Hills Balsam Dry Cough Liquid
Out of date information, search anotherSUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Hill's Balsam Dry Cough Liquid
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Pholcodine Ph Eur 10 mg/5 ml
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Brown, viscous, oral solution with aromatic odour
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
For the symptomatic relief of a dry, tickly or painful unproductive cough due to upper respiratory infection or influenza.
4.2 Posology and method of administration
For oral use only.
NOT RECOMMENDED FOR CHILDEN UNDER 12 YEARS Adults and children over 12 years:
One 5ml spoonful to be taken three times a day and at bedtime (in a little warm water).
4.3 Contraindications
Contraindicated in patients suffering from liver disease and ventilatory failure. In patients with a known history of allergy to pholcodine or any of the listed excipients, and in those with a history of allergy toward morphine, suxamethonium or other structurally related therapeutic agents.
Not to be used in children under the age of 6 years.
Pholcodine should not be given to subjects in or at risk of developing respiratory failure.
Patients with chronic bronchitis, COPD, bronchiolitis or bronchiectasis due to sputum retention.
Patients taking monoamine oxidase inhibitors (MAOIs) or within 14 days of stopping such treatment (See Section 4.5, “Interactions with other medicinal products and other forms of interaction”).
4.4 Special warnings and precautions for use
As pholcodine is a sedative, use with caution in patients who have airways disease e.g asthma, as respiratory depression may occur and renal impairment.
If taking regular medication you should consult your doctor.
Ask a doctor before use if you suffer from a chronic or persistent cough, if you have asthma, suffering from an acute asthma attack or where the cough is accompanied by excessive secretions.
Caution is also needed in patients with kidney disease or a history of drug abuse.
Pholcodine should not be taken with any other cough or cold medicine (See Section 4.5, “Interactions with other medicinal products and other forms of interaction”).
Use of pholcodine with alcohol or other CNS depressants may increase the effects on the CNS and cause toxicity in relatively smaller doses.
4.5 Interaction with other medicinal products and other forms of interaction
Use of Pholcodine with alcohol or other CNS depressants may increase the effect on the CNS. Which may lead to greater drowsiness and sedation.
Pholcodine should not be taken with any other cough or cold medicine.
Not to be used in patients taking MAOIs or within 14 days of stopping treatment.
Interaction with neuromuscular blocking agents (anaphylaxis) has been reported.
Pholcodine may accentuate the hypotensive effects of antihypertensives. The same effect may be seen when administered with diuretics.
Pholcodine may enhance the sedative effects of central nervous system depressants including alcohol, barbiturates, hypnotics, narcotic analgesics, sedatives and tranquillisers (phenothiazines and tricyclic antidepressants).
4.6 Fertility, Pregnancy and lactation
Although Pholcodine has been in general use for many years, there is no evidence of ill consequences during human pregnancy.
HILL’S BALSAM DRY COUGH LIQUID should not be used in pregnancy especially during the first trimester unless the expected benefit is thought to outweigh any possible risk to the foetus. Although the amount of pholcodine excreted in breast milk is negligible, the use of HILL’S BALSAM DRY COUGH LIQUID during lactation is not recommended.
4.7 Effects on ability to drive and use machines
As with other opioid, pholcodine may affect the ability to drive or use machines.
Drowsiness occurs occasionally after taking pholcodine.
4.8 Undesirable effects
Occasional dizziness, excitation, confusion, sputum retention, vomiting, and skin reactions including rash.
Nausea occasionally occurs after Pholcodine administration. Although Pholcodine may cause constipation, this is far less likely than with some of the other opioid analgesic such as Codeine. Allergic reactions including angiodema have been reported. Drowsiness has also been reported.
Immune system disorders: hypersensitivity reactions, anaphylaxis.
4.9 Overdose
Pholcodine is thought to be of low toxicity but the effects in overdosage will be potentiated by simultaneous ingestion of alcohol and psychotropic drugs.
Symptoms of overdosage would be attributable to the pholcodine content of the formulation. Respiratory depression, restlessness, excitement and ataxia may occur.
Treatment may involve intensive support therapy for correction of the respiratory failure and shock. Gastric lavage may be of use. In severe cases of overdosage a specific antagonist such as naloxone should be used to reverse central or peripheral opioid effects in children (0.01 mg/kg body weight). Consider activated charcoal (50g for adults and 10-15 g in children) if more than 4mg/kg has been ingested within 1 hour, provided the airway can be protected. Charcoal has been shown to be effective in reducing absorption in volunteers for up to 2 hours after ingestion.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Pholcodine is widely used in the treatment of dry unproductive cough. Pholcodine has a predominantly central nervous system depressant action and can relieve local irritation of the respiratory tract for about 4 to 5 hours. Pholcodine has less sedatory and depressant effects on respiration when compared with morphine.
5.2 Pharmacokinetic properties
Pholcodine is well absorbed from the gastro-intestinal tract and is metabolised in the liver.
5.3 Preclinical safety data
There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Citric acid
Sodium methyl hydroxybenzoate Sodium propyl hydroxybenzoate Hydroxyethylcellulose Treacle
Special flavour NI 225892 Capsicum tincture Compound benzoin tincture Ethanol (96%)
Anise oil Peppermint oil Sucrose Purified water.
6.2 Incompatibilities
None known.
6.3 Shelf life
2 years
6.4 Special precautions for storage
Do not store above 25°C
6.5 Nature and contents of container
Amber glass bottle with a child resistant closure. Registered pack sizes of 100ml and 200ml. Currently only the 100ml pack size is marketed.
6.6 Special precautions for disposal
None.
7 MARKETING AUTHORISATION HOLDER
Infohealth Laboratories Limited
28 Chipstead Valley Road
Coulsdon
Surrey
CR5 2RA
United Kingdom
8 MARKETING AUTHORISATION NUMBER(S)
PL 00415/0201
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
2nd February 2005
10 DATE OF REVISION OF THE TEXT
28/04/2014