PENTASA 2 g PROLONGED-RELEASE GRANULES

Introduction

Package Leaflet: Information for the User

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

1. What is Pentasa and what is it used for

Pentasa sachets are indicated for the treatment of mild to moderate ulcerative colitis flare-ups and to help maintain you free of further 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 sachets contain granules that slowly release the active substance (mesalazine). This helps to reduce inflammation and painful symptoms.

2. What you need to know before you take Pentasa

Do not take Pentasa

• if you are allergicto mesalazineor any of the other ingredients of this medicine (listed in section 6)
• if you are allergicto other salicylates, for example aspirin
• if you have severe kidneyand/or liverproblems

Warnings and precautions

Consult your doctor or pharmacist before taking Pentasa:

• 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 treatment that may affect kidney function, for example non-steroidal anti-inflammatory drugs (NSAIDs) such as aspirin
• if you have lung problems, asthma in particular
• treatment should be discontinued 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 mouth sores 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 the 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 (TEN), have been observed with mesalazine treatment. Stop taking mesalazine and seek medical attention immediately if you experience any of the symptoms related to these severe skin reactions described in section 4.

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

Using Pentasa with other medicines

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 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 discontinued.

Driving and using machines

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

3. How to take Pentasa

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

Adults:

To treat a flare-up of colitis,your doctor will normally prescribe a dose of up to 4g of mesalazine per day, which can be taken either once a day or divided into two doses. It can be taken as one sachet of Pentasa 4g or as two sachets of Pentasa 2g once a day. Pentasa 1g 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 2g of mesalazine per day, administered as one sachet of Pentasa 2g or two sachets of Pentasa 1g once a day.

Use in children and adolescents (aged 6 years and above)

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 40kg will be half the usual recommended dose in adults, and for those with a body weight above 40kg, 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 your tongue and swallow the granules immediately with water or orange juice, making sure none remain in your mouth.

Or

1. Mix the contents of the sachet with yoghurt. 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 Toxicology Information Service, telephone 91 562 04 20, stating the medicine and the amount taken.

If you forget to take Pentasa

If you have missed 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 further questions on 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.

Very rare cases of severe allergic reactions (including severe skin reactions that can affect the skin as a protective barrier of the body) 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 experience any of the following symptoms:

• red 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, widespread rash, fever, and enlarged lymph nodes. These severe skin reactions 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 effectsaffect between 1 and 10 in every 10,000 patients treated:

• inflammation of certain areas of the heart (myocarditis and pericarditis) that can 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 sensitivity of the skin to sunlight and ultraviolet light (photosensitivity)

The following very rare side effectsaffect less than 1 in every 10,000 patients treated:

• 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)
• allergic and fibrotic lung reactions, inflammation of the lung lining, or scarring of the lung (symptoms include cough, bronchospasm, chest discomfort, or pain when breathing, difficulty breathing, bloody or excessive sputum)
• 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 unusual 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
• low sperm count (oligospermia) (this is reversible)
• severe diarrhea and abdominal pain due to an allergic reaction to this medicine in the intestine
• allergic reactions and fever may occasionally occur

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

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

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 disturbances.

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 Medicines and Health Products Agency (AEMPS) website: http://www.aemps.gob.es/. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Pentasa

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 after EXP. The expiry date refers to the last day of the month shown.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and further information

Composition of Pentasa 2g prolonged-release granules

The active substance is mesalazine.

Each sachet contains 2g 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 white-grayish/white pale brown and cylindrical in shape.

This medicine is available in aluminum sachets in packs of:

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

Marketing authorization holder and manufacturer

Marketing authorization holder

FERRING S.A.U.

C/ del Arquitecto Sánchez Arcas nº3, 1º

28040 Madrid

Spain

Manufacturer

Ferring GmbH

Wittland 11

D-24109 Kiel

Germany

Date of last revision of this leaflet: May 2023

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