Pentasa

Leaflet accompanying the packaging: patient information

PENTASA, 4 g, prolonged-release granules

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 any not listed in this leaflet, tell 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 granules in a continuous manner throughout the entire length of the intestine, regardless of 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, TELL YOUR DOCTOR:

• If you have ever experienced a severe skin rash or skin peeling after taking mesalazine, 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 dysfunction,
if you have stomach or duodenal ulcer,
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 dysfunction,
if you are being treated with medicines that may affect kidney function,
if you are being treated with azathioprine (an immunosuppressive agent), 6-mercaptopurine (an antineoplastic and immunosuppressive agent) or tioguanine (an antineoplastic agent),
if you have lung disorders, especially bronchial asthma,
if you experience severe or recurring headache, vision disturbances or ringing or buzzing in the ears, you should contact your doctor immediately.
Mesalazine may cause kidney stones. Symptoms may include pain in the sides of the abdomen and blood in the urine. During mesalazine treatment, you 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. You should stop taking mesalazine and seek medical attention immediately if you experience any of these severe skin reactions, listed in section 4.
Rarely, mesalazine has been reported to cause cardiac hypersensitivity reactions (myocarditis and pericarditis).
Very rarely, serious blood disorders have been reported.
If you experience acute intolerance symptoms, such as abdominal cramps, 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 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 in children (from 6 to 18 years) are limited.

Pentasa and other medicines

Tell your doctor about all the medicines you are taking now or have taken recently, and about the medicines you plan to take. In particular, this concerns such medicines 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 child, 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 and use machines has been observed.

3. How to take Pentasa

This medicine should always be taken exactly as your doctor has told you. If you are not sure, ask your doctor.
The recommended dose is:
Ulcerative colitis, treatment of active phase of the disease:
Adults:the dose is determined individually by the doctor, up to 4 g per day once a day or in divided doses.
Children from 6 years of age:the dose is determined individually by the doctor; usually, 30 to 50 mg/kg body weight per day in divided doses are used. 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 from 6 years of age:the dose is determined individually by the doctor; usually, 15 to 30 mg/kg body weight per day in divided doses are used. 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 phase of the disease:
Adults:the dose is determined individually by the doctor, up to 4 g per day in divided doses.
Children from 6 years of age:the dose is determined individually by the doctor; usually, 30 to 50 mg/kg body weight per day in divided doses are used. 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 from 6 years of age:the dose is determined individually by the doctor; usually, 15 to 30 mg/kg body weight per day in divided doses are used. The total dose should not exceed 2 g per day. Pentasa should not be used in children under 6 years of age.
In case of treatment with lower doses than 4 g, the available Pentasa granules for prolonged release of 2 g or 1 g should be used.
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, other treatment should be used.
In elderly patients, there is no need to change 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, washed down 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, this medicine 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, plate-like or round patches on the torso, often with blisters in the center, skin peeling, ulcers in the mouth, throat, nose, genitals and around the 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 you experience acute intolerance symptoms, such as abdominal cramps, acute abdominal pain, fever, severe headache or rash, you should stop the treatment and contact your doctor immediately.
Severe side effects with unknown frequency (cannot be estimated from the available data)

• you should 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 - i.e. pulmonary infiltration with eosinophilia in the blood (an increase in the number of acidophilic white blood cells), interstitial lung disease, pulmonary infiltration, pneumonia
• kidney dysfunction (acute and chronic interstitial nephritis, nephrotic syndrome - i.e. a syndrome of symptoms caused 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 - i.e. a very low number of granulocytes, neutropenia - i.e. a low number of neutrophilic granulocytes, leukopenia - i.e. a low number of white blood cells (including granulocytopenia, i.e. a low number of granulocytes), pancytopenia - i.e. a low number of all blood cells, thrombocytopenia - i.e. a low number of platelets and eosinophilia (as part of an allergic reaction)
• reactions similar to lupus erythematosus
• peripheral neuropathy - i.e. peripheral nerve dysfunction
• pancolitis - i.e. a severe form of ulcerative colitis, in which the disease affects the entire colon
• transient oligospermia (low sperm count in male semen)
• 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 you experience any side effects, including any not listed in this leaflet, tell 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.
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 30°C.
Store in the original packaging to protect from light.
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. 1 sachet of prolonged-release granules contains 4 g of mesalazine.
The other ingredients are: ethylcellulose (40-52 cP), povidone (K 29-32).

What Pentasa looks like and contents of the pack

Pentasa is available as prolonged-release granules.
The granules are white-grey to light brown in color.
Packaging:
30 sachets containing prolonged-release granules, placed in a cardboard box.

Marketing authorization holder

Ferring GmbH
Wittland 11
D-24109 Kiel
Germany

Manufacturer

Ferring GmbH
Wittland 11
D-24109 Kiel
GermanyFerring 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