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Thornton & Ross Ltd

Telephone: +44 (0)1484 842217
Fax: +44 (0)1484 847301
WWW: http://www.thorntonandross.com
Medical Information Direct Line: +44(0)1484 848 251
Medical Information e-mail: phv@thorntonross.co.uk
Customer Care direct line: +44(0)1484 842 217
Medical Information Fax: +44(0)1484 847 301

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Summary of Product Characteristics last updated on the eMC: 10/11/2011
SPC Ipecacuanha and Morphine Mixture BP 1980


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1. NAME OF THE MEDICINAL PRODUCT

Ipecacuanha and Morphine Mixture BP 1980


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2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Morphine Hydrochloride BP

0.458mg per 5ml.

Ipecacuanha Tincture BP 1999

0.1ml per 5ml.

Liquorice Liquid Extract BP

0.525ml per 5ml.


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3. PHARMACEUTICAL FORM

Mixture


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4. CLINICAL PARTICULARS

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4.1 Therapeutic indications

For the symptomatic relief of coughs.


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4.2 Posology and method of administration

Oral.

Recommended doses and dosage schedule

Adults, the elderly and children over 12 years: 10ml.

This dose can he repeated up to 4 times in any 24 hours.

Children under 12 years: Not recommended.


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4.3 Contraindications

Due to the presence of morphine this product is contraindicated in respiratory depression. It should not be given during an attack of bronchial asthma or in heart failure secondary to chronic lung disease.


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4.4 Special warnings and precautions for use

Caution is advised in patients with asthma, hepatic and renal disease, and a history of drug abuse.

Labels state:

Do not exceed the stated dose.

If symptoms persist consult your doctor.

Keep all medicines away from children.

Shake the bottle.


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4.5 Interaction with other medicinal products and other forms of interaction

Concomitant administration of other central nervous system depressants eg. alcohol, hypnotics, sedatives, may result in an enhancement of effects.

It may antagonise the effect of metoclopramide.


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4.6 Pregnancy and lactation

As with all medicines use should be avoided during pregnancy, especially in the first trimester, and in lactation unless recommended by a doctor.


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4.7 Effects on ability to drive and use machines

Although morphine may cause drowsiness, it is not expected that the quantities present in this product will have an effect on the ability to drive etc.


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4.8 Undesirable effects

Adverse effects would not be expected to occur when this preparation is taken at the recommended dose. However, a number of effects are known to arise from administration of morphine, the commonest of these being nausea, vomiting, constipation, drowsiness and confusion.


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4.9 Overdose

Overdose with this preparation is unlikely to occur due to the low concentrations of the active ingredients present.

Large doses of ipecacuanha irritate the gastro-intestinal tract and may give rise to bloody vomiting and diarrhoea. Absorption of emetine may have adverse effects on the heart, such as conduction abnormalities or myocardial infarction.

Respiratory depression, nausea and vomiting may occur due to the morphine.

After acute overdosage of ipecacuanha, activated charcoal should be given to delay absorption, followed by gastric lavage if necessary. Excessive vomiting should be controlled by administration of an ant-emetic, and fluid and electrolyte imbalance corrected if necessary.

In acute opiold poisoning the stomach should be emptied by aspiration and lavage, intensive supportive therapy may be required to correct respiratory failure and shock.

Severe respiratory depression and coma produced by excessive doses of opioids can be counteracted by the administration of naloxone given intravenously at a dose of 0.4 to 2mg, repeated at 2-3 minute intervals if necessary, up to 10mg.


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5. PHARMACOLOGICAL PROPERTIES

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5.1 Pharmacodynamic properties

Ipecacuanha is an expectorant, and in larger doses an emetic.

Morphine is an opioid analgesic acting mainly on the central nervous system and smooth muscle. It is used for relief of moderate to severe pain and is also effective as a cough suppressant.


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5.2 Pharmacokinetic properties

Emetine one of the major alkaloids of ipecacuanha is excreted or metabolised slowly, it has been detected in urine 40-60 days after discontinuation of treatment.

Morphine salts are absorbed from the gastro-intestinal tract. Morphine is distributed throughout the body. It crosses the placenta and traces have been found in milk and sweat.

Conjugation to morphine 3- and 6- glucuronides occurs in the liver. About 10% of a dose is excreted through the bile into the faeces, the remainder being excreted in the urine in the form of conjugates. About 90% of total morphine is excreted in 24 hours with traces up to 48 hours.


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5.3 Preclinical safety data

None.


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6. PHARMACEUTICAL PARTICULARS

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6.1 List of excipients

Treacle Black Commercial, Peppermint Oil BP, Ethanol (96%) BP, Diethyl Ether (Peroxide Free), Chloroform BP, Syrup BP and Purified Water BP.


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6.2 Incompatibilities

None known.


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6.3 Shelf life

18 months unopened, 8 weeks after first opening.


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6.4 Special precautions for storage

Store below 25°C.


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6.5 Nature and contents of container

200ml: Amber glass bottle with plastic screw cap and liner or white 28mm Child-resistant cap with Tamper Evident band and EPE/Saranex Liner.


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6.6 Special precautions for disposal and other handling

None.


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7. MARKETING AUTHORISATION HOLDER

Thornton & Ross Limited

Linthwaith Laboratories

Huddersfield

HD7 5QH


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8. MARKETING AUTHORISATION NUMBER(S)

PL 00240/6491R


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9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

05/03/2009


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10. DATE OF REVISION OF THE TEXT

30/10/2009



More information about this product

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