Lansoprazole 30mg gastro-resistant capsules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Lansoprazole

Available from:

Alliance Healthcare (Distribution) Ltd

ATC code:

A02BC03

INN (International Name):

Lansoprazole

Dosage:

30mg

Pharmaceutical form:

Gastro-resistant capsule

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 01030500

Patient Information leaflet

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LANSOPRAZOLE 15MG, 30MG
GASTRO-RESISTANT CAPSULES
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BBBA6155
READ ALL OF THIS LEAFLET CAREFULLY
BEFORE YOU START TAKING THIS MEDICINE
BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
• Keep this leaflet. You may need to
read it again.
• If you have any further questions, ask
your doctor or pharmacist.
• This medicine has been prescribed
for you only. Do not pass it on to
others. It may harm them, even if their
signs of illness are the same as yours.
• If you get any side effects, talk to your
doctor or pharmacist. This includes
any possible side effects not listed in
this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1
WHAT LANSOPRAZOLE CAPSULES
ARE AND WHAT THEY ARE USED FOR
2 WHAT YOU NEED TO KNOW
BEFORE YOU TAKE LANSOPRAZOLE
CAPSULES
3 HOW TO TAKE LANSOPRAZOLE
CAPSULES
4 POSSIBLE SIDE EFFECTS
5 HOW TO STORE LANSOPRAZOLE
CAPSULES
6 CONTENTS OF THE PACK AND OTHER
INFORMATION
1 WHAT LANSOPRAZOLE CAPSULES
ARE AND WHAT THEY ARE USED FOR
The active ingredient in Lansoprazole
Capsules is lansoprazole, which is a
proton pump inhibitor. Proton pump
inhibitors reduce the amount of acid that
your stomach makes.
Your doctor may prescribe Lansoprazole
for the following indications:
• Treatment of duodenal and stomach
ulcer
• Treatment of inflammation in your
oesophagus (reflux oesophagitis)
• Prevention of reflux oesophagitis
• Treatment of heartburn and acid
regurgitation
• Treatment of infections caused by the
bacteria _Helicobacter pylori_ when given
in combination with antibiotic therapy
• Treatment or prevention of duodenal
or stomach ulcer in patients requiring
continued NSAID treatment (NSAID
treatment is used against pain or
inflammation)
• Treatment of Zollinger-Ellison
syndrome.
Your doctor may have prescribed
Lansoprazole for another indication or
with a dose different from that which is
written in this information leaflet. Please
follow your doctor’s instructions for
taking your medicine.
You must talk to a doctor if you do not
feel

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Lansoprazole 30 mg Gastro-Resistant Capsules
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 30 mg lansoprazole
Excipient with known effect:
Each 30 mg capsule contains 200.949 mg sucrose
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Lansoprazole 30 mg: opaque white cap and body capsules. Each capsule
contains
white or almost white spherical microgranules.
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 to official