Panto-Denk 40 Tablets 40 mg

Country: Tanzania

Language: English

Source: Tanzania Medicinces & Medical Devices Authority

Active ingredient:

Pantoprazole

Available from:

Denk Pharma GmbH & Co. KG, GERMANY

ATC code:

Anti-peptic ulcerants

INN (International Name):

Pantoprazole

Dosage:

40 mg

Pharmaceutical form:

Tablets

Manufactured by:

Advance Pharma GmbH, GERMANY

Product summary:

Physical description: Yellow oval shaped tablets; Local technical representative: Talemwa Investment Consulting Co., Ltd (44520)

Authorization status:

Registered/Compliant

Authorization date:

2019-09-18

Summary of Product characteristics

Page: 1 of 11
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Panto-Denk 40
_ _
_ _
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 gastro-resistant tablet contains 40 mg pantoprazole (equivalent to
45.1 mg pantoprazole
sodium 1.5 H
2
O).
Excipients: 1 tablet contains 76.85 mg maltitol (see section 4.4).
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Gastro-resistant tablets
Yellow, oval tablet.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
-
Duodenal ulcer
-
Gastric ulcer
-
Moderate and severe forms of reflux oesophagitis
-
Long-term treatment of Zollinger-Ellison syndrome and other disorders
associated with
pathological hypersecretion of gastric acid
-
Eradication of
_Helicobacter pylori_
, in combination with antibiotics in patients with
duodenal ulcer or gastric ulcer
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
ADULTS AND ADOLESCENTS AGED 12 YEARS AND OLDER
_ _
Moderate and severe forms of reflux oesophagitis
The recommended dose for reflux oesophagitis is 1 Panto-Denk 40
gastro-resistant tablet dai-
ly.
In individual cases, especially in patients yet to respond to therapy
with other medicinal prod-
ucts, the dose can be doubled (i.e. 2 Panto-Denk 40 gastro-resistant
tablets daily).
ADULTS
Page: 2 of 11
Gastric and duodenal ulcers
For monotherapy with Panto-Denk 40, the following dosing guidelines
apply:
For gastroduodenal ulcers, the dose is 1 Panto-Denk 40
gastro-resistant tablet daily.
In individual cases, especially in patients yet to respond to therapy
with other medicinal prod-
ucts, the double dose can be given (an increase to 2 Panto-Denk 40
gastro-resistant tablets
daily).
Zollinger-Ellison syndrome
For the long-term therapy of Zollinger-Ellison syndrome and other
disorders associated with
pathological hypersecretion of gastric acid, the recommended starting
dose is 80 mg daily
(2 Panto-Denk 40 tablets).Thereafter, the dosage can be individually
adjusted to the extent of
gastric acid secretion. At dosages of more than 80 mg daily, the daily
dose should be