Neo Baby Gripe Mixture
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Neo Baby Gripe Mixture
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5ml contains Sodium Bicarbonate 50mg
Excipient(s) with known effect:
Strong Tincture of Ginger (contains ethanol)
Sucrose
Parahydroxybenzoates (methyl E218, ethyl E214, propyl E216 & butyl) Propylene Glycol
For the full list of excipients, see section 6.1
3. PHARMACEUTICAL FORM
Oral solution
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
For the symptomatic relief of wind pain and gripes.
4.2 Posology and method of administration
Posology
Paediatric population
For oral administration to infants and children 1 month up to 1 year:
5ml to be given three times a day as required.
Method of administration Oral
4.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1
4.4 Special warnings and precautions for use
Parahydroxybenzoates (methyl E218, ethyl E214, propyl E216 & butyl) may cause allergic reactions (possibly delayed).
Patients with hereditary problems of fructose intolerance, glucose-glactose malabsorption or sucrose-isomaltase insufficiency should not take this medicine.
The ingredient Strong Tincture of Ginger contains small amounts of ethanol (alcohol), less than 100mg per dose.
Propylene glycol may cause alcohol-like symptoms.
4.5. Interactions with other medicaments and other forms of interaction
None known.
4.6. Pregnancy and lactation
Can be given regularly to nursing mothers, pregnant women and adults suffering from wind pains.
4.7 Effects on ability to drive and use machines
Not relevant.
4.8 Undesirable effects
None known.
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, website: www.mhra.gov.uk/yellowcard.
4.9. Overdose
Not applicable.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Antacids with sodium bicarbonate, ATC code: A02AH Sodium Bicarbonate neutralises stomach acid and relieves dyspepsia.
5.2 Pharmacokinetic properties
The active is in solution and is available for direct action in the stomach and upper alimentary tract.
5.3. Preclinical safety data
None stated.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Strong Tincture of Ginger, Oil of Dill, Disodium Edetate, Sucrose, Soluble Saccharin, Parahydroxybenzoates (methyl E218, ethyl E214, propyl E216 & butyl), Propylene Glycol and Purified Water.
6.2 Incompatibilities
Not applicable.
6.3. Shelf life
36 months.
6.4. Special precautions for storage
Store below 25°C.
6.5. Nature and contents of container
Glass bottle (either Amber or White Flint) containing 150ml.
6.6 Special precautions for disposal
No special requirements
7 MARKETING AUTHORISATION HOLDER
Neo Laboratories Ltd.
51-53 Stert Street Abingdon
Oxfordshire OX14 3JF United Kingdom
8. MARKETING AUTHORISATION NUMBER
PL 02019/5001R
9. DATE OF FIRST AUTHORISATION/RENEWAL OF AUTHORISATION
6 August 1992
10 DATE OF REVISION OF THE TEXT
09/07/2015