Esomeprazole 20mg gastro-resistant capsules

Riik: Suurbritannia

keel: inglise

Allikas: MHRA (Medicines & Healthcare Products Regulatory Agency)

Toimeaine:

Esomeprazole magnesium dihydrate

Saadav alates:

Viatris UK Healthcare Ltd

ATC kood:

A02BC05

INN (Rahvusvaheline Nimetus):

Esomeprazole magnesium dihydrate

Annus:

20mg

Ravimvorm:

Gastro-resistant capsule

Manustamisviis:

Oral; Gastroenteral

Klass:

No Controlled Drug Status

Retsepti tüüp:

Valid as a prescribable product

Toote kokkuvõte:

BNF: 01030500; GTIN: 5016695003788

Infovoldik

PAGE 1 OF 8
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ESOMEPRAZOLE 20 MG GASTRO-RESISTANT CAPSULES, HARD
ESOMEPRAZOLE 40 MG GASTRO-RESISTANT CAPSULES, HARD
esomeprazole
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist or
nurse
-
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 any of the side effects gets serious, talk to your doctor or
pharmacist or nurse. This includes
any possible side effects not listed in this leaflet.
IN THIS LEAFLET:
1.
What
Esomeprazole is and what it is used for
2.
What you need to know before you take Esomeprazole
3.
How to take Esomeprazole
4.
Possible side effects
5.
How to store Esomeprazole
6.
Contents of the pack and other information
1.
WHAT ESOMEPRAZOLE IS AND WHAT IT IS USED FOR
Esomeprazole contains 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 is used to treat the following conditions:
Adults and young people aged 12 years and above

‘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 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.
Adults

Stomach ulcers caused by medicines called NSAIDs (Non-Steroidal
Anti-Inflammatory
Drugs). Esomeprazole can also be used to stop stomach ulcers from
forming if you are taking
NSAIDs.

Too much acid in the stomach caused by a growth in the pancreas
(Zollinger-Ellison
syndrome).

Prolonged treatme

Toote omadused

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Esomeprazole 20mg Gastro-resistant capsules, hard
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 20 mg of esomeprazole (as magnesium dihydrate).
Excipient with known effect: each capsule contains 8.04 mg of sucrose,
1.85
micrograms methyl-p-hydroxybenzoate (E218) and 0.56 microgram of
propyl-p-
hydroxybenzoate (E216) (see section 4.4).
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Gastro-resistant capsule, hard
Capsule with an opaque yellow cap and an opaque white body imprinted
in black
with “20 mg” both on the cap and on the body. The capsule contains
off-white to
greyish spherical microgranules.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
_Adults _
Esomeprazole capsules are indicated in adults for:
Gastroesophageal Reflux Disease (GORD)
-
treatment of erosive reflux esophagitis
-
long-term management of patients with healed esophagitis to prevent
relapse
-
symptomatic treatment of gastroesophageal 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.
Prolonged treatment after i.v. induced prevention of rebleeding of
peptic ulcers
Treatment of Zollinger Ellison Syndrome
_ _
_Adolescents from the age of 12 years_
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