Pirfenidone Kern Pharma 801 mg film-coated tablets EFG

Package leaflet: Information for the user

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 the entire 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 and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Leaflet contents:

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

1. What Pirfenidona Kern Pharma is and what it is 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 lung tissues become inflamed and progressively scarred over time, making it difficult to breathe deeply. Under these circumstances, the lungs have difficulty functioning properly. This medicine helps reduce lung scarring and inflammation, helping you breathe better.

2. What you need to know before starting to take Pirfenidona Kern Pharma

Do not take Pirfenidona Kern Pharma

• if you are allergic to pirfenidone or to 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, 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 apply to you, do not take this medicine. If you have any doubts, consult your doctor or pharmacist.

Warnings and precautions

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

• You may become more sensitive to sunlight (photosensitivity reaction) while taking this medicine. Avoid sunlight (including UVA lamps) while taking this medicine. Use sunscreen daily and cover your arms, legs, and head to reduce exposure to sunlight (see section 4: Possible side effects).

• You should not take other medicines such as tetracycline antibiotics (e.g. doxycycline) that may increase your sensitivity to sunlight.

• You must inform your doctor if you have kidney problems.

• You must inform your doctor if you have mild to moderate liver problems.

• You must refrain from smoking before and during treatment with this medicine. Tobacco may reduce the effect of pirfenidone.

• This medicine may cause dizziness and fatigue. Be cautious if you need to perform activities requiring 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 immediate medical attention if you notice any symptoms related to these serious 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 Pirfenidona Kern Pharma, once a month for the first 6 months, and then every 3 months while taking this medicine, to check that your liver is functioning properly. It is important that you have these blood tests performed regularly 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 Pirfenidona Kern Pharma

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

This is especially important if you are taking the following medicines, as they may alter the effect of Pirfenidona 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 conditions such as indigestion, gastroesophageal reflux disease)
• rifampicin (a type of antibiotic)

Taking Pirfenidona Kern Pharma with food and drink

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

Pregnancy and breastfeeding

As a precautionary measure, it is preferable to avoid using this medicine 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 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 operate machinery if you feel dizzy or tired after taking this medicine.

Pirfenidona Kern Pharma contains lactose and sodium

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

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

3. How to take Pirfenidone Kern Pharma

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

Follow exactly the instructions for administration of this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

You will normally be given this medicine with a gradually increasing dose as follows:

• during 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 days 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 onwards (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 this medicine 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 tablets whole with water, during or after a meal, to reduce the risk of side effects such as nausea (feeling unwell) and dizziness. If symptoms persist, contact your doctor.

Dose reduction due to side effects

Your doctor may decide to reduce your 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, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medicine and the amount ingested.

.

If you forget to take Pirfenidone Kern Pharma

If you miss 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 a minimum interval of 3 hours. Do not take more tablets per day than prescribed in your daily dose.

If you stop taking Pirfenidone Kern Pharma

In certain situations, your doctor may 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 at a dose of 267 mg three times a day and gradually increase it to 801 mg three times a day.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

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

Stop taking Pirfenidone Kern Pharma and seek immediate medical attention 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 faint, which are signs of angioedema, a serious 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 area of the stomach (abdomen), 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 an uncommon adverse effect of Pirfenidone Kern Pharma.
• Red, flat or circular patches on the trunk, often with central blisters, peeling skin, or ulcers in the mouth, throat, nose, genitals, and eyes. These severe skin rashes may 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 syndrome or drug hypersensitivity syndrome).

Other possible adverse effects are

If you experience any adverse effect, consult your doctor.

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

• Throat infections or respiratory tract infections reaching the lungs and/or sinusitis
• Feeling unwell (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 adverse effects (may affect up to 1 in 10 people):

• Bladder infections
• Drowsiness
• Taste disturbance
• Hot flushes
• Stomach problems, such as feeling of fullness, pain and discomfort in the abdomen, heartburn, and flatulence
• Blood tests may show increased liver enzymes
• Skin reactions after exposure to sunlight 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

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

• Low levels of sodium in the blood. This can cause headache, dizziness, confusion, weakness, muscle cramps, or nausea and vomiting
• Blood test results may show decreased white blood cells.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish System for Pharmacovigilance of Human Medicines: www.notificaRAM.es. By reporting adverse 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 stated on the blister and carton after EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. Ask your pharmacist how to properly dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Pirfenidone Kern Pharma

Tablets of 267 mg

• The active substance is pirfenidone. Each film-coated tablet contains 267 mg of pirfenidone.
• 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 534 mg

• The active substance is pirfenidone. Each film-coated tablet contains 534 mg of pirfenidone.
• 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 801 mg

• The active substance is pirfenidone. Each film-coated tablet contains 801 mg of pirfenidone.
• 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).

Nature of the product and pack contents

Tablets of 267 mg

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

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

Tablets of 534 mg

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

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

Tablets of 801 mg

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

Packs contain unit-dose blisters with 84 film-coated tablets.

Marketing Authorization 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 the most recent revision of this leaflet: January 2024

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