Pentasa

Package Leaflet: Information for the Patient

PENTASA, 1 g, suppositories

Mesalazine

Read the package 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. 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 rectal wall.
Pentasa is used to treat ulcerative proctitis.

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 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 bleeding 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 other 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 headache, vision disturbances, or ringing or buzzing in the ears, you should contact your doctor immediately.
Taking mesalazine may lead to kidney stones. Symptoms may include pain in the sides of the abdomen and blood in the urine. During mesalazine treatment, you should drink plenty 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 help immediately if you experience any of these serious skin reactions, listed in section 4.
Rarely, mesalazine has been reported to cause heart hypersensitivity reactions (myocarditis and pericarditis).
Very rarely, serious blood disorders have been reported.
If you experience acute intolerance symptoms, such as colicky abdominal pain, acute abdominal pain, fever, severe headache, or rash, you should stop the treatment and contact your doctor immediately.
Usually, before and during treatment, your doctor will have you undergo 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 the toilet water. This is a chemical reaction between mesalazine and bleach and is harmless.

Children and adolescents

Experience with the use of Pentasa in children is limited, and clinical data are restricted.

Pentasa and other medicines

Tell your doctor about all the medicines you are taking, or have recently taken, and any you plan to take, especially:
sulfasalazine, azathioprine, 6-mercaptopurine, or tioguanine, warfarin.

Pregnancy, breastfeeding, and fertility

If you are pregnant, breastfeeding, or think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine.
Mesalazine passes into 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:
Adults
1 g (one suppository) 1-2 times a day.
No dose adjustment is needed in elderly patients.
The medicine is administered rectally.

Instructions for use:

• 1. It is recommended to empty the bowel before using the suppository.
• 2. To maintain hygiene, a protective sheath can be placed on the finger before inserting the suppository.
• 3. Insert the suppository into the rectum. To facilitate insertion, the suppository can be moistened with water.
• 4. If the suppository is expelled within 10 minutes, another suppository should be inserted.

Overdose of Pentasa

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
You should 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 the available data)

• 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
• discomfort and irritation in the anal area
• anal itching
• painful defecation

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 lung inflammation, 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 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 stagnation 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
• temporary oligospermia (low sperm count)
• hypersensitivity reactions, including allergic rash, anaphylactic reaction, erythema multiforme
• drug fever.

Frequency not known(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, characterized by 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 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
Phone: +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.
Reporting side effects will help to gather 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 that 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 suppository contains 1 g of mesalazine.
The other ingredients are: povidone, macrogol 6000, magnesium stearate, talc

What Pentasa looks like and contents of the pack

Pentasa is available as rectal suppositories.
The suppository is oblong, scored, and white to light brown in color.
The pack contains 14 or 28 suppositories.
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.
Szamocka 8 Street
01-748 Warsaw
Phone: +48 22 246 06 80, Fax: +48 22 246 06 81
Date of last revision of the leaflet:January 2025