Salofalk 250 mg Suppositories

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Mesalazine

Available from:

Dr. Falk Pharma GmbH

ATC code:

A07EC; A07EC02

INN (International Name):

Mesalazine

Dosage:

250 milligram(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:

1989-02-08

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
SALOFALK
® 250MG SUPPOSITORIES
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.
- 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 250mg Suppositories are and what they are used for
2. What you need to know before you use Salofalk 250mg Suppositories
3. How to use Salofalk 250mg Suppositories
4. Possible side effects
5. How to store Salofalk 250mg Suppositories
6. Contents of the pack and other information
1. WHAT SALOFALK 250MG SUPPOSITORIES ARE AND WHAT THEY ARE USED FOR
Salofalk 250mg Suppositories contain the active substance mesalazine,
an anti-inflammatory
agent used to treat inflammatory bowel disease.
Salofalk 250mg Suppositories 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 250MG SUPPOSITORIES
DO NOT USE SALOFALK 250MG SUPPOSITORIES:
– 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 250mg Suppositories (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 250MG
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
rel

Summary of Product characteristics

Health Products Regulatory Authority
14 February 2024
CRN00DLPP
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Salofalk 250 mg Suppositories
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each suppository contains 250 mg of mesalazine.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Suppository
White to creamy coloured suppository.
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, for acute inflammatory symptoms, 2
Salofalk 250 Suppositories are to be introduced rectally
morning, noon and evening. In severe cases of the disease, the dosage
may be doubled. For long-term treatment and
prevention of recurrences, one suppository to be introduced rectally
morning, noon and evening.
Treatment with Salofalk 250 Suppositories, whether during an acute
inflammatory stage or in long-term treatment of patients,
must be faithfully and strictly adhered to, as this is essential if
the desired therapeutic success is to be obtained.
_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 suppositories are for rectal administration.
4.3 CONTRAINDICATIONS
Salofalk is contraindicated in cases of:
Hypersensitivity to the active substance to salicylates or 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 t