Pentasa 4 g prolonged-release granules

Package leaflet: Information for the user

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 give it to others, even if they have the same symptoms as you. It may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if the side effects are not listed in this leaflet. See section 4.

Contents of this leaflet

1. What Pentasa 4 g is and what it is used for
2. What you need to know before taking Pentasa 4 g
3. How to take Pentasa 4 g
4. Possible side effects
5. How to store 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 flare-ups of ulcerative colitis and to help maintain remission and prevent new flare-ups.

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

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

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

Do not take Pentasa 4 g

• if you are allergic (hypersensitive) to mesalazine or to any of the other ingredients of this medicine (see section 6)
• if you are allergic to 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 allergy to salicylates)
• if you currently have or have previously had impaired kidney or liver function
• if you have a disease that may make you prone to bleeding
• if you have active peptic ulcer (stomach ulcer or duodenal ulcer)
• if you are receiving treatment that may affect renal function, for example non-steroidal anti-inflammatory drugs (NSAIDs) such as aspirin
• if you have lung problems, particularly asthma
• treatment with Pentasa must be stopped immediately if you experience abdominal cramps, abdominal pain, fever, severe headache, or 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 an adequate amount of fluid during treatment with mesalazine.
• If you have ever experienced a severe skin rash, skin peeling, blisters, or mouth sores after taking mesalazine.

If you experience severe or recurrent headache, vision disturbances, or ringing or buzzing in the ears, contact your doctor immediately.

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

Exercise special caution with mesalazine:

Severe skin reactions such as drug reaction with eosinophilia and systemic symptoms (DRESS), Stevens-Johnson syndrome (SJS), and toxic epidermal necrolysis (TEN) have been observed with mesalazine-containing treatments. Stop taking mesalazine and seek immediate medical attention if you notice any of the symptoms related to these severe skin reactions described in section 4.

While being treated with this medicine, your doctor will usually perform blood and urine tests to monitor your kidney function, especially at the beginning of treatment.

Interaction of Pentasa 4 g with other medicines

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

• azathioprine (used after organ transplants or to treat autoimmune diseases)
• 6-mercaptopurine or thioguanine (chemotherapeutic agents used to treat leukemia)
• certain drugs that inhibit blood clotting (medicines for thrombosis or blood thinners)

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before taking this medicine.

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

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

Driving and use of machines:

It is not known that this medicine affects the ability to drive and/or operate machinery.

3. How to take Pentasa 4 g

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

Adults:

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

Pentasa 1 g may also be used to provide the dose best suited to you.

To help you remain free from further flare-ups, your doctor may generally prescribe 2 g of mesalazine per day, administered as one sachet of Pentasa 2 g or as two sachets of Pentasa 1 g once daily.

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 adult dose; for those children and adolescents with a body weight above 40 kg, the dose will be the same as the usual recommended adult dose.

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 remains in the mouth.

Or

1. Mix the entire contents of the sachet with yoghurt. 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 at telephone number 91 562 04 20, indicating the medication 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 your usual time. Do not take a double dose to make up for the forgotten dose.

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

4. Possible adverse effects

Like all medicines, Pentasa sachets can cause adverse effects, although not everyone experiences them.

Serious adverse effects:

Very few cases of severe allergic reaction have been reported (including severe skin erosions that may affect the skin as the body's protective barrier). The allergic reaction could lead to swelling of the face and neck and/or difficulty breathing or swallowing (angioedema). If this occurs, contact your doctor or emergency services immediately.

Inform your doctor immediately if you experience severe or recurrent headache, visual disturbances, or ringing or buzzing in the ears. These may be symptoms of increased pressure within the skull (idiopathic intracranial hypertension). This very rare adverse effect affects fewer than 1 in 10,000 treated patients.

Stop taking mesalazine and seek immediate medical help if you develop any of the following symptoms: non-elevated red patches, or circular or coin-shaped patches on the chest, often with central blisters, skin peeling, mouth, throat, nose, genital or eye ulcers, widespread rash, fever, and swollen lymph nodes. These severe skin reactions are often preceded by fever or flu-like symptoms.

The following common adverse effects affect between 1 and 10 in every 100 treated patients:

• Diarrhea
• Abdominal pain
• Nausea
• Vomiting
• Headache
• Skin rash
• Flatulence (gas)

The following rare adverse effects, affecting between 1 and 10 in every 10,000 treated patients:

• Inflammation of certain areas of the heart (myocarditis and pericarditis), which may cause difficulty breathing, chest pain, or palpitations (rapid or irregular heartbeat)
• Inflammation of the pancreas (includes 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 very rare adverse effects, affecting fewer than 1 in 10,000 treated patients:

• Anaemia and other blood disorders (reduction in the number of certain blood cells, which may 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 oedema (swelling due to fluid accumulation))
• Peripheral neuropathy (a condition affecting nerves in the hands and feet, including symptoms of tingling and numbness)
• Allergic and fibrotic pulmonary reactions, inflammation of the lining of the lungs or lung scarring (symptoms include cough, bronchospasm, chest discomfort or pain on breathing, difficulty breathing, bloody and/or excessive sputum)
• Pancolitis (a type of inflammatory bowel disease (IBD) affecting the entire inner lining of the large intestine)
• Hair loss (this is reversible)
• Muscle or joint pain
• Inflammation that may affect various parts of the body such as the joints, skin, kidneys, heart, etc. (symptoms include painful joints, fatigue, fever, abnormal or unexplained bleeding (e.g., nosebleeds), bruising, purple skin discoloration, spots under the skin (including severe skin erosions and severe burning that may affect the skin as the body's protective barrier))
• Fluid accumulation around the heart (pericardial effusion), which may 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 available data):

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

Reporting of adverse effects:

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: http;//www.notificaram.es. By reporting adverse 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 stated on the packaging and on the aluminium sachet. 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. Unused containers and medicines should be returned to the SIGRE Point at your pharmacy. If you have any doubts, ask your pharmacist how to 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 Pentasa sachets

The active substance is mesalazine.

Each sachet contains 4 g of mesalazine.

The other components are ethylcellulose and povidone.

Appearance of the medicine and contents of the pack

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

This medicine is available in aluminium 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 European Economic Area member states under the following names:

Quintasa Sachets: Denmark

Pentasa Sachets: Germany (1g), Ireland, Spain, Sweden

Pentasa Xtend: Germany (2g)

Pentasa: Slovenia, Cyprus, Greece

The last revision of this leaflet was in October 2025.

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