Losec 40mg gastro-resistant capsules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Omeprazole

Available from:

Neon Healthcare 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; GTIN: 5014162007352

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
LOSEC 10 MG HARD GASTRO-RESISTANT CAPSULES
LOSEC 20 MG HARD GASTRO-RESISTANT CAPSULES
LOSEC 40 MG HARD GASTRO-RESISTANT CAPSULES
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 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 Losec is and what it is used for
2.
What you need to know before you take Losec
3.
How to take Losec
4.
Possible side effects
5. How to store Losec
6.
Contents of the pack and other information
1.
WHAT LOSEC IS AND WHAT IT IS USED FOR
Losec 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.
Losec is used to treat the following conditions:
In adults:

‘Gastro-oesophageal reflux disease’ (GORD). 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). Losec
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-Ellison
syndrome).
In children:
_Children over 1 year o

Summary of Product characteristics

OBJECT 1
LOSEC CAPSULES 40MG
Summary of Product Characteristics Updated 09-Jun-2017 | AstraZeneca
UK Limited
1. Name of the medicinal product
Losec 40 mg hard gastro-resistant capsules
2. Qualitative and quantitative composition
Each capsule contains 40 mg omeprazole.
Excipient(s) with known effect
Each capsule contains 9 mg lactose.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Gastro-resistant capsule, hard (gastro-resistant capsule).
Hard gelatine capsules with an opaque reddish-brown body, marked 40
and an opaque reddish-brown cap
marked A/OL, containing enteric coated pellets.
4. Clinical particulars
4.1 Therapeutic indications
Losec capsules are indicated in:
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
Losec 20 mg 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