Lansoprazole 15mg gastro-resistant capsules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Lansoprazole

Available from:

Teva UK 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: 5017007016717

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
LANSOPRAZOLE 15 MG & 30 MG GASTRO-RESISTANT CAPSULES
Lansoprazole
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 of the side effects, talk to your doctor or pharmacist
. This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IN THIS LEAFLET
1.
What Lansoprazole Capsules is and what it is 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 IS AND WHAT IT IS USED FOR
The active ingredient in Lansoprazole 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.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE LANSOPRAZOLE CAP

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