Omeprazole 40mg gastro-resistant capsules

Nchi: Uingereza

Lugha: Kiingereza

Chanzo: MHRA (Medicines & Healthcare Products Regulatory Agency)

Viambatanisho vya kazi:

Omeprazole

Inapatikana kutoka:

Genesis Pharmaceuticals Ltd

ATC kanuni:

A02BC01

INN (Jina la Kimataifa):

Omeprazole

Kipimo:

40mg

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; GTIN: 5060014442666

Taarifa za kipeperushi

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
OMEPRAZOLE 10MG GASTRO-RESISTANT CAPSULES
OMEPRAZOLE 20MG GASTRO-RESISTANT CAPSULES
OMEPRAZOLE 40MG GASTRO-RESISTANT CAPSULES
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 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 grow

Tabia za bidhaa

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Omeprazole 40mg gastro-resistant capsules, hard
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Omeprazole 40 mg capsules: one capsule contains 40 mg of omeprazole.
Excipient(s) with known effect:
•
Each 40mg capsule contains 203 to 233mg of sucrose
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Gastro-resistant capsule, hard
Omeprazole 40 mg capsules: opaque yellow capsule containing off-white
to
cream-white spherical microgranules.
4.1
THERAPEUTIC INDICATIONS
Omeprazole is 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
•
Reflux
oesophagitis.
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 Omeprazole 40 mg once daily is recommende