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BOOTS NIGHT COUGH RELIEF ORAL SOLUTION

Active substance(s): DIPHENHYDRAMINE HYDROCHLORIDE / PHOLCODINE

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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
Diphenhydramine hydrochloride Ph Eur
Pholcodine Ph Eur

3

mg/5ml
12.5
3.75

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, glucosegalactose 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.
treatment should be syinptomatic and supportive.

Otherwise

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

6.4

Special precautions for storage
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

9

DATE OF FIRST AUTHORISATION/RENEWAL OF
THE AUTHORISATION
12/02/1981 / 15/03/2006

10

DATE OF REVISION OF THE TEXT
15/09/2015

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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 combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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