Bells Healthcare Chesty Cough Oral Solution
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NAME OF THE MEDICINAL PRODUCT
Bell's Healthcare Chesty Cough Oral Solution.
Numark Chesty Cough Compound of Glycerin Lemon & Ipecacuanha
Buttercup Chesty Cough Oral Solution
Vantage Chesty Cough Oral Solution
Morrisons Chesty Cough Oral Solution
Wilko Chesty Cough Oral Solution
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QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5 ml contains
Glycerol 0.5 ml
Ipecacuanha Liquid Extract 0.0098 ml
This product also contains:
Amaranth solution containing amaranth Syrup containing sucrose and glucose
Nipasept containing Ethylparaben (E214), Propylparaben (E216) and Methylparaben (E218)
For full list of excipients, see section 6.1
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CLINICAL PARTICULARS Therapeutic indications
The mixture is taken orally for the symptomatic relief of coughs.
Posology and method of administration
Adults and children of 12 years and over One to two 5 ml spoonfuls.
This medicinal product is contraindicated in children under the age of 12 years (see section 4.3)
Sip and swallow three or four times a day.
Not more than 4 doses should be given in any 24 hours. Do not exceed the stated dose.
Do not take with any other cough and cold medicine. Keep out of the reach and sight of children.
4.3 Contraindications
• Hypersensitivity to the active substances or any of the excipients.
• Not to be used in children under the age of 12 years.
• Impaired renal hepatic or cardiac function.
4.4 Special warnings and precautions for use
If symptoms persist for more than 5 days a doctor should be consulted. Ipecac is cardio active and so should be avoided by patients on anti-arrhythmic drugs. It should be avoided by diabetics. Parabens may cause allergic reactions (possibly delayed). Amaranth may cause allergic reactions. Contains 3.2 g sucrose per 10ml. This should be taken into account with patients with diabetes mellitus. Also contains glucose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
4.5 Interaction with other medicinal products and other forms of interaction
Whilst unlikely at recommended doses there is a theoretical risk of interaction with anti-arrhythmic drugs.
4.6 Pregnancy and lactation
No information or evidence is available on the safe use of ipecac during pregnancy or lactation is available.
It should not be used with out consulting a doctor and then only if the benefits outweigh the risks.
4.7 Effects on ability to drive and use machines
None known.
4.8 Undesirable effects
Ipecac is generally well tolerated at recommended doses but large doses and chronic usage may cause gastric irritation, nausea, vomiting, diarrhoea and cardiac conduction abnormalities.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard by reporting side effects you can help provide more information on the safety of this medicine.
4.9 Overdose
Acute doses of ipecac have an irritant effect on the gastro-intestinal tract as indeed large doses and chronic usage and may cause gastric irritation, nausea, vomiting, diarrhoea and cardiac conduction abnormalities or myocardial infarction. These combine with dehydration due to vomiting may cause vasometer collapse followed by death. Activated charcoal is given to delay the absorption, followed, if necessary, by gastric lavage.
Prolonged vomiting can be controlled by the intra-muscular injection of antiemetics followed by the correction of fluid and electrolyte imbalance.
Glycerin and liquid glucose cause dehydration and steps should be taken to balance fluid and electrolyte levels. Resuscitation facilities may be required.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Glycerin is a demulcent.
Ipecac acts according to its principal alkaloids emetine and cephaeline. Namely as a reflex expectorant.
5.2 Pharmacokinetic properties
Ipecac is absorbed as emetine, which may cause adverse effects on the heart such as conduction abnormalities or myocardial infarction. There is the possibility of the accumulation of emetine causing cardiotoxicity and myopathy. Emetine is slowly metabolised and excreted in the urine and faeces.
Glycerin is readily absorbed from the gastro intestinal tract and undergoes extensive metabolism principally in the liver. It may be used in the synthesis of lipids to glucose or glycogen or oxidised to CO2 and water. It may also be excreted unchanged.
5.3
6
6.1
6.2
6.3
6.4
Preclinical safety data
None available.
PHARMACEUTICAL PARTICULARS
List of excipients
Liquid Glucose
Sucrose Citric Acid Lemon Oil Acetic Acid 33%
Camphor
Nipasept (methyl/ethyl/propylparaben)
Amaranth
Water
Incompatibilities
None known.
Shelf life
36 months in unopened bottle.
Special precautions for storage
Store at room temperature away from direct sources of heat and sunlight.
6.5 Nature and contents of container
Bottle: Amber (Type III) glass
Closures: Child resistant closure (CRC) fitted with low density polyethylene EPE/AL/PET liner
OR
Roll on pilfer proof (ROPP) screw cap fitted with low density polyethylene EPE/AL/PET liner
Sizes: 50 ml, 100 ml, 125 ml, 150 ml, 200 ml.
6.6 Special precautions for disposal
None.
7 MARKETING AUTHORISATION HOLDER
Bell, Sons and Co (Druggists) Ltd [Trading Style - Bell’s Healthcare] Gifford House,
Slaidburn Crescent Southport Merseyside PR9 9AL
8 MARKETING AUTHORISATION NUMBER(S)
PL 03105/0056
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
18/08/1997 / 13/12/2004
10 DATE OF REVISION OF THE TEXT
28/07/2016