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ENO

Active substance: SODIUM CARBONATE ANHYDROUS

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Eno

2.

QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5 g of powder contains:
Sodium Bicarbonate Ph Eur
2.32 g
Citric Acid Ph Eur
2.18 g
Anhydrous Sodium Carbonate Ph Eur

0.50 g

Sodium content:
Each 5g of powder contains 0.85 g of sodium

3.

PHARMACEUTICAL FORM
Powder.

4.

CLINICAL PARTICULARS

4.1.

Therapeutic indications
The symptomatic relief of indigestion, flatulence and nausea.

4.2.

Posology and method of administration
The powder is to dissolved in water before taking orally.
Adults and children aged 12 years and over:
5 g (one 5 ml spoonful) or one sachet every two or three hours if necessary.
Do not take more than six 5 ml spoonfuls or six sachets in 24 hours.
Children under 12 years:
Only on medical advice.
The elderly can take the adult dose.

4.3.

Contraindications
Patients on salt restricted diets.
Impaired hepatic and renal function.

4.4.

Special warnings and precautions for use
If symptoms persist consult your doctor.

4.5.

Interactions 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 concomittantly.

4.6.

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.

4.7.

Effects on ability to drive and use machines
None.

4.8.

Undesirable effects
None.

4.9.

Overdose

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.

5.

PHARMACOLOGICAL PROPERTIES

5.1.

Pharmacodynamic properties
This product is an antacid.
Sodium bicarbonate
Sodium carbonate
Citric acid

5.2.

) 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.

Pharmacokinetic properties
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
considerations.
Residual sodium and citrate ions available for absorption are safely handled by
the body and excreted by normal metabolic routes.

5.3.

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.

6.

PHARMACEUTICAL PARTICULARS

6.1.

List of excipients
None.

6.2.

Incompatibilities
None.

6.3.

Shelf life
Three years.

6.4.

Special precautions for storage
None.

6.5. Nature and Contents of Container
Clear, flint glass jar (150 g) with polythene, tamper-evident,
Jay-cap closure.
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
boxboard carton.
6.6.
Instructions for use/handling
Not applicable.

7.

MARKETING AUTHORISATION HOLDER
Beecham Group plc,
980 Great West Road
Brentford
Middlesex
TW8 9GS
United Kingdom
trading as:
GlaxoSmithKline Consumer Healthcare, Brentford, TW8 9GS, UK

8.

MARKETING AUTHORISATION NUMBER(S)
PL 0079/0273

9.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
10 June 1991 / 1 December 1998

10

DATE OF REVISION OF THE TEXT
09/09/2014

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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