Pentasa
Poland
Table of Contents
Package leaflet: Information for the patient
PENTASA, 1 g, prolonged-release tablets
Mesalazinum
Please read the entire leaflet carefully before using the medicine, as it contains
important information for the patient.
- Keep this leaflet, so you can read it again if necessary.
- If you have any doubts, please consult your doctor.
- This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm someone else, even if their symptoms are identical.
- If you experience any adverse reactions, including any adverse reactions not listed in this leaflet, inform your doctor. See section 4.
Table of contents of the leaflet:
- What Pentasa is and what it is used for
- Important information before taking Pentasa
- How to take Pentasa
- Possible side effects
- How to store Pentasa
- Contents of the package 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 values.
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, YOU SHOULD 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
if the patient is allergic to mesalazine or to 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 disease of the stomach or duodenum,
if the patient has a bleeding disorder.
Warnings and precautions
Before starting treatment with Pentasa, discuss this with your doctor.
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, adequate fluid intake should be maintained.
Severe skin reactions have occurred 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 severe skin reactions listed in section 4 occur, mesalazine must be discontinued immediately and medical help must be sought.
Rarely, mesalazine-induced cardiac hypersensitivity reactions (myocarditis and pericarditis) have been reported.
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 should be stopped immediately and the patient should contact their doctor.
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
You should tell 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 particularly includes medicines such as:
sulfasalazine, azathioprine, 6-mercaptopurine, thioguanine, or warfarin.
Pregnancy, breastfeeding, and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor before using this medicine.
Mesalazine crosses the placenta.
Mesalazine is excreted in breast milk.
Driving and using machines
No effects of Pentasa on the ability to drive or operate machinery have been observed.
3. How to use Pentasa
This medicine should always be used exactly as prescribed by the doctor. In case of doubt, consult your doctor.
Recommended dosage:
Ulcerative colitis, treatment of active disease phase:
Adults: The doctor determines the dosage individually, up to 4 g daily as a single dose or in divided doses.
Children aged 6 years and older: The doctor 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. 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 doctor determines the dosage individually; usually 15 to 30 mg/kg body weight per day in divided doses. 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 doctor determines the dosage individually, up to 4 g per day in divided doses.
Children aged 6 years and older: The doctor 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. 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 doctor determines the dosage individually, up to 4 g per day in divided doses.
Children aged 6 years and older: The doctor determines the dosage individually; usually 15 to 30 mg/kg body weight per day in divided doses. Total daily 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 necessary in elderly patients.
This medicine is for oral use.
Do not chew or crush the tablets.
To make swallowing easier, the tablet may be 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.
If you forget to take Pentasa
Do not take a double dose to make up for a missed dose.
4. Possible adverse reactions
Like any medicine, this medicine can cause adverse reactions, although not everyone will experience 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 round spots on the trunk, often with blisters in the center, 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.
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)
Immediate medical attention should be sought:
- 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 frequently (may occur in 1 to 10 out of 100 patients treated):
- diarrhoea
- nausea
- abdominal pain
- headache
- vomiting
- bloating
- rash
- urticaria
The following adverse reactions occur rarely (may occur in 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 occur in less 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 of disease symptoms caused by excessive loss of protein in urine, renal failure), urine discoloration
- 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 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 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 may also be reported to the marketing authorization holder.
Reporting adverse reactions contributes to further information on the safety of the medicine.
- How to store Pentasa
Keep the medicine out of sight and reach of children.
Store in the original packaging to protect from light.
Do not store above 25 °C.
Do not use this medicine after the expiry date stated on the packaging after the EXP label.
The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via the sewage system or household waste. Ask a pharmacist how to dispose of medicines no longer in use. Such measures help protect the environment.
6. Contents of the pack and other information
What Pentasa contains
The active substance is mesalazine.
Each prolonged-release tablet contains 1 g of mesalazine.
The other ingredients are: 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, oval-shaped, with the imprint "PENTASA" embossed on both sides.
The pack contains 60 tablets in aluminum foil blisters, 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.
Szamocka Street 8
01-748 Warsaw
Poland
Tel.: +48 22 246 06 80, Fax: +48 22 246 06 81