Active substance(s): CITRIC ACID / SODIUM BICARBONATE / SODIUM CARBONATE ANHYDROUS
NAME OF THE MEDICINAL PRODUCT
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5 g of powder contains:
Sodium Bicarbonate Ph Eur
Citric Acid Ph Eur
Anhydrous Sodium Carbonate Ph Eur
Each 5g of powder contains 0.85 g of sodium
The symptomatic relief of indigestion, flatulence and nausea.
Posology and Method of Administration
For oral administration.
Adults and children aged 12 years and over:
5 g (one 5 ml spoonful of powder) or one sachet dissolved in a glass of water.
Drink as symptoms occur.
A second dose may be taken after 2-3 hours.
Minimum dosing interval: 2 hours.
Maximum daily dose (MDD): 2 x relevant dosage (5 g).
Maximum duration of antacid use at MDD: 14 days.
Children under 12 years: Do not use.
The elderly can take the adult dose.
Persons on a restricted sodium diet e.g. those suffering from hypertension or
congestive heart failure, should not use this product unless directed by a
Patients with impaired hepatic and renal function.
Sodium Carbonate + Sodium Bicarbonate + Citric Acid is contraindicated in
patients with a prior hypersensitivity reaction to Sodium Carbonate + Sodium
Bicarbonate + Citric Acid or any other ingredient of the preparation.
Special Warnings and Precautions for Use
Do not exceed the recommended dose as excess or prolonged use may lead to
Treatment should be discontinued if there is no improvement in condition.
Keep out of reach and sight of children.
Interaction with other medicinal products and other forms of interaction
The acid neutralising capacity of the product may alter the absorption profile
of pH specific drugs given concomitantly.
Fertility, Pregnancy and lactation
For Eno no clinical data on exposed pregnancies are available.
Animal studies on each of the active ingredients do not indicate direct or
indirect harmful effects with respect to pregnancy, embryonal/foetal
development, parturition or postnatal development.
Caution should be exercised when recommending to pregnant women.
Effects on ability to drive and use machines
Specific estimation of the frequency of adverse events for non-prescription
products from post-marketing data is inherently difficult (particularly
numerator data). On this basis, no estimate for MedDRA frequency categories
Gastrointestinal System SOC:
Minor gastrointestinal irritations, including belching, flatulence, and
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal
product is important. It allows continued monitoring of the benefit/risk
balance of the medicinal product. Healthcare professionals are asked to report
any suspected adverse reactions via the Yellow Card Scheme at
It would be difficult to take an overdosage of the product either in the dry form
or when mixed with water.
Moderate, acute overdosage may result in belching and gastro-intestinal
disturbances. Treatment would be withdrawal of the product and symptomatic
measures, as appropriate.
Severe acute overdosage may precipitate sodium overload (hypernatraemia or
hyperosmolality) and possibly metabolic alkalosis. Symptoms may include
restlessness, weakness, thirst, reduced salivation, dizziness, headache and
possibly hypotension and tachycardia. Treatment would consist mainly of
appropriate correction of fluid-electrolyte balance.
Acute ingestion of the neat powder may lead to gastric irritation, gas liberation
and possibly stomach perforation. Treatment would be gastric lavage and
general supportive and symptomatic measures.
This product is an antacid.
) These react in the glass of water to produce sodium
) citrate, which has antacid buffering properties, and
) carbon dioxide which facilitates eructation. A slight
excess of sodium bicarbonate remains with a small,
direct acid neutralising contribution.
Since the antacid combination acts locally in the stomach and the components
are all dissolved, a consideration of their systemic bioavailability and
pharmacokinetic behaviour is not appropriate to safety and efficacy
Residual sodium and citrate ions available for absorption are safely handled by
the body and excreted by normal metabolic routes.
Preclinical safety data
Preclinical safety data on these active ingredients in the literature, have not
revealed any pertinent and conclusive findings which are of relevance to the
recommended dosage and use of the product.
List of excipients
Special precautions for storage
Nature and contents of container
Clear, flint glass jar (150 g) with polythene, tamper-evident,
Sachet of laminate comprising 40 gsm paper/12 gsm low density
polythene/0.012 mm aluminium foil/23 gsm low density polythene,
containing 5 g of powder. The sachets (1 or 10) may be contained in a
Special precautions for disposal
MARKETING AUTHORISATION HOLDER
GlaxoSmithKline Consumer Healthcare (UK) Trading Limited
980 Great West Road
MARKETING AUTHORISATION NUMBER(S)
DATE OF FIRST AUTHORISATION/RENEWAL OF THE
10 June 1991 / 1 December 1998
DATE OF REVISION OF THE TEXT
Source: Medicines and Healthcare Products Regulatory Agency
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