PENTASA 4 g PROLONGED-RELEASE GRANULES

Introduction

Package Leaflet: Information for the User

Pentasa 4 g prolonged-release granules

Mesalazine

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 Pentasa 4 g is and what it is used for
2. What you need to know before you take Pentasa 4 g
3. How to take Pentasa 4 g
4. Possible side effects
5. Storage of Pentasa 4 g
6. Contents of the pack and other information

1. What Pentasa 4 g is and what it is used for

Pentasa 4 g is indicated for the treatment of mild to moderate ulcerative colitis flare-ups and to help maintain you free of new flare-ups.

Ulcerative colitis is an inflammatory bowel disease in which the lining of the intestine is inflamed and develops many small breaks in its surface (ulcers) that can bleed.

Pentasa 4 g contains granules that slowly release the active ingredient (mesalazine). This helps to reduce inflammation and painful symptoms.

2. What you need to know before you take Pentasa 4 g

Do not take Pentasa 4 g

• if you are allergic (hypersensitive)to mesalazineor to any of the other components of this medicine (see section 6)
• if you are allergicto other salicylates, for example, acetylsalicylic acid
• if you have severe kidney and/or liver problems

Warnings and precautions

Consult your doctor or pharmacist before starting to take Pentasa 4 g:

• if you are allergic to sulfasalazine(risk of salicylate allergy)
• if you currently have or have had kidney or liver function impairment
• if you have a disease that may make you prone to bleeding
• if you have an active peptic ulcer(stomach or duodenal ulcer)
• if you are on treatmentthat may affect kidney function, for example, non-steroidal anti-inflammatory drugs (NSAIDs) such as aspirin
• if you have lung problems, asthma in particular
• treatment with Pentasa should be interrupted immediately in case of abdominal cramps, abdominal pain, fever, severe headache, and rash
• kidney stones may occur with the use of mesalazine. Symptoms include pain in the sides of the abdomen and blood in the urine. Make sure to drink a sufficient amount of liquid during treatment with mesalazine.
• If you have ever suffered from a severe skin rash, skin peeling, blisters, or sores in the mouth after using mesalazine.

Mesalazine may cause a discoloration of the urine to a reddish-brown color after contact with sodium hypochlorite bleach in the toilet water. This is a chemical reaction between mesalazine and bleach and is harmless.

Be careful with mesalazine:

Severe skin reactions, including drug reaction with eosinophilia and systemic symptoms (DRESS), Stevens-Johnson syndrome (SSJ), and toxic epidermal necrolysis (NET), have been observed with mesalazine treatment. Stop taking mesalazine and seek medical attention immediately if you notice any of the symptoms related to these severe skin reactions described in section 4.

While you are on treatment with this medicine, your doctor will normally perform blood and urine tests to monitor your kidney function, especially at the start of treatment.

Interaction of Pentasa 4 g with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.This is especially important if you are taking any of the following medicines:

• azathioprine(used after transplants or to treat autoimmune diseases)
• 6-mercaptopurine or thioguanine(chemotherapy, used to treat leukemia)
• certain medicines that inhibit blood coagulation (medicines for thrombosis or to thin the blood)

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

There is limited experience with the use of mesalazine during pregnancy and breastfeeding.

Blood disorders have been observed in newborns of mothers treated with this medicine. Newborns may develop allergic reactions after breastfeeding, for example, diarrhea. If the newborn has diarrhea, breastfeeding should be interrupted.

Driving and using machines:

This medicine is not known to affect the ability to drive and/or use machines.

3. How to take Pentasa 4 g

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

Adults:

To treat a flare-up of colitis,your doctor will normally prescribe a dose of up to 4 g of mesalazine per day, which can be administered either once a day or divided into two doses. It can be taken as one sachet of Pentasa 4 g or as two sachets of Pentasa 2 g once a day.

Pentasa 1 g can also be used to provide the dose that best suits you.

To help you stay free of new flare-ups,your doctor may prescribe 2 g of mesalazine per day, administered as one sachet of Pentasa 2 g or two sachets of Pentasa 1 g once a day.

Use in children and adolescents:

Children aged 6 years and older

For children and adolescents, the dose will be calculated by your doctor based on body weight. The recommended dose in children and adolescents with a body weight of up to 40 kg will be half the usual recommended dose in adults, and for those children and adolescents with a body weight over 40 kg, the dose will be the same as the usual recommended dose in adults.

You should take the granules orally (by mouth),immediately after opening the sachet, as described below. Do not chew the granules.

1. Open the sachet.
2. Pour the contents of the sachet onto the tongue and swallow the granules immediately with water or orange juice, making sure that none remain in the mouth.

Or

1. Mix the entire contents of the sachet with yogurt. Swallow immediately without chewing the granules.

If you take more Pentasa 4 g 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 ingested.

If you forget to take Pentasa 4 g

If you have forgotten to take a dose, take it as soon as you remember, and then take the next dose at the usual time. Do not take a double dose to make up for the forgotten dose.

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

4. Possible side effects

Like all medicines, Pentasa sachets can cause side effects, although not everybody gets them.

Very rare cases of severe allergic reactions, including serious skin reactions (such as Stevens-Johnson syndrome, toxic epidermal necrolysis, and erythema multiforme), have been reported. The allergic reaction could lead to swelling of the face and neck and/or difficulty breathing or swallowing (angioedema). If this happens, contact your doctor or emergency services immediately.

Stop taking mesalazine and seek medical attention immediately if you notice any of the following symptoms: reddish patches, or circular or coin-shaped patches on the chest, often with central blisters, skin peeling, ulcers in the mouth, throat, nose, genitals, and eyes, generalized rash, fever, and swollen lymph nodes. These severe skin reactions are often preceded by fever or flu-like symptoms.

The following side effects are common(affect 1 to 10 users in 100):

• diarrhea
• abdominal pain
• nausea
• vomiting
• headache
• skin rash
• flatulence (gas)

The following side effects are rare(affect 1 to 10 users in 1,000):

• inflammation of some areas of the heart (myocarditis and pericarditis) that can cause difficulty breathing and chest pain or palpitations (rapid or irregular heartbeat)
• inflammation of the pancreas (including symptoms of back and/or stomach pain)
• increased amylase (an enzyme that helps digest carbohydrates)
• dizziness
• increased sensitivity of the skin to sunlight and ultraviolet light (photosensitivity)

The following side effects are very rare(affect less than 1 user in 1,000):

• anemia and other blood disorders (decrease in the number of certain blood cells, which can cause unexplained bleeding, bruising, fever, or sore throat)
• liver disorders (symptoms include jaundice (yellowing of the skin and/or eyes) and/or pale stools)
• kidney disorders (symptoms include blood in the urine and/or edema (swelling due to increased fluid))
• peripheral neuropathy (a condition that affects the nerves of the hands and feet, including symptoms of tingling and numbness)
• pulmonary allergic and fibrotic reactions, inflammation of the lining of the lungs, or scarring of the lung (symptoms include cough, bronchospasm, chest discomfort or pain when breathing, difficulty breathing, bloody or excessive sputum)
• Pancolitis (a type of inflammatory bowel disease (IBD) that affects the entire lining of the large intestine)
• hair loss (this is reversible)
• muscle or joint pain
• inflammation that can affect several parts of the body, such as joints, skin, kidneys, heart, etc. (symptoms include painful joints, fatigue, fever, unexplained or abnormal bleeding (e.g., nosebleeds), bruising, purple discoloration of the skin, spots under the skin (including severe skin reactions and severe burns that can affect the skin as a protective barrier of the body))
• fluid accumulation around the heart (pericardial effusion) that can cause chest pain or pressure
• change in urine color
• semen with low sperm concentration (oligospermia) (this is reversible)
• severe diarrhea and abdominal pain due to an allergic reaction to this medicine in the intestine
• occasionally, allergic reactions and fever may occur

Frequency not known (cannot be estimated from the available data)

• kidney stones and associated kidney pain (see also section 2).

Isolated cases of benign intracranial hypertension (increased fluid around the brain) have been reported in adolescents. Symptoms include headache, nausea, vomiting, and/or visual or auditory distortion.

Reporting of side effects:

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: http://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Pentasa 4 g

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 packaging and on the aluminum sachet. The expiry date is the last day of the month stated.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicine in the SIGRE collection point at your pharmacy. If you have any further questions, 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 Pentasa sachets

The active substance is mesalazine.

Each sachet contains 4 g of mesalazine.

The other ingredients are ethylcellulose and povidone

Appearance of the product and pack contents

This medicine contains prolonged-release granules. The granules are grayish-white/ pale brown and cylindrical in shape.

This medicine is available in aluminum sachets in packs of:

Sachets 4g: 20, 30, 50, or 100

Marketing authorization holder

FERRING S.A.U

C/ del Arquitecto Sánchez Arcas 3, 1º

Madrid 28040

• Spain

Manufacturer

Ferring GmbH

Wittland 11

D-24109 Kiel

Germany

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

Quintasa Sachets: Denmark

Pentasa Sachets: Germany (1g), Ireland, Sweden, United Kingdom (Northern Ireland)

Pentasa Xtend: Germany (2g)

Pentasa: Slovenia, Cyprus, Greece

Pentasa 4 grams prolonged-release granules: Spain

The last revision of this leaflet was in January 2023.

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