PANTOPRAZOLE Tablets 20 mg

País: Tanzània

Idioma: anglès

Font: Tanzania Medicinces & Medical Devices Authority

ingredients actius:

Pantoprazole Sodium Sesquihydrate

Disponible des:

BEXIMCO PHARMACEUTICALS LTD., Bangladesh

Codi ATC:

Drugs for peptic ulcer and gastro-oesophageal refl

Designació comuna internacional (DCI):

Pantoprazole Sodium Sesquihydrate

Dosis:

20 mg

formulario farmacéutico:

Tablets

Fabricat per:

Beximco Pharmaceuticals Ltd, BANGLADESH

Resumen del producto:

Physical description: Yellow colored, oval, biconvex enteric coated tablets plain on both the sides; Local technical representative: Abacus Pharma Africa Limited (8473)

Estat d'Autorització:

Registered/Compliant

Data d'autorització:

2022-05-04

Fitxa tècnica

SUMMARY OF PRODUCT CHARACTERISTIC (SMPC)
PANTOPRAZOLE 20MG DELAYED RELEASE TABLETS
1. NAME OF THE MEDICINAL PRODUCT
Pantoprazole 20 mg delayed release tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 20 mg of pantoprazole (as sodium sesquihydrate).
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Delayed-Release Tablet.
Yellow coloured, oval, biconvex enteric coated tablets plain on both
the sides.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Pantoprazole is indicated for use in adults and adolescents 12 years
of age and above for:
• Symptomatic gastro-oesophageal reflux disease.
• Long-term management and prevention of relapse in reflux
oesophagitis.
Pantoprazole is indicated for use in adults for:
• Prevention of gastroduodenal ulcers induced by non-selective
non-steroidal anti-inflammatory
drugs (NSAIDs) in patients at risk with a need for continuous NSAID
treatment (see section 4.4).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults and adolescents 12 years of age and above_
Symptomatic gastro-oesophageal reflux disease
The recommended oral dose is one Pantoprazole 20 mg tablet per day.
Symptom relief is
generally accomplished within 2-4 weeks. If this is not sufficient,
symptom relief will normally be
achieved within a further 4 weeks. When symptom relief has been
achieved, reoccurring
symptoms can be controlled using an on-demand regimen of 20 mg once
daily, taking one tablet
when required. A switch to continuous therapy may be considered in
case satisfactory symptom
control cannot be maintained with on-demand treatment.
Long-term management and prevention of relapse in reflux oesophagitis
For long-term management, a maintenance dose of one Pantoprazole 20 mg
tablet per day is
recommended, increasing to 40 mg pantoprazole per day if a relapse
occurs. Pantoprazole 40
mg tablet is available for this case. After healing of the relapse the
dose can be reduced again
to Pantoprazole 20 mg tablet.
_Adults_
Prevention of gastroduodenal ulcers ind