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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 J Collis Browne's Mixture


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1. NAME OF THE MEDICINAL PRODUCT

J Collis Browne's Mixture.


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2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each 5ml contains:

Morphine hydrochloride equivalent to 1.0mg anhydrous Morphine Peppermint Oil 1.5 microlitre


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3. PHARMACEUTICAL FORM

Aqueous based mixture.


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4. CLINICAL PARTICULARS

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4.1 Therapeutic indications

For the alleviation of coughs and the symptoms of diarrhoea.


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4.2 Posology and method of administration

Oral

Adults, the Elderly and Children over 12 years of age

For coughs: One to two 5 ml medicinal teaspoonsful. May be repeated every four hours.

For diarrhoea: Two to three 5 ml medicinal teaspoonsful. May be repeated once or twice at four hourly intervals if required.

Children aged 6 to 12 years of age

For coughs: One 5 ml medicinal teaspoonful. May be repeated every four hours.

For diarrhoea: One 5 ml medicinal teaspoonful. May be repeated once or twice at four hourly intervals if required

Not suitable for children under 6 years of age


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4.3 Contraindications

Contraindicated in acute respiratory depression (asthma), acute alcoholism, paralytic ileus, acute ulcerative colitis, raised intra-cranial pressure and head injury.

Hypersensitivity to any of the ingredients.


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4.4 Special warnings and precautions for use

Do not exceed the stated dose.

If symptoms persist, consult the doctor.

Keep out of the reach of children.


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4.5 Interaction with other medicinal products and other forms of interaction

This product should be given with caution to patients exhibiting the following clinical conditions: hypotension, hypothyroidism, prostatic hypertrophy, renal or hepatic impairment, convulsive disorders, dependence, also if elderly or debilitated

The depressant effects of opioid analgesics are enhanced by other CNS depressants such as alcohol, anxiolytics, hypnotics, antidepressants including tricyclic antidepressants, anticoagulants such as warfarin, antiepileptics and antipsychotics.

Anhydrous morphine may interact with monoamine oxidase inhibitors (MAOI's) or within 14 days of stopping such treatment. If opioid analgesics are required they should be given with extreme caution. The effects of anhydrous morphine in reducing gastrointestinal motility may interfere with the absorption of antiarrhythmics such as mexiletine, and may counteract the stimulatory effect of metoclopramide, domperidone and cisapride.

Cimetidine inhibits the metabolism of some opioids.


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4.6 Pregnancy and lactation

No known effects in pregnancy and lactation. However, as with all medicines, use with caution.


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4.7 Effects on ability to drive and use machines

No known effects.


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4.8 Undesirable effects

Side effects are nausea, vomiting, constipation, drowsiness, difficulty in micturition, ureteric or biliary spasm, dry mouth, sweating, headache, facial flushing, vertigo, bradycardia, tachycardia, palpitations, postural hypotension, hypothermia, hallucinations, dysphoria, mood changes, dependence, miosis, decreased libido or potency, rashes, urticaria and pruritus.


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4.9 Overdose

Gastric lavage and symptomatic treatment as for morphine is recommended. Naloxone may be used to counteract central nervous system depression.


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5. PHARMACOLOGICAL PROPERTIES

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5.1 Pharmacodynamic properties

Morphine, among other actions, diminishes propulsive peristalsis in the intestinal tract. It is an effective agent for treating diarrhoea. Peppermint Oil is a carminative which relieves flatulence and intestinal griping.


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5.2 Pharmacokinetic properties

No information available.


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5.3 Preclinical safety data

None stated.


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6. PHARMACEUTICAL PARTICULARS

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6.1 List of excipients

Ethanol (96%)

BP

Benzoic Acid

BP

Capsicum Tincture

BPC 1973

Caramel (E150)

BPC 1973

Chloroform BP

 

Citric Acid

Ph Eur

Hypromellose

Ph Eur

Sorbitol Solution

Ph Eur

Treacle

 

Purified Water

Ph Eur


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6.2 Incompatibilities

None stated.


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6.3 Shelf life

Five years unopened.


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6.4 Special precautions for storage

No special precautions for storage.


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6.5 Nature and contents of container

Amber glass bottle with 28mm white polypropylene cap with tamper evident band and EPE/Aluminium/Melinex/ liner in packs of 45ml and 100ml quantities.


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6.6 Special precautions for disposal and other handling

No special requirements.


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7. MARKETING AUTHORISATION HOLDER

Thornton &Ross Limited

Linthwaite

Huddersfield

West Yorkshire

HD7 5QH

United Kingdom


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8. MARKETING AUTHORISATION NUMBER(S)

PL 00240/0088


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9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

25 November 2002


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10. DATE OF REVISION OF THE TEXT

20/01/2009



More information about this product

Link to this document from your website: http://www.medicines.org.uk/emc/medicine/25271/SPC/


Active Ingredients/Generics

 
   peppermint oil
   morphine hydrochloride