PENTASA

Package leaflet: Information for the patient

PENTASA, 2 g, prolonged-release granules
Mesalazinum
Please read this leaflet carefully before taking the medicine, as it contains important information for the patient.

• 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 give it to others. The medicine may harm someone else, even if their symptoms are the same.
• If any adverse reactions occur, 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, exerts a local anti-inflammatory effect on the diseased wall of the small and large intestine. Mesalazine is released continuously from the granules along the entire length of the intestine, regardless of pH value.
Pentasa is used in the treatment of mild to moderate 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),
• The patient is allergic to salicylates, such as aspirin,
• The patient has severe liver and/or kidney function disorders,
• The patient has gastric or duodenal ulcer,
• The patient has a bleeding disorder.

Warnings and precautions
Discuss the use of Pentasa with your doctor before starting treatment.
Exercise caution if:

• The patient is allergic to sulfasalazine,
• The patient has liver and/or kidney function disorders,
• The patient is concurrently treated with medicines that may impair kidney function,
• The patient is concurrently treated with azathioprine (an immunosuppressive medicine), 6-mercaptopurine (an anticancer and immunosuppressive medicine), or thioguanine (an anticancer medicine),
• The patient has lung disorders, particularly bronchial asthma,
• The patient experiences severe or recurrent headache, visual disturbances, or ringing or buzzing in the ears – in such cases, contact your doctor immediately.

Mesalazine treatment may lead to the formation of kidney stones. Symptoms may include flank pain and haematuria. Adequate fluid intake is recommended during mesalazine therapy.

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, discontinue mesalazine immediately and seek medical help.

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 contacted.

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

Mesalazine may cause a reddish-brown discoloration of urine when it comes into contact with sodium hypochlorite bleach present 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 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 into breast milk.

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

3. How to take Pentasa

This medicine should always be taken as directed by the physician. In case of doubt, consult your
doctor.
Recommended dosage:
Ulcerative colitis, treatment of active disease phase:
Adults: the physician determines the dosage individually, up to 4 g per day as a single dose or in divided doses.
Children aged 6 years and older: the physician determines the dosage individually; 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 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 physician determines the dosage individually; 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 physician determines the dosage individually, up to 4 g per day in divided doses.
Children aged 6 years and older: the physician determines the dosage individually; 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 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 physician determines the dosage individually, up to 4 g per day in divided doses.
Children aged 6 years and older: the physician determines the dosage individually; 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 adult patients with active Crohn's disease who do not respond adequately to treatment with 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.
Dosage adjustment is not required in elderly patients.
This medicine is taken orally.
The granules must 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 may also be mixed with yoghurt and consumed immediately, without chewing the granules.
To achieve the desired 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.
If you forget to take 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 everyone experiences them.
Treatment with mesalazine should be discontinued and immediate medical attention sought if the patient develops any of the following symptoms:

• Red, flat, disc-shaped or circular patches on the trunk, often with blisters in the center, skin peeling, mouth, throat, nose, genital or eye ulcers, widespread rash, fever and swollen lymph nodes. Such severe skin reactions may be preceded by fever and flu-like symptoms.

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

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

• The patient experiences severe or recurring 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 commonly (may affect 1 to 10 in 100 treated patients):

• Diarrhoea
• Nausea
• Abdominal pain
• Headache
• Vomiting
• Flatulence
• Rash
• Urticaria

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

• 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 less than 1 in 10,000 treated patients):

• Muscle pain
• Joint pain
• Transient alopecia
• Allergic alveolitis, allergic reactions and fibrotic lung changes (including dyspnoea, cough, bronchospasm), pulmonary eosinophilia – i.e. lung infiltrates due to hypersensitivity with accompanying blood eosinophilia (increased number of eosinophilic white blood cells), interstitial lung disease, pulmonary infiltrates, pneumonia
• Renal function disorders (acute and chronic interstitial nephritis, nephrotic syndrome – i.e. a syndrome of disease symptoms caused by excessive protein loss in urine, renal failure), urine discoloration
• Increased liver enzyme activity, elevated cholestasis markers (substances indicating bile stasis in the liver) and bilirubin levels, 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 kidney 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 mouth and genital organs.

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

5. How to store Pentasa

Keep the medicine out of the sight and reach of children.
Do not store above 25 °C.
Store in the original packaging to protect from light.
Do not use this medicine after the expiry date stated on the pack following the word EXP.
The expiry date refers to the last day of the stated month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the packaging and other information

What Pentasa contains
The active substance is mesalazine. One sachet of prolonged-release granules contains 2 g of mesalazine.
Other components: ethylcellulose, povidone.

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 colour.
Pack: 60 sachets containing prolonged-release granules, placed in a cardboard box.

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

Manufacturer
Ferring GmbH
Wittland 11
D-24109 Kiel
Germany

For further information, please contact the Marketing Authorisation 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