Lansoprazole 15mg orodispersible tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Lansoprazole

Available from:

A A H Pharmaceuticals Ltd

ATC code:

A02BC03

INN (International Name):

Lansoprazole

Dosage:

15mg

Pharmaceutical form:

Orodispersible tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 01030500; GTIN: 5025903015550

Patient Information leaflet

350 mm
235 mm
5670
Lansoprazole 15mg Orodispersible Tablets/
Lansoprazole 30mg Orodispersible Tablets
258216
PACKAGE LEAFLET: INFORMATION FOR THE USER
LANSOPRAZOLE 15MG ORODISPERSIBLE TABLETS
LANSOPRAZOLE 30MG ORODISPERSIBLE TABLETS
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 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 orodispersible tablets are and what they are used
for
2.
What you need to know before you take Lansoprazole orodispersible
tablets
3.
How to take Lansoprazole orodispersible tablets
4.
Possible side effects
5.
How to store Lansoprazole orodispersible tablets
6.
Contents of the pack and other information
1. WHAT LANSOPRAZOLE ORODISPERSIBLE TABLETS ARE AND WHAT THEY ARE USED
FOR
The active ingredient in Lansoprazole 15mg and 30mg orodispersible
tablets is lansoprazole, which is a proton pump inhibitor. Proton pump
inhibitors reduce the amount of acid that your stomach makes.
Lansoprazole orodispersible tablets are used to treat adults
Your doctor may prescribe Lansoprazole orodispersible tablets 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 inflamma

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Lansoprazole 15mg Orodispersible Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each orodispersible tablet contains 15 mg of lansoprazole
Excipient(s) with known effect:
Each orodispersible tablet contains 5.25 mg of aspartame
For a full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Orodispersible tablet.
White to yellowish white uncoated tablets, speckled with orange to
dark brown
pellets, debossed with “I5” on one side of the tablet and plain on
the other side.
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.
Lansoprazole orodispersible tablets are indicated in adults
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