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Opiate Squill Linctus B.P.

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.

6.1 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