Salofalk 1g suppositories

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Mesalazine

Available from:

Dr. Falk Pharma UK Ltd

ATC code:

A07EC02

INN (International Name):

Mesalazine

Dosage:

1gram

Pharmaceutical form:

Suppository

Administration route:

Rectal

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 01050100; GTIN: 5060096430384

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
SALOFALK
® 1G 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 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 1g Suppositories are and what they are used for
2. What you need to know before you use Salofalk 1g Suppositories
3. How to use Salofalk 1g Suppositories
4. Possible side effects
5. How to store Salofalk 1g Suppositories
6. Contents of the pack and other information
1. WHAT SALOFALK 1G SUPPOSITORIES ARE AND WHAT THEY ARE USED FOR
Salofalk 1g Suppositories contain the active substance mesalazine, an
anti-
inflammatory agent used to treat inflammatory bowel disease.
Salofalk 1g Suppositories are used for:
– the treatment of mild to moderate acute episodes of an
inflammatory
disease limited to the rectum (back passage) known by doctors as
ulcerative colitis or ulcerative proctitis.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE SALOFALK 1G SUPPOSITORIES
DO NOT USE SALOFALK 1G SUPPOSITORIES
– If you are allergic to salicylic acid, to salicylates such as
acetylsalicylic acid
(aspirin) or to the other ingredient of this medicine (listed in
section 6).
– If you have a serious liver or kidney disease.
WARNINGS AND PRECAUTIONS
TALK TO YOUR DOCTOR BEFORE USING SALOFALK 1G SUPPOSITORIES
– 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 your LIVER.
– If you suffer with problems of you

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Salofalk 1g Suppositories
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each suppository contains 1 g mesalazine.
For the full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
Suppositories
Appearance: light beige coloured, torpedo-shaped suppositories
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of acute mild to moderate ulcerative colitis that is limited
to the rectum
(ulcerative proctitis).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Adults and older people:
One Salofalk 1g Suppository once daily (equivalent to 1g mesalazine
daily) inserted
into the rectum.
Paediatric population
There is little experience and only limited documentation for an
effect in children.
Method of administration:
For rectal administration only.
Salofalk 1g Suppositories should be administered preferably at
bedtime.
Treatment
with
Salofalk
1g
Suppositories
must
be
administered
regularly
and
consistently, because only in this way can healing be successfully
achieved.
Duration of treatment
The duration of use is determined by the physician.
4.3
CONTRAINDICATIONS
Salofalk 1g Suppositories_ _are contraindicated in patients with:
-
known hypersensitivity to salicylates or to the excipient 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 the findings are normal, follow-up tests should be carried out
every 3
months. If additional symptoms occur, these tests should be performed
immediately.
Caution is recommended in patients with impaired hepatic function.
Salofalk 1g Suppositories should not be used in patie