Pentasa Sachet 1g prolonged-release granules

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:

Prolonged-release granules

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Aminosalicylic acid and similar agents; mesalazine

Authorization status:

Marketed

Authorization date:

1998-11-27

Patient Information leaflet

1
For Internal Use - Internal
PACKAGE LEAFLET: INFORMATION FOR THE USER
PENTASA
® SACHET 1G PROLONGED RELEASE GRANULES
PENTASA
® SACHET 2G PROLONGED RELEASE GRANULES
PENTASA
® SACHET 4G PROLONGED RELEASE GRANULES
Mesalazine
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you. Do not pass it on to
others. It may harm them, even if their
symptoms are the same as yours.
-
If you get any side effect, 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 Sachet is and what it is used for
2.
What you need to know before you take Pentasa Sachet
3.
How to take Pentasa Sachet
4.
Possible side effects
5.
How to store Pentasa Sachet
6.
Contents of the pack and other information
1.
WHAT PENTASA SACHET IS AND WHAT IT IS USED FOR
PENTASA
SACHET IS USED FOR THE TREATMENT OF MILD TO MODERATE ATTACKS OF
ULCERATIVE COLITIS AND TO HELP
MAINTAIN FREEDOM FROM FURTHER ATTACKS.
Ulcerative colitis is an inflammatory bowel disease in which the
lining of the intestine becomes inflamed and
develops many tiny breaks in its surface (ulcers) which may bleed.
Pentasa Sachet contains granules that slowly release the active
ingredient (mesalazine).
This helps reduce
the inflammation and the painful symptoms.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE PENTASA SACHET
DO NOT TAKE PENTASA SACHET
-
if you are
ALLERGIC (HYPERSENSITIVE)
to
MESALAZINE
or any of the other ingredients of this medicine (see
Section 6)
-
if you are
ALLERGIC
to other
SALICYLATES E.G. ACETYLSALICYLIC ACID
-
if you have severe
LIVER
and/or
KIDNEY
problems
WARNINGS AND PRECAUTIONS
TALK TO YOUR DOCTOR OR PHARMACIST BEFORE TAKING PENTASA SACHET:
-
if you are allergic to
SULPHASALAZINE
(risk of allergy to salicylates)
-
if you currently have or

Summary of Product characteristics

Health Products Regulatory Authority
14 December 2023
CRN00DDCW
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Pentasa Sachet 1g prolonged-release granules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each sachet contains mesalazine 1 g.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Prolonged release granules
White-grey to pale white-brown granules.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Mild to moderate ulcerative colitis.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Ulcerative colitis
_ _
ADULTS
_Active disease_
Individual dosage, up to 4 g mesalazine once daily or divided into 2-4
doses.
_ _
_Maintenance treatment_
Individual dosage. Recommended dosage, 2 g mesalazine once daily.
PAEDIATRIC POPULATION:
The safety and efficacy in children below 6 years of age have not been
established.
There is only limited documentation for an effect in children (age
6-18 years).
Children 6 years of age and older:
_Active disease:_ To be determined individually, starting with 30-50
mg/kg/day in divided doses. Maximum dose: 75 mg/kg/day
in divided doses. The total dose should not exceed 4 g/day (maximum
adult dose).
_Maintenance treatment:_ To be determined individually, starting with
15-30 mg/kg/day in divided doses. The total dose should
not exceed 2 g/day (recommended adult dose).
It is generally recommended that half the adult dose may be given to
children up to a body weight of 40 kg; and the normal
adult dose to those above 40 kg.
Method of administration
Oral use
_The granules must not be chewed._
_The contents of the sachet should be emptied onto the tongue and
washed down with some water or orange juice. Alternatively _
_the entire content of the sachet can be taken with yogurt and
consumed immediately._
Health Products Regulatory Authority
14 December 2023
CRN00DDCW
Page 2 of 7
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 WARNING