1. Name Of The Medicinal Product
J Collis Browne's Mixture.
2. Qualitative And Quantitative Composition
Each 5ml contains:
Morphine hydrochloride equivalent to 1.0mg anhydrous Morphine Peppermint Oil 1.5 microlitre
3. Pharmaceutical Form
Aqueous based mixture.
4. Clinical Particulars
4.1 Therapeutic Indications
For the alleviation of coughs and the symptoms of diarrhoea.
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
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.
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.
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.
4.6 Pregnancy And Lactation
No known effects in pregnancy and lactation. However, as with all medicines, use with caution.
4.7 Effects On Ability To Drive And Use Machines
No known effects.
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.
4.9 Overdose
Gastric lavage and symptomatic treatment as for morphine is recommended. Naloxone may be used to counteract central nervous system depression.
5. Pharmacological Properties
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.
5.2 Pharmacokinetic Properties
No information available.
5.3 Preclinical Safety Data
None stated.
6. Pharmaceutical Particulars
6.1 List Of Excipients
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6.2 Incompatibilities
None stated.
6.3 Shelf Life
Five years unopened.
6.4 Special Precautions For Storage
No special precautions for storage.
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.
6.6 Special Precautions For Disposal And Other Handling
No special requirements.
7. Marketing Authorisation Holder
Thornton &Ross Limited
Linthwaite
Huddersfield
West Yorkshire
HD7 5QH
United Kingdom
8. Marketing Authorisation Number(S)
PL 00240/0088
9. Date Of First Authorisation/Renewal Of The Authorisation
25 November 2002
10. Date Of Revision Of The Text
20/01/2009
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