Salofalk 250mg Gastro-Resistant Tablets

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:

Gastro-resistant tablet

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Aminosalicylic acid and similar agents; mesalazine

Authorization status:

Marketed

Authorization date:

1989-10-11

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
SALOFALK
® 250MG GASTRO-RESISTANT TABLETS
Mesalzine (5-aminosalicylic acid)
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.
- 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 tablets are and what they are used for
2. What you need to know before you take Salofalk 250mg tablets
3. How to take Salofalk 250mg tablets
4. Possible side effects
5. How to store Salofalk 250mg tablets
6. Contents of the pack and other information
1. WHAT SALOFALK 250MG TABLETS ARE AND WHAT THEY ARE USED FOR
Salofalk 250mg tablets contain the active substance mesalazine, an
anti-inflammatory agent used to
treat inflammatory bowel disease.
Salofalk 250mg tablets are used for the management of ulcerative
colitis and treatment of Crohn’s
disease.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE SALOFALK 250MG TABLETS
DO NOT TAKE SALOFALK 250MG TABLETS:
– If you are allergic to mesalazine, salicylic acid, salicylates
such as acetylsalicylic acid (e.g., aspirin)
or any of the other ingredients of this medicine (listed in section
6).
– If you have a serious liver or kidney disease.
WARNINGS AND PRECAUTIONS
TALK TO YOUR DOCTOR OR PHARMACIST BEFORE YOU START TAKING SALOFALK
250MG TABLETS:
− 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 your
KIDNEY
.
– If you have ever developed a severe skin rash or skin pee

Summary of Product characteristics

Health Products Regulatory Authority
14 February 2024
CRN00DLPP
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Salofalk 250mg Gastro-Resistant Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 250 mg of mesalazine.
Excipient: Each tablet contains 48mg sodium.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Gastro-resistant tablet
Round, biconvex, yellow tablets.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
As an anti-inflammatory in the management of ulcerative colitis, and
in the treatment of Crohn’s disease.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
_Adults_and_ elderly:_
When symptoms of acute inflammation are present, 2 Salofalk 250mg
tablets should be taken. with ample fluid in the morning,
afternoon and evening after meals, unless otherwise prescribed. In
severe cases of the diseases the dosage may be doubled.
As maintenance therapy to prevent recurrence, 2 tablets should be
taken in the morning, afternoon and evening.
Paediatric population: 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
30-50mg/kg/day in divided doses. Maximum dose: 75mg/kg/day.
The total dose should not exceed the maximum dose for adults.
MAINTENANCE TREATMENT: To be determined individually, starting with
15-30mg/kg/day in divided doses. The total dose should
not exceed the recommended dose for adults.
It is generally recommended that half the adult dose may be given to
children up to a body weight of 40kg and the normal
adult dose to those above 40kg.
_Duration of treatment_
The treatment of acute episodes of ulcerative colitis usually lasts 8
weeks. The duration of use is determined by the physician.
Method of administration
Salofalk 250mg tablets are for oral administration.
Take after meals with ample fluid.
4.3 CONTRAINDICATIONS
Salofalk is contraindicated in cases of:
Hypersensitivity to the active substance,