PIRFENIDONE KERN PHARMA 534 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Pirfenidone Kern Pharma 267mg film-coated tablets EFG

Pirfenidone Kern Pharma 534mg film-coated tablets EFG

Pirfenidone Kern Pharma 801mg film-coated tablets EFG

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 pass it on to others, as it may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack:

1. What is Pirfenidone Kern Pharma and what is it used for
2. What you need to know before you take Pirfenidone Kern Pharma
3. How to take Pirfenidone Kern Pharma
4. Possible side effects
5. Storage of Pirfenidone Kern Pharma
6. Contents of the pack and further information

1. What is Pirfenidone Kern Pharma and what is it used for

This medicine contains the active substance pirfenidone and is used for the treatment of Idiopathic Pulmonary Fibrosis (IPF) in adults.

IPF is a disease in which the lung tissue becomes swollen and scarred over time, making it difficult to breathe deeply. In these circumstances, the lungs have difficulty functioning properly. This medicine helps reduce scarring and swelling of the lungs, and helps you breathe better.

2. What you need to know before you take Pirfenidone Kern Pharma

Do not take Pirfenidone Kern Pharma

• if you are allergic to pirfenidone or any of the other ingredients of this medicine (listed in section 6)
• if you have previously had angioedema with pirfenidone, 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 medicine 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 you, do not take this medicine. If you are unsure, consult your doctor or pharmacist.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Pirfenidone Kern Pharma

• You may have increased sensitivity to sunlight (photosensitivity reaction) when taking this medicine. Avoid the sun (also UVA lamps) while taking this medicine. Use a sunscreen daily and cover your arms, legs, and head to reduce exposure to sunlight (see section 4: Possible side effects).

• You must not take other medicines, such as tetracycline antibiotics (e.g. doxycycline), which may increase your sensitivity to sunlight.
• You should inform your doctor if you have kidney problems.
• You should inform your doctor if you have mild to moderate liver problems.
• You should avoid smoking before and during treatment with this medicine. Tobacco can reduce the effect of pirfenidone.
• This medicine may cause dizziness and fatigue. Be careful if you need to perform activities that require attention and coordination.
• This medicine may cause weight loss. Your doctor will monitor your weight while you are taking this medicine.
• Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS) have been reported in association with pirfenidone treatment. Stop taking this medicine and seek medical attention immediately if you notice any of the symptoms related to these severe skin reactions described in section 4.

This medicine may cause serious liver problems. Some cases have been fatal. You will need to have a blood test before starting to take Pirfenidone Kern Pharma, once a month for the first 6 months, and then every 3 months while taking this medicine, to check your liver is working properly. It is important that you have these blood tests periodically throughout the time you are taking this medicine.

Children and adolescents

Do not give this medicine to children and adolescents under 18 years of age.

Other medicines and Pirfenidone Kern Pharma

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

This is especially important if you are taking the following medicines, as they may alter the effect of Pirfenidone Kern Pharma.

The following medicines may increase the side effects of pirfenidone:

• enoxacin (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 medicines may reduce the effectiveness of pirfenidone:

• omeprazole (used to treat disorders such as indigestion, gastroesophageal reflux disease)
• rifampicin (a type of antibiotic)

Taking Pirfenidone Kern Pharma with food and drinks

Do not drink grapefruit juice while taking this medicine. Grapefruit juice may make this medicine not work properly.

Pregnancy and breastfeeding

As a precautionary measure, it is preferable to avoid the use of this medicine if you are pregnant, planning to become pregnant, or think you may be pregnant, as the potential risks to the fetus are not known.

If you are breastfeeding or planning to breastfeed, talk to your doctor or pharmacist before taking this medicine. Since it is not known whether pirfenidone is excreted in breast milk, your doctor will explain the risks and benefits of taking this medicine during breastfeeding if you decide to do so.

Driving and using machines

Do not drive or use machines if you feel dizzy or tired after taking this medicine.

Pirfenidone Kern Pharma contains lactose and sodium

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult with them before taking this medicine.

This medicine contains less than 1 mmol of sodium (23 mg) per tablet, which is essentially "sodium-free".

3. How to take Pirfenidone Kern Pharma

Treatment with this medicine should be initiated and supervised by specialist doctors with experience in the diagnosis and treatment of IPF.

Follow the instructions for administration of this medicine exactly as indicated by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

Normally, you will be given this medicine with a gradual increase in 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)
• between days 8 and 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 maintenance dose of this medicine is 801 mg (3 yellow tablets or 1 brown tablet) three times a day with food, a total of 2,403 mg/day.

Swallow the tablets whole with water, during or after a meal 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 decide to reduce the dose if you experience side effects such as stomach problems, skin reactions to sunlight or UVA lamps, or significant changes in liver enzymes.

If you take more Pirfenidone Kern Pharma than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount taken.

.

If you forget to take Pirfenidone Kern Pharma

If you forget to take a dose, take it as soon as you remember. Do not take a double dose to make up for forgotten doses. Each dose should be separated by an interval of at least 3 hours. Do not take more tablets per day than your prescribed daily dose.

If you stop taking Pirfenidone Kern Pharma

In certain situations, your doctor will advise you to stop taking this medicine. If for any reason you stop taking Pirfenidone Kern Pharma for more than 14 consecutive days, your doctor will restart your treatment with a dose of 267 mg 3 times a day and gradually increase it to 801 mg 3 times a day.

If you have any other questions about the use of this medicine, ask 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 Kern Pharma 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 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, pain in the upper right side of the abdomen (stomach), loss of appetite, bleeding or bruising more easily than normal, or feeling tired. These could be signs of abnormal liver function and may indicate liver damage, which is a rare side effect of Pirfenidone Kern Pharma.
• Red patches that are not raised or circular on the trunk, often with central blisters, skin peeling, ulcers in the mouth, throat, nose, genitals, and eyes. These severe skin rashes can often be preceded by fever or flu-like symptoms (Stevens-Johnson syndrome or toxic epidermal necrolysis).
• Widespread rash, high body temperature, and swollen lymph nodes (DRESS or drug hypersensitivity syndrome).

Other possible side effects are

If you experience any type of side effect, consult your doctor.

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

• infections of the throat or respiratory tract that reach the lungs and/or sinusitis
• feeling sick (nausea)
• stomach problems, such as acid reflux, vomiting, and constipation
• diarrhea
• indigestion or stomach heaviness
• weight loss
• decreased appetite
• difficulty sleeping
• fatigue
• dizziness
• headache
• difficulty breathing
• cough
• joint pain

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

• bladder infections
• drowsiness
• altered taste
• hot flashes
• stomach problems, such as feeling heavy, pain, and discomfort in the abdomen, heartburn, and flatulence
• blood tests may indicate increased liver enzymes
• skin reactions after exposure to sunlight or UVA lamps
• skin problems such as itching, irritation, or redness, dryness, rash
• muscle pain
• weakness or lack of energy
• chest pain
• sunburn

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

• low sodium levels in the blood. This can cause headache, dizziness, confusion, weakness, muscle cramps, or nausea and vomiting
• blood test results may show a decrease in white blood cells.

Reporting of side effects

If you experience any side effect, talk to your doctor, pharmacist, or nurse, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines and Healthcare Products Agency (AEMPS) website (http://www.aemps.gob.es/). By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Pirfenidone Kern Pharma

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 blister and carton after EXP. The expiry date is the last day of the month shown.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to a pharmacy for disposal. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and further information

Composition of Pirfenidone Kern Pharma

267 mg tablets

• The active substance is pirfenidone. Each film-coated tablet contains 267 mg of pirfenidone.
• The other ingredients are:

Tablet core: lactose, sodium croscarmellose, anhydrous colloidal silica, magnesium stearate. Tablet coating: poly(vinyl alcohol), titanium dioxide (E171), macrogol, talc, and yellow iron oxide (E172).

534 mg tablets

• The active substance is pirfenidone. Each film-coated tablet contains 534 mg of pirfenidone.
• The other ingredients are:

Tablet core: lactose, sodium croscarmellose, anhydrous colloidal silica, magnesium stearate. Tablet coating: poly(vinyl alcohol), titanium dioxide (E171), macrogol, talc, yellow iron oxide (E172), and red iron oxide (E172).

801 mg tablets

• The active substance is pirfenidone. Each film-coated tablet contains 801 mg of pirfenidone.
• The other ingredients are:

Tablet core: lactose, sodium croscarmellose, anhydrous colloidal silica, magnesium stearate. Tablet coating: poly(vinyl alcohol), titanium dioxide (E171), macrogol, talc, red iron oxide (E172), and black iron oxide (E172).

Appearance of the product and pack contents

267 mg tablets

Pirfenidone Kern Pharma 267 mg film-coated tablets are yellow, oval, biconvex, film-coated tablets with the inscription "267".

The packs contain unit-dose blisters with 21, 63, or 252 film-coated tablets.

534 mg tablets

Pirfenidone Kern Pharma 534 mg film-coated tablets are orange, oval, biconvex, film-coated tablets with the inscription "534".

The packs contain unit-dose blisters with 21 or 84 film-coated tablets.

801 mg tablets

Pirfenidone Kern Pharma 801 mg film-coated tablets are brown, oval, biconvex, film-coated tablets with the inscription "801".

The packs contain unit-dose blisters with 84 film-coated tablets.

Marketing authorisation holder

Kern Pharma, S.L.

Venus, 72 – Pol. Ind. Colón II

08228 Terrassa – Barcelona

Spain

Manufacturer

Rontis Hellas, Medical and Pharmaceutical Products S.A.

P.O. Box 3012, Larissa Industrial Area

41500 Larissa

Greece

or

PharOS MT Ltd.

HF62X, Hal Far Industrial Estate,

Birzebbugia BBG3000

Malta

Date of last revision of this leaflet:January 2024

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS) (http://www.aemps.gob.es/)