Pentasa 500 mg prolonged-release tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

PENTASA 500 mg prolonged-release tablets

Mesalazine

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read 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 other people, even if they have the same symptoms as you, since it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet contents

1. What Pentasa tablets are and what they are used for
2. What you need to know before taking Pentasa tablets
3. How to take Pentasa tablets
4. Possible adverse effects
5. How to store Pentasa tablets
6. Contents of the pack and other information

1. What Pentasa tablets are and what they are used for

Pentasa tablets are indicated to help you stay free from new flare-ups of ulcerative colitis.

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

Pentasa contains the active substance mesalazine, which belongs to a group of medicines called intestinal anti-inflammatory agents that help reduce inflammation and painful symptoms.

2. What you need to know before taking Pentasa tablets

Do not take Pentasa tablets:

• if you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6).

• if you are allergic to salicylates, 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 tablets:

• if you are allergic to sulfasalazine (risk of allergy to salicylates).

• if you currently have or have previously had impaired liver or kidney function.

• if you have a disease that may make you prone to bleeding.

• if you are taking treatment that may affect kidney function, for example non-steroidal anti-inflammatory drugs (NSAIDs) such as aspirin.

• if you have respiratory problems, particularly asthma.

• treatment must be stopped immediately if you experience 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 you 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 using mesalazine.

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

Take special care with mesalazine:

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

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

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

Use in patients over 65 years of age:

Pentasa should be used with caution in patients over 65 years of age and only in those with normal kidney function.

Children and adolescents:

There is limited data on the use of this medicine in children (6–18 years of age). Dosage will be determined by the doctor.

Use of Pentasa tablets with other medicines:

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take 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 coagulation (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 using this medicine.

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

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

Fertility:

Animal data on mesalazine show no effect on male or female fertility.

Driving and using machines:

Treatment with Pentasa tablets does not appear to have any influence on the ability to drive and/or use machines.

3. How to take Pentasa tablets

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

The recommended dose is:

Adults:

To help you remain free from further flare-ups of colitis, your doctor will generally prescribe 2 grams of mesalazine per day, administered as 4 tablets taken once daily.

Use in children and adolescents (aged 6 years and older):

For children and adolescents, the dose will be calculated by your doctor according to 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 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 tablets whole orally (by mouth). To facilitate administration, the tablets may be suspended in water or orange juice, shaken, and immediately ingested.

If you think that the effect of this medicine is too strong or too weak, inform your doctor.

If you take more Pentasa tablets than you should

Cases of overdose in humans have not been reported; however, if an overdose is suspected, you should immediately consult your doctor or pharmacist.

In case of overdose or accidental ingestion, consult immediately your doctor, pharmacist, or call the Toxicology Information Service at Telephone: 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Pentasa tablets:

Do not take a double dose to make up for forgotten doses.

If you stop taking Pentasa tablets:

Your doctor will advise you on the duration of your treatment with Pentasa tablets. Do not discontinue treatment early, even if you feel better, as symptoms may return if treatment is stopped too soon. Strictly follow the treatment regimen as instructed by your doctor for the established maintenance period.

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 tablets can cause adverse effects, although not everyone experiences them.

Serious adverse effects:

Very rare 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, vision disturbances, or ringing or buzzing in the ears. These could be symptoms of increased pressure inside the skull (idiopathic intracranial hypertension).

Stop taking mesalazine and seek immediate medical help if you experience 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 ulcers, throat, nose, genital or eye lesions, widespread rash, fever, and swollen lymph nodes. These severe skin rashes are often preceded by fever or flu-like symptoms.

The following are common adverse effects, occurring in between 1 and 10 out of every 100 treated patients:

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

The following are rare adverse effects, occurring in between 1 and 10 out of 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) and increased amylase levels
• dizziness
• increased sensitivity of the skin to sunlight and ultraviolet light (photosensitivity)

The following are very rare adverse effects, occurring in fewer than 1 out of every 10,000 treated patients:

• eosinophilia (as part of an allergic reaction) and blood disorders such as reduction in red blood cells (anemia), white blood cells (leukopenia), or platelets (thrombocytopenia), which may increase the likelihood of infections or bleeding
• liver disorders (hepatitis), characterized by symptoms including jaundice (yellowing of the skin and/or eyes) and/or pale stools
• kidney disorders (symptoms include blood in the urine, edema (swelling due to fluid retention, which may cause ankle swelling), and increased blood pressure (nephritis))
• peripheral neuropathy (a condition affecting nerves in the hands and feet, including symptoms of tingling and numbness)
• pulmonary allergic and fibrotic reactions (symptoms include cough, difficulty breathing, bronchospasm, bloody and/or excessive sputum)
• hair loss (this is reversible)
• muscle or joint pain
• inflammation that may 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., nosebleeds), bruising, purplish skin discoloration, spots under the skin (including severe skin erosions and severe burning that may affect the skin as the body's protective barrier)
• 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 available data):

• kidney stones and associated kidney pain (see also section 2)
• change in urine color
• If you experience severe or recurrent headache, vision disturbances, or ringing or buzzing in the ears. These could be symptoms of increased pressure inside the skull (idiopathic intracranial hypertension).

Some of these adverse reactions may also be attributable to the underlying disease itself.

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 may 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 tablets

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month indicated.

Do not store above 25°C. Keep in the original packaging to protect from light.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of unused medicines and their containers. This will help protect the environment.

6. Contents of the pack and other information

Composition of Pentasa tablets

• The active substance is mesalazine. Each tablet contains 500 milligrams of mesalazine.
• The other components are: povidone, ethylcellulose, magnesium stearate, talc, microcrystalline cellulose.

Appearance of the product and contents of the pack

Pentasa tablets are presented as greyish-white/pale brown, round, speckled, film-coated tablets, marked and engraved: 500 mg on one side, PENTASA on the other side.

They are available in double aluminum blisters containing 50 or 100 tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturing Responsible Party

Marketing Authorization Holder:

Ferring S.A.U

C/ del Arquitecto Sánchez Arcas nº3, 1º

28040 Madrid

Spain

Manufacturing Responsible Party:

FERRING GmbH

Wittland 11

24109 Kiel, Germany

Date of the most recent review of this leaflet: January 2025

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