Dulcolax^® Pico Liquid, 5 mg / 5 ml, oral solution.

Each 5ml of liquid contains 5 mg sodium picosulfate.

Dulcolax^® Pico Liquid also contains methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), ethanol and the colouring agent sunset yellow FCF (E110).

For full list of excipients , see section 6.1.

Oral solution.

Golden orange coloured liquid, with a fruit-like odour and taste.

Pharmacy only and GSL:

Short term relief of constipation

Pharmacy only:

For the management of constipation of any aetiology.

For oral administration

Unless otherwise prescribed by the doctor, the following dosages are recommended:

Pharmacy only and GSL:

Adults and children over 10 years:

One to two 5 ml spoonfuls (5 - 10 mg) at night.

Pharmacy only:

Children under 10 years:

Not to be taken by children under 10 years without medical advice.

Children (4 - 10 years):

Half to one 5 ml spoonful (2.5 - 5 mg) at night.

Children under 4 years:

The recommended dosage is 250 micrograms per kilogram body weight.

In the management of constipation, once regularity has restarted dosage should be reduced and can usually be stopped.

Diluent: Can be diluted with purified water.

DULCOLAX is contraindicated in patients with ileus, intestinal obstruction, acute abdominal conditions including appendicitis, acute inflammatory bowel diseases, and severe abdominal pain associated with nausea and vomiting which may be indicative of the aforementioned severe conditions.

DULCOLAX is also contraindicated in severe dehydration and in patients with known hypersensitivity to sodium picosulfate or any other component of the product.

In case of rare hereditary conditions that may be incompatible with an excipient of the product (see section 4.4) the use of the product is contraindicated.

As with all laxatives, DULCOLAX should not be taken on a continuous daily basis for more than five days without investigating the cause of constipation.

Prolonged excessive use may lead to fluid and electrolyte imbalance and hypokalaemia.

Dizziness and/or syncope have been reported in patients who have taken DULCOLAX. The details available for these cases suggest that the events would be consistent with defaecation syncope (or syncope attributable to straining at stool), or with a vasovagal response to abdominal pain related to the constipation, and not necessarily to the administration of sodium picosulfate itself.

DULCOLAX should not be taken by children under 10 years without medical advice.

Dulcolax^® Pico Liquid contains 5.9 vol % ethanol (alcohol) i.e. up to 480 mg per dose, equivalent to 12 ml beer, 5 ml wine per dose. Harmful for those suffering from alcoholism. To be taken into account in pregnant or breast-feeding women, children and high-risk groups such as patients with liver disease, or epilepsy.

Dulcolax^® Pico Liquid contains the preservatives methyl parahydroxybenzoate, propyl parahydroxybenzoate and the colouring agent sunset yellow FCF (E110) which may cause allergic reactions (possibly delayed).

The concomitant use of diuretics or adreno-corticosteroids may increase the risk of electrolyte imbalance if excessive doses of DULCOLAX are taken.

Electrolyte imbalance may lead to increased sensitivity to cardiac glycosides.

Concurrent administration of antibiotics may reduce the laxative action of this product.

There are no adequate and well-controlled studies in pregnant women. Long experience has shown no evidence of undesirable or damaging effects during pregnancy.

Clinical data show that neither the active moiety of sodium picosulfate (BHPM or bis-(p-hydroxyphenyl)-pyridyl-2-methane) nor its glucuronides are excreted into the milk of healthy lactating females.

Nevertheless, as with all medicines, DULCOLAX should not be taken in pregnancy, especially the first trimester, and during breast feeding unless the expected benefit is thought to outweigh any possible risk and only on medical advice.

No studies on the effects on the ability to drive and use machines have been performed.

However, patients should be advised that due to a vasovagal response (for example, due to abdominal spasm), dizziness and /or syncope may be experienced. If patients experience abdominal spasm they should avoid potentially hazardous tasks such as driving or operating machinery.

Adverse events have been ranked under headings of frequency using the following convention:

Very common ( 1/10); common ( 1/100, < 1/10); uncommon ( 1/1000, <1/100); rare ( 1/10000, <1/1000); very rare (<1/10000); not known – cannot be estimated from the available data.

Immune system disorders

Not known: Hypersensitivity including angioneurotic oedema and skin reactions.

Nervous system disorders

Uncommon: Dizziness

Not known: Syncope^*

Dizziness and syncope occurring after taking sodium picosulfate appear to be consistent with a vasovagal response (for example, due to abdominal spasm, defaecation).

Gastrointestinal disorders

Very common: Diarrhoea

Common: Abdominal discomfort, abdominal pain, abdominal cramps.

Uncommon: Nausea, vomiting.

*This adverse event has been observed in post-marketing experience. With 95% certainty, the frequency category is not greater than uncommon, but might be lower. A precise frequency estimation is not possible as the adverse event did not occur in a clinical trial database of 1020 patients.

Symptoms: If high doses are taken diarrhoea, abdominal cramps and a clinically significant loss of fluid, potassium and other electrolytes can occur.

Furthermore, cases of colonic mucosal ischaemia have been reported in association with doses of DULCOLAX considerably higher than those recommended for the routine management of constipation.

Laxatives when taken in chronic overdosage may cause chronic diarrhoea, abdominal pain, hypokalaemia, secondary hyperaldosteronism and renal calculi. Renal tubular damage, metabolic alkalosis and muscle weakness secondary to hypokalaemia have also been described in association with chronic laxative abuse.

Therapy: Within a short time of ingestion, absorption can be minimised or prevented by inducing vomiting or by gastric lavage. Replacement of fluids and correction of electrolyte imbalance may be required. This is especially important in the elderly and the young.

Administration of antispasmodics may be of some value.

Sodium picosulfate is a locally acting laxative from the triarylmethane group, which after bacterial cleavage in the colon, has a dual-action with stimulation of the mucosa of both the large intestine and of the rectum. Stimulation of the mucosa of the large intestine results in colonic peristalsis, with promotion of accumulation of water, and consequently electrolytes, in the colonic lumen. This results in stimulation of defaecation, reduction of transit time and softening of the stool. Stimulation of the rectum causes increased motility and a feeling of rectal fullness. The rectal effect may help to restore the “call to stool” although its clinical relevance remains to be established.

After oral ingestion, sodium picosulfate reaches the colon without any appreciable absorption. Therefore, enterohepatic circulation is avoided. The active laxative compound, bis-(p-hydroxyphenyl)-pyridyl-2-methane (BHPM), is formed by bacterial cleavage in the intestine. Consequently, the onset of action of the preparation is usually between 6 - 12 hours, which is determined by the release of the active substance.

After oral administration, only small amounts of the drug are systemically available.

There is no relationship between the laxative effect and plasma levels of the active moiety.

There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.

Sodium Carboxymethylcellulose

Methyl Parahydroxybenzoate (E218)

Propyl Parahydroxybenzoate (E216)

Glycerol

Aroma Tutti Frutti (flavouring)

Saccharin Sodium

FD & C Yellow 6 (E110) (colouring)

Ethanol 96%

0.1 M Sodium Hydroxide

Purified Water

None stated

3 years

Keep the container in the outer carton

Amber glass bottles with aluminium ROPP caps.

Pack sizes of 30, 40, 50, 60, 90, and 500 ml.

Amber glass bottles with polypropylene tamper-evident closure with expanded polyethylene (coated with LDPE) liner.

Pack sizes of 100, 250 and 300 ml.

Not all pack sizes may be marketed.

Not applicable.

Boehringer Ingelheim Limited

Ellesfield Avenue

Bracknell

Berkshire

RG12 8YS

Trading as Boehringer Ingelheim Self-Medication Division

PL 00015/0249

16^th September 2005

January 2012

90, 100, 250, 300, 500 ml : P

30, 40, 50, 60 ml : GSL