Lansoprazole 15mg gastro-resistant capsules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Lansoprazole

Available from:

Arrow Generics Ltd

ATC code:

A02BC03

INN (International Name):

Lansoprazole

Dosage:

15mg

Pharmaceutical form:

Gastro-resistant capsule

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 01030500; GTIN: 5060034833291

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Lansoprazole 15mg Gastro-resistant Capsules
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 15mg of Lansoprazole.
Excipient with known effect
Each capsule contains 81mg sucrose.
For the full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
Gastro-resistant capsule, hard
White / red-brownish capsules (size no. 3) filled with a white to
light brown or
slightly pink coloured pellets.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
•
Treatment of duodenal and gastric ulcer
•
Treatment of reflux oesophagitis
•
Prophylaxis of reflux oesophagitis
•
Eradication of _Helicobacter pylori _(_H. pylori_) concurrently given
with
appropriate antibiotic therapy for treatment of _H.pylori_-associated
ulcers
•
Treatment of NSAID-associated benign gastric and duodenal ulcers in
patients
requiring continued NSAID treatment
•
Prophylaxis of NSAID-associated gastric ulcers and duodenal ulcers in
patients at risk (see section 4.2) requiring continued therapy
•
Symptomatic gastroesophageal reflux disease
•
Zollinger-Ellison syndrome.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Treatment of duodenal ulcer:
The recommended dose is 30 mg once daily for 2 weeks. In patients not
fully
healed within this time, the medication is continued at the same dose
for
another two weeks.
Treatment of gastric ulcer:
The recommended dose is 30 mg once daily for 4 weeks. The ulcer
usually
heals within 4 weeks, but in patients not fully healed within this
time, the
medication may be continued at the same dose for another 4 weeks.
Reflux oesophagitis:
The recommended dose is 30 mg once daily for 4 weeks. In patients not
fully
healed within this time, the treatment may be continued at the same
dose for
another 4 weeks.
Prophylaxis of reflux oesophagitis:
15 mg once daily. The dose may be increased up to 30 mg daily as
necessary.
Eradication of _Helicobacter pylori: _
When selecting appropriate combination therapy consideration should be
given