Nexium Control
Land: Den Europæiske Union
Sprog: engelsk
Kilde: EMA (European Medicines Agency)
Indlægsseddel
(PIL)
20-03-2024
Produktets egenskaber
(SPC)
20-03-2024
Offentlige vurderingsrapport
(PAR)
20-09-2013
Aktiv bestanddel:
esomeprazole
Tilgængelig fra:
GlaxoSmithKline Dungarvan Limited
ATC-kode:
A02BC05
INN (International Name):
esomeprazole
Terapeutisk gruppe:
Proton pump inhibitors
Terapeutisk område:
Gastroesophageal Reflux
Terapeutiske indikationer:
Nexium Control is indicated for the short-term treatment of reflux symptoms (e.g. heartburn and acid regurgitation) in adults.
Produkt oversigt:
Revision: 17
Autorisation status:
Authorised
Autorisation dato:
2013-08-26
Indlægsseddel
40
B. PACKAGE LEAFLET
41
PACKAGE LEAFLET: INFORMATION FOR THE USER
NEXIUM CONTROL_ _20 MG GASTRO-RESISTANT TABLETS
esomeprazole
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
Always take this medicine exactly as described in this leaflet or as
your pharmacist has told you.
-
Keep this leaflet. You may need to read it again.
-
Ask your pharmacist if you need more information or advice.
-
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.
-
You must talk to a doctor if you do not feel better or if you feel
worse after 14 days
WHAT IS IN THIS LEAFLET
1.
What Nexium Control is and what it is used for
2.
What you need to know before you take Nexium Control
3.
How to take Nexium Control
4.
Possible side effects
5.
How to store Nexium Control
6.
Contents of the pack and other information
- Further helpful information
1.
WHAT NEXIUM CONTROL_ _IS AND WHAT IT IS USED FOR
Nexium Control
_ _
contains the active substance esomeprazole. It belongs to a group of
medicines called
‘proton pump inhibitors’. They work by reducing the amount of acid
that your stomach produces.
This medicine is used in adults for the short-term treatment of reflux
symptoms (for example,
heartburn and acid regurgitation).
Reflux is the backflow of acid from the stomach into the gullet
(“foodpipe”) which may become
inflamed and painful. This may cause you symptoms such as a painful
sensation in the chest rising up
to your throat (heartburn) and a sour taste in the mouth (acid
regurgitation).
Nexium Control is not meant to bring immediate relief. You may need to
take the tablets for 2-3 days
in a row before you feel better. You must talk to a doctor if you do
not feel better or if you feel worse
after 14 days.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE NEXIUM CONTROL_ _
_ _
DO NOT TAKE NEXIUM CONTROL_ _
-
If you are allergic to esomeprazole or any of the other ingredients of
th
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Produktets egenskaber
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Nexium Control
_ _
20 mg gastro-resistant tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gastro-resistant tablet contains 20 mg esomeprazole (as magnesium
trihydrate)
Excipient(s) with known effect
Each gastro-resistant tablet contains 28 mg sucrose.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Gastro-resistant tablet.
A light pink, oblong, biconvex, film-coated, gastro-resistant tablet
of 14 mm x 7 mm engraved with
‘20 mG’ on one side and ‘A/EH’ on the other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Nexium Control is indicated for the short-term treatment of reflux
symptoms (e.g. heartburn and acid
regurgitation) in adults.
_ _
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_ _
The recommended dose is 20 mg esomeprazole (one tablet) per day.
It might be necessary to take the tablets for 2-3 consecutive days to
achieve improvement of
symptoms. The duration of treatment is up to 2 weeks. Once complete
relief of symptoms has
occurred, treatment should be discontinued.
If no symptom relief is obtained within 2 weeks of continuous
treatment, the patient should be
instructed to consult a doctor.
_Special populations _
_Patients with renal impairment _
Dose adjustment is not required in patients with impaired renal
function. Due to limited experience in
patients with severe renal insufficiency, such patients should be
treated with caution (see section 5.2).
_Patients with hepatic impairment _
Dose adjustment is not required in patients with mild to moderate
liver impairment. However, patients
with severe liver impairment should be advised by a doctor before
taking Nexium Control (see
sections 4.4 and 5.2).
_Elderly patients (≥65 years old) _
Dose adjustment is not required in elderly patients.
3
_Paediatric population _
There is no relevant use of Nexium Control in the paediatric
population below 18 years of age for the
indication of “short-term treatment of reflux sympto
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