Omeprazole 40mg gastro-resistant capsules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Omeprazole

Available from:

IVAX Pharmaceuticals UK Ltd

ATC code:

A02BC01

INN (International Name):

Omeprazole

Dosage:

40mg

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

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
OMEPRAZOLE 10MG GASTRO-RESISTANT CAPSULES, HARD
OMEPRAZOLE 20MG GASTRO-RESISTANT CAPSULES, HARD
OMEPRAZOLE 40MG GASTRO-RESISTANT CAPSULES, HARD
OMEPRAZOLE
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 illnes 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 Omeprazole is and what it is used for
2.
What you need to know before you take Omeprazole
3.
How to take Omeprazole
4.
Possible side effects
5.
How to store Omeprazole
6.
Contents of the pack and other information
1.
WHAT OMEPRAZOLE IS AND WHAT IT IS USED FOR
Omeprazole contains the active substance omeprazole. It belongs to a
group of medicines called
‘proton pump inhibitors’. They work by reducing the amount of acid
that your stomach produces.
Omeprazole is used to treat the following conditions:
In adults:
•
‘Gastro-oesophageal reflux disease’ (GERD). This is where acid
from the stomach escapes into
the gullet (the tube which connects your throat to your stomach)
causing pain, inflammation and
heartburn.
•
Ulcers in the upper part of the intestine (duodenal ulcer) or stomach
(gastric ulcer).
•
Ulcers which are infected with bacteria called ‘
_Helicobacter pylori_
’. If you have this condition,
your doctor may also prescribe antibiotics to treat the infection and
allow the ulcer to heal.
•
Ulcers caused by medicines called NSAIDs (Non-Steroidal
Anti-Inflammatory Drugs).
Omeprazole can also be used to stop ulcers from forming if you are
taking NSAIDs.
•
Too much acid in the stomach caused by a growth in the pancreas
(Zollinger-Ell

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Omeprazole 40mg Gastro-resistant Capsules, hard
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 40mg omeprazole.
Excipients with known effect: sucrose 28-32mg and lactose anhydrous
1.7mg.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Gastro-resistant capsule, hard.
Gastro-resistant capsules, hard No.2 (length approximately 18.0mm)
with light brown
body and brown cap. Capsule contains off white to slightly
yellowish-brown spherical
pellets.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Omeprazole 40mg gastro-resistant capsules are indicated for:
Adults
•
Treatment of duodenal ulcers
•
Prevention of relapse of duodenal ulcers
•
Treatment of gastric ulcers
•
Prevention of relapse of gastric ulcers
•
In combination with appropriate antibiotics, _Helicobacter pylori (H.
pylori) _
eradication in peptic ulcer disease
•
Treatment of NSAID-associated gastric and duodenal ulcers
•
Prevention of NSAID-associated gastric and duodenal ulcers in patients
at risk
•
Treatment of reflux oesophagitis
•
Long-term management of patients with healed reflux oesophagitis
•
Treatment of symptomatic gastro-oesophageal reflux disease
•
Treatment of Zollinger-Ellison syndrome
Paediatric use
_Children over 1 year of age and _
≥
_ 10 kg _
•
Treatment of reflux oesophagitis
•
Symptomatic treatment of heartburn and acid regurgitation in
gastro-oesophageal
reflux disease
_ _
_Children and adolescents over 4 years of age _
•
In combination with antibiotics in treatment of duodenal ulcer caused
by _H. pylori _
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_ _
Posology
Adults
_ _
_Treatment of duodenal ulcers _
The recommended dose in patients with an active duodenal ulcer is
omeprazole 20mg
once daily. In most patients healing occurs within two weeks. For
those patients who
may not be fully healed after the initial course, healing usually
occurs during a further
two weeks treatment period. In patients with