Pentasa

Leaflet attached to the packaging: patient information

PENTASA, 500 mg, prolonged-release tablets

Mesalazine

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, please inform your 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 pack 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, INFORM YOUR DOCTOR:

• If you have ever experienced a severe skin rash or skin peeling after taking mesalazine, or blisters or ulcers in the mouth.

When not to take Pentasa

if you are allergic to mesalazine or any of the other ingredients of this medicine (listed in section 6), if you are allergic to salicylates, such as aspirin, if you have severe liver or kidney problems, if you have stomach or duodenal ulcers, if you have haemorrhagic diathesis.

Warnings and precautions

Before taking Pentasa, discuss it with your doctor. Be cautious: if you are allergic to sulfasalazine, if you have liver or kidney problems, if you are being treated with medicines that may affect kidney function, if you are being treated with azathioprine (an immunosuppressant), 6-mercaptopurine (an anticancer and immunosuppressant), or tioguanine (an anticancer), if you have lung problems, especially asthma, if you experience severe or recurring headache, vision disturbances, or ringing or buzzing in the ears, you should contact your doctor immediately. Taking mesalazine may lead to the formation of kidney stones. Symptoms may include pain in the sides of the abdomen and blood in the urine. During treatment with mesalazine, you should drink an adequate amount of fluids. Serious 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. You should stop taking mesalazine and seek medical attention immediately if you experience any of the symptoms of these serious 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 you experience acute symptoms of intolerance, such as crampy abdominal pain, acute abdominal pain, fever, severe headache, or rash, you should stop treatment and contact your doctor immediately. Usually, before and during treatment, your doctor will order blood and urine tests to assess liver, kidney, or blood function. Mesalazine may cause a reddish-brown discoloration of urine after contact with sodium hypochlorite bleach in toilet water. This is a harmless chemical reaction between mesalazine and bleach.

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

Tell your doctor about all medicines you are taking or have recently taken, and about any medicines you plan to take. In particular, this applies to medicines such as sulfasalazine, azathioprine, 6-mercaptopurine, or tioguanine, warfarin. Pregnancy, breastfeeding, and fertility If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, ask your doctor for advice before taking this medicine. Mesalazine passes through the placenta. Mesalazine passes into breast milk. Driving and using machines Pentasa has not been shown to affect the ability to drive or use machines.

3. How to take Pentasa

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your 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 flare-up 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. The score line on the tablet is only to facilitate breaking the tablet to make it easier to swallow. To facilitate swallowing, the tablet can be broken or placed in a container with a small amount of water or juice, stirred, and the resulting suspension taken immediately. To achieve the desired effect, the recommended doses should be taken regularly and consistently.

Overdose of Pentasa

In case of overdose, hospital treatment and monitoring of kidney function are recommended.

Missed dose of Pentasa

Do not take a double dose to make up for a missed dose.

4. Possible side effects

Like all medicines, Pentasa can cause side effects, although not everybody gets them. You should stop taking mesalazine and seek medical attention immediately if you 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.

Severe side effects with unknown frequency (cannot be estimated from available data) Seek medical attention immediately

• if you experience severe or recurring 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 up to 1 in 10 people):

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

The following side effectsare uncommon(may affect up to 1 in 100 people):

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

The following side effectsare rare(may affect up to 1 in 1,000 people):

• 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 problems (acute and chronic interstitial nephritis, nephrotic syndrome - a collection of symptoms indicating severe kidney damage, kidney failure), urine discoloration
• increased liver enzyme activity, increased levels of cholestasis indicators (substances indicating bile stasis in the liver) and bilirubin, liver damage (including hepatitis, cholestatic hepatitis, cirrhosis, liver failure)
• blood disorders, such as anemia, aplastic anemia, agranulocytosis - a very low granulocyte count, neutropenia - a low neutrophil count, leukopenia - a low white blood cell count (including granulocytopenia - a low granulocyte count), pancytopenia - a low count of all blood cells, thrombocytopenia - a low platelet count, 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
• temporary oligospermia (low sperm count)
• hypersensitivity reactions, including allergic rash, anaphylactic reaction, erythema multiforme
• drug fever.

Frequency unknown(cannot be estimated from 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 genital areas.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please inform your doctor. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration 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 authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

• 5.

How to store Pentasa

Keep the medicine out of the sight and reach of children. 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. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

• 6.

Contents of the pack and other information

What Pentasa contains

The active substance is mesalazine. One prolonged-release tablet contains 500 mg of mesalazine. The other ingredients are povidone, ethyl cellulose, magnesium stearate, talc, 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, round, 13.5 mm in diameter, with a score line and embossed with "500 mg" on one side and "PENTASA" on the other side. The pack contains 100 tablets.

Marketing authorization holder

Ferring GmbH, Wittland 11, D-24109 Kiel, Germany, Manufacturer Ferring GmbH, Wittland 11, D-24109 Kiel, Germany. For more detailed information, please contact the representative of the marketing authorization holder. Poland 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