Lansoprazole 30mg gastro-resistant capsules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Lansoprazole

Available from:

Accord-UK 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; GTIN: 5012617015150

Patient Information leaflet

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LANSOPRAZOLE 15MG, 30MG
GASTRO-RESISTANT CAPSULES
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

OBJECT 1
LANSOPRAZOLE 30MG GASTRO-RESISTANT
CAPSULES
Summary of Product Characteristics Updated 18-Nov-2022 | Accord-UK Ltd
•
1. Name of the medicinal product
•
2. Qualitative and quantitative composition
•
3. Pharmaceutical form
•
4. Clinical particulars
•
4.1 Therapeutic indications
•
4.2 Posology and method of administration
•
4.3 Contraindications
•
4.4 Special warnings and precautions for use
•
4.5 Interaction with other medicinal products and other forms of
interaction
•
4.6 Fertility, pregnancy and lactation
•
4.7 Effects on ability to drive and use machines
•
4.8 Undesirable effects
•
4.9 Overdose
•
5. Pharmacological properties
•
5.1 Pharmacodynamic properties
•
5.2 Pharmacokinetic properties
•
5.3 Preclinical safety data
•
6. Pharmaceutical particulars
•
6.1 List of excipients
•
6.2 Incompatibilities
•
6.3 Shelf life
•
6.4 Special precautions for storage
•
6.5 Nature and contents of container
•
6.6 Special precautions for disposal and other handling
•
7. Marketing authorisation holder
•
8. Marketing authorisation number(s)
•
9. Date of first authorisation/renewal of the authorisation
•
10. Date of revision of the text
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