Emozul 40mg gastro-resistant capsules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Esomeprazole magnesium dihydrate

Available from:

Krka UK Ltd

ATC code:

A02BC05

INN (International Name):

Esomeprazole magnesium dihydrate

Dosage:

40mg

Pharmaceutical form:

Gastro-resistant capsule

Administration route:

Oral; Gastroenteral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 01030500; GTIN: 5391512451028

Patient Information leaflet

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 or nurse. This includes any possible
side effects not listed in this leaflet.
See section 4. WHAT IS IN THIS LEAFLET
1. What Emozul is and what it is used for
2. What you need to know before you take Emozul
3. How to take Emozul
4. Possible side effects
5. How to store Emozul
6. Contents of the pack and other information
1. WHAT EMOZUL IS AND WHAT IT IS USED FOR
Emozul contains a medicine called esomeprazole
magnesium dihydrate. This belongs to a group of
medicines called “proton pump inhibitors”. They
work by reducing the amount of acid that your
stomach produces.
EMOZUL IS USED TO TREAT THE FOLLOWING CONDITIONS:
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 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.
•
Stomach ulcers caused by medicines called
NSAIDs (Non-Steroidal Anti-Inflammatory Drugs).
Emozul 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 treatment after prevention of
rebleeding of ulcers with intravenous
esomeprazole.
ADOLESCENTS AGED 12 YEARS AND ABOVE
•
“Gastroesophageal reflux disease” (GORD). This
is where acid from the sto

Summary of Product characteristics

OBJECT 1
EMOZUL 40 MG GASTRO-RESISTANT CAPSULES, HARD
Summary of Product Characteristics Updated 20-Nov-2017 | Consilient
Health Ltd
1. Name of the medicinal product
Emozul 40 mg gastro-resistant capsules, hard
2. Qualitative and quantitative composition
Each gastro-resistant capsule, hard, contains 40 mg esomeprazole (as
esomeprazole magnesium
dihydrate).
Excipient (s) with known effect:
40 mg gastro-resistant capsules, hard
sucrose
56.93–65.11 mg
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Gastro-resistant capsule, hard
The body and the cap are off-pink in colour; the capsules contain
white to almost white pellets. Capsule
size: no. 1.
4. Clinical particulars
4.1 Therapeutic indications
Emozul 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 IV INDUCED PREVENTION OF REBLEEDING OF
PEPTIC ULCERS
TREATMENT OF ZOLLINGER ELLISON SYNDROME
Emozul capsules are indicated in adolescents from the age of 12 years
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 ANTIBIOTICS IN TREATMENT OF DUODENAL ULCER CAUSED
BY _HELICOBACTER PYLORI_
4.2 Posology and method of administration
Posology
Adults
GAST