Nexium Control 20mg gastro-resistant tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Esomeprazole magnesium trihydrate

Available from:

Pfizer Consumer Healthcare Ltd

ATC code:

A02BC05

INN (International Name):

Esomeprazole magnesium trihydrate

Dosage:

20mg

Pharmaceutical form:

Gastro-resistant tablet

Administration route:

Gastroenteral; Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 01030500

Patient Information leaflet

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Technical
Text Area
Pharma code
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PFIZER -
Product Name:
INS-NEXIUM FCT 7 EA BLST 1-2 EA IFC ENG
PLEASE ENSURE ARTWORK IS CHECKED WITH THIS SETTINGS: PRINT PRODUCTION
>> OUTPUT PREVIEW >> OVERPRINT PREVIEW TURNED ON AND COLOR PROFILE
SIMULATION SET TO “COATED FOGRA 39”
Realized by:
PACKAGING DEVELOPMENT CENTER
[e-mail]
Draft No:
02 -
Date:
10/11/2017 -
Operator: 009E
Barcode Type(s):
-
X-Hight Rule:
N
Label Text Number:
N/A
CUSTOMER APPROVAL SECTION
..........................
Dieline:
170 X 500 MM
Pharmacode:
430
Standard Color:
0032
Item Code:
CI3185-05
PAR:
2017-0009611
Market:
IRELAND-MALTA-UNITED KINGDOM
v.10
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not
everybody gets them.
If you notice any of the following serious side effects, stop taking
Nexium Control and contact a doctor immediately:
•
Sudden wheezing, swelling of your lips, tongue and throat, rash,
fainting or difficulties in swallowing (severe allergic
reaction, seen rarely)
•
Reddening of the skin with blisters or peeling. There may also be
severe blisters and bleeding in the lips, eyes, mouth,
nose and genitals. This could be ‘Stevens-Johnson syndrome’ or
‘toxic epidermal necrolysis’
, seen very rarely.
•
Yellow skin, dark urine and tiredness, which can be symptoms of liver
problems, seen rarely.
Talk to your doctor as soon as possible if you experience any of the
following signs of infection:
This medicine may in very rare cases affect the white blood cells
leading to immune deficiency. If you have an
infection with symptoms such as fever with a severely reduced general
condition or fever with symptoms of a local
infection such as pain in the neck, throat or mouth or difficulties in
urinating, you must consult your doctor as soon as
possible so that a lack of white blood cells (agranulocytosis) can be
ruled out by a blood test. It is important for you to
give information about your medicine at this time.
Other side effects include:
Common (may

Summary of Product characteristics

OBJECT 1
NEXIUM CONTROL
Summary of Product Characteristics Updated 14-Dec-2017 | Pfizer
Consumer Healthcare
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 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.
_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 o