Esomeprazole 20mg gastro-resistant capsules

Država: Velika Britanija

Jezik: angleščina

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktivna sestavina:

Esomeprazole magnesium dihydrate

Dostopno od:

Sigma Pharmaceuticals Plc

Koda artikla:

A02BC05

INN (mednarodno ime):

Esomeprazole magnesium dihydrate

Odmerek:

20mg

Farmacevtska oblika:

Gastro-resistant capsule

Pot uporabe:

Gastroenteral; Oral

Razred:

No Controlled Drug Status

Tip zastaranja:

Valid as a prescribable product

Povzetek izdelek:

BNF: 01030500

Navodilo za uporabo

ESOMEPRAZOLE
20MG AND 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.
- The full name of this medicine is Esomeprazole 20mg and 40mg
Gastro-resistant Capsules but
within the leaflet it will be referred to as Esomeprazole capsules.
WHAT IS IN THIS LEAFLET:
1. WHAT ESOMEPRAZOLE CAPSULES ARE AND WHAT THEY ARE USED FOR
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ESOMEPRAZOLE CAPSULES
3. HOW TO TAKE ESOMEPRAZOLE CAPSULES
4. POSSIBLE SIDE EFFECTS
5. HOW TO STORE ESOMEPRAZOLE CAPSULES
6. CONTENTS OF THE PACK AND OTHER INFORMATION
1. WHAT ESOMEPRAZOLE
CAPSULES ARE AND WHAT THEY ARE USED FOR
Esomeprazole capsules
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 capsules are used to treat the following conditions:
ADULTS AND ADOLESCENTS 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 capsules can also be used to stop sto

Lastnosti izdelka

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