Dulcolax^® Pico Perles^®, 2.5 mg soft capsules.

Each capsule contains 2.5 mg sodium picosulfate as Sodium Picosulfate Monohydrate.

For excipients, see 6.1

Small, pearl-shaped, soft gelatin capsules.

Short term relief of constipation.

For the management of constipation of any aetiology.

For oral administration

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

Adults and children over 10 years:

Two to four capsules (5 - 10 mg) at night

Children under 10 years:

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

Children (4 - 10 years):

One to two capsules (2.5 - 5 mg) at night.

Children under 4 years:

Not recommended for children under 4 years of age.

Once regularity has restarted dosage should be reduced and can usually be stopped.

The capsules should be swallowed with adequate fluid.

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.

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 a 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.

Propylene glycol

Polyethylene glycol 400

Gelatin

Glycerol

Purified water

None stated.

36 months

Do not store above 25°C

Keep the bottle within the outer carton

Type III colourless glass bottles with polypropylene screw caps or child resistant polypropylene screw caps, each containing 20, 24 or 50 capsules

Not applicable.

Boehringer Ingelheim Ltd

Consumer Healthcare

Ellesfield Avenue

Bracknell

Berkshire

RG12 8YS

United Kingdom

PL 00015/0254

14 July 2000

January 2012

Pharmacy only, unless

General Sale List: packs up to 24 capsules, with child resistant caps