Pentasa 1g Suppositories

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Mesalazine

Available from:

Ferring Ireland Ltd

ATC code:

A07EC; A07EC02

INN (International Name):

Mesalazine

Dosage:

1 gram(s)

Pharmaceutical form:

Suppository

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Aminosalicylic acid and similar agents; mesalazine

Authorization status:

Marketed

Authorization date:

1992-12-21

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
PENTASA
®
1 G SUPPOSITORIES
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 Suppositories are and what they are used for
2. What you need to know before you use PENTASA Suppositories
3. How to use PENTASA Suppositories
4. Possible side effects
5. How to store PENTASA Suppositories
6. Contents of the pack and other information
1. WHAT PENTASA SUPPOSITORIES ARE AND WHAT THEY ARE USED FOR
The name of this medicine is PENTASA 1g Suppositories. Each
suppository contains mesalazine
1g as the active ingredient. Mesalazine belongs to a group of
medicines called salicylates.
PENTASA is used to treat inflammation in the gut caused by conditions
such as ulcerative colitis.
Sometimes ulcerative colitis only affects the back passage (rectum),
this is known as ulcerative
proctitis. PENTASA Suppositories are used to treat ulcerative
proctitis and are intended for rectal
use only.
The suppositories release the active ingredient slowly which then acts
locally to reduce the
inflammation and help relieve or stop the pain.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE PENTASA SUPPOSITORIES
DO NOT USE PENTASA SUPPOSITORIES:
•
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 other salicyclates e.g. aspirin
•
if you have SEVERE LIVER OR KIDNEY problems
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking PENTASA Suppositories.
You should consult

Summary of Product characteristics

Health Products Regulatory Authority
02 June 2023
CRN00DDL5
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Pentasa 1g Suppositories
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each suppository contains mesalazine 1g.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Suppository
White to tan, spotted, oblong suppository.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the treatment of ulcerative proctitis.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Adults:
_Active treatment:_
1 g mesalazine twice daily for two to four weeks.
_Maintenance treatment: _
1-2 g mesalazine daily.
Paediatric population:
There is little experience with 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 of
other known nephrotoxic agents should