Pentasa

Leaflet attached to the packaging: patient information

PENTASA, 1 g, prolonged-release tablets

Mesalazine

Please read carefully the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• Please keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should consult your doctor.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor. See section 4.

Table of contents of the leaflet:

• 1. What is Pentasa and what is it used for
• 2. Important information before taking Pentasa
• 3. How to take Pentasa
• 4. Possible side effects
• 5. How to store Pentasa
• 6. Contents of the packaging and other information

1. What is Pentasa and what is it used for

Mesalazine, the active substance of Pentasa, acts locally as an anti-inflammatory agent on the diseased wall of the small and large intestine. Mesalazine is released from the tablets in a continuous manner throughout the entire length of the intestine, regardless of the pH value. Pentasa is used to treat mild and moderate ulcerative colitis and Crohn's disease.

2. Important information before taking Pentasa

BEFORE TAKING MESALAZINE, THE PATIENT SHOULD INFORM THEIR DOCTOR:

• If the patient has ever experienced severe skin rash or skin peeling after taking mesalazine, or blisters or ulcers in the mouth.

When not to take Pentasa

if the patient is allergic to mesalazine or any of the other ingredients of this medicine (listed in section 6), if the patient is allergic to salicylates, such as aspirin, if the patient has severe liver or kidney dysfunction, if the patient has stomach or duodenal ulcer, if the patient has haemorrhagic diathesis.

Warnings and precautions

Before starting treatment with Pentasa, the patient should discuss it with their doctor. Caution should be exercised: if the patient is allergic to sulfasalazine, if there are liver or kidney function disorders, if the patient is being treated with medicines that may affect kidney function, if the patient is being treated with azathioprine (an immunosuppressive agent), 6-mercaptopurine (a cytotoxic agent and immunosuppressive agent), or tioguanine (a cytotoxic agent), if there are lung disorders, especially bronchial asthma, if the patient experiences severe or recurrent headache, vision disturbances, or ringing or buzzing in the ears, they should contact their doctor immediately. Mesalazine may cause kidney stones. Symptoms may include pain in the sides of the abdomen and haematuria. During treatment with mesalazine, the patient should drink an adequate amount of fluids. Severe skin reactions, including drug reaction with eosinophilia and systemic symptoms (DRESS), Stevens-Johnson syndrome (SJS), and toxic epidermal necrolysis (TEN), have been reported with mesalazine treatment. The patient should stop taking mesalazine and seek medical attention immediately if they experience any symptoms of these severe skin reactions, listed in section 4. Rarely, mesalazine has been associated with myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the lining surrounding the heart). Very rarely, serious blood disorders have been reported. If acute intolerance symptoms, such as abdominal cramps, acute abdominal pain, fever, severe headache, or rash, occur during treatment, the patient should stop treatment and contact their doctor immediately. Usually, before and during treatment, the doctor will order blood and urine tests to assess liver, kidney, or blood function. Mesalazine may cause reddish-brown discoloration of urine after contact with sodium hypochlorite bleach in toilet water. This is a chemical reaction between mesalazine and bleach and is harmless.

Children and adolescents

Pentasa should not be used in children under 6 years of age. Clinical data on the use of Pentasa in children (aged 6 to 18 years) are limited.

Pentasa and other medicines

The patient should tell their doctor about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. In particular, this applies to medicines such as sulfasalazine, azathioprine, 6-mercaptopurine, or tioguanine, warfarin. Pregnancy, breastfeeding, and fertility If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor before taking this medicine. Mesalazine crosses the placenta. Mesalazine is excreted in human milk. Driving and using machines Pentasa has not been shown to affect the ability to drive or use machines.

3. How to take Pentasa

This medicine should always be taken exactly as prescribed by the doctor. If the patient has any doubts, they should consult their doctor. The recommended dose is: Ulcerative colitis, treatment of active disease phase: Adults: the dose is determined individually by the doctor, up to 4 g per day, once a day or in divided doses. Children aged 6 and over: the dose is determined individually by the doctor; usually, 30 to 50 mg/kg body weight per day in divided doses. The maximum dose is 75 mg/kg body weight per day in divided doses. The total dose should not exceed 4 g per day (the maximum dose for adults). Pentasa should not be used in children under 6 years of age. Ulcerative colitis, maintenance treatment: Adults: the recommended dose is 2 g once a day. Children aged 6 and over: the dose is determined individually by the doctor; usually, 15 to 30 mg/kg body weight per day in divided doses. The total dose should not exceed 2 g per day. Pentasa should not be used in children under 6 years of age. Crohn's disease, treatment of active disease phase: Adults: the dose is determined individually by the doctor, up to 4 g per day in divided doses. Children aged 6 and over: the dose is determined individually by the doctor; usually, 30 to 50 mg/kg body weight per day in divided doses. The maximum dose is 75 mg/kg body weight per day in divided doses. The total dose should not exceed 4 g per day (the maximum dose for adults). Pentasa should not be used in children under 6 years of age. Crohn's disease, maintenance treatment: Adults: the dose is determined individually by the doctor, up to 4 g per day in divided doses. Children aged 6 and over: the dose is determined individually by the doctor; usually, 15 to 30 mg/kg body weight per day in divided doses. The total dose should not exceed 2 g per day. Pentasa should not be used in children under 6 years of age. In patients with active Crohn's disease who do not respond to treatment with a dose of 4 g per day within 6 weeks, and in patients with Crohn's disease who experience disease relapse during maintenance treatment with a dose of 4 g per day, alternative treatment should be used. In elderly patients, there is no need to adjust the dose.

The medicine is taken orally.

The tablets should not be chewed or crushed. To facilitate swallowing, the tablet can be placed in a container with a small amount of water or juice, mixed, and the resulting suspension should be taken immediately. To achieve the desired effect, the recommended doses should be taken regularly and consistently.

Overdose of Pentasa

In case of overdose, symptomatic treatment is recommended in a hospital and monitoring of kidney function.

Missed dose of Pentasa

A double dose should not be taken to make up for a missed dose.

4. Possible side effects

Like all medicines, Pentasa can cause side effects, although not everybody gets them. The patient should stop taking mesalazine and seek medical attention immediately if they experience any of the following symptoms:

• red, flat, target-like, or circular patches on the torso, often with blisters in the center, skin peeling, ulcers in the mouth, throat, nose, genitals, and eyes, widespread rash, fever, and swollen lymph nodes. The occurrence of such severe skin rashes may be preceded by fever and flu-like symptoms.

If acute intolerance symptoms, such as abdominal cramps, acute abdominal pain, fever, severe headache, or rash, occur during treatment, the patient should stop treatment and contact their doctor immediately. Serious side effects with unknown frequency (cannot be estimated from the available data) The patient should seek medical attention immediately

• if they experience severe or recurrent headache, vision disturbances, or ringing or buzzing in the ears. These may be symptoms of increased intracranial pressure (idiopathic intracranial hypertension).

The following side effectsare common(may affect 1 to 10 in 100 patients):

• diarrhoea
• nausea
• abdominal pain
• headache
• vomiting
• bloating
• rash
• hives

The following side effectsare rare(may affect 1 to 10 in 10,000 patients):

• dizziness
• myocarditis
• pericarditis
• increased amylase activity
• acute pancreatitis
• increased skin sensitivity to sunlight and ultraviolet radiation (photosensitivity).

The following side effectsare very rare(may affect less than 1 in 10,000 patients):

• muscle pain
• joint pain
• temporary hair loss
• allergic pneumonia, allergic reactions, and fibrotic changes in the lungs (including shortness of breath, cough, bronchospasm), eosinophilic pneumonia - a lung condition with increased eosinophils in the blood, interstitial lung disease, lung infiltration, pneumonia
• kidney disorders (acute and chronic interstitial nephritis, nephrotic syndrome - a condition characterized by excessive loss of protein in the urine, kidney failure), urine discoloration
• increased liver enzyme activity, increased levels of cholestasis markers (substances indicating bile stasis in the liver) and bilirubin, liver damage (including hepatitis, cholestatic hepatitis, cirrhosis, liver failure)
• blood disorders, such as anaemia, aplastic anaemia, agranulocytosis - a very low number of granulocytes, neutropenia - a low number of neutrophils, leucopenia - a low number of white blood cells (including granulocytopenia - a low number of granulocytes), pancytopenia - a low number of all blood cells, thrombocytopenia - a low number of platelets, and eosinophilia (as part of an allergic reaction)
• reactions similar to lupus erythematosus
• peripheral neuropathy - a disorder of the peripheral nerves
• pancolitis - a severe form of ulcerative colitis that affects the entire colon
• transient oligospermia (low sperm count)
• hypersensitivity reactions, including allergic rash, anaphylactic reaction, erythema multiforme
• drug fever.

Unknown frequency(cannot be estimated from the available data)

• kidney stones and associated kidney pain (see also section 2)
• drug reaction with eosinophilia and systemic symptoms (DRESS), Stevens-Johnson syndrome (SJS) - severe skin reactions, i.e. non-permanent blisters on mucous membranes, mainly in the mouth and genitals.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should tell their doctor. Side effects can be reported directly to the Department of Post-Marketing Surveillance of Medicinal Products, Medical Devices, and Biocidal Products: Aleje Jerozolimskie 181C, 02-222 Warsaw, Tel: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorisation holder. By reporting side effects, more information can be gathered on the safety of the medicine.

• 5.

How to store Pentasa

The medicine should be stored out of sight and reach of children. Store in the original packaging to protect from light. Do not store above 25°C. Do not use this medicine after the expiry date stated on the packaging after the EXP label. The expiry date refers to the last day of the month. Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Pentasa contains

The active substance is mesalazine. One prolonged-release tablet contains 1 g of mesalazine. The other ingredients are povidone, ethylcellulose, magnesium stearate, talc, and microcrystalline cellulose.

What Pentasa looks like and contents of the pack

Pentasa is available as prolonged-release tablets. The tablet is white to light brown, speckled, oval, with the inscription "PENTASA" on both sides. The packaging contains 60 tablets in aluminium foil blisters, placed in a cardboard box.

Marketing authorisation holder

Ferring GmbH, Wittland 11, D-24109 Kiel, Germany. Manufacturer Ferring GmbH, Wittland 11, D-24109 Kiel, Germany. For more information, the patient should contact the representative of the marketing authorisation holder. Ferring Pharmaceuticals Poland Sp. z o.o., ul. Szamocka 8, 01-748 Warsaw, Tel.: +48 22 246 06 80, Fax: +48 22 246 06 81. Date of last revision of the leaflet:January 2025