Salofalk 4g/60ml Enema

Land: Ierland

Taal: Engels

Bron: HPRA (Health Products Regulatory Authority)

Werkstoffen:

Mesalazine

Beschikbaar vanaf:

Dr. Falk Pharma GmbH

ATC-code:

A07EC; A07EC02

INN (Algemene Internationale Benaming):

Mesalazine

Dosering:

4g/60 millilitre(s)

farmaceutische vorm:

Rectal suspension

Prescription-type:

Product subject to prescription which may be renewed (B)

Therapeutisch gebied:

Aminosalicylic acid and similar agents; mesalazine

Autorisatie-status:

Marketed

Autorisatie datum:

1989-02-08

Bijsluiter

PACKAGE LEAFLET: INFORMATION FOR THE USER
SALOFALK
® 4G/60ML ENEMA
Mesalazine (5-aminosalicylic acid)
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 any 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 Salofalk 4g/60ml Enema is and what it is used for
2.
What you need to know before you use Salofalk 4g/60ml Enema
3.
How to use Salofalk 4g/60ml Enema
4.
Possible side effects
5.
How to store Salofalk 4g/60ml Enema
6.
Contents of the pack and other information
1.
WHAT SALOFALK 4G/60ML ENEMAS ARE AND WHAT THEY ARE USED FOR
Salofalk 4g/60ml Enemas contain the active substance mesalazine, an
anti-inflammatory agent used
to treat inflammatory bowel disease.
Salofalk 4g/60ml Enemas are used for the treatment of:
Inflammation of the large intestine (colon) and rectum (back passage)
known by doctors as
ulcerative
colitis. It may be used alone or, particularly in the acute phase,
with corticosteriods.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE SALOFALK 4G/60ML ENEMAS
DO NOT USE SALOFALK 4G/60ML ENEMA:
–
If you are allergic to salicylic acid, to salicylates such as
acetylsalicylic acid (e.g., aspirin) or to
any of the other ingredients of
Salofalk 4g/60ml Enemas (listed in section 6).
–
If you have a serious liver or kidney disease.
WARNINGS AND PRECAUTIONS
TALK TO YOUR DOCTOR OR PHARMACIST BEFORE USING SALOFALK 4G/60ML ENEMAS
–
If you have a history of problems with your lungs, particularly if you
suffer from
BRONCHIAL ASTHMA
.
–
If you have a
HISTORY OF ALLERGY
to
SULPHASALAZINE
, a substance related to mesalazine.
–
If you suffer with problems of yo

Productkenmerken

Health Products Regulatory Authority
14 February 2024
CRN00DLPP
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Salofalk 4g/60ml Enema
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Salofalk enema contains 4.0 g of mesalazine (5-aminosalicylic
acid) in 60.0 g of suspension (60 g = 60 ml).
Excipients with known effect:
One Salofalk 4g/60ml Enema contains 280.8 mg potassium metabisulphite
(E 224) and 60 mg sodium benzoate (E 211).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Rectal suspension (enema).
Creamy coloured rectal suspension with lubricated applicator.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
As an anti-inflammatory in the management of ulcerative colitis, alone
or, particularly in the acute phase, with corticosteroids.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults and elderly_
Unless prescribed otherwise, the contents of one enema vial (60ml
suspension) are given once per day rectally before retiring.
The best results are obtained if gut lavage is carried out prior to
the Salofalk enema.
_Paediatric population_
There is little experience and only limited documentation for an
effect in children.
_Duration of treatment_
The duration of use is determined by the physician.
Method of administration
Salofalk enemas are for rectal administration.
Shake well before use to homogenise the suspension.
4.3 CONTRAINDICATIONS
Salofalk is contraindicated in cases of:
Hypersensitivity to the active substance, salicylates or to any of the
excipients listed in section 6.1.
Severe impairment of hepatic or renal function.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Blood tests (differential blood count; liver function parameters such
as ALT or AST; serum creatinine) and urinary status (dip
sticks) should be determined prior to and during treatment, at the
discretion of the treating physician. As a guideline, follow-up
tests are recommended 14 days after commencement of treatment, then a
further two to three tests at intervals of 4 weeks.
If t