Leaflet: Information for the User

Pirfenidona Kern Pharma 267mg Film-Coated Tablets

Pirfenidona Kern Pharma 534mg Film-Coated Tablets

Pirfenidona Kern Pharma 801mg 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, consult 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 Pirfenidona Kern Pharma is and what it is used for

2.What you need to know before you start taking Pirfenidona Kern Pharma

3.How to take Pirfenidona Kern Pharma

4.Possible side effects

5.Storage of Pirfenidona Kern Pharma

6.Contents of the pack and additional information

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

IPFis a disease in which the lung tissues become swollen and filled with scars over time, making it difficult to breathe deeply. In these circumstances, the lungs have trouble functioning correctly. This medication helps to reduce lung scarring and swelling, and helps you breathe better.

Do not take Pirfenidona Kern Pharma

• if you are allergic to pirfenidona or any of the other components of this medication(listed in section 6)
• if you have previously had 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 you, do not take this medication. If you have any doubts, consult your doctor or pharmacist.

Warnings and precautions

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

• You may be more sensitive to sunlight (photosensitivity reaction) when taking this medication. Avoid the sun (also UV lamps) while taking this medication. 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 this medication. Tobacco may reduce the effect of pirfenidona.
• This medication may cause dizziness and fatigue. Be careful if you have to perform activities that require attention and coordination.
• This medication may cause weight loss. Your doctor will monitor your weight while you are taking this medication.
• 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 this medication and seek medical attention immediately if you notice any symptoms related to these severe skin reactions described in section 4.

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

Children and adolescents

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

Other medications and Pirfenidona Kern Pharma

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 Kern Pharma.

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 Kern Pharma with food and drinks

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

Pregnancy and breastfeeding

As a precaution, it is recommended to avoid using this medication 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 breastfeed, talk to your doctor or pharmacist before taking this medication. 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 tired after taking this medication.

Pirfenidona Kern Pharma contains lactose and sodium

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

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

The treatment with this medication should be initiated and supervised by specialist doctors with experience in the diagnosis and treatment of FPI.

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

This medication will normally be administered by gradually increasing the dose as follows:

• During the first 7 days, take a dose of 267mg (1 yellow tablet), 3 times a day with food (a total of 801mg/day)
• Between days 8 and 14, take a dose of 534mg (2 yellow tablets or 1 orange tablet), 3 times a day with food (a total of 1.602mg/day)
• From day 15 (maintenance), take a dose of 801mg (3 yellow tablets or 1 brown tablet), 3 times a day with food (a total of 2.403mg/day).

The recommended daily maintenance dose ofthis medicationis 801mg (3 yellow tablets or 1 brown tablet) three times a day with food, a total of 2.403mg/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 Pirfenidona Kern Pharma than you should

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 Pirfenidona Kern Pharma

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 Pirfenidona Kern Pharma

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

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

Like all medications,this medicationmay cause side effects, although not everyone will experience them.

Stop taking Pirfenidona 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 a feeling of fainting, which are signs of angioedema, a severe allergic reaction, or anaphylaxis.
• Yellowing of the eyes or skin, dark urine, possibly accompanied by itching of the skin, stomach pain on the upper right side, 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 Pirfenidona Kern Pharma.
• Flat, circular patches on the trunk, often with central blisters, skin peeling, ulcers in the mouth, throat, nose, genitals, and eyes. These severe skin eruptions may often be preceded by fever or symptoms similar to the flu (Stevens-Johnson syndrome or toxic epidermal necrolysis).
• Generalized rash, elevated body temperature, and enlargement of lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).

Other possible side effects are

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

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
• Tiredness
• Dizziness
• Headache
• Difficulty breathing
• Cough
• Joint pain

Common 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 increased liver enzymes
• Skin reactions after exposure to the sun or 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 headache, dizziness, confusion, muscle cramps, nausea, and vomiting
• Lab test results may show a decrease in white blood cells.

Reporting side effects

If you experienceany type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possibleside effect that does not appear in this prospectus.You can also report them directly through the Spanish System of Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es.By reporting side effects, you can contribute to providing more information on the safety of this medication.

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

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

This medication does not require special conditions for conservation.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE point of your pharmacy. Ask your pharmacist how to dispose of packaging and medications you no longer need. This will help protect the environment.

Pirfenidona Kern Pharma Composition

Tablets of 267mg

• The active ingredient is pirfenidona. Each film-coated tablet contains 267mg of pirfenidona.
• The other components 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).

Tablets of 534mg

• The active ingredient is pirfenidona. Each film-coated tablet contains 534mg of pirfenidona.
• The other components 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).

Tablets of 801mg

• The active ingredient is pirfenidona. Each film-coated tablet contains 801mg of pirfenidona.
• The other components 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 Contents of the Package

Tablets of 267mg

Pirfenidona Kern Pharma 267mg film-coated tablets are yellow, oval, biconvex film-coated tablets with the inscription “267”.

The packages contain single-dose blisters with 21, 63, or 252 film-coated tablets.

Tablets of 534mg

Pirfenidona Kern Pharma 534mg film-coated tablets are orange, oval, biconvex film-coated tablets with the inscription “534”.

The packages contain single-dose blisters with 21 or 84 film-coated tablets.

Tablets of 801mg

Pirfenidona Kern Pharma 801mg film-coated tablets are brown, oval, biconvex film-coated tablets with the inscription “801”.

The packages contain single-dose blisters with 84 film-coated tablets.

Marketing Authorization Holder

Kern Pharma, S.L.

Venus, 72 – Pol. Ind.Colón II

08228 Terrassa – Barcelona

Spain

Responsible for Manufacturing

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

Last Review Date of this Leaflet:January 2024

The detailed information of this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/)