Pentasa

Package Leaflet: Information for the Patient

PENTASA, 1 g, prolonged-release granules

Mesalazine

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

• Keep this package 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 symptoms are the same as yours.
• If you experience any side effects, including those not listed in this package leaflet, please inform your doctor. See section 4.

Table of Contents of the Package 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 intestinal wall. Mesalazine is released from the granules in a continuous manner throughout the entire length of the intestine, regardless of pH. Pentasa is used to treat mild and moderate ulcerative colitis and Crohn's disease.

2. Important information before taking Pentasa

BEFORE TAKING MESALAZINE, TELL YOUR DOCTOR:

• If you have ever experienced a severe skin rash or skin peeling after taking mesalazine, or if you have had blisters or ulcers in your 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 a blood clotting disorder.

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 taking medicines that may affect kidney function, if you are taking azathioprine (a medicine that reduces the activity of the immune system), 6-mercaptopurine (a medicine used to treat cancer and reduce the activity of the immune system), or tioguanine (a medicine used to treat cancer), if you have lung problems, especially asthma, if you experience severe or recurring headaches, vision disturbances, or ringing or buzzing in the ears, you should contact your doctor immediately. 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 (from 6 to 18 years) are limited.

Pentasa and other medicines

Tell your doctor about all the 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 become pregnant, ask your doctor for advice before taking this medicine. Mesalazine passes through the placenta. Mesalazine passes into breast milk.

Driving and using machines

No effect of Pentasa on the ability to drive or use machines has been observed.

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: Adults:the dose is determined individually by the doctor, up to 4 g per day, once a day or in divided doses. Children 6 years and older: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 6 years and older: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: Adults:the dose is determined individually by the doctor, up to 4 g per day in divided doses. Children 6 years and older: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 6 years and older: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 a 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 granules should not be chewed or crushed. The contents of the sachet should be poured onto the tongue and swallowed, with water or juice. The entire contents of the sachet can also be mixed with yogurt and taken immediately, without chewing the granules. To achieve the desired effect, the recommended doses should be taken regularly and consistently.

Overdose of Pentasa

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

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. Stop taking mesalazine and seek medical help 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 help immediately

• if you experience severe or recurring headaches, 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 caused by an allergic reaction with eosinophilia in the blood, interstitial lung disease, lung infiltration, pneumonia
• kidney problems (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 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 number of granulocytes, neutropenia - a low number of neutrophils, leukopenia - 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 in semen)
• hypersensitivity reactions, including allergic rash, anaphylactic reaction, erythema multiforme
• drug fever.

Frequency not known(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, including non-permanent blisters on mucous membranes, mainly in the mouth and genitals.

Reporting side effects

If you experience any side effects, including those not listed in this package 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 this 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 EXP. 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 sachet of prolonged-release granules contains 1 g of mesalazine. The other ingredients are ethylcellulose, povidone.

What Pentasa looks like and contents of the pack

Pentasa is available as prolonged-release granules. The granules are white-gray to light brown in color. The pack contains 50 sachets of granules.

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. 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 package leaflet:January 2025