Sudafed Dry Coughs With Decongestant Liquid
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Sudafed Dry Coughs with Decongestant Liquid
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5 ml of this medicine contains:
Pseudoephedrine hydrochloride 30.00 mg
Dextromethorphan hydrobromide 10.00 mg
3 PHARMACEUTICAL FORM
A clear red liquid for oral administration.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
For the symptomatic relief of upper respiratory tract disorders which may benefit from a combination of a nasal decongestant and an antitussive.
4.2. Posology and method of administration
Adults and Children aged 12 years and over:
Oral. 10 ml every 4 - 6 hours up to 4 times a day.
Children under 12 years:
This medicine is contraindicated in children under the age of 12 years (see section 4.3).
Use in the Elderly
There have been no specific studies of Sudafed in the elderly. Experience has indicated that normal adult dosage is appropriate.
Hepatic Dysfunction
Caution should be exercised when administering this medicine to patients with severe hepatic impairment.
Renal Dysfunction
Caution should be exercised when administering this medicine to patients with moderate to severe renal impairment.
Do not exceed the stated dose.
Keep of the reach and sight of children.
4.3. Contraindications
This medicine is contraindicated in individuals with known hypersensitivity to the product or any of its components. This medicine is contraindicated in individuals with severe hypertension or coronary artery disease.
This medicine is contraindicated in individuals who are taking or have taken monoamine oxidase inhibitors within the preceding two weeks. The concomitant use of pseudoephedrine and this type of product may occasionally cause a rise in blood pressure.
This medicine is not intended for use in chronic or persistent cough as occurs with asthma or where cough is accompanied by excessive secretions. Dextromethorphan, in common with other centrally acting antitussive agents should not be given to patients with or at risk of developing respiratory failure.
Not to be used in children under the age of 12 years.
4.4. Special warnings and precautions for use
Although pseudoephedrine has virtually no pressor effects in normotensive patients, this medicine should be used with caution in patients suffering mild to moderate hypertension. As with other sympathomimetic agents, this medicine should be used with caution in patients with hypertension, heart disease, diabetes, hyperthyroidism, elevated intraocular pressure and prostatic enlargement.
Caution should be exercised when using the product in the presence of severe hepatic impairment or moderate to severe renal impairment (particularly if accompanied by cardiovascular disease).
There have been a few reports of abuse of dextromethorphan but there is no evidence of drug dependance at therapeutic doses.
Not more than 4 doses should be given in any 24 hours.
The pack carries the following statements:
This medicine can make you feel sleepy. Do not drive while taking this medicine until you know how it makes you feel. See the leaflet inside for more information.
Store below 25°C. Protect from light.
Keep out of the reach and sight of children.
‘Warning: do not exceed stated dose.’
Avoid alcoholic drink.
As with all medicines if you are pregnant, or currently taking any other medicine, consult your doctor or pharmacist before taking this product.
If symptoms persist consult your doctor.
4.5. Interactions with other medicinal products and other forms of interaction
Concomitant use of this medicine with tricyclic antidepressants, sympathomimetic agents (such as decongestants, appetite suppressants and amfetamine-like psychostimulants) or with monoamine oxidase inhibitors, which interfere with the catabolism of sympathomimetic amines, may occasionally cause a rise in blood pressure.
Because of its pseudoephedrine content, this medicine may partially reverse the hypotensive action of drugs which interfere with sympathetic activity including bretylium, betanidine, guanethedine, debrisoquine, methyldopa, alpha and beta-adrenergic blocking agents.
4.6 Pregnancy and Lactation
Although pseudoephedrine and dextromethorphan have been in widespread use for many years without apparent ill consequence, there are no specific data on their use during pregnancy. Caution should therefore be exercised by balancing the potential benefit of treatment to the mother against any possible hazards to the developing foetus.
Systemic administration of pseudoephedrine, up to 50 times the human daily dosage in rats and up to 35 times the human daily dosage in rabbits, did not produce teratogenic effects. There is insufficient information available to determine whether or not dextromethorphan has teratogenic potential.
Pseudoephedrine is excreted in breast milk in small amounts but the effect of this on breast fed infants is not known. It has been estimated that 0.5 - 0.7% of a single dose of pseudoephedrine ingested by a mother will be excreted in the breast milk over 24 hours. It is not known whether dextromethorphan or its metabolites are excreted in breast milk.
4.7. Effects on ability to drive and use machines
This medicine can impair cognitive function and can affect a patient’s ability to drive safely. This class of medicine is in the list of drugs included in regulations under 5a of the Road Traffic Act 1988. When taking this medicine, patients should be told:
• The medicine is likely to affect your ability to drive
• Do not drive until you know how the medicine affects you
• It is an offence to drive while under the influence of this medicine
• However, you would not be committing an offence (called ‘statutory defence’) if: o The medicine has been taken to treat a medical or dental problem and
o You have taken it according to the information provided with the medicine and
o It was not affecting your ability to drive safely.
Details regarding a new driving offence concerning driving after drugs have been taken in the UK may be found here: https://www.gov.uk/drug-driving-law
4.8 Undesirable effects
Serious adverse effects associated with the use of pseudoephedrine are rare.
Symptoms of central nervous system excitation may occur including sleep disturbance and rarely, hallucinations. Skin rashes; with or without irritation have occasionally been reported.
Urinary retention has been reported occasionally in men receiving pseudoephedrine; prostatic enlargement could have been an important predisposing factor.
Side effects attributed to dextromethorphan are uncommon; occasionally nausea, vomiting or gastro-intestinal disturbance may occur.
Reporting of suspected adverse reactions:
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
4.9. Overdose
The effects of acute toxicity from this medicine may include nystagmus, hypertension, irritability, restlessness, tremor, convulsions, palpitations, difficulty with micturition, depression, nausea and vomiting.
Necessary measures should be taken to maintain and support respiration and control convulsions. Gastric lavage should be performed if indicated. Catherisation of the bladder may be necessary. If desired, the elimination of pseudoephedrine can be accelerated by acid diuresis or by dialysis.
Naloxone has been used successfully as a specific antagonist to dextromethorphan toxicity in a child.
5
PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Pseudoephedrine has direct and indirect sympathomimetic activity and is an effective upper respiratory tract decongestant. Pseudoephedrine is substantially less potent than ephedrine in producing both tachycardia and elevation of systolic blood pressure and is considerably less potent in causing stimulation of the central nervous system.
Dextromethorphan provides antitussive activity by acting on the medullary cough centre.
5.2 Pharmacokinetic Properties
Pseudoephedrine is rapidly and completely absorbed after oral administration. After an oral dose of 180 mg to man, peak plasma concentrations of 500-900 ng/ml were obtained about 2 hours post dose. The plasma half-life was approximately 5.5 hours and was increased in subjects with alkaline urine and decreased in subjects with acid urine. The only metabolism was n-demethylation, which occurred to a small extent. Excretion was mainly via the urine.
Dextromethorphan is well absorbed following oral administration with peak plasma levels (30 mg dose) being seen 2 hours post dose. It is metabolised in the liver by n-and o-demethylation followed by sulphate or glucuronic acid conjugation. It is excreted unchanged and as metabolites in the urine (up to 56 per cent of dose).
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 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Sucrose
Sorbitol Solution Sodium Benzoate Methyl Hydroxybenzoate Ethanol (96 %)
Flavour, Blackcurrant L-Menthol Ponceau 4R, E124
Purified Water
6.2 Incompatibilities
None known
6.3 Shelf-Life
36 months unopened
6.4 Special Precautions for Storage
Store below 25°C.
Protect from light.
6.5 Nature and contents of container
100 ml amber glass bottles with a 2 piece or a 3 piece plastic child resistant, tamper evident closure fitted with a polyvinylidene chloride (PVDC) faced wad.
A spoon with a 5ml and a 2.5ml measure is supplied with this product.
6.6 Instructions for Use, Handling and Disposal
Not applicable
7 MARKETING AUTHORISATION HOLDER
McNeil Products Limited Foundation Park Roxborough Way Maidenhead Berkshire SL6 3UG United Kingdom
MARKETING AUTHORISATION NUMBER
8.
PL 15513/0028
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
15 August 2000
10 DATE OF REVISION OF THE TEXT
15/07/2015