PIRFENIDONE UMEDICA 267 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Pirfenidona Umedica 267mg film-coated tablets EFG

Pirfenidona Umedica 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. It may harm them, even if their signs of illness are the same as yours.
• If you get 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 Pirfenidona Umedica and what is it used for
2. What you need to know before you take Pirfenidona Umedica
3. How to take Pirfenidona Umedica
4. Possible side effects
5. Storage of Pirfenidona Umedica
6. Contents of the pack and other information

1. What is Pirfenidona Umedica and what is it used for

Pirfenidona Umedica 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 thickened 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 Pirfenidona Umedica

Do not take Pirfenidona Umedica

• 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 Pirfenidona Umedica. If you are unsure, consult your doctor or pharmacist.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Pirfenidona Umedica

• You may have increased sensitivity to sunlight (photosensitivity reaction) when taking this medicine. Avoid the sun (also UVA lamps) while taking Pirfenidona Umedica. Use a sunscreen daily and cover your arms, legs, and head to reduce sun exposure (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.
• 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 Pirfenidona Umedica.
• Pirfenidone may cause dizziness and fatigue. Be careful if you need to perform activities that require attention and coordination.
• Pirfenidona Umedica may cause weight loss. Your doctor will monitor your weight while you are taking this medicine.
• Stevens-Johnson syndrome and toxic epidermal necrolysis have been reported in association with Pirfenidona Umedica 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 Pirfenidona Umedica, once a month for the first 6 months, and then every 3 months while taking this medicine, to check your liver function. It is essential 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 Pirfenidona Umedica

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 Pirfenidona Umedica.

The following medicines may increase the adverse effects of Pirfenidona Umedica:

• 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 efficacy of Pirfenidona Umedica:

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

Taking Pirfenidona Umedica 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 using this medicine if you are pregnant, think you may be pregnant, or plan to become pregnant, as the potential risks to the fetus are not known.

If you are breastfeeding or plan to breastfeed, consult your doctor or pharmacist before taking this medicine. Since it is not known whether Pirfenidona Umedica 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 Umedica contains sodium

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

3. How to take Pirfenidona Umedica

Treatment with Pirfenidona Umedica 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 Pirfenidona Umedica 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 adverse effects such as nausea (feeling unwell) and dizziness. If symptoms persist, consult your doctor.

Dose reduction due to adverse effects

It is possible that your doctor may decide to reduce the dose if you experience adverse effects such as stomach problems, skin reactions to sunlight or UVA lamps, or significant changes in liver enzymes.

If you take more Pirfenidona Umedica than you should

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

If you forget to take Pirfenidona Umedica

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.

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 ingested.

If you stop taking Pirfenidona Umedica

In certain situations, your doctor will advise you to stop taking this medicine. If for any reason you stop taking Pirfenidona Umedica for more than 14 consecutive days, your doctor will restart your treatment with a dose of 267 mg three times a day and gradually increase it to 801 mg three 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 this medicine and inform your doctor immediately:

• If you experience 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.
• If you notice that your eyes or skin turn yellow or your urine is dark, and possibly accompanied by itching of the skin, pain in the upper right side of the abdomen, loss of appetite, bleeding, or bruising more easily than usual, or if you feel tired; these may be signs of abnormal liver function and may indicate liver damage, a rare side effect of pirfenidone.
• If you experience red patches without relief or circular patches on the trunk, often with blisters in the center, skin peeling, ulcers in the mouth, throat, nose, genitals, and eyes. These severe skin rashes can be preceded by fever and flu-like symptoms. These signs and symptoms may indicate Stevens-Johnson syndrome or toxic epidermal necrolysis.

Other side effects

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

• bladder infections
• drowsiness
• taste alteration
• hot flashes
• stomach problems, such as feeling of heaviness, pain, and discomfort, heartburn, and flatulence
• blood tests may indicate increased liver enzymes
• skin reactions after sun exposure 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 side effects (may affect up to 1 in 100 people):

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

Reporting of side effects

If you experience any side effects, consult your doctor or pharmacist, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines Vigilance System for Human Use: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Pirfenidona Umedica

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 indicated.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and any unused medicine in the SIGRE collection point at the pharmacy. If you are unsure, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Contents of the pack and other information

Composition of Pirfenidona Umedica

267 mg tablets

• The active substance is pirfenidone. Each film-coated tablet contains 267 mg of pirfenidone.
• The other ingredients are microcrystalline cellulose, sodium croscarmellose, povidone K30, and magnesium stearate.

The film coating contains poly(vinyl alcohol), titanium dioxide (E 171), macrogol 3350, talc, yellow iron oxide (E 172).

801 mg tablets

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

The other ingredients are microcrystalline cellulose, sodium croscarmellose, povidone K30, and magnesium stearate.

The film coating contains poly(vinyl alcohol), titanium dioxide (E 171), macrogol 3350, talc, red iron oxide (E 172), black iron oxide (E 172).

Appearance of the product and pack contents

267 mg tablets

Pirfenidona Umedica 267 mg film-coated tablets are yellow, oval, approximately 13.10 mm x 6.30 mm, and have the inscription "PIR" on one side and "267" on the other.

The blisters contain 21, 42, 84, or 168 film-coated tablets, and the multipacks contain 63 (2-week starter pack of 21 + 42) or 252 (continuation pack of 3 x 84) film-coated tablets.

Not all pack sizes may be marketed.

801 mg tablets

Pirfenidona Umedica 801 mg film-coated tablets are brown, oval, approximately 20.10 mm x 9.40 mm, and have the inscription "PIR" on one side and "801" on the other.

The blisters contain 84 film-coated tablets, and the multipack contains 252 (continuation pack of 3 x 84) film-coated tablets.

Each of the 801 mg blister strips may be marked with the following symbols and day abbreviations as a reminder to take a dose three times a day:

(dawn; morning dose) (afternoon dose) and (night dose).

MO, TU, WE, TH, FR, SA, SU

Not all pack sizes may be marketed.

Marketing authorisation holder

Umedica Netherlands B.V.

Korte Lijnbaanssteeg 1 CB-4181

1012SL Amsterdam

The Netherlands

Manufacturer

Misom Labs Limited

Malta Life Sciences Park, LS2.01.06 Industrial estate

SGN 3000, San Gwann,

Malta

This medicine is authorised in the Member States of the European Economic Area under the following names:

Date of last revision of this leaflet: January 2024

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