Blood test results may show a decrease in white blood cells.

Reporting side effects

Consult your doctor, pharmacist, or nurse if you experience any type of side effect. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the bottle, blister pack, and box after CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the containers and medication that you no longer need. By doing so, you will help protect the environment.

Pirfenidona Dr. Reddys Composition

267 mg Tablet

The active ingredient is pirfenidona. Each film-coated tablet contains 267 mg of pirfenidona.

The other components are: lactose, sodium croscarmellose, anhydrous colloidal silica, magnesium stearate.

The film coating is composed of: polyvinyl alcohol, titanium dioxide (E171), macrogol, talc, yellow iron oxide (E172).

534 mg Tablet

The active ingredient is pirfenidona. Each film-coated tablet contains 534 mg of pirfenidona.

The other components are: lactose, sodium croscarmellose, anhydrous colloidal silica, magnesium stearate.

The film coating is composed of: polyvinyl alcohol, titanium dioxide (E171), macrogol, talc, yellow iron oxide (E172) and red iron oxide (E172).

801 mg Tablet

The active ingredient is pirfenidona. Each film-coated tablet contains 801 mg of pirfenidona.

The other components are: lactose, sodium croscarmellose, anhydrous colloidal silica, magnesium stearate.

The film coating is composed of: polyvinyl alcohol, titanium dioxide (E171), macrogol, talc, red iron oxide (E172) and black iron oxide (E172).

Product Appearance and Packaging Contents

267 mg Tablet

Pirfenidona Dr. Reddys 267 mg film-coated tablets EFG are yellow, oval, biconvex, and engraved with “267”.

The blister pack contains 63 film-coated tablets (blister pack of 63 film-coated tablets or composite blister pack consisting of 1 blister pack containing 21 film-coated tablets and 1 blister pack containing 42 film-coated tablets) or 252 film-coated tablets (blister pack of 252 film-coated tablets or composite blister pack with 3 blister packs, each containing 84 film-coated tablets).

534 mg Tablet

Pirfenidona Dr. Reddys 534 mg film-coated tablets are orange-colored, oval, biconvex, and engraved with “534”.

The blister pack contains 21, 63, or 84 film-coated tablets.

The bottle contains 90 film-coated tablets.

801 mg Tablet

The film-coated tablets of Pirfenidona Dr. Reddys 801 mg are brown-colored, oval, biconvex, and engraved with “801”.

The blister pack contains 84 film-coated tablets.

Only some package sizes may be marketed.

Marketing Authorization Holder and Responsible Manufacturer

Marketing Authorization Holder

Reddy Pharma Iberia, S.A.

Avda. Josep Tarradellas nº 38

08029 Barcelona (Spain)

Phone: 93.355.49.16

Fax: 93.355.49.61

Responsible Manufacturer

betapharm Arzneimittel GmbH

Kobelweg 95

86156 Augsburg

Germany

or

PharOS MT Ltd.

HF62X, Hal Far Industrial Estate,

Birzebbugia BBG3000

Malta

or

Rontis Hellas Medical and Pharmaceutical Products S.A.

Larissa Industrial Area, P.O. BOX 3012,

Larissa, 41500

Greece

This medicinal product is authorized in the member states of the European Economic Area with the following names:

Last review date of this leaflet:April 2024

For detailed information about this medicinal product, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es.