Omeprazole 10mg gastro-resistant capsules

Nchi: Uingereza

Lugha: Kiingereza

Chanzo: MHRA (Medicines & Healthcare Products Regulatory Agency)

Viambatanisho vya kazi:

Omeprazole

Inapatikana kutoka:

Wockhardt UK Ltd

ATC kanuni:

A02BC01

INN (Jina la Kimataifa):

Omeprazole

Kipimo:

10mg

Dawa fomu:

Gastro-resistant capsule

Njia ya uendeshaji:

Oral

Darasa:

No Controlled Drug Status

Dawa ya aina:

Valid as a prescribable product

Bidhaa muhtasari:

BNF: 01030500

Taarifa za kipeperushi

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Details
OMEPRAZOLE 10MG & 20MG GASTRO-RESISTANT CAPSULES PIL- UK
Black
BBBA3101
R.Wrey
03/10/18
08/10/18
R.Wrey
140 x 540
8pt
Liconsa
03/10/18
04/10/18
3
Version 2
01.11.2017
OMEPRAZOLE 10 MG AND 20 MG
GASTRO-RESISTANT CAPSULES
BBBA3101
_Continued over page_
_Continued top of next column_
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 CAPSULES ARE
AND WHAT THEY ARE USED FOR
2 WHAT YOU NEED TO KNOW BEFORE
YOU TAKE OMEPRAZOLE CAPSULES
3 HOW TO TAKE OMEPRAZOLE CAPSULES
4 POSSIBLE SIDE EFFECTS
5 HOW TO STORE OMEPRAZOLE CAPSULES
6 CONTENTS OF THE PACK AND OTHER
INFORMATION
1 WHAT OMEPRAZOLE CAPSULES ARE
AND WHAT THEY ARE USED FOR
Omeprazole capsules contain 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 i

Tabia za bidhaa

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Omeprazole 10mg hard gastro-resistant capsules
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 10 mg of omeprazole.
Excipient(s) with known effect:
•
Each 10mg capsule contains 51 to 58mg of sucrose
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Gastro-resistant capsule, hard (gastro-resistant capsule).
Omeprazole 10 mg capsules: hard gelatine capsules with opaque
yellow
capsule containing off-white to cream-white spherical microgranules.
4.1 THERAPEUTIC INDICATIONS
_ _
Omeprazole capsules is indicated for 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 esophagitis
• Long-term management of patients with healed reflux esophagitis
• Treatment of symptomatic gastro-esophageal reflux disease
• Treatment of Zollinger-Ellison syndrome
Paediatric use
_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 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 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
patients
with poorly responsive duodenal ulcer