Document: spc-doc_PL 21880-0019 change

• spc-doc_PL 06464-0186
• spc-doc_PL 21880-0019

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SUMMARY OF PRODUCT CHARACTERISTICS

1. NAME OF THE MEDICINAL PRODUCT

Bisacodyl 5mg Tablets

Boots Constipation Relief 5mg Gastro-resistant Tablets

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each tablet contains Bisacodyl 5mg.

For a full list of excipients, see section 6.1.

3 PHARMACEUTICAL FORM

Gastro-resistant tablet.

Biconvex, yellow, sugar-coated and enteric-coated tablet.

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

Short term relief of constipation.

Constipation, either chronic or of recent onset, whenever a stimulant laxative is required.

Bowel clearance before surgery or radiological investigation. Replacement of the evacuant enema in all its indications.

4.2 Posology and method of administration

Children aged 10 years or younger with chronic constipation should only be treated under the guidance of a physician. Bisacodyl should not be used in children aged below 2

years of age or younger.

Short-term treatment for constipation:

Adults and children over 10 years:

1 - 2 coated tablets (5 - 10 mg) daily before bedtime, or 1 suppository (10 mg) for immediate effect.

Children 2 - 10 years: 1 coated tablet (5 mg) daily before bedtime, or

1    suppository (5 mg) for immediate effect.

For preparation of diagnostic procedures and preoperatively Should only be used under medical supervision.

Adults and children over 10 years:

2    coated tablets (10 mg) in the morning and 2 coated tablets (10 mg) in the evening and 1 suppository (10 mg) on the following morning is recommended.

Children 4-10 years of age:

1 coated tablet (5 mg) in the evening and one suppository (5 mg) on the following morning is recommended.

Due to the specific pharmaceutical form of the product from Guerbet (bottle containing a phosphate laxative and 4 (5 mg each) film-coated bisacodyl tablets for use as bowel preparation specifically for adults, the present posology should be maintained (For adults only. Do not administer to children below the age of 15 years)

4.3    Contraindications

Bisacodyl is contraindicated in:

•    patients with a known hypersensitivity to Bisacodyl or any other ingredient in the product

•    patients with ileus, intestinal obstruction or acute surgical abdominal conditions such as acute appendicitis

•    patients with acute inflammatory bowel diseases

•    patients with severe abdominal pain associated with nausea and vomiting which may be indicative of the aforementioned severe conditions

•    patients with severe dehydration

4.4    Special warnings and precautions for use

As with all laxatives, Bisacodyl tablets should not be taken on a continuous basis for more than five days.

If laxatives are needed every day, the cause of constipation should be investigated. Prolonged and excessive use may lead to fluid and electrolyte imbalance and hypokalaemia, and may precipitate the onset of rebound constipation.Prolonged use may precipitate the onset of an atonic, non-functioning colon. Laxatives do not help in longterm weight loss.

Intestinal loss of fluids can promote dehydration. Symptoms may include thirst and oliguria. In patients suffering from fluid loss where dehydration may be harmful (e.g. renal insufficiency, elderly patients) bisacodyl should be discontinued and only be restarted under medical supervision.

Patients may experience haematochezia (blood in stool) that is generally mild and selflimiting.

Dizziness and /or syncope have been reported in patients who have taken Bisacodyl. 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 bisacodyl itself.

There have been isolated reports of abdominal pain and bloody diarrhoea occurring after taking bisacodyl. Some cases have been shown to be associated with colonic mucosal ischaemia.

Children under 10 years should not take Bisacodyl tablets without medical advice. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

4.5 Interaction with other medicinal products and other forms of interaction

The concomitant use of antacids and milk products may reduce the resistance of the coating of the tablets and result in dyspepsia and gastric irritation.

The concomitant use of diuretics or adreno-corticosteroids may increase the risk of electrolyte imbalance. However, this situation only arises if excessive doses of Bisacodyl tablets are taken (See Overdose Section).

Electrolyte imbalance may lead to increased sensitivity to cardiac glycosides.

4.6 Pregnancy and lactation

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 bisacodyl (BHPM or bis - (p-hydroxyphenyl) - pyridyl - 2 - methane) nor its glucuronides are excreted in the milk of healthy lactating females.

Nevertheless, as with all medicines, bisacodyl 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.

4.7 Effects on ability to drive and use machines

Bisacodyl tablets have no effect on ability to drive and use machinery.

4.8    Undesirable effects

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 Rare: hypersensitivity

Not known: anaphylactic reactions, angioedema.

Metabolism and nutrition disorders Not known: dehydration.

Gastrointestinal disorders

Common: abdominal pain, abdominal cramps, nausea and diarrhoea Uncommon: vomiting, haematochezia (blood in stool), abdominal discomfort, anorectal discomfort.

Not known: Colitis

4.9    Overdose

Symptoms: If high doses are taken diarrhoea, abdominal cramps and a clinically significant loss of potassium and other electrolytes can occur. This may also lead to increased sensitivity to cardiac glycosides.

Chronic overdose with laxatives 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 after ingestion of Bisacodyl tablets, absorption can be minimised or prevented by inducing vomiting. Otherwise, gastric lavage should be performed. Replacement of fluids and correction of electrolyte imbalance (particularly hypokalaemia) may be required. This is especially important in the elderly and the young. Administration of antispasmodics may be of some value.

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Laxatives, ATC code: A06AB02

Bisacodyl is a locally acting laxative of the triarylmethane group, which, after bacterial cleavage in the colon, has the dual action of stimulating the mucosa of both the large intestine causing peristalsis and of the rectum causing 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.

5.2 Pharmacokinetic properties

Hydrolysis of Bisacodyl by enzymes of the enteric mucosa forms desacetylbisacodyl which is absorbed and excreted partly via urine and bile as glucuronide. By bacterial cleavage the active form, the free diphenol, is formed in the colon. Bisacodyl tablets are resistant to gastric and small intestinal juice, reaching the colon without any appreciable absorption and thereby avoiding enterohepatic circulation. Consequently, Bisacodyl tablets have an onset of action between 6 - 12 hours after administration.

After administration, only small amounts of the drug are systemically available. Urinary excretion reflects low systemic burden after administration.

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

5.3 Preclinical safety data

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

6 PHARMACEUTICAL PARTICULARS

6.1    List of excipients

Lactose Maize Starch Liquid Paraffin Magnesium Stearate

Coating:

Polyvinyl alcohol - part hydrolysed Titanium dioxide (E171)

Macrogol 3350

Talc

Silica

Methylacrylic acid co-polymer Sodium lauryl sulphate Triethyl citrate

Quinoline yellow aluminium lake (E104) Simethicone 30%Emulsion Shellac (E904)

Beeswax (E901)

Carnauba wax yellow (E903)

6.2    Incompatibilities

Not known

6.3    Shelf life

3 years ( Securitainers)

24 months ( blister)

6.4    Special precautions for storage

Do not store above 25°C and protect from light.

Blister : Do not store above 25⁰C. Store in the original package

6.5    Nature and contents of container

The product is available in packs of 500 and 1000 tablets in securitainers. The container is made up of a high density polypropylene body and low density polyethylene cap.