Esomeprazole 20mg gastro-resistant tablets

Country: Bretland

Tungumál: enska

Heimild: MHRA (Medicines & Healthcare Products Regulatory Agency)

Virkt innihaldsefni:

Esomeprazole

Fáanlegur frá:

NorthStar Healthcare Unlimited Company

ATC númer:

A02BC05

INN (Alþjóðlegt nafn):

Esomeprazole

Skammtar:

20mg

Lyfjaform:

Gastro-resistant tablet

Stjórnsýsluleið:

Gastroenteral; Oral

Tegund:

No Controlled Drug Status

Gerð lyfseðils:

Valid as a prescribable product

Vörulýsing:

BNF: 01030500; GTIN: 05051089990367

Upplýsingar fylgiseðill

WHAT IS IN THIS LEAFLET
1.
What Esomeprazole gastro-resistant tablets are and what they are used
for
2.
What you need to know before you take Esomeprazole gastro-resistant
tablets
3.
How to take Esomeprazole gastro-resistant tablets
4.
Possible side effects
5.
How to store Esomeprazole gastro-resistant tablets
6.
Contents of the pack and other information
1. WHAT ESOMEPRAZOLE GASTRO-RESISTANT TABLETS ARE AND WHAT THEY
ARE USED FOR
Esomeprazole gastro-resistant tablets contain a medicine called
esomeprazole. This
belongs to a group of medicines called ‘proton pump inhibitors’.
They work by reducing the
amount of acid that your stomach produces.
Esomeprazole gastro-resistant tablets are used to treat the following
conditions:
Adults
Ÿ
‘Gastroesophageal 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.
Ÿ
Ulcers in the stomach or upper part of the gut (intestine) that 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.
Ÿ
Stomach ulcers caused by medicines called NSAIDs (Non-Steroidal
Anti-Inflammatory
Drugs). Esomeprazole gastro-resistant tablets can also be used to stop
stomach
ulcers from forming if you are taking NSAIDs.
Ÿ
Too much acid in the stomach caused by a growth in the pancreas
(Zollinger-Ellison
syndrome).
Ÿ
Prolonged treatment after prevention of rebleeding of ulcers with
intravenous
esomeprazole.
Adolescents aged 12 years and above
Ÿ
‘Gastroesophageal 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.
Ÿ
Ulcers in the stomach or upper part of the gut (intestine) that are
infected with
bacteria called ‘_Helicobacter pylori’_. If you have this
condition, your doctor may also
prescribe antibiotics t

Vara einkenni

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Esomeprazole 20mg Gastro-resistant Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
One gastro-resistant tablet contains 20mg of esomeprazole
(corresponding to
21.75mg esomeprazole magnesium dihydrate).
Excipient with known effect:
Each tablet contains no more than 5.65 mg of sucrose.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Gastro-resistant tablet.
20mg: A light pink, elliptically shaped, biconvex film-coated tablet,
6.55 x 13.6 mm.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
_Adults _
Esomeprazole 20mg tablets are indicated in adults for:
Gastro-oesophageal Reflux Disease (GORD)
-
treatment of erosive reflux oesophagitis
-
long-term management of patients with healed oesophagitis to prevent
relapse
-
symptomatic treatment of gastro-oesophageal reflux disease (GORD)
In combination with appropriate antibacterial therapeutic regimens for
the eradication
of _Helicobacter pylori _and_ _
-
healing of _Helicobacter pylori _associated duodenal ulcer and
-
prevention of relapse of peptic ulcers in patients with _Helicobacter
pylori _
associated ulcers
Patients requiring continued NSAID therapy
- healing of gastric ulcers associated with NSAID therapy.
-
prevention of gastric and duodenal ulcers associated with NSAID
therapy, in
patients at risk.
Treatment of Zollinger Ellison Syndrome
Esomeprazole 20mg tablets are indicated in adolescents from the age of
12 years for:
Gastro-oesophageal Reflux Disease (GORD)
-
treatment of erosive reflux oesophagitis
-
long-term management of patients with healed oesophagitis to prevent
relapse
-
symptomatic treatment of gastro-oesophageal reflux disease (GORD)
In combination with antibiotics in treatment of duodenal ulcer caused
by
_Helicobacter pylori_
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults _
Gastro-oesophageal Reflux Disease (GORD)
-
treatment of erosive reflux oesophagitis
40mg esomeprazole once daily for 4 weeks.
An additional 4 weeks treatment is recommend