RAFASSAL 1 GRAM SUPPOSITORIES

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

MESALAZINE

Available from:

RAFA LABORATORIES LTD

ATC code:

A07EC02

Pharmaceutical form:

SUPPOSITORIES

Composition:

MESALAZINE 1000 MG

Administration route:

RECTAL

Prescription type:

Required

Manufactured by:

RAFA LABORATORIES LTD, JERUSALEM

Therapeutic group:

MESALAZINE

Therapeutic area:

MESALAZINE

Therapeutic indications:

Treatment and prevention of ulcerative colitis and Crohn's disease.

Authorization date:

2020-11-30

Patient Information leaflet

Page1 of 6
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE
1986
-
PHARMACISTS’ REGULATIONS (PREPARATIONS)
The medicine is dispensed with a doctor’s prescription only
Rafassal® 500 mg Suppositories
Rafassal® 1 gram Suppositories
Active ingredient:
Each Rafassal 500 mg suppository contains: mesalazine 500 mg.
Each Rafassal 1 gram suppository contains: mesalazine 1 gram.
The active ingredient is also called mesalamine or 5-aminosalicylic
acid.
For the list of the additional ingredients, see section 6.
Read the entire leaflet carefully before using the medicine.
This leaflet contains concise information about the medicine. If you
have any further
questions, please refer to the doctor or pharmacist.
This medicine has been prescribed to treat your illness. Do not pass
it on to others. It
may harm them, even if it seems to you that their illness is similar
to yours.
1. What is the medicine intended for?
The medicine is intended for treatment and prevention of ulcerative
colitis
(ulcerative inflammation of the large intestine) and Crohn's disease.
Therapeutic group: anti-inflammatory medicine from the salicylate
group.
2. Before using the medicine
Do not use the medicine if:
•
You are sensitive (allergic) to the active ingredient, to salicylic
acid, to salicylates such
as acetylsalicylic acid (aspirin) or to any of the additional
ingredients the medicine
contains (for the list of the additional ingredients, see section 6).
•
You suffer from severe impairment of liver or kidney function.
Special warnings regarding the use of the medicine:
Before (and during) treatment with the medicine, tell your doctor if:
•
You suffer or have suffered in the past from lung problems,
particularly if you suffer
from asthma (bronchial).
•
You suffer or have suffered in the past from allergy to a substance
named
sulphasalazine, which is a substance related to the active ingredient
mesalazine. In
such a case, close medical supervision will be required. (If acute
symptoms of
intolerance appear, for instance: abdominal pain or cram

Summary of Product characteristics

Rafassal Caplets-DL-July 2023-04
1.
NAME OF THE MEDICINAL PRODUCT
RAFASSAL
®
500 MG CAPLETS
RAFASSAL
®
1 GRAM CAPLETS
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Rafassal 500mg Caplets: Each gastro-resistant caplet contains 500mg
mesalazine (5 -
Aminosalicylic acid).
Rafassal 1 gram Caplets: Each gastro-resistant caplet contains 1000mg
mesalazine (5 - Aminosalicylic
acid).For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Gastro-resistant caplets
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment and prevention of ulcerative colitis and Crohn's disease.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology (oral and rectal)
During the acute inflammatory stage and in long-term maintenance
therapy, Rafassal must be taken reliably
and consistently by the patient. This is essential in order to attain
the desired therapeutic success.
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_Rafassal Caplets _
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For acute inflammatory symptoms:
Individual dosage up to 4 gram/day, divided into 2 or 3 doses.
Rafassal Caplets should be taken with an ample amount of fluid
1 hour before meals.
As soon as remission occurs, the dose should be reduced (to 2 g
divided into 2 or 3 doses, to avoid
recurrence.
Children_ _
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. The total dose should not exceed the maximum adult
dose (4 grams).
MAINTENANCE TREATMENT (ULCERATIVE COLITIS): To be determined
individually, starting with
15-30 mg/kg/day in divided doses. The total dose should not exceed the
recommended adult dose (2
grams).
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.
_Rafassal Suppositories _
For acute inflammatory symptoms: 1 suppository of 500 mg 3 times
daily. The suppositories should be
inserted deeply.
As soon as rem