Pentasa 10 mg/ml Rectal Suspension

Nchi: Ayalandi

Lugha: Kiingereza

Chanzo: HPRA (Health Products Regulatory Authority)

Viambatanisho vya kazi:

Mesalazine

Inapatikana kutoka:

Ferring Ireland Ltd

ATC kanuni:

A07EC; A07EC02

INN (Jina la Kimataifa):

Mesalazine

Kipimo:

10 milligram(s)/millilitre

Dawa fomu:

Rectal suspension

Dawa ya aina:

Product subject to prescription which may be renewed (B)

Eneo la matibabu:

Aminosalicylic acid and similar agents; mesalazine

Idhini hali ya:

Marketed

Idhini ya tarehe:

1989-02-02

Taarifa za kipeperushi

PACKAGE LEAFLET: INFORMATION FOR THE USER
PENTASA
® 10 MG/ML RECTAL SUSPENSION
Mesalazine
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
- Keep this leaflet. You may need to read it again.
- If you have further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them
even if their signs of illness are the same as yours.
- If you get any side effects talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4
WHAT IS IN THIS LEAFLET:
1. What PENTASA Rectal Suspension is and what it is used for
2. What you need to know before you use PENTASA Rectal Suspension
3. How to use PENTASA Rectal Suspension
4. Possible side effects
5. How to store PENTASA Rectal Suspension
6. Contents of the pack and other information
1. WHAT PENTASA RECTAL SUSPENSION IS AND WHAT IT IS USED FOR
The name of this medicine is PENTASA 10 mg/ml Rectal Suspension.
PENTASA Rectal
Suspension contains mesalazine 1 g as the active ingredient in 100 mls
of liquid. Mesalazine
belongs to a group of medicines called salicylates.
PENTASA Rectal Suspension is used to treat ulcerative colitis
affecting the last part of the colon
and rectum (back passage).
PENTASA Rectal Suspension acts locally to reduce the inflammation and
help relieve or stop the
pain.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE PENTASA RECTAL SUSPENSION
DO NOT USE PENTASA RECTAL SUSPENSION:
- if you are ALLERGIC (HYPERSENSITIVE) to MESALAZINE or any of the
other ingredients of this
medicine (listed in Section 6)
- if you are ALLERGIC to any other salicylates, e.g. aspirin
- if you have SEVERE LIVER AND/OR KIDNEY problems
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking PENTASA Rectal
Suspension.
You should consult your doctor before using this medicine:
- if you experience any unexplained bleeding, bruising, skin rashes,
fever or sore throat while
using thi

Tabia za bidhaa

Health Products Regulatory Authority
02 June 2023
CRN00DDL5
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Pentasa 10 mg/ml Rectal Suspension
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each bottle of rectal suspension contains mesalazine 1g in 100ml.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Rectal suspension
White to slightly yellow suspension
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Pentasa Rectal Suspension is indicated in the management of active
ulcerative colitis.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Adults:
The recommended dosage is 1 g mesalazine (100 ml Rectal Suspension) at
bedtime.
Paediatric population:
There is little experience and only limited documentation for an
effect in children.
4.3 CONTRAINDICATIONS
Hypersensitivity to mesalazine, any of the excipients listed in
section 6.1, or salicylates.
Severe liver and
/
or renal impairment.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Most patients who are intolerant or hypersensitive to sulphasalazine
are able to take Pentasa without risk of similar reactions.
However, caution is recommended when treating patients allergic to
sulphasalazine (risk of allergy to salicylates). In case of
acute intolerance reactions such as abdominal cramps, acute abdominal
pain, fever, severe headache and rash, therapy should
be discontinued immediately.
Caution is recommended in patients with impaired liver function. Liver
function parameters like ALT or AST should be assessed
prior to and during treatment, at the discretion of the treating
physician.
The drug is not recommended for use in patients with renal impairment.
The renal function should be monitored regularly (e.g.
serum creatinine), especially during the initial phase of treatment.
Urinary status (dip sticks) should be determined prior to and
during treatment at the discretion of the treating physician.
Mesalazine-induced nephrotoxicity should be suspected in patients
developing renal dysfunction during treatment. The concurrent use o