Acidex oral suspension peppermint

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Calcium carbonate; Sodium alginate; Sodium bicarbonate

Available from:

Pinewood Healthcare

ATC code:

A02BX13

INN (International Name):

Calcium carbonate; Sodium alginate; Sodium bicarbonate

Dosage:

16mg/1ml ; 50mg/1ml ; 26.7mg/1ml

Pharmaceutical form:

Oral suspension

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 01010201; GTIN: 5099186003399 5099186005256

Patient Information leaflet

250 ML
P
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.
See leaflet for further information. Store below 25ºC. 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 29831/0698 23LL05557PW 108173/3
_ACIDEX_
_ _
_ _
_ _
_ADVANCE_
_ACIDEX_
_ _
_ _
_ _
_ADVANCE_
_ORAL SUSPENSION_
_ORAL SUSPENSION_
(PEPPERMINT FLAVOUR)
SODIUM ALGINATE,
POTASSIUM HYDROGEN CARBONATE
_HEARTBURN AND_
_INDIGESTION SUSPENSION_
_ACIDEX_
_ _
_ _
_ _
_ADVANCE_
_ACIDEX_
_ _
_ _
_ _
_ADVANCE_
_ORAL SUSPENSION_
_ORAL SUSPENSION_
(PEPPERMINT FLAVOUR)
SODIUM ALGINATE,
POTASSIUM HYDROGEN CARBONATE
_HEARTBURN AND_
_INDIGESTION SUSPENSION_
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

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Acidex Oral Suspension
LloydsPharmacy Heartburn and Indigestion Liquid Peppermint Flavoured
Boots Heartburn Relief Peppermint Flavour
Peptac Peppermint Liquid
Tesco Heartburn & Indigestion relief
Heartburn and Indigestion Oral Suspension Peppermint Flavour
Healthpoint Heartburn and Indigestion Oral Suspension
Rennie Liquid Heartburn Relief Oral Suspension
Well Pharmaceuticals Heartburn & Indigestion Peppermint Flavour Oral
Suspension
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5ml contains:
Sodium Bicarbonate PhEur - 133.5mg
Sodium Alginate PhEur - 250mg
Calcium Carbonate PhEur - 80mg
3
PHARMACEUTICAL FORM
Oral Suspension
Peppermint Flavoured White Suspension
Gluten and Sugar free
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Acidex alleviates the painful conditions resulting from the reflux of
gastric
acid and bile into the oesophagus by suppressing the reflux itself. It
is
indicated in heartburn, including heartburn of pregnancy, dyspepsia
associated
with gastric reflux, hiatus hernia, reflux oesophagitis, regurgitation
and all
cases of epigastric and retrosternal distress where the underlying
cause is
gastric reflux.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
For oral use
Adults and children over 12 years:
Two to four 5ml spoonfuls
Children 6 -12 years:
One to two 5ml spoonfuls
Not recommended in children under six years of age.
Doses should be taken after meals and at bedtime.
4.3
CONTRAINDICATIONS
This medicinal product is contraindicated in patients with known or
suspected
hypersensitivity to the active substances or to any of the excipients
listed in section
6.1, including methyl parahydroxybenzoate (E218) and propyl
parahydroxybenzoate
(E216) (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.
Each 10 ml dose of Acidex contains about 6 mmoles of sodium and
therefore
care should be exercised in patients on a sodium restricted diet.
Ea