4.1. Therapeutic indications

For the symptomatic relief of distress associated with wind in infants up to one year old.

4.2. Posology and method of administration

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.

4.3. Contraindications

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.

4.4. Special warnings and precautions for use

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).

This medicinal product contains 15.73 mg sodium per 5 ml, equivalent to 0.8% 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. Calorific value 2.3 kcal/g maltitol.

Maximum Daily Dose:

Sodium:

188.76 mg (8.21 mmol)

Propylene glycol for child aged 6 - 12 months**:

2400 mg

Propylene glycol for child aged 1 - 6 months***:

1200 mg

Maltitol liquid:

11.4 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).

4.5. Interaction with other medicinal products and other forms of interaction

A time-interval of 2 hours should be considered between intake of this product and the administration of other medicinal products.

4.6. Fertility, pregnancy and lactation

Not applicable

4.7. Effects on ability to drive and use machines

Not applicable

4.8. Undesirable effects

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. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard

4.9. Overdose

Symptoms following overdose are rare and are generally due to the effects of sodium hydrogen carbonate. These may include diarrhoea, metabolic alkalosis, hypokalaemia and hypernatraemia. In the event of severe overdosing, medical advice should be sought immediately.

Symptoms of hypernatraemia may include drowsiness and irritability, pyrexia and tachypnoea, muscle weakness and arrhythmia. In more severe instances of acute sodium overload, signs of dehydration and convulsions may occur.

The treatment of metabolic alkalosis consists of correction of fluid and electrolyte balance.

The treatment of hypernatraemia includes repair of any dehydration present and gradual reduction of the plasma sodium. The alkalosis, if present, will respond usually to the treatment of hypernatraemia. At all times intensive monitoring of the electrolytes, and patients circulatory and central nervous system are necessary.