Boots Constipation Relief 5mg Tablets Adult: Clinical Particulars

1. Name of the medicinal product

Bisalax

Asda Constipation Relief Tablets

Wilko Constipation Relief Tablets

Entrolax

Tesco Constipation Relief

Morrisons Laxative Tablets

Superdrug Constipation Relief Tablets

Numark Constipation Relief

Sainsbury's Constipation Relief

Boots Constipation Relief Tablets

2. Qualitative and quantitative composition

Bisacodyl BP 5.00mg

See 6.1 for excipients

3. Pharmaceutical form

Enteric sugar-coated tablets

4. Clinical particulars

4.1 Therapeutic indications

Short term relief of constipation

4.2 Posology and method of administration

Adults and children over 10 years: 1 to 2 coated tablets (5-10 mg) daily at night.

It is recommended to take the coated tablets at night to have a bowel movement the following morning. They should be swallowed whole with an adequate amount of fluid.

The coated tablets should not be taken together with products which reduce the acidity of the upper gastrointestinal tract, such as milk, antacids or proton pump inhibitors, in order not to prematurely dissolve the enteric coating.

No specific information on the use of this product in the elderly is available. Clinical trials have included patients over 65 years and no adverse reactions specific to this age group have been reported.

Route of administration: oral

4.3 Contraindications

Bisalax 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.

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

Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

Patients with rare hereditary problems of fructose intolerance or sucrase-isomaltase insufficiency should not take this medicine.

4.4 Special warnings and precautions for use

As with all laxatives, Bisacodyl 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.

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 self-limiting.

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.

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

Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

The tablets should not be crushed or chewed but swallowed whole. Antacids should not be given one hour after taking the tablets.

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 if excessive doses of Bisacodyl are taken.

Electrolyte imbalance may lead to increased sensitivity to cardiac glycosides.

4.6 Fertility, 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 into 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

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

4.8 Undesirable effects

The most commonly reported adverse reactions during treatment are abdominal pain and diarrhoea.

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)

Immune system disorders

Rare: anaphylactic reactions, angioedema, hypersensitivity

Metabolism and nutrition disorders

Rare: dehydration

Nervous system disorders

Uncommon: dizziness

Rare: Syncope

Dizziness and syncope occurring after taking bisacodyl appear to be consistent with a vasovagal response (e.g. to abdominal spasm, defaecation).

Gastrointestinal disorders

Uncommon: haematochezia (blood in stool), vomiting, abdominal discomfort, anorectal discomfort

Common: abdominal cramps, abdominal pain, diarrhoea and nausea

Rare: 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.

Laxatives when taken in chronic overdose 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 oral forms of Bisacodyl, 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. Pharmacological properties

5.1 Pharmacodynamic properties

Bisacodyl is a stimulant laxative that increases intestinal motility. The product resulting from the hydrolysis of Bisacodyl is responsible for its laxative effect.

5.2 Pharmacokinetic properties

After oral administration a small amount is absorbed from the gastrointestinal tract and excreted in the urine as the glucuronide. About 3% of the glucuronide appears in the bile after about 10 hours but Bisacodyl is mainly excreted in the faeces.

5.3 Preclinical safety data

Not applicable

6. Pharmaceutical particulars

6.1 List of excipients

Lactose

Maize starch

Magnesium stearate

Pregelatinised maize starch

Cellulose acetate phthalate

Diethylphthalate

Sucrose

Povidone

Talc

Titanium dioxide E171

Quinoline yellow E104

6.2 Incompatibilities

None known

6.3 Shelf life

3 years for containers and blister packs

6.4 Special precautions for storage

Do not store above 25°C

Keep in original container

6.5 Nature and contents of container

Cylindrical polypropylene containers with polythene lids and polyurethane or polythene inserts

Pack sizes: 8, 10 and 20

PVC/Aluminium blister packs

Pack sizes: 8, 10, 20 and 40

Not all pack sizes will be marketed in all liveries

6.6 Special precautions for disposal and other handling

No special instructions

7. Marketing authorisation holder

Dr. Reddy's Laboratories (UK) Ltd

6 Riverview Road

Beverley

East Yorkshire

HU17 0LD

UK

8. Marketing authorisation number

PL 08553/0199

9. Date of first authorisation/renewal of the authorisation

03/12/2004 / 04/02/2010

10. Date of revision of the text

24/01/2012