WOODWARDS GRIPE WATER - ALCOHOL FREE & SUGAR FREE

For oral use Adults & the Elderly:

Not applicable Children: 1 - 6 months old - One 5ml spoonful 6 - 12 months old - Two 5ml spoonsful Under one month old - Not to be used Children aged 1 year and over: Do not use. These doses may be given during or after each feed or up to six times in 24 hours.

Adverse events which have been associated with dill seed oil and sodium bicarbonate are given below, tabulated by system organ class and frequency.

Frequencies are defined as:

Very common (≥1/10); Common (≥1/100 and <1/10); Uncommon (≥1/1000 and <1/100); Rare (≥1/10,000 and <1/1000); Very rare (< 1/10,000); Not known (cannot be estimated from the available data). Within each frequency grouping, adverse events are presented in order of decreasing seriousness.

System Organ Class Frequency Adverse Events Immune System Disorders Not known Hypersensitivity 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. uk/yellowcard

If symptoms persist, medical advice should be sought. Keep all medicines out of the sight and reach of children. Patients with rare hereditary problems of fructose intolerance should not take this medicine.

Label must include equivalent sentences of:

This medicine contains hydroxybenzoate derivatives (E215, E217 and E219) which may cause allergic reactions (possibly delayed). 8% of the WHO recommended maximum daily intake of 2 g sodium for an adult. This product is considered high in sodium.

This should be particularly taken into account for those on a low salt diet. Do not use in children under 1 month. This medicine contains 200 mg propylene glycol in each 5 ml which is equivalent to 200 mg/5 ml. Talk to your doctor or pharmacist before giving your child this medicine, in particular if they use other medicines that contain propylene glycol or alcohol.

If you suffer from a liver or kidney disease, do not take this medicine unless recommended by your doctor. Your doctor may carry out extra checks while you are taking this medicine. This medicine contains maltitol. Patients with rare hereditary problems of fructose intolerance should not take this medicine.

May have a mild laxative effect. 3 kcal/g maltitol. 4 g **(343 mg/kg/day based on weight of 7 kg for a 6 month old) *** (300 mg/kg/day based on weight of 4 kg for a 1 month old) This medicine contains parahydroxybenzoates and their esters* which may cause allergic reactions (possibly delayed).

Should not be used where impaired kidney function or hypersensitivity to hydroxybenzoates exists. Hypersensitivity to dill seed oil, sodium hydrogen carbonate (sodium bicarbonate) or to any excipients in the product. Patients with metabolic or respiratory alkalosis, hypocalcaemia, or hypochloraemia.