Pentasa 1g granulado de liberacion prolongada

Prospect: information for the user

Pentasa 1g prolonged-release granule

Mesalazine

Read this prospect carefully beforestarting totakethis medication, because it contains important information for you.

• Keep this prospect, as you may need to read it again.
  If you have any questions, consult yourdoctororpharmacist
• This medication has been prescribed to you alone,and you must not give it to other people even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult yourdoctororpharmacist,even if they are not listed in this prospect.

1. What isPentasaand what is it used for

2. What you need to know before starting totakePentasa

3. How to take Pentasa

4. Possible adverse effects

5. Storage ofPentasa

6. Contents of the package and additional information

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

Do not take Pentasa

• if you areallergic (hypersensitive)tomesalazineor to any of the other components of this medication (see section 6)
• if you areallergicto othersalicylates, for example aspirin
• if you have severe kidney and/or liver problems

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 previously impaired kidney or liver function
• if you have a condition that may make you prone to bleeding
• if you have an activepeptic ulcer(stomach ulcer or duodenal ulcer)
• if you are undergoing a treatment that may affect kidney function, for example non-steroidal anti-inflammatory drugs (NSAIDs) such as aspirin
• if you have lung problems, particularly asthma
• immediately stop treatment 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 on one side 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 peeling of the skin, 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 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 interaction with other medications

Inform yourdoctor 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 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 discontinued.

Driving and operating machinery:

This medication 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, which can be taken once a day or divided into doses.You can take two Pentasa sachets of 2 g 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 2 g of mesalazine per day, administered in the form of a Pentasa 2 g sachet or two Pentasa 1 g sachets once a day.

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 weighing up to 40 kg will be half the usual dose recommended for adults.For children and adolescents weighing more than 40 kg, the dose will be the same as the usual dose recommended for adults.

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

1. Open the sachet.
2. Empty the contents of the sachet onto the tongue and swallow immediately with water or orange juice, ensuring 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 sachets 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 medication and the amount ingested.

If you forget to take Pentasa sachets

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, Pentasa suppositories may 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, 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, generalised rash, fever, and swollen lymph nodes. 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
• abdominal pain
• nausea
• vomiting
• headache
• 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)
• 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 in 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 pale 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 leaflet. You can also report them directly through the Spanish System for 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 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.

Pentasa sachets composition

The active ingredient is mesalazine.

Each sachet contains 1g of mesalazine.

The other components areethylcellulose and povidone

Appearance of the product and content of the container

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

This medication is presented in aluminium sachets in containers of:

Sachets 1g: 50 or100

Marketing authorization holder

FERRING S.A.U

C/ del Arquitecto Sánchez Arcas 3, 1º

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:Cyprus, Germany, Greece, Ireland, Spain, Sweden, United Kingdom (Northern Ireland)

Pentasa:Slovenia

The last review of this leaflet was in January 2023.

The 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/