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OPIATE SQUILL LINCTUS B.P.

Active substance(s): OPIUM TINCTURE / SQUILL AQUEOUS SOFT EXTRACT

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Opiate Squill Linctus B.P.

2.

QUALITATIVE AND QUANTITATIVE COMPOSITION
Opium Tincture B.P. 0.09 ml/5 ml
Squill Aqueous Soft Extract 46.5 mg/5 ml.

2.

PHARMACEUTICAL FORM

Oral liquid.

4.

CLINICAL PARTICULARS

4.1

Therapeutic Indications
For the symptomatic relief of cough.

4.2

Posology and Method of Administration
Adults and children over 12 years
5 ml three to four times a day.
Elderly patients
Dosage should be reduced in elderly or debilitated patients.
Children
Not recommended for children under 12 years.
Route of administration
Oral.

4.3

Contra-Indications
Preparations containing morphine are generally contraindicated in respiratory
depression especially in the presence of cyanosis and excessive bronchial
secretion. They are also contraindicated in head injury and acute alcoholism.
They should not be given during an attack of bronchial asthma. Preparations
containing squill should not be given to patients with impaired renal function.
Their use is inadvisable in patients with cardiac disorders.

4.4

Special Warnings and Special Precautions for Use
Do not exceed the stated dose. Avoid alcoholic drinks.

4.5
Interactions with other Medicinal Products and other Forms of
Interaction
Products containing morphine should not be given concurrently with (a) other
CNS depressants or with (b) monoamine oxidase inhibitors or within two
weeks of treatment with the latter.

4.6

Pregnancy and Lactation
It is not recommended during pregnancy or lactation.

4.7

Effects on Ability to Drive and Use Machines
The morphine content of this product may cause drowsiness and impair the
ability to drive and operate machines.

4.8

Undesirable Effects
Squill has an irritant effect on the gastro-mucosa and large doses may give rise
to vomiting. The product may cause constipation.

4.9

Overdose

Signs of overdosage due to morphine 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 consists of general supportive therapy and may include gastric
lavage. In cases of respiratory depression naloxone hydrochloride, given
intravenously, can be used as an antidote

5.

Pharmacological Properties

5.1

Pharmacodynamic Properties
Morphine and related opioids depress the cough reflex, at least in part, by a
direct effect on the cough centre.
Squill irritates the gastric mucosa. It has a reflex expectorant action.

5.2

Pharmacokinetic Properties
Opioids are readily absorbed from the gastrointestinal tract. Oral
bioavailability is low due to significant first pass metabolism in the liver.
Morphine is distributed throughout the body but mainly in the kidneys, liver,
lungs and spleen with lower concentrations in the brain and muscles.
Morphine diffuses across the placenta and traces also appear in milk and
sweat. The majority of a dose of morphine is conjugated with glucuronic acid
in the liver and gut to produce its major metabolite, morphine-3-glucuronide,
which is inactive and the active metabolite, morphine-6-glucuronide. Other
active metabolites include normorphine, codeine and morphine ethereal
sulphate. Mean plasma elimination half-lives of 1.7 hours for morphine and
2.4 - 6.7 hours for morphine-3-glucuronide have been reported. Up to 10% of
a dose of morphine may eventually be excreted as conjugates, through the bile
into faeces. The remainder is excreted in the urine. About 90% of total
morphine is excreted in 24 hours with traces in urine for 48 hours or more.
The glycosides of squill are poorly absorbed from the gastrointestinal tract.
No further pharmacokinetic data are available for squill.

5.3

Pre-clinical Safety Data
No relevant data.

6.

PHARMACEUTICAL PARTICULARS

6.1

List of Excipients
Syrup
Honey
Acetic Acid 80%
Camphor
Benzoic Acid
Cinnamic Acid
Ethyl Cinnamate
Vanillin
Cinnamon Oil
Anise Oil
Tragacanth
Ethanol 96% v/v
Potable water

6.2

Incompatibilities
None.

6.3

Shelf-Life
36 months.

6.4

Special Precautions for Storage
Store below 25oC.

6.5

Nature and contents of container
200 ml amber glass bottle with a white low density polyethylene Jay cap.
100 ml amber glass bottle with a white low density polyethylene Jay cap.
The 100 ml and 200 ml packs are labelled ‘Gee’s Linctus BP.
2 litre amber glass bottle with a white plastic cap.

6.6

Special precautions for disposal
None.

7.

MARKETING AUTHORISATION HOLDER
Wise Pharmaceuticals Limited
Hani Wells Business Park
Unit 7
Hardicker Street
Manchester
M19 2RB
United Kingdom.

8.

MARKETING AUTHORISATION NUMBER
PL 18374/0029

9.
DATE OF FIRST AUTHORISATION/RENEWAL OF
AUTHORISATION
14th April 2005

10

DATE OF REVISION OF THE TEXT
14/04/2005

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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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