Gees Linctus Bp
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Gee’s Linctus BP
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Camphorated Opium Tincture BP 33.3 33% v/v
Squill Oxymel BP 33.333% v/v
For excipients see 6.1
3 PHARMACEUTICAL FORM
Oral Solution
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Gee’s Linctus is an antitussive preparation indicated for the relief of unproductive cough.
4.2 Posology and method of administration
Oral administration
Adults and children over 12 years: One 5ml spoonful to be taken 3-4 times daily. Not to be given to infants. To be used with caution in the elderly.
4.3 Contraindications
i. Hypersensitivity to opium.
ii. Respiratory depression and obstructive airways disease.
iii. Concurrent administration of other opiates and monoamine oxidase inhibitors;
also within two weeks of discontinuation of treatment with them.
iv. Not to be used during exacerbation of asthma.
v. Impaired renal function, impaired hepatic function, cardiac disorders, moderate to severe respiratory insufficiency, alcoholism and raised intracranial pressure or if hypersensitive to any ingredient.
4.4 Special warnings and precautions for use
Gee’s Linctus may suppress respiration especially in the very young, the elderly, very ill or debilitated patients and those patients with respiratory problems. Dosage reduction is therefore advised in the elderly, the debilitated and those with impaired function.
Care is required in patients with impaired renal function and cardiac disorders.
Care should also be taken in patients with inflammatory or obstructive bowel disorders.
Physical dependence with or without psychological dependence may occur with chronic administration of high doses; an abstinence syndrome may occur when the medication is discontinued.
4.5 Interaction with other medicinal products and other forms of interaction
Concurrent administration of Gee’s Linctus with antidiarrhoeals, antiperistaltic drugs such as diphenoxylate and atropine, kaolin, pectin, loperamide and opium tincture increases the risk of severe constipation as well as central nervous system depression.
Concurrent administration of the linctus with hypotension producing medication potentiates the hypotensive effects, leading to increased risk of orthostatic hypotension. Patients should therefore be monitored during concurrent use.
Concurrent administration of the Linctus with antimuscarinic action or other medications with antimuscarinic action may result in increased risk of severe constipation; resulting in paralytic ileus and/or urinary retention.
Concurrent administration with metoclopramide may antagonise the effects of metoclopramide on gastro-intestinal motility.
Concurrent administration with CNS depression producing medications may result in increased CNS depressant, respiratory depressant and hypotensive effects.
Concurrent use with other CNS depressants having habituation potential may increase the risk of habituation.
4.6 Pregnancy and lactation
Problems in humans have not been documented; opium alkaloids cross the placenta. Morphine, a major alkaloid of opium is teratogenic in high doses. Regular use during pregnancy results in physical dependence in the foetus leading to withdrawal symptoms in the neonate. Administration of opiates to the mother shortly before delivery may cause respiratory depression in the neonate, especially premature neonate. Camphor also crosses the placenta and may produce respiratory depression and death in the infant.
Opium alkaloids are excreted in breast milk. Neonates are more susceptible to the side effects especially respiratory depressant effects. They are also susceptible to serious toxicity induced by camphor including convulsions and respiratory depression and to benzoic acid induced hyperbilirubinemia. This product is therefore, not recommended for use during pregnancy or lactation.
4.7 Effects on ability to drive and use machines
Gee’s Linctus may cause dizziness, light-headedness and drowsiness. If affected do not drive or operate machinery
4.8 Undesirable effects
In normal therapeutic dosage, the patient does not experience any serious side-effects. However in large toxic doses, the patient may complain of the following adverse effects;
Patients may complain of nausea and vomiting and violent purging has been reported.
Patients may experience unusual tiredness, weakness, dizziness, light-headedness, feeling faint. These effects are more frequently encountered in ambulatory patients and may be attributed to orthostatic hypotension; however hypotension may also occur in recumbent patients.
These effects may also reflect the CNS depressant actions of opioids and may occur independently of hypotension.
Drowsiness is also encountered. Other side effects are confusion, tremors, uncontrolled muscular movements, disturbed vision, oliguria, dysuria, frequent urge to urinate, dry mouth, false sense of well being, general feeling of discomfort or illness, headache, increased sweating, flushing of the face and restlessness.
Rarely, hallucination, fast slow or pounding heart beat, hives, itching, skin rash, swelling of the face, mental depression, dyspnoea, constipation and unusual excitement especially in children have occurred.
4.9 Overdose
Signs of overdosage include pin-point pupils, depressed respiration and coma. In severe poisoning there may be dilation of the pupils, shock, severe respiratory depression and pulmonary oedema.
Treatment of overdosage consists of emptying the stomach by induction of emesis or gastric lavage. Adequate, respiratory exchange should be established through provision of a patent airway and utilisation of assisted or controlled respiration.
Naloxone, nalorphine or levallorphan tartrate may be given as an antidote.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Morphine is the main alkaloid present in camphorated opium tincture contained in Gee’s Linctus. It lends the product an antitussive action, resulting from the suppression of cough reflex by a direct central action probably in the medulla or pons.
Opioid analgesics bind with stereospecific receptors at many sites within the central nervous system to alter processes affecting both the perception of pain and the emotional response to pain. Although the precise sites and mechanisms of action have not been fully determined, alteration in release of various neurotransmitters from afferent nerves sensitive to painful stimuli may be partially responsible for the analgesic effect.
Squill liquid extract is the second active ingredient incorporated in Gee’s Linctus BP. It has an irritant effect on the gastric mucosa resulting in reflex expectoration.
5.2 Pharmacokinetic properties
Gee’s Linctus is well absorbed from the gastrointestinal tract. Protein binding of the active ingredient morphine is low and half life being 2-3 hours. The duration of action is 4-5 hours. It is eliminated in bile and through the kidneys.
5.3 Preclinical safety data
None available.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Sucrose
Tolu-Flavour Solution Purified Water
6.2 Incompatibilities
None.
6.3 Shelf life
36 months (unopened).
6.4 Special precautions for storage
Keep out of the reach of children.
Store in a cool place.
Protect from light.
6.5 Nature and contents of container
100 or 200ml Amber glass bottles fitted with steran wadded ROPP metal caps.
6.6 Special precautions for disposal
7 MARKETING AUTHORISATION HOLDER
STERLING PHARMACEUTICALS LIMITED
288 UPPER BALSALL HEATH ROAD
BIRMINGHAM
B12 9DR
UNITED KINGDOM
8 MARKETING AUTHORISATION NUMBER(S)
PL 32515/0001
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
15/01/2001
10 DATE OF REVISION OF THE TEXT
07/04/2008