Omeprazole 20 mg Gastro-resistant Capsules, hard

Šalis: Airija

kalba: anglų

Šaltinis: HPRA (Health Products Regulatory Authority)

Veiklioji medžiaga:

Omeprazole

Prieinama:

WPR Healthcare Limited

ATC kodas:

A02BC; A02BC01

INN (Tarptautinis Pavadinimas):

Omeprazole

Dozė:

20 milligram(s)

Vaisto forma:

Gastro-resistant capsule

Vartojimo būdas:

Oral use

Vienetai pakuotėje:

Packs of 28 capsules

Recepto tipas:

Product subject to prescription which may be renewed (B)

Pagaminta:

TEVA UK Limited

Farmakoterapinė grupė:

Proton pump inhibitors

Gydymo sritis:

Proton pump inhibitors; omeprazole

Terapinės indikacijos:

It is indicated for: 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..

Autorizacija statusas:

Authorised

Leidimo data:

2015-04-17

Pakuotės lapelis

_ _
PACKAGE LEAFLET: INFORMATION FOR THE USER
OMEPRAZOLE 10 MG GASTRO-RESISTANT CAPSULES, HARD
OMEPRAZOLE 20 MG GASTRO-RESISTANT CAPSULES, HARD
OMEPRAZOLE 40 MG 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 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 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’ (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). 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
(Zo

Prekės savybės

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Omeprazole 20 mg Gastro-resistant Capsules, hard
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains omeprazole 20 mg.
Excipient(s) with known effect: Also contains sucrose.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Gastro-resistant Capsules, hard.
_Product imported from the UK;_
Omeprazole 20 mg Gastro-resistant hard Capsules
Each capsule consists of an orange body and blue cap. The capsule is
marked with the letter ‘O’ on the cap and with the
number ‘20’ on the body using white ink. The capsule contains
white to off-white micropellets.
4 CLINICAL PARTICULARS
As per PA0749/160/002
5 PHARMACOLOGICAL PROPERTIES
As per PA0749/160/002
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Sugar spheres (sucrose and corn starch)
Sodium starch glycolate
Sodium laurilsulfate
Povidone K-30
Trisodium phosphate dodecahydrate
Hypromellose
Methacrylic acid - ethyl acrylate copolymer
Triethyl citrate
Sodium hydroxide
Titanium dioxide (E171)
Talc
Capsule – Erythrosine (E127) Indigo carmine (E132), Titanium dioxide
(E171), Water, Gelatin, Quinoline yellow
(E104)
Printing Ink
Shellac
Polyvinylpyrrolidone
Propylene glycol
Sodium Hydroxide
Titanium Dioxide (E171)
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6.2 INCOMPATIBILITIES
Not applicable