Package Insert: Information for the User

Pentasa 4 g Delayed-Release Granules

Mesalamine

Read this entire package insert carefully before taking this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed for you only, and you should not give it to others who may have the same symptoms of illness as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

1. What is Pentasa 4 g and how is it used

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

3. How to take Pentasa 4 g

4. Possible adverse effects

5. Storage of Pentasa 4 g

6. Contents of the package and additional information

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 intestinal disease in which the intestinal lining 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.

Do not take Pentasa 4 g

• if you areallergic (hypersensitive)tomesalazineor to any of the other ingredients of this medication (see section 6)
• if you areallergicto othersalicylates, 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 tosulfasalazine(risk of salicylate allergy)
• if you currently have or have had previously impaired kidney or liver function
• if you have a disease that may make you prone tobleeding
• if you have an activepeptic ulcer(stomach ulcer or duodenal ulcer)
• if you are undergoing a treatment that may affect kidney function, for example nonsteroidal anti-inflammatory drugs (NSAIDs) such as aspirin
• if you have lung problems, particularly asthma
• treatment with Pentasa should be stopped immediately in case of abdominal cramps, abdominal pain, fever, severe headache, and rash
• renal calculi may occur with the use of mesalazine. Symptoms include abdominal pain and presence of blood in the urine. Ensure you drink a sufficient amount of liquid during treatment with mesalazine.
• if you have ever experienced a severe skin rash or skin peeling, blisters, or mouth sores after using mesalazine.

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

Be especially careful with mesalazine:

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

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

Pentasa 4 g interaction with other medications

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

• azathioprine(used after transplants or to treat autoimmune diseases)
• 6-mercaptopurine or thioguanine(chemotherapy, used to treat leukemia)
• certain medications that inhibit blood clotting (blood thinners or medications to dilute the blood)

Pregnancy, breastfeeding, and fertility

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

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

Blood abnormalities have been observed in newborns of mothers treated with this medication. Newborns may develop allergic reactions, such as diarrhea, after breastfeeding. If the newborn experiences diarrhea, breastfeeding should be stopped.

Driving and operating machinery:

This medication is not known to affect the ability to drive and/or operate machinery.

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

Adults:

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

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

To help you stay free of further flare-ups, your doctor may prescribe 2 g of mesalazine per day, administered in the form of one Pentasa 2 g packet or two Pentasa 1 g packets once a day.

Use in children and adolescents:

Children aged 6 years or older:

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

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

1. Open the packet.
2. Empty the contents of the packet onto the tongue and swallow immediately the granules with water or orange juice, ensuring that none remain in the mouth.

Or

1. Mix the entire contents of the packet 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 Toxicological Information Service, phone 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 missed dose.

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

Like all medications, Pentasa suppositories may cause side effects,although not everyone will experience them.

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

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

The following frequent side effectsaffect between 1 and 10 of every 100 patients treated:

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

The following rare side effects,affect between 1 and 10 of every 10,000 patients treated:

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

The following very rare side effects,affect fewer than 1 of every 10,000 patients treated:

• anemia and other blood disorders (decrease in the number of certain blood cells, which may cause unexplained bleeding, bruises, fever, or sore throat)
• liver disorders (symptoms include jaundice (yellowing of the skin and/or eyes) and/or white stools)
• kidney disorders (symptoms include blood in the urine, and/or swelling due to increased fluids)
• peripheral neuropathy (condition affecting the nerves of the hands and feet, including symptoms of tingling and numbness)
• allergic and fibrotic pulmonary reactions, inflammation of the lung lining or lung scarring (symptoms include cough, bronchospasm, chest discomfort or pain, difficulty breathing, bloody or excessive sputum, and/or hemoptysis)
• Pancolitis (a type of inflammatory bowel disease (IBD) that affects the entire inner lining of the large intestine)
• hair loss (this is reversible)
• muscle or joint pain
• inflammation that can affect various parts of the body, such as joints, skin, kidneys, heart, etc. (symptoms include painful joints, fatigue, fever, abnormal or unexplained bleeding (e.g., nosebleed), bruising, purple discoloration of the skin, and/or subcutaneous nodules (including severe skin erosions and severe burning that can affect the skin as a protective barrier of the body))
• pericardial effusion (fluid accumulation around the heart) that 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 medication in the intestine
• occasionally, allergic reactions and fever may occur

Unknown frequency (cannot be estimated from available data)

• renal calculi and associated renal 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 type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicinal Products for Human Use: http;//www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

Keep this medicationout of the sight and reach of children.

Do not use this medicationafter the expiration date that appears on the packaging and on the aluminum foil wrapper. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and unused medications at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Pentasa sachets

The active ingredient is mesalazine.

Each sachet contains 4g of mesalazine.

The other components areethylcellulose and povidone

Appearance of the product and content of the packaging

This medicationcontains prolonged-release granules. The granules arewhite greyish/ pale brownand cylindrical in shape.

This medication is presented in aluminium sachets in packs of:

Sachets 4g: 20, 30, 50 or100

Marketing Authorization Holder

FERRING S.A.U

C/ del Arquitecto Sánchez Arcas 3, 1st

Madrid 28040

- Spain

Responsible for manufacturing

Ferring GmbH

Wittland 11

D-24109 Kiel

Germany

This medication is authorized in the member states of the European Economic Area with 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 granule:Spain

The last review of this leaflet was in January 2023.

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