Omeprazole Mylan 20mg gastro-resistant capsules, hard

国: マルタ

言語: 英語

ソース: Medicines Authority

有効成分:

OMEPRAZOLE

から入手可能:

Generics UK Limited Station Close, Potters Bar, Herts, EN6 1TL, United Kingdom

ATCコード:

A02BC01

INN（国際名）:

OMEPRAZOLE 20 mg

医薬品形態:

GASTRO-RESISTANT HARD CAPSULE

構図:

OMEPRAZOLE 20 mg

処方タイプ:

POM

治療領域:

DRUGS FOR ACID RELATED DISORDERS

認証ステータス:

Withdrawn

承認日:

2012-07-06

情報リーフレット

PACKAGE LEAFLET
PACKAGE LEAFLET: INFORMATION FOR THE USER
Omeprazole Mylan 20mg Gastro-resistant capsule, 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. 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 or
nurse. 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 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-esophageal 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 intestines (duodenal ulcer) or stomach
(gastric ulcer).

To stop ulcers in the upper part of the intestines (duodenal ulcer) or
stomach (gastric ulcer)
from coming back.

Ulcers which are also infected with a 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 pancrea

製品の特徴

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Omeprazole Mylan 20mg Gastro-resistant capsule, hard
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Gastro-resistant capsule, hard contains 20 mg omeprazole
Excipients with known effect:
Each 20mg Gastro-resistant capsule, hard contains 33.8 mg sucrose
For a full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Gastro-resistant capsules, hard:
Capsule with dark pink opaque cap and white opaque body hard shell
gelatine
capsule filled with white to off-white pellets. The capsule is axially
printed
with “MYLAN” over “OM20” in black ink on cap and body
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Omeprazole is indicated in adults and children over 1 year of age and

10kg.
Omeprazole 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 esophagitis
-
Long term management of patients with healed reflux esophagitis
-
Treatment of symptomatic gastro-esophageal reflux disease
-
Treatment of Zollinger-Ellison syndrome
Paedriatric population:
_Children over 1 year of age and ≥10 kg _
- Treatment of reflux esophagitis,
- Symptomatic treatment of heartburn and acid regurgitation in gastro-
esophageal reflux disease
_Children and adolescents over 4 years of age_
- In combination with antibiotics in the treatment of duodenal ulcer
caused by
_H. pylori_
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology in adults
_Treatment of duodenal ulcers _
The recommended dose in patients with an active duodenal ulcer is
Omeprazole 20
mg once daily. In most patients healing occurs within two weeks. For
those patients
who may n