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. 4.1.
CLINICAL PARTICULARS 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. 5.1.
PHARMACOLOGICAL PROPERTIES Pharmacodynamic properties This product is an antacid. Sodium bicarbonate Sodium carbonate Citric acid ) 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.
5.2.
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. 6.1.
PHARMACEUTICAL PARTICULARS 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 (109, 150 or 218 g) with polythene, tamper-evident, Jaycap 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 (PARTIAL) REVISION OF THE TEXT 21 April 2004
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. 4.1.
CLINICAL PARTICULARS 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. 5.1.
PHARMACOLOGICAL PROPERTIES Pharmacodynamic properties This product is an antacid. Sodium bicarbonate Sodium carbonate Citric acid ) 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.
5.2.
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. 6.1.
PHARMACEUTICAL PARTICULARS 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 (109, 150 or 218 g) with polythene, tamper-evident, Jaycap 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 (PARTIAL) REVISION OF THE TEXT 21 April 2004
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 drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
