Biolax Tablets
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
BIOLAX/Bisacodyl 5 mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains Bisacodyl 5 mg
Also contains 41.1 mg of lactose and 36.0 mg of sucrose per tablet. For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Gastro-resistant tablets
Yellow sugar-coated tablet with gastro-resistant coating
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
For human medicinal use
Short-term relief of Constipation either chronic or of recent onset.
4.2 Posology and method of administration
Posology:
It is recommended to take the coated tablets at night to have a bowel movement the following morning.
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.
Short-term treatment of constipation:
Adults and children over 10 years: 1 to 2 coated tablets (5-10 mg) daily before
bedtime
Route of administration: Oral
The tablets should not be crushed or chewed but swallowed whole with water.
4.3 Contraindications
Bisacodyl must not be used in;
• Conditions where any laxative is contraindicated
• Patients with hypersensitivity to Bisacodyl or to any of the excipients listed in section 6.1
• Patients with ileus, intestinal obstruction
• Acute surgical abdominal conditions such as acute appendicitis
• Acute inflammatory bowel diseases
• Severe abdominal pain associated with nausea and vomiting
• Severe dehydration
4.4 Special warnings and precautions for use
Bisacodyl should not be taken on a continuous daily basis for more than 5 days without investigating the cause of constipation.
Prolonged use can precipitate the onset of an atonic non-functioning colon.
Prolonged and 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.
Laxatives do not help in long-term weight loss.
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 defecation 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 galactose intolerance, fructose intolerance, the Lapp lactase deficiency, glucose-galactose malabsorbtion 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 if excessive doses of Bisacodyl are taken. Electrolyte imbalance may lead to increased sensitivity to cardiac glycosides.
4.6 Fertility, pregnancy and lactation
Pregnancy
Pregnancy:
There are no adequate and well-controlled studies in pregnant women.
Long experience has shown no evidence of undesirable or damaging effects during pregnancy.
Breast-feeding:
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.
Fertility:
No studies on the effect on human fertility have been conducted.
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.
However, patients should be advised that due to a vasovagal response (e.g. to abdominal spasm) they may experience dizziness and / or syncope. If patients experience abdominal spasm they should avoid potentially hazardous tasks such as driving or operating machinery.
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: Hypersensitivity, anaphylactic reactions, angioedema
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
Common: Abdominal pain, abdominal cramps, nausea and diarrhoea.
Uncommon: Vomiting, haematochezia (blood in stool), abdominal discomfort,
anorectal discomfort.
Rare: Colitis
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:
If high doses are taken watery stools (diarrhoea), abdominal cramps and a clinically significant loss of fluid, 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:
After ingestion of oral forms of Bisacodyl, absorption can be minimised or prevented by inducing vomiting or 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.
5.1 Pharmacodynamic properties
ATC code: A06AB02
Bisacodyl is a locally acting stimulant laxative from the diphenylmethane derivatives group having a dual action.. As a contact laxative, for which also antiresorptive hydragogue effects have been described, bisacodyl stimulates after hydrolysis in the large intestine, 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 defecation, 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.
5.2 Pharmacokinetic properties
Following oral administration, bisacodyl is rapidly hydrolyzed to the active principle bis-(p-hydroxyphenyl)-pyridyl-2-methane (BHPM), mainly by esterases of the enteric mucosa.
Administration as an enteric coated tablet was found to result in maximum BHPM plasma concentrations between 4 - 10 hours post administration whereas the laxative effect occurred between 6 - 12 hours post administration. In contrast, following the administration as a suppository, the laxative effect occurred on average approximately 20 minutes post administration; in some cases it occurred 45 minutes after administration. The maximum BHPM-plasma concentrations were achieved 0.5 - 3 hours following the administration as a suppository. Hence, the laxative effect of bisacodyl does not correlate with the plasma level of BHPM. Instead, BHPM acts locally in the lower part of the intestine and there is no relationship between the laxative effect and plasma levels of the active moiety. For this reason, bisacodyl coated tablets are formulated to be resistant to gastric and small intestinal juice. This results in a main release of the drug in the colon, which is the desired site of action.
After oral and rectal administration, only a small amount of the drug is absorbed and is almost completely conjugated in the intestinal wall and the liver to form the inactive BHPM glucuronide. The plasma elimination half-life of BHPM glucuronide was estimated to be approximately 16.5 hours. About 3% of the glucuronide appears in the bile after about 10 hours but Bisacodyl is mainly excreted in the faeces. Following the administration of bisacodyl coated tablets, an average of 51.8% of the dose was recovered in the faeces as free BHPM and an average of 10.5% of the dose was recovered in the urine as BHPM glucuronide.
5.3 Preclinical safety data
No relevant information additional to that contained elsewhere in the SPC.
6.1 List of excipients
Lactose
Maize starch
Magnesium stearate
Pregelatinised maize starch
Cellulose acetate phthalate
Diethylphthalate
Talc
Sucrose
Povidone
Titanium dioxide
Quinoline yellow (E104)
6.2 Incompatibilities
Not applicable
6.3 Shelf life
36 months
6.4 Special precautions for storage
Do not store above 25°C. Store in the original package
6.5 Nature and contents of container
Strips of 250 micron PVC glass-clear/bluish rigid PVC (Pharmaceutical grade) 20 micron hard-tempered aluminium foil coated on the dull side with 6-7 gsm heat seal lacquer and printed on the bright side.
Pack sizes: 10
Special precautions for disposal
Not applicable
7
MARKETING AUTHORISATION HOLDER
Chelonia Healthcare Limited 11 Boumpoulinas Street,
3rd Floor, 1060 Nicosia Cyprus
8
9
10
19/05/2015