Package Insert: Information for the User

Pentasa 2g Delayed-Release Granules

Mesalamine

Read this package insert carefully before taking your medicine, 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 medicine has been prescribed for you only, and you should not give it to others even if they have the same symptoms 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 and how is it used

2. What you need to know before starting Pentasa

3. How to take Pentasa

4. Possible adverse effects

5. Storage of Pentasa

6. Contents of the package and additional information

Pentasa sachets are indicated for the treatment of mild to moderate ulcerative colitis flare-ups and to help keep you free of new flare-ups.

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

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

Do not take Pentasa

• If you areallergictomesalazineor any of the other ingredients of this medicine (listed in section 6)
• if you areallergicto othersalicylates, for example aspirin
• if you have severekidneyand/orliverproblems

Warnings and precautions

Consult your doctor or pharmacist before starting to take Pentasa:

• if you are allergic tosulfasalazine(risk of salicylate allergy)
• if you currently have or have had previouslykidney or liver function impairment
• if you have a condition that may make you prone tobleeding
• if you have anactive peptic ulcer(stomach ulcer or duodenal ulcer)
• if you are undergoing atreatmentthat may affect kidney function, for example non-steroidal anti-inflammatory drugs (NSAIDs) such as aspirin
• if you havelung problems, particularly asthma
• Stop treatment immediately in case ofabdominal cramps, abdominal pain, fever, severe headache, and rash
• Renal calculi may occur with the use of mesalazine. Symptoms include abdominal pain and blood in the urine. Ensure you drink a sufficient amount of liquid during mesalazine treatment.
• If you have ever experienced a severe skin rash or skin peeling, blisters, or mouth sores after using mesalazine

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

Be particularly careful with mesalazine:

Severe skin reactions, such asdrug 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 notice any symptoms related to these severe skin reactions described in section 4.

While 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.

Use of Pentasa with other medicines

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medicine. 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 clotting (blood thinners or medications to dilute 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 using this medicine.

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 medicine. Newborns may develop allergic reactions, such as diarrhea, after breastfeeding. If the newborn experiences diarrhea, breastfeeding should be stopped.

Driving and operating machinery

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

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. In case of 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 that can be taken either once a day or divided into two doses. You can take Pentasa 4 g or two Pentasa 2 g packets once a day. Pentasa 1 g prolonged-release granules 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 you generally 2 g of mesalazine per day, administered in the form of a Pentasa 2 g packet or two Pentasa 1 g packets once a day.

Use in children and adolescents (6 years of age 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 recommended dose in adults, and for those children and adolescents with a body weight greater than 40 kg, the dose will be the same usual recommended dose in adults.

You should 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

3. Mix the complete contents of the packet with yogurt. Swallow immediately without chewing the granules.

If you take more Pentasa 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 forgot to take Pentasa

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 medicines, this medicinemay cause side effects, although not everyone will experience them.

There have been very few reported cases of severe allergic reaction (including severe skin erosions that can affect the skin as a protective barrier of the body). 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 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 rash, fever, and lymph node enlargement. These severe skin eruptions are often preceded by fever or flu-like symptoms.

The following common side effectsaffect between 1 and 10 in every 100 patients treated:

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

The following rare side effects,affect between 1 and 10 in 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)
• inflammation of the pancreas (including symptoms of back and/or stomach pain) dizziness
• increased skin sensitivity to sunlight and ultraviolet light (photosensitivity)

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

• anemia and other blood disorders (decrease in 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 edema (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 lung 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)
• 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 skin discoloration, skin lesions under the skin (including severe skin erosions and severe burning that can affect the skin as a protective barrier of the body)
• fluid accumulation around the heart (pericardial effusion) that may cause chest pain or pressure
• 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)

• kidney stones and associated renal pain (see also section 2)
• change in urine color

There have been isolated cases of benign intracranial hypertension (increased fluid around the brain) 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 leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use: http;//www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

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

This medication does not require special conditions for conservation.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Pentasa 2 g prolonged-release granules

The active ingredient is mesalazine.

Each sachet contains 2g of mesalazine.

The other components are ethylcellulose and povidone.

Appearance of the product and contents of the packaging

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

This medicine is presented in aluminium sachets in packs of:

Sachets 2g: 60 sachets or 10 sachets (samples).

Holder of the marketing authorisation and manufacturer responsible

Holder of the marketing authorisation

FERRING S.A.U.

C/ del Arquitecto Sánchez Arcas nº3, 1º

28040 Madrid

Spain

Manufacturer responsible

Ferring GmbH

Wittland 11

D-24109 Kiel

Germany

Last review date of this leaflet in May 2023

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