1. Name Of The Medicinal Product
Opiate Squill Linctus BP/Gee's Linctus BP
2. Qualitative And Quantitative Composition
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3. Pharmaceutical Form
Oral solution.
4. Clinical Particulars
4.1 Therapeutic Indications
For the symptomatic relief of chesty cough.
4.2 Posology And Method Of Administration
For oral administration.
Adults and children over 12 years
5ml three to four times daily.
Children under 12 years
Not recommend for children under 12 years unless prescribed by a physician.
Elderly
There is no need for dosage reduction in the elderly.
4.3 Contraindications
Hypersensitivity to ingredients. Patients with impaired renal or hepatic function or cardiac disorders. Moderate to severe respiratory depression, acute alcoholism, convulsive disorders, head injuries and conditions in which there is raised intracranial pressure.
4.4 Special Warnings And Precautions For Use
Should be used with caution in patients with colitis as there is risk of precipitating toxic megacolon. Should be used with caution in elderly patients as there is a risk of percipitating faecal impaction and intestinal obstruction. Excessive, long term use could induce dependence.
Warning: Do not exceed the stated dose.
If symptoms persist, consult your doctor.
Keep all medicines out of the reach of children.
May cause drowsiness.
This medicinal product contains 60.2g of sucrose. When taken according to the dosage recommendations each 5ml dose supplies up to 1.5g of sucrose. Unsuitable in hereditary fructose intolerance, glucose-galactose malabsorption syndrome or sucrase–isomaltase deficiency. (Sucrose)
Warning: this product contains 18.9% by volume of ethanol.
Each 5ml dose contains 0.76g of alcohol.
Harmful for those suffering from liver disease, alcoholism, epilepsy, brain injury or disease as well as for pregnant women and children.
May modify or increase the effect of other medicines. (Alcohol)
4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction
Clinically significant interactions may occur in patients taking MAOI's concurrently or within 14 days of such treatment and these reactions may be serious. The depressant effects of morphine may enhance depressants of the central nervous system such as alcohol, anaesthetics, hypnotics, sedatives and phenothiazines.
4.6 Pregnancy And Lactation
The safety of this product during pregnancy and lactation has not been established.
4.7 Effects On Ability To Drive And Use Machines
Opiate Squill Linctus may cause drowsiness in certain individuals and may therefore interfere with the ability to drive and to operate machinery.
4.8 Undesirable Effects
May cause constipation if used over a long period. If hypersensitive to squill could cause violent purging, nausea, vomiting and drowsiness.
4.9 Overdose
Nausea, vomiting, constipation, drowsiness – signs of morphine overdose. Treat by aspiration and lavage. In severe cases of overdosage morphine-induced depression may be reversed with the specific opiate antagonist naloxone. Intoxication due to squill glycosides, treat as for digoxin overdose.
5. Pharmacological Properties
5.1 Pharmacodynamic Properties
Tincture of opium has a suppressant action on the cough centre due to its morphine and codeine content. Squill facilitates removal of mucus from bronchial passageways by virtue of a reflex action on bronchial secretions resulting from irritation of the gastrointestinal tract.
5.2 Pharmacokinetic Properties
Opioids are readily absorbed from the gastrointestinal tract, and undergo significant first pass metabolism in the liver. The major pathway for detoxification is conjugation with glucuronic acid. Very little morphine is excreted unchanged, it is eliminated by glomerular filtration. 90% of an administered dose is excreted within 24 hours. Codeine is likewise excreted chiefly in the urine.
5.3 Preclinical Safety Data
There are no preclinical data of relevance to the prescriber which are additional to that already included.
6. Pharmaceutical Particulars
6.1 List Of Excipients
Tolu flavour solution
Liquid sugar
Honey
Alcohol (96%)
Benzoic acid
Racemic camphor
Star anise oil
Tragacanth powdered
Purified water
6.2 Incompatibilities
None stated.
6.3 Shelf Life
36 months.
6.4 Special Precautions For Storage
None
6.5 Nature And Contents Of Container
100, 200, 2000ml amber-coloured glass bottle with a polypropylene screw cap, unfitted or an aluminium pilfer-proof, roll-on cap and a PVC flowed-in liner or a triseal (LDPE/EPE/LDPE) liner.
6.6 Special Precautions For Disposal And Other Handling
Not applicable
7. Marketing Authorisation Holder
The Boots Company PLC
1 Thane Road West
Nottingham NG2 3AA
8. Marketing Authorisation Number(S)
PL00014/5721R
9. Date Of First Authorisation/Renewal Of The Authorisation
Date of first authorisation: 21 July 1989
Renewal of the authorisation: 29 September 2002
10. Date Of Revision Of The Text
January 2010
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