Boots Nirolex Night Time Cough Relief Linctus
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Boots Nirolex Night Time Cough Relief Linctus Almus Night Time Cough Relief Linctus Boots Night Cough Relief Oral Solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredient mg/5ml
Diphenhydramine hydrochloride Ph Eur 12.5 Pholcodine Ph Eur 3.75
3 PHARMACEUTICAL FORM
Oral Solution
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
For the symptomatic relief of dry, ticklish and unproductive coughs.
4.2 Posology and method of administration
Adults and Children over 12 years: 20ml (4 teaspoonfuls) at bedtime. Children under 12 years: Not recommended.
Elderly: There is no need for dosage reduction.
For oral administration.
4.3
Contraindications
Hypersensitivity to any of the ingredients, liver disease, ventilatory failure and porphyria.
4.4 Special warnings and precautions for use
Children under 12 years should not be given this medicine.
Cough suppressants may cause sputum retention and this may be harmful in patients with chronic bronchitis and bronchiectasis.
This medicine should be used with care in conditions such as closed angle glaucoma, urinary retention, prostatic hypertrophy or pyloroduodenal obstruction. Caution should also be observed in patients with epilepsy and severe cardiovascular disorders.
As pholcodine is a sedative, caution is needed in those patients who have airway disease e.g. asthma, chronic obstructive pulmonary disease (COPD) and ventilatory insufficiency, as respiratory depression may occur. Caution is also needed in patients with kidney disease or a history of drug abuse.
Warning: May cause drowsiness. If affected do not drive or operate machinery.
Avoid alcoholic drink.
Do not exceed the stated dose.
If symptoms persist for longer than 5 days talk to your doctor.
Keep all medicines out of the sight and reach of children.
Information related specifically to the excipients in this formulation (see section 6.1) Sucrose: Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine. Each 20ml dose contains 9g sucrose.
Ethanol: Each 20ml dose contains 0.8g alcohol (ethanol), equivalent to 20ml beer or 8ml wine. Harmful for those suffering from alcoholism. To be taken into account in pregnant or breastfeeding women, children and high-risk groups such as patients with liver disease or epilepsy.
Sodium: Each 20ml dose contains 41mg of sodium. To be taken into consideration by patients on a controlled sodium diet.
4.5 Interaction with other medicinal products and other forms of interaction
Diphenhydramine
CNS depressants: may enhance the sedative effects of CNS depressants including barbiturates, hypnotics, opioid analgesics, anxiolytic sedatives, antipsychotics and alcohol.
Antimuscarinic drugs: may have an additive antimuscarinic action with other drugs, such as atropine and some antidepressants.
MAOIs: not to be used in patients taking MAOIs or within 14 days of stopping treatment as there is a risk of serotonin syndrome.
Pholcodine
Not to be used in patients taking MAOIs or within 14 days of stopping treatment.
Interaction with neuromuscular blocking agents (anaphylaxis) has been reported.
The reduction in 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
The safety of pholcodine in pregnancy has not been fully established but its use has not revealed any direct evidence of teratogenicity. However, in view of the possible association of foetal abnormalities with first trimester exposure to diphenhydramine, use of the product during pregnancy should be avoided. The safety of this product during lactation has not been established and use during this period should be avoided.
4.7 Effects on ability to drive and use machines
May cause drowsiness. If affected do not drive or operate machinery.
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 prescribing 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 a ‘statutory defence’) if:
-The medicine has been prescribed to treat a medical or dental problem and -You have taken it according to the instructions given by the prescriber and in the information provided with the medicine and -It was not affecting your ability to drive safely
4.8 Undesirable effects
May occasionally cause nausea, vomiting, drowsiness, skin rashes and anticholinergic side effects such as dryness of the mouth, constipation, urinary retention and blurred vision. May also cause elation or depression, irritability and nightmares.
Immune system disorders: hypersensitivity reactions, anaphylaxis.
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
Symptoms of overdosage may include nausea, vomiting, drowsiness, restlessness excitement, ataxia, respiratory depression and occasionally convulsions and hyperpyrexia.
In cases of severe overdosage, the stomach should be emptied by aspiration and lavage. The patient should be kept quite to minimise excitation which occurs particularly in children. The specific narcotic antagonist naloxone may be used to reverse any respiratory depression.
Convulsions may be controlled with intravenous diazepam. Otherwise treatment should be syinptomatic and supportive.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Pholcodine is a cough suppressant with mild sedative but little analgesic action.
Diphenhydramine has antihistamine properties with a pronounced sedative action.
5.2 Pharmacokinetic properties
Pholcodine is readily absorbed from the gastrointestinal tract. It can relieve local irritation of the respiratory tract for about 4 to 5 hours.
Peak plasma levels of diphenhydramine hydrochloride occur 2 to 4 hours after administration. Diphenhydramine is about 85 - 98% bound to plasma proteins. The plasma half life ranges form 2.4 to 8 hours.
Diphenhydramine undergoes extensive pre-systemic metabolism which results in 50% metabolism of an oral dose. The major route of elimination is in the urine, largely as metabolites with very little unchanged drug present.
5.3 Preclinical safety data
Not applicable.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Hyetellos
Glycerol Liquid Sugar Citric acid monohydrate Sodium citrate Sodium benzoate Quinoline yellow Patent Blue V Alcohol
Grenadine flavour 514485E (contains propylene glycol) Purified water
6.2 Incompatibilities
Not applicable
6.3 Shelf life
36 months
Special precautions for storage
6.4
Do not store above 25 °C.
6.5 Nature and contents of container
1. A 50ml, 100ml, 125ml, 150ml, 200ml or 250ml glass bottle either with a child-resistant polypropylene cap without a liner or a roll on pilfer proof cap with a liner.
2. A 50ml, 100ml, 125ml, 150ml, 200ml, or 250ml amber glass bottle either with a child-resistant polypropylene cap without a liner or a roll on pilfer proof cap with a liner.
3. A 50ml, 100ml, 125ml, 150ml, 200ml or 250ml amber PET bottle fitted with a polypropylene a child resistant cap and an expanded polyethylene liner.
6.6 Special precautions for disposal
Not applicable
7 MARKETING AUTHORISATION HOLDER
The Boots Company PLC or Trading Style BCM 1 Thane Road West Nottingham NG2 3AA
8 MARKETING AUTHORISATION NUMBER(S)
PL 00014/0230
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
12/02/1981 / 15/03/2006
10
DATE OF REVISION OF THE TEXT
15/09/2015