PEPTAZOL 40 TABLET

Nazione: Sudafrica

Lingua: inglese

Fonte: South African Health Products Regulatory Authority (SAHPRA)

Commercializzato da:

Pharmacorp (Pty) Ltd

Dosaggio:

See ingredients

Forma farmaceutica:

TABLET

Composizione:

EACH TABLET CONTAINS PANTOPRAZOLE 40,0 mg

Stato dell'autorizzazione:

Registered

Data dell'autorizzazione:

2014-03-08

Foglio illustrativo

PEPTAZOL 40 (TABLETS)
Approved Patient Information Leaflet
Page 1 of 10
SCHEDULING STATUS
S4
PEPTAZOL 40, 40 MG, ENTERIC COATED TABLETS
PANTOPRAZOLE (AS SODIUM SESQUIHYDRATE)
SUGAR FREE
READ ALL OF THIS LEAFLET CAREFULLY BEFORE STARTING PEPTAZOL 40.
•
Keep this leaflet. You may need to read it again.
•
If you have further questions, please ask your doctor, pharmacist,
nurse, or other healthcare
provider.
•
PEPTAZOL 40 has been prescribed for you personally and you should not
share your
medicine with other people. It may harm them, even if their symptoms
are the same as yours.
WHAT IS IN THIS LEAFLET
1
What PEPTAZOL 40 is and what it is used for
2. What you need to know before you take PEPTAZOL 40
3. How to take PEPTAZOL 40
4. Possible side effects
5. How to store PEPTAZOL 40
6. Contents of the pack and other information
1. WHAT PEPTAZOL 40 IS AND WHAT IT IS USED FOR
PEPTAZOL 40 contains pantoprazole. Pantoprazole belongs to a class of
medicine called proton
pump inhibitors, which reduces stomach acid production.
PEPTAZOL 20, available in a different formulation, is used for the
symptomatic improvement
PEPTAZOL 40 (TABLETS)
Approved Patient Information Leaflet
Page 2 of 10
(e.g., heartburn, acid regurgitation, pain on swallowing) and healing
of mild gastro-oesophageal
reflux disease i.e., a disease which causes mucosal damage and
inflammation of the food pipe
due to stomach acid being pushed back up into the food pipe (reflux).
For long-term management and prevention of relapse in
gastro-oesophageal reflux disease.
If you are on chronic treatment with anti-inflammatories and you are
at an increased risk of
developing gastro-intestinal complications, your doctor will prescribe
PEPTAZOL 20 (available in
a different formulation, as PEPTAZOL 40 cannot be divided) to prevent
stomach and duodenal
ulcers which are caused when using these medicines.
PEPTAZOL 40 is used to treat acid reflux (a type of heartburn) and
ulcers in the stomach (gastric
ulcer) or in the upper part of the intestine (duodenal ulcer).
PEPTAZOL

Scheda tecnica

PEPTAZOL 40 (TABLETS)
Approved Professional Information Leaflet
Page 1 of 17
SCHEDULING STATUS
S4
1. NAME OF THE MEDICINE
PEPTAZOL 40, 40 mg, Enteric coated tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
PEPTAZOL 40: Each enteric coated tablet contains 45,1 mg pantoprazole
sodium sesquihydrate
equivalent to 40 mg pantoprazole.
Sugar free.
Contains colouring agent as tartrazine yellow.
Each tablet contains 3,86 mg sodium.
For full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Enteric coated tablets (Tablets)
PEPTAZOL 40: Round, biconvex, with both sides smooth, yellow enteric
coated tablets.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
PEPTAZOL 20 mg, which is available as a different formulation, is
indicated for the symptomatic
improvement (e.g., heartburn, acid regurgitation, pain on swallowing)
and healing of mild gastro-
oesophageal reflux disease (GERD).
•
for long-term management and prevention of relapse in
gastro-oesophageal reflux disease
(GERD).
•
for the prevention of gastroduodenal lesions and dyspeptic symptoms
induced by non-selective
non-steroidal
anti-inflammatory
drugs (NSAID’s)
in
patients
at
risk
and
with
a
need for
Page 2 of 17
continuous NSAID treatment.
PEPTAZOL 40 is indicated for short-term treatment of duodenal ulcer,
gastric ulcer and reflux
oesophagitis. If the duodenal ulcer has been demonstrated to be
associated with Helicobacter
pylori infection, PEPTAZOL 40 used in combination with appropriate
antibiotics may be useful.
PEPTAZOL 40 is indicated for the treatment of Zollinger-Ellison
syndrome.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
_Mild gastro-oesophageal reflux disease (GERD) _
The recommended oral dosage is one PEPTAZOL 20 tablet per day. A
4-week period is usually
required for healing of mild GERD.
If symptom control has not been achieved after four weeks of treatment
with the prescribed daily
dose, further investigation is recommended.
In patients with healed reflux disease, recurring symptoms can be
controlled using an on-demand
regim