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BOOTS VEGETABLE LAXATIVE TABLETS

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Product Summary
1.

Trade Name of the Medicinal Product
Boots Vegetable Laxative Tablets

2.

Qualitative and Quantitative Composition
Active ingredient
Compound colocynth extract
Jalap resin
Hyoscyamus dry extract
Peppermint oil

3.

Quantity/unit dose mg
60.0
15.0
15.0
0.006ml

Pharmaceutical Form
White, sugar-coated tablet

Clinical Particulars
4.1

Therapeutic Indications
For the relief of occasional constipation.

4.2

Posology and Method of Administration
For oral administration.
Adults and children over 12 years: Unless otherwise directed by the doctor, one to three
tablets to be taken with water.
Children under 12 years: Not suitable for children under 12 years.
Elderly: The normal adult dosage is appropriate in the elderly.

4.3

Contra-Indications
Hypersensitivity to any of the ingredients. Contraindicated in patients with abdominal pain,
nausea and vomiting, prostatic enlargement, pyloric stenosis, closed angle glaucoma,
paralytic ileus, toxic megacolon and myasthenia gravis.

4.4

Special Warnings and Precautions for Use

This product should not be used for prolonged periods since it may decrease the sensitivity
of the intestinal mucous membranes, so larger doses have to be taken and the bowel fails to
respond to normal stimuli.
Should be used with caution in patients with asthma, hypertension, cardiac dysfunction,
tachycardia and unstable angina.
Warning: Do not exceed the stated dose.
For use in occasional constipation.
Laxatives should not be taken where there is severe abdominal pain or used regularly for
prolonged periods except on medical advice.
Keep all medicines out of the reach of children.

4.5

Interactions with other Medicaments and other forms of Interaction
The effects of the hyoscyamus content may be enhanced by other drugs with anticholinergic
properties including amantadine, some antihistamines, butyrophenones, phenothiazines and
tricyclic antidepressants.

4.6

Pregnancy and Lactation
The use of this product during pregnancy and lactation is contraindicated.

4.7

Effects on Ability to Drive and Use Machines
No adverse effects known.

4.8

Undesirable Effects
Undesirable effects may include dryness of the mouth, thirst, mydriasis, loss of
accommodation, dysphagia, impotence, urinary retention or hesitancy, dermal flushing,
dizziness, insomnia, photophobia, increased intraocular pressure, dry skin, bradycardia,
followed by tachycardia with palpitations and arrhythmias.
Prolonged use may produce watery diarrhoea with excessive loss of fluid and electrolytes,
muscular weakness and weight loss.

4.9

Overdose
Symptoms of overdosage may include those given under 4.8 above and severe abdominal
pain, vomiting, diarrhoea with blood-stained watery stools and delirium, hyperpyrexia
(particularly in children), urinary retention and excitation.
Treatment consists of emptying the stomach by emesis or aspiration and lavage. Treatment
should include symptomatic and supportive measures, replacement of fluid and electrolyte
losses and the administration of neostigmine injection, either subcutaneously or
intramuscularly, to reverse the peripheral anticholinergic effects.

Pharmacological Properties
5.1

Pharmacodynamic Properties
Jalap and colocynth are stimulant (drastic) purgatives. Hyoscyamus dry extract has
anticholinergic properties and counteracts the spasm and griping induced by jalap and
colocynth.
Peppermint oil has carminative properties and also counteracts the griping induced by jalap
and colocynth.

5.2

Pharmacokinetic Properties
Not available.

5.3

Preclinical Safety Data
There are no preclinical data of relevance to the prescriber which are additional to that
already included.

Pharmaceutical Particulars
6.1

List of Excipients
Maize starch pdr
Lactose
Isopropyl alcohol
Refined sugar
Liquid glucose BPC '63 (solids)
French chalk for tablets (tablet dusting)
Titanium dioxide (powder 16)
Purified water
Tragacanth pdrd
French chalk for tablets
White beeswax
Light petroleum 125-150°
Heavy magnesium carbonate
Stearic acid pdr

6.2

Incompatibilities
None

6.3

Shelf Life
36 months

6.4

Special Precautions for Storage
None

6.5

Nature and Contents of Container
30ml rectangular amber glass bottle having a wadless white polypropylene cap; the ullage is
filled with cotton wool.
Pack size: 100

6.6

Instructions for Use/Handling
Not applicable

Administrative Data
7.

Marketing Authorisation Holder
The Boots Company PLC
1 Thane Road West
Nottingham NG2 3AA

8.

Marketing Authorisation Number
PL 00014/5018R

9.

Date of First Authorisation/Renewal of Authorisation
Date of first authorisation: 24 March 1988
Date of last renewal: 24 March 1993

10.

Date of (Partial) Revision of the Text
December 1997

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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