Biolax Tablets
Out of date information, search anotherSUMMARY OF PRODUCT CHARACTERISTICS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 lactose and sucrose. For 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
Constipation either chronic or of recent onset.
Bowel Clearance before surgery, labour or radiological investigation.
4.2 Posology and method of administration
Route of administration: oral
The tablets should not be crushed or chewed but swallowed whole with water.
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.
GSL product:
Short-term treatment of constipation:
Adults and children over 10 years: 1 to 2 coated tablets (5-10 mg) daily before
bedtime
P product:
Children aged 10 years or younger with chronic or persistent constipation should only be treated under the guidance of a physician. Bisacodyl should not be used in children aged 4 years or younger.
Short-term treatment of constipation:
Adults and children over 10 years: 1 to 2 coated tablets (5-10 mg) daily before
bedtime
Children 4-10years: 1 coated tablet (5 mg) daily before bedtime
In the management of constipation, once regularity has been restarted dosage should be reduced and can usually be stopped.
In preparation for radiological investigation, 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: 1 coated tablet (5 mg) in the evening and 1
suppository (5 mg) on the following morning is recommended
When using Bisacodyl to prepare the patient for radiographic examination of the abdomen or employing it preoperatively, tablets should be combined with suppositories in order to achieve complete evacuation of the intestine.
4.3 Contraindications
Bisacodyl must not be used in;
• Conditions where any laxative is contraindicated
• Patients with hypersensitivity to Bisacodyl or to the constituents listed
• 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 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 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 / fructose intolerance, Lapp lactase deficiency or 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 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
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 - incidence cannot be estimated from the available data.
Immune system disorders:
Rare:
Hypersensitivity
Not known: Anaphylactic reactions, angiooedema
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 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 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
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
Dispersed yellow (E104)
6.2. Incompatibilities
Not applicable
6.3. Shelf Life
36 months for containers and strips.
6.4. Special Precautions for Storage
Containers: Do not store above 25°C. Store in the original container. Keep the container tightly closed.
Strips: Do not store above 25°C. Store in the original package.
6.5. Nature and Contents of Container
High-density polystyrene with Polythene lids and/or polypropylene containers with polypropylene or Polythene lids and polyurethane/Polythene inserts.
Pack sizes: 8, 10, 28, 30, 50, 56, 60, 84,100, 250, 500 and 1000 for the P product only.
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: 8, 10, 28, 30, 50, 56, 60, 84, 100, 250, 500 and 1000 for the P product. 10 only for the GSL product.
6.6. Instruction for Use/Handling
Not applicable
7 MARKETING AUTHORISATION HOLDER
Chatfield Pharmaceuticals Limited T/A Chatfield Laboratories Kramer Mews London SW5 9JL United Kingdom
8 MARKETING AUTHORISATION NUMBER(S)
PL 02142/0028
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
09/03/2009
10 DATE OF REVISION OF THE TEXT
27/04/2011