COVONIA DRY COUGH SUGAR FREE FORMULA
Active substance: PHOLCODINE
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SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Covonia Dry Cough Sugar Free Formula
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Pholcodine 5.0mg/5ml For a full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM Oral solution
A viscous red coloured liquid
4
4.1
CLINICAL PARTICULARS
Therapeutic indications Cough suppressant for the relief of acute non-productive cough associated with upper respiratory tract infections
4.2
Posology and method of administration For oral administration Adults and Children over 12 years One or two 5ml spoonfuls three or four times daily. Not more than 4 doses should be given in any 24 hours Elderly: Adult dose is appropriate.
4.3
Contraindications Liver failure.
Should not be administered to patients in or at risk of developing respiratory failure or during an attack of asthma. Patients with chronic bronchitis, chronic obstructive pulmonary disease (COPD), bronchiolitis or bronchiectasis due to sputum retention. Patients receiving monoamine oxidase inhibitors or within 2 weeks of cessation of their use (see section 4.5). Known hypersensitivity to the active substance or to any of the excipients. Do not give to children under 12 years. 4.4 Special warnings and precautions for use Should be used with caution in patients with renal, hepatic or respiratory disease, including a history of asthma. Covonia Dry Cough Sugar Free Formula and other cough suppressants may cause sputum retention and this may be harmful in patients with chronic bronchitis and bronchiectasis. Ask a doctor before use if you suffer from a chronic or persistent cough, if you have asthma, are suffering from an acute asthma attack or where cough is accompanied by excessive secretions. Use of pholcodine with alcohol or other CNS depressants may increase the effects on the CNS and cause toxicity in relatively smaller doses. This medicinal product contains small amounts of ethanol (alcohol), less than 100mg per 10 ml dose. It also contains sodium methyl, sodium ethyl and sodium propyl parahydroxybenzoates (E219, E215 and E217) and amaranth dye (E123) which may cause allergic reactions (possibly delayed). Keep out of the sight and reach of children. Do not exceed the stated dose Do not take with other cough and cold medicines. Do not give to children under 12 years. If symptoms persist consult your doctor. 4.5 Interaction with other medicinal products and other forms of interaction Not to be used in patients taking MAOIs or within 14 days of stopping treatment (see Section 4.3). Interaction with neuromuscular blocking agents (anaphylaxis) has been reported.
The reduction of blood pressure caused by antihypertensives may accentuate the hypotensive effects of pholcodine. Diuretics may have the same effect. Pholcodine may enhance the sedative effect of central nervous system depressants including alcohol, barbiturates, hypnotics, narcotic analgesics, sedatives and tranquillisers (phenothiazines and tricyclic antidepressants). 4.6 Pregnancy and lactation
No data available on the use of Covonia Dry Cough Sugar Free Formula in pregnancy or lactation. Covonia Dry Cough Sugar Free Formula should only be used in pregnancy if considered necessary by the physician and should be avoided during the first trimester. Pholcodine has been detected in human milk but in amounts unlikely to affect the suckling infant.
4.7
Effects on ability to drive and use machines
Using the dose recommended, it is not considered a hazard, however, the use of pholcodine may cause sedation, dizziness and nausea. If affected, driving or operation of machinery would not be advised.
4.8
Undesirable effects The following side effects may be associated with the use of pholcodine: (frequencies not known: cannot be estimated from the available data) Immune system disorders: Hypersensitivity reactions and anaphylaxis, skin reactions including rash. Psychiatric disorders: Excitation, confusion. Nervous system disorders: Occasional drowsiness, dizziness. Respiratory, thoracic and mediastinal disorders: Sputum retention, respiratory depression (in overdose). Gastrointestinal disorders: Vomiting, gastrointestinal disturbances (nausea and constipation).
4.9
Overdose It 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 overdose include respiratory depression, nausea, drowsiness restlessness, excitement and ataxia.
Treatment should be symptomatic to maintain vital functions. Respiratory distress should be treated by supportive means. Airways protective gastric lavage may be used. In severe cases a narcotic antagonist such as naloxone may be considered. Naloxone has been used successfully to reverse central or peripheral opioid effects in children (0.01mg/kg body weight). Other treatment option is activated charcoal (1g/kg body weight) if more than 4mg/kg has been ingested within 1 hour, provided the airway can be protected.
5
5.1
PHARMACOLOGICAL PROPERTIES
Pharmacodynamic properties
R05D A08 Opium alkaloids and derivatives. Covonia Dry Cough Sugar Free Formula contains pholcodine which is a centrally acting cough suppressant. It has none of the other properties of opiate agents.
5.2
Pharmacokinetic properties
None stated.
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
6.1
PHARMACEUTICAL PARTICULARS
List of excipients Citric acid monohydrate (E330) Sodium Methyl Parahydroxybenzoate (E219), Sodium Ethyl Parahydroxybenzoate (E215) Sodium Propyl Parahydroxybenzoate (E217) Ethanol (96%) Amaranth (E123) Carmellose sodium Saccharin sodium Menthol Condensed milk flavour Aniseed flavour Glycerol (E422) Purified water
6.2
Incompatibilities
None stated.
6.3
Shelf life
Two years from the date of manufacture.
6.4
Special precautions for storage
Do not store above 25 C
6.5
Nature and contents of container Amber glass bottles embossed Covonia with a 28mm tamper evident child resistant cap with EPE/Saranex liner. Pack sizes: 150ml and 300ml
6.6
Special precautions for disposal
None stated.
7
MARKETING AUTHORISATION HOLDER
Thornton & Ross Ltd Linthwaite Huddersfield HD7 5QH United Kingdom
8
MARKETING AUTHORISATION NUMBER(S)
PL 00240/0353
9
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
04/12/2009
10
DATE OF REVISION OF THE TEXT
11/03/2013
1
NAME OF THE MEDICINAL PRODUCT
Covonia Dry Cough Sugar Free Formula
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Pholcodine 5.0mg/5ml For a full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM Oral solution
A viscous red coloured liquid
4
4.1
CLINICAL PARTICULARS
Therapeutic indications Cough suppressant for the relief of acute non-productive cough associated with upper respiratory tract infections
4.2
Posology and method of administration For oral administration Adults and Children over 12 years One or two 5ml spoonfuls three or four times daily. Not more than 4 doses should be given in any 24 hours Elderly: Adult dose is appropriate.
4.3
Contraindications Liver failure.
Should not be administered to patients in or at risk of developing respiratory failure or during an attack of asthma. Patients with chronic bronchitis, chronic obstructive pulmonary disease (COPD), bronchiolitis or bronchiectasis due to sputum retention. Patients receiving monoamine oxidase inhibitors or within 2 weeks of cessation of their use (see section 4.5). Known hypersensitivity to the active substance or to any of the excipients. Do not give to children under 12 years. 4.4 Special warnings and precautions for use Should be used with caution in patients with renal, hepatic or respiratory disease, including a history of asthma. Covonia Dry Cough Sugar Free Formula and other cough suppressants may cause sputum retention and this may be harmful in patients with chronic bronchitis and bronchiectasis. Ask a doctor before use if you suffer from a chronic or persistent cough, if you have asthma, are suffering from an acute asthma attack or where cough is accompanied by excessive secretions. Use of pholcodine with alcohol or other CNS depressants may increase the effects on the CNS and cause toxicity in relatively smaller doses. This medicinal product contains small amounts of ethanol (alcohol), less than 100mg per 10 ml dose. It also contains sodium methyl, sodium ethyl and sodium propyl parahydroxybenzoates (E219, E215 and E217) and amaranth dye (E123) which may cause allergic reactions (possibly delayed). Keep out of the sight and reach of children. Do not exceed the stated dose Do not take with other cough and cold medicines. Do not give to children under 12 years. If symptoms persist consult your doctor. 4.5 Interaction with other medicinal products and other forms of interaction Not to be used in patients taking MAOIs or within 14 days of stopping treatment (see Section 4.3). Interaction with neuromuscular blocking agents (anaphylaxis) has been reported.
The reduction of blood pressure caused by antihypertensives may accentuate the hypotensive effects of pholcodine. Diuretics may have the same effect. Pholcodine may enhance the sedative effect of central nervous system depressants including alcohol, barbiturates, hypnotics, narcotic analgesics, sedatives and tranquillisers (phenothiazines and tricyclic antidepressants). 4.6 Pregnancy and lactation
No data available on the use of Covonia Dry Cough Sugar Free Formula in pregnancy or lactation. Covonia Dry Cough Sugar Free Formula should only be used in pregnancy if considered necessary by the physician and should be avoided during the first trimester. Pholcodine has been detected in human milk but in amounts unlikely to affect the suckling infant.
4.7
Effects on ability to drive and use machines
Using the dose recommended, it is not considered a hazard, however, the use of pholcodine may cause sedation, dizziness and nausea. If affected, driving or operation of machinery would not be advised.
4.8
Undesirable effects The following side effects may be associated with the use of pholcodine: (frequencies not known: cannot be estimated from the available data) Immune system disorders: Hypersensitivity reactions and anaphylaxis, skin reactions including rash. Psychiatric disorders: Excitation, confusion. Nervous system disorders: Occasional drowsiness, dizziness. Respiratory, thoracic and mediastinal disorders: Sputum retention, respiratory depression (in overdose). Gastrointestinal disorders: Vomiting, gastrointestinal disturbances (nausea and constipation).
4.9
Overdose It 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 overdose include respiratory depression, nausea, drowsiness restlessness, excitement and ataxia.
Treatment should be symptomatic to maintain vital functions. Respiratory distress should be treated by supportive means. Airways protective gastric lavage may be used. In severe cases a narcotic antagonist such as naloxone may be considered. Naloxone has been used successfully to reverse central or peripheral opioid effects in children (0.01mg/kg body weight). Other treatment option is activated charcoal (1g/kg body weight) if more than 4mg/kg has been ingested within 1 hour, provided the airway can be protected.
5
5.1
PHARMACOLOGICAL PROPERTIES
Pharmacodynamic properties
R05D A08 Opium alkaloids and derivatives. Covonia Dry Cough Sugar Free Formula contains pholcodine which is a centrally acting cough suppressant. It has none of the other properties of opiate agents.
5.2
Pharmacokinetic properties
None stated.
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
6.1
PHARMACEUTICAL PARTICULARS
List of excipients Citric acid monohydrate (E330) Sodium Methyl Parahydroxybenzoate (E219), Sodium Ethyl Parahydroxybenzoate (E215) Sodium Propyl Parahydroxybenzoate (E217) Ethanol (96%) Amaranth (E123) Carmellose sodium Saccharin sodium Menthol Condensed milk flavour Aniseed flavour Glycerol (E422) Purified water
6.2
Incompatibilities
None stated.
6.3
Shelf life
Two years from the date of manufacture.
6.4
Special precautions for storage
Do not store above 25 C
6.5
Nature and contents of container Amber glass bottles embossed Covonia with a 28mm tamper evident child resistant cap with EPE/Saranex liner. Pack sizes: 150ml and 300ml
6.6
Special precautions for disposal
None stated.
7
MARKETING AUTHORISATION HOLDER
Thornton & Ross Ltd Linthwaite Huddersfield HD7 5QH United Kingdom
8
MARKETING AUTHORISATION NUMBER(S)
PL 00240/0353
9
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
04/12/2009
10
DATE OF REVISION OF THE TEXT
11/03/2013
Source: Medicines and Healthcare Products Regulatory Agency
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
