Acidex Advance oral suspension aniseed

Страна: Великобритания

Език: английски

Източник: MHRA (Medicines & Healthcare Products Regulatory Agency)

Активна съставка:

Sodium alginate; Potassium bicarbonate

Предлага се от:

Wockhardt UK Ltd

INN (Международно Name):

Sodium alginate; Potassium bicarbonate

дозиране:

100mg/1ml ; 20mg/1ml

Лекарствена форма:

Oral suspension

Начин на приложение:

Oral

Клас:

No Controlled Drug Status

Вид предписание :

Valid as a prescribable product

Каталог на резюме:

BNF: 01010201; GTIN: 5099186004693 5099186004679

Листовка

Each 10 ml of the oral suspension contains 1000 mg of
sodium alginate and 200 mg of potassium hydrogen
carbonate. Also contains parahydroxybenzoates
(Parabens, E214 and E216) which may cause allergic
reactions (possibly delayed). This medicinal product
contains about 5.1 mmol of sodium and 2 mmol of
potassium per 10 ml dose. To be taken into consideration
by patients on a controlled sodium diet or when taking
drugs which can increase potassium levels. Care should
also be taken if on calcium controlled diet. Read the
attached leaflet carefully before use. To be taken by
mouth after meals and at bedtime. Shake bottle well
before use. Keep out of the sight and reach of children.
Take special care if you are allergic to any of the
ingredients of this medicine. Side effects are occasional.
See leaflet for further information. Store below 25°C.
Do not use after the expiry date shown on the label.
Do not refrigerate or freeze.
MA HOLDER: Wockhardt UK Ltd, Ash Road North,
Wrexham, LL13 9UF, UK.
PL 29831/0697 23LL05555PW 108171/3
_ACIDEX_
_ _
_ _
_ _
_ADVANCE_
_ACIDEX_
_ _
_ _
_ _
_ADVANCE_
_ORAL SUSPENSION_
_ORAL SUSPENSION_
SODIUM ALGINATE AND
POTASSIUM HYDROGEN
CARBONATE
ANISEED FLAVOUR
_HEARTBURN AND_
_INDIGESTION SUSPENSION_
250 ML
P
Each 10 ml of the oral suspension contains 1000 mg of
sodium alginate and 200 mg of potassium hydrogen
carbonate. Also contains parahydroxybenzoates
(Parabens, E214 and E216) which may cause allergic
reactions (possibly delayed). This medicinal product
contains about 5.1 mmol of sodium and 2 mmol of
potassium per 10 ml dose. To be taken into consideration
by patients on a controlled sodium diet or when taking
drugs which can increase potassium levels. Care should
also be taken if on calcium controlled diet. Read the
attached leaflet carefully before use. To be taken by
mouth after meals and at bedtime. Shake bottle well
before use. Keep out of the sight and reach of children.
Take special care if you are allergic to any of the
ingredients of this medicine. Side effects are occasional.
S

Данни за продукта

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Acidex Advance Oral Suspension (Aniseed Flavour)
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 10 ml contains:
Sodium Alginate
1000 mg
Potassium hydrogen carbonate
200 mg
Excipients include:
Ethyl parahydroxybenzoate (E214) 15.0 mg/10 ml
Propyl parahydroxybenzoate (E216) 5.50 mg/10 ml
Butyl parahydroxybenzoate 2.50 mg/10 ml
For a full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
Oral Suspension,
Aniseed flavoured white or cream coloured suspension
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of symptoms resulting from the reflux of acid, bile and
pepsin into
the oesophagus such as acid regurgitation, heartburn, indigestion
(occurring
due to the reflux of stomach contents), for instance, after gastric
surgery, as a
result of hiatus hernia, during pregnancy, accompanying reflux
oesophagitis,
including symptoms of laryngopharyngeal reflux such as hoarseness and
other
voice disorders, sore throats and cough. Can also be used to treat the
symptoms of gastro-oesophageal reflux during concomitant treatment
with or
following withdrawal of acid suppressing therapy.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Adults and children 12 years and over: 5 -10ml after meals and at
bedtime
Children under 12 years: Should be given only on medical advice.
Elderly: no dose modification is required in this age group.
4.3
CONTRAINDICATIONS
This medicinal product is contraindicated in patients with known or
suspected
hypersensitivity to any of the ingredients, or any of the excipients
listed in
section 6.1, including the esters of hydroxybenzoates (Parabens) (see
section
4.4).
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
If symptoms do not improve after seven days, the clinical situation
should be
reviewed.
This medicinal product contains 106 mg (5.1mmol) sodium per 10 ml
dose,
equivalent to 5.3% of the WHO recommended maximum daily intake for
sodium.
The maximum daily dose of this product is equivalent to 21% of the WHO
recommended maximum d