Pentasa

Patient Information Leaflet

PENTASA, 500 mg, prolonged-release tablets
Mesalazinum
Please read this leaflet carefully before taking this medicine, as it contains important information for you.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any questions, please consult your doctor.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm others, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor. See section 4.

Table of contents:

1. What Pentasa is and what it is 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 Pentasa is and what it is used for

Mesalazine, the active substance in Pentasa, acts locally as an anti-inflammatory agent on the diseased wall of the small and large intestine. Mesalazine is released continuously from the tablets along the entire length of the intestine, independently of pH value.
Pentasa is used in the treatment of mild to moderate forms of ulcerative colitis and Crohn's disease.

2. Important information before using Pentasa

BEFORE STARTING MESALAZINE TREATMENT, INFORM YOUR DOCTOR IF:

• The patient has ever experienced severe skin rash, skin peeling, blisters, or oral ulcers after taking mesalazine.

When not to use Pentasa
Do not use this medicine 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, e.g. aspirin,
if the patient has severe impairment of liver and/or kidney function,
if the patient has peptic ulcer of the stomach or duodenum,
if the patient has a bleeding disorder.

Warnings and precautions
Discuss this with your doctor before starting treatment with Pentasa.
Exercise caution:
if the patient is allergic to sulfasalazine,
if there are impairments of liver and/or kidney function,
if the patient is concurrently being treated with medicines that may impair kidney function,
if the patient is concurrently being treated with azathioprine (an immunosuppressive medicine),
6-mercaptopurine (an anticancer and immunosuppressive medicine), or thioguanine (an anticancer medicine),
if the patient has lung disorders, especially bronchial asthma,
if the patient experiences severe or recurring headache, visual disturbances, or ringing or buzzing in the ears,
they should contact their doctor immediately.

Treatment with mesalazine may lead to the formation of kidney stones. Symptoms may include flank pain and haematuria. During treatment with mesalazine, an adequate fluid intake should be maintained.

Serious skin reactions have been reported with mesalazine treatment, including drug reaction with eosinophilia and systemic symptoms (DRESS), Stevens-Johnson syndrome (SJS), and toxic epidermal necrolysis (TEN). If any of the symptoms of these serious skin reactions (listed in section 4) occur, mesalazine must be discontinued immediately and medical help should be sought without delay.

Rarely, mesalazine has been associated with cardiac hypersensitivity reactions (myocarditis and pericarditis).

Very rarely, serious blood disorders have been reported.

If acute intolerance symptoms occur during treatment, such as colicky abdominal pain, acute abdominal pain, fever, severe headache, or rash, treatment must be stopped immediately and the doctor should be contacted.

Usually, before starting and during treatment, the doctor will order blood and urine tests to monitor liver, kidney, or haematopoietic system function.

Mesalazine may cause a reddish-brown discoloration of urine upon contact with sodium hypochlorite bleach present in toilet water. This is due to a chemical reaction between mesalazine and the bleach and is harmless.

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

Pentasa and other medicines
Inform your doctor about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take. This is particularly important for medicines such as:
sulfasalazine, azathioprine, 6-mercaptopurine, thioguanine, and warfarin.

Pregnancy, breastfeeding, and fertility
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor before using this medicine.
Mesalazine crosses the placenta.
Mesalazine is excreted in breast milk.

Driving and operating machinery
No influence of Pentasa on the ability to drive vehicles or operate machinery has been observed.

3. How to use Pentasa

This medicine should always be taken exactly as your doctor has instructed. If in doubt, consult your
doctor.
Recommended dosage:
Ulcerative colitis, treatment of active disease phase:
Adults: The dosage is individually determined by the doctor, up to 4 g per day as a single dose or in divided doses.
Children aged 6 years and older: The dosage is individually determined by the doctor; usually 30 to
50 mg/kg body weight per day in divided doses. Maximum dose: 75 mg/kg body weight per day in divided doses. The total daily dose should not exceed 4 g per day (maximum adult dose). Pentasa should not be used in children under 6 years of age.
Ulcerative colitis, maintenance treatment:
Adults: The recommended dose is 2 g once daily.
Children aged 6 years and older: The dosage is individually determined by the doctor; usually 15 to
30 mg/kg body weight per day in divided doses. The total daily 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 dosage is individually determined by the doctor, up to 4 g per day in divided doses.
Children aged 6 years and older: The dosage is individually determined by the doctor; usually 30 to
50 mg/kg body weight per day in divided doses. Maximum dose: 75 mg/kg body weight per day in divided doses. The total daily dose should not exceed 4 g per day (maximum adult dose). Pentasa should not be used in children under 6 years of age.
Crohn’s disease, maintenance treatment:
Adults: The dosage is individually determined by the doctor, up to 4 g per day in divided doses.
Children aged 6 years and older: The dosage is individually determined by the doctor; usually 15 to
30 mg/kg body weight per day in divided doses. The total daily 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 adequately to treatment with a dose of
4 g per day within 6 weeks, and in patients with Crohn’s disease who experience disease flare during maintenance treatment with 4 g per day, alternative therapy should be considered.
No dosage adjustment is required in elderly patients.
This medicine is for oral use.
Do not chew or crush the tablets.
The score line on the tablet is only intended to facilitate breaking the tablet for easier swallowing.
To make swallowing easier, the tablet may be divided or placed in a container with a small amount of water
or juice, stirred, and the resulting suspension consumed immediately.
To achieve the desired therapeutic effect, the recommended doses should be taken regularly and consistently.
Taking more Pentasa than recommended
In case of overdose, symptomatic treatment in hospital is indicated, with monitoring of kidney function.
Missing a dose of Pentasa
Do not take a double dose to make up for a missed dose.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.
Treatment with mesalazine should be discontinued and immediate medical attention should be sought if the patient experiences any of the following symptoms:

• red, flat, disc-shaped or round spots on the trunk, often with blisters in the centre, skin peeling, oral, throat, nasal, genital or ocular ulcers, extensive rash, fever and swollen lymph nodes. Such severe skin reactions may be preceded by fever and flu-like symptoms.

Severe adverse reactions of unknown frequency (cannot be estimated from available data)
Seek immediate medical help:

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

The following adverse reactions occur frequently (may affect 1 to 10 out of 100 patients treated):

• diarrhoea
• nausea
• abdominal pain
• headache
• vomiting
• flatulence
• rash
• urticaria

The following adverse reactions occur rarely (may affect 1 to 10 out of 10,000 patients treated):

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

The following adverse reactions occur very rarely (may affect fewer than 1 out of 10,000 patients treated):

• muscle pain
• joint pain
• transient alopecia
• allergic alveolitis, allergic reactions and fibrotic changes in the lungs (including dyspnoea, cough, bronchospasm), pulmonary eosinophilia – i.e. pulmonary infiltrate of allergic origin with accompanying blood eosinophilia (increased number of acidophilic white blood cells), interstitial lung disease, pulmonary infiltrate, pneumonia
• renal function disorders (acute and chronic interstitial nephritis, nephrotic syndrome – i.e. a syndrome caused by excessive loss of protein in urine, renal failure), discolouration of urine
• increased liver enzyme activity, increased levels of cholestasis markers (substances indicating bile stasis in the liver) and bilirubin, hepatotoxic effects (including: hepatitis, cholestatic hepatitis, cirrhosis, liver failure)
• blood disorders such as: anaemia, aplastic anaemia, agranulocytosis – i.e. very low granulocyte count, neutropenia – i.e. low neutrophil count, leukopenia – i.e. low white blood cell count (including granulocytopenia – i.e. low granulocyte count), pancytopenia – i.e. low count of all blood cells, thrombocytopenia – i.e. low platelet count, and eosinophilia (as part of an allergic reaction)
• lupus-like reactions
• peripheral neuropathy – i.e. dysfunction of peripheral nerves
• pancolitis – i.e. severe form of ulcerative colitis affecting the entire colon
• transient oligospermia (low sperm count in male semen)
• hypersensitivity reactions, including allergic rash, anaphylactic reaction, erythema multiforme
• drug fever.

Frequency unknown (cannot be estimated from available data):

• kidney stones and associated renal pain (see also section 2)
• drug reaction with eosinophilia and systemic symptoms (DRESS), Stevens-Johnson syndrome (SJS) – severe skin reactions, i.e. non-transient blisters appearing on mucous membranes, mainly in the oral cavity and genital organs.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at 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
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Pentasa

Keep this medicine out of 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 stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures 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.
Other ingredients: povidone, ethylcellulose, 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-grey to light brown, mottled, round, 13.5 mm in diameter, with a central break line and engraved markings: "500 mg" on one side and "PENTASA" on the other.
Pack contains 100 tablets.

Marketing Authorisation Holder
Ferring GmbH
Wittland 11
D-24109 Kiel
Germany

Manufacturer
Ferring GmbH
Wittland 11
D-24109 Kiel
Germany

For further information, contact the representative of the marketing authorisation 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