Carafate

Pays: Nouvelle-Zélande

Langue: anglais

Source: Medsafe (Medicines Safety Authority)

Ingrédients actifs:

Sucralfate 1 g equivalent to to 190 mg aluminium;  

Disponible depuis:

Viatris Limited

DCI (Dénomination commune internationale):

Sucralfate 1 g (Equiv. to 190 mg aluminium)

Dosage:

1 g

forme pharmaceutique:

Tablet

Composition:

Active: Sucralfate 1 g equivalent to to 190 mg aluminium   Excipient: Carmellose sodium Macrogol 1500 Magnesium stearate Microcrystalline cellulose Water

Unités en paquet:

Bottle, plastic, HDPE, 1x120, 120 tablets

classe:

General sale

Type d'ordonnance:

General sale

Fabriqué par:

Fuji Chemical Industries Co. Ltd.

indications thérapeutiques:

Treatment of acute, non-malignant gastric ulcer and duodenal ulcer. Maintenance therapy to prevent the recurrence of duodenal ulcers.

Descriptif du produit:

Package - Contents - Shelf Life: Bottle, plastic, HDPE, 1x120 - 120 tablets - 24 months from date of manufacture stored at or below 30°C

Date de l'autorisation:

1983-04-28

Notice patient

Page 1 of 3
NEW ZEALAND CONSUMER MEDICINE INFORMATION
CARAFATE
_SUCRALFATE, TABLET 1G _
WHAT IS IN THIS LEAFLET
Please read this leaflet carefully
before you start taking CARAFATE.
This leaflet answers some common
questions about CARAFATE.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor or pharmacist
has weighed the risks of you taking
CARAFATE. against the benefits
they expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE
MEDICINE. You may need to read it
again.
WHAT CARAFATE IS
TAKEN FOR
CARAFATE is taken to treat and
prevent duodenal and gastric
ulcers_._
CARAFATE contains the active
ingredient sucralfate. It belongs to a
group of medicines used to treat
ulcers and gastro-oesophageal
reflux disease.
It works in the stomach by
producing a substance that sticks to
the ulcer site that protects it from
the damaging action of enzymes
and stomach acid which can cause
ulcers
CARAFATE is not an antacid.
Your doctor or pharmacist may
have recommended this medicine
for another reason.
ASK YOUR DOCTOR OR PHARMACISTS IF
YOU HAVE ANY QUESTIONS ABOUT
WHY THIS MEDICINE HAS BEEN
RECOMMENDED FOR YOU.
This medicine is available from your
pharmacy without a prescription.
This medicine is not addictive.
BEFORE YOU TAKE
CARAFATE
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE CARAFATE IF YOU
HAVE AN ALLERGY TO:

any medicine containing
sucralfate

any of the ingredients listed
at the end of this leaflet.
Some of the symptoms of an
allergic reaction may include:
shortness of breath; wheezing or
difficulty breathing; swelling of the
face, lips, tongue or other parts of
the body; rash, itching or hives on
the skin.
DO NOT GIVE THIS MEDICINE TO A
CHILD UNDER THE AGE OF 18 YEARS.
Safety and effectiveness in children
younger than 18 years have not
been established.
DO NOT TAKE THIS MEDICINE IF YOU

are on dialysis

have a bleed

Résumé des caractéristiques du produit

Page 1 of 5
NEW ZEALAND DATA SHEET
CARAFATE
1. PRODUCT NAME
Carafate, 1 g, tablet.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 1 g sucralfate
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Carafate is a white, uncoated capsule-shaped tablet. One side is
plain, the other embossed with the
word ‘CARAFATE’.
Dimensions: 20 mm x 9 mm x 7mm
4. CLINICAL PARTICULARS
_4.1 _
_THERAPEUTIC INDICATIONS_
Treatment of acute, non-malignant gastric ulcer and duodenal ulcer.
Maintenance therapy to prevent the recurrence of duodenal ulcers.
_4.2_
_DOSE AND METHOD OF ADMINISTRATION_
ACUTE ULCEROUS CONDITIONS
The recommended adult dose of Carafate for duodenal ulcer and gastric
ulcer is 1 g tablet three
times a day, one hour before meals and one 1 g tablet at bedtime or
two 1 g tablets twice daily taken
before breakfast and at bedtime (for up to 8 weeks).
For relief of pain, antacids may be added to the treatment. However,
they should not be taken within
two hours before or after sucralfate intake.
In duodenal ulcer, while healing with sucralfate often occurs within
two to four weeks, treatment
should be continued for up to 8 weeks unless healing has been
demonstrated by x-ray and/or
endoscopic examination. In the case of gastric ulcers an alternative
treatment should be considered
if no objective improvement is observed following 6 weeks of
sucralfate therapy. Large gastric ulcers
that show a progressive healing tendency may require the full 8 weeks
of therapy.
MAINTENANCE TREATMENT
To reduce the risk of recurrence of duodenal ulcers, the recommended
dose is one 1 g tablet before
breakfast and one at bedtime (for up to 12 months). When necessary for
relief of pain, antacids may
be added to the treatment. However, they should not be taken within
two hours before or after taking
sucralfate.
Page 2 of 5
_4.3_
_CONTRAINDICATIONS_
Carafate is contraindicated in patients on dialysis as long term
administration may cause symptoms
such as aluminium encephalopathy, aluminium osteomalacia and