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BOOTS NIGHT COLD & FLU RELIEF ORAL SOLUTION

Active substance(s): DIPHENHYDRAMINE HYDROCHLORIDE / PARACETAMOL / PHOLCODINE / PSEUDOEPHEDRINE HYDROCHLORIDE

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1.

NAME OF THE MEDICINAL PRODUCT
Almus Cold & Flu Night Liquid
Boots Night Cold & Flu Relief Oral Solution

2.

3.

QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredient

% w/v

mg/30ml

Paracetamol
Pseudoephedrine hydrochloride
Diphenhydramine hydrochloride
Pholcodine

3.333
0.200
0.083
0.033

1000.0
60.0
25.0
10.0

PHARMACEUTICAL FORM
Oral solution

4.

CLINICAL PARTICULARS

4.1.

Therapeutic Indications
For the relief of the symptoms of colds and influenza thus aiding restful sleep.
For oral administration

4.2

Posology and method of administration

Adults and children over 16 years: 30ml to be given at bedtime only.
Elderly: There is no specific requirement for dosage reduction in the elderly.
Children under 16 years: Not to be given to children under 16 years of age.
4.3.

Contra-indications
Hypersensitivity to any of the ingredients. Avoid in patients with
cardiovascular disease, hypertension, diabetes, hyperthyroidism,
phaeochromocytoma, angle closure glaucoma, prostatic enlargement, severe
kidney disease or liver failure and in patients with chronic bronchitis and
bronchiectasis.

4.4

Special warnings and precautions for use
Should be given with caution to patients with impaired renal or hepatic function.
The hazards of overdose are greater in those with non-cirrhotic alcoholic liver
disease.
Contains paracetamol.
Do not take more medicine than the label tells you to. If you do not get better, talk to
your doctor.
Children under 16 years should not be given this medicine.
Warning: May cause drowsiness. If affected do not drive or operate machinery.
Avoid alcoholic drink.
Asthmatics should consult their doctor before using this product.
Do not use this product for longer than 7 days, unless your doctor agrees.
If symptoms persist consult your doctor.
Do not take anything else containing paracetamol while taking this medicine.
Keep all medicines out of the sight and reach of children.
Label:
Talk to a doctor at once if you take too much of this medicine, even if you feel well.
Leaflet or combined label/leaflet:
Talk to a doctor at once if you take too much of this medicine even if you feel well.
This is because too much paracetamol can cause delayed, serious liver damage.
Warning: This product contains 4.8% by volume of ethanol. Each 30ml dose contains
up to 1.16g of alcohol. Harmful to those suffering from liver disease, alcoholism,
epilepsy, brain injury or disease as well as for pregnant women and children. May
modify or increase the effect of other medicines (Alcohol).
Harmful in high doses. Can cause headache, stomach upset and diarrhoea (Glycerol).
May cause diarrhoea (Maltitol/polyols).

4.5.

Interactions with other Medicaments and other forms of Interaction
Should not be given to patients being treated with monamine oxidase
inhibitors or within 14 days of stopping such treatment. May enhance the
sedative effect of central nervous system depressants including alcohol,
barbiturates, hypnotics, narcotic analgesics, sedatives and tranquillisers. The
effects of anticholinergic drugs such as atropine and tricyclic antidepressants
may also be enhanced. May diminish the antihypertensive effects of
hypotensive drugs and increase the possibility of arrhythmias in digitalised
patients.

The speed of absorption of paracetamol may be increased by metoclopramide
or domperidone and absorption reduced by cholestyramine.
The anticoagulant effect of warfarin and other coumarins may be enhanced by
prolonged regular use of paracetamol with increased risk of bleeding;
occasional doses have no significant effect.

4.6.

Pregnancy and Lactation
In view of the possible association of foetal abnormalities with first trimester
exposure to pseudoephedrine and diphenhydramine, use of the product during
pregnancy should be avoided.
Epidemiological studies in human pregnancy have shown no ill effects due to
paracetamol used in the recommend dosage, but patients should follow the
advice of their doctor regarding its use.
Although the safety of this product during lactation has not been established
data on the individual ingredients are available.
Paracetamol is excreted in breast milk but not in a clinically significant
amount. Available published data do not contraindicate breast feeding.
Amounts of pseudoephedrine secreted into breast milk are considered to be too
small to be harmful.
There is no information available as to whether pholcodine is excreted in
breast milk but it is unlikely to be harmful to the infant.
Diphenhydramine is excreted in breast milk but this has not been quantified.
In view of these data, in particular the lack of data on diphenhydramine, the
product should be avoided during lactation.

4.7

Effects on ability to drive and use machines
The product may cause drowsiness and patients should be warned not to 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
Adverse effects of paracetamol are rare but hypersensitivity including skin
rash may occur.
Paracetamol: Very rare cases of serious skin reactions have been reported.
May occasionally cause drowsiness, lassitude, dizziness and muscular
weakness. Other side effects include nausea, vomiting, diarrhoea or
constipation, stomach upset, epigastric pain, headache, blurred vision, tinnitus,
irritability, nightmares, anorexia, difficulty in micturition, dryness of the
mouth, tachycardia, tremors, sputum retention and sweating.
Very rarely there have been reports of blood dyscrasias including
thrombocytopaenia and agranulocytosis, but these were not necessarily
causally related to paracetamol. Hallucinations have been reported rarely, in
association with psuedoephedrine (particularly in children).
Harmful in high doses. Can cause headache, stomach upset and diarrhoea
(Glycerin).
May cause diarrhoea (Maltitol/Polyols).
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
Immediate treatment is essential in the management of overdosage. Despite a
lack of significant early symptoms, patients should be referred to hospital
urgently for immediate medical attention and any patient who has ingested the
equivalent of 7.5g or more of paracetamol in the preceding 4 hours should

undergo gastric lavage. Administration of oral methionine or intravenous nacetylcysteine, which may have a beneficial effect up to at least 48 hours after
overdose, may be required. General supportive measures must be available
including the administration of a beta-blocker if supraventricular tachycardia
supervenes and the administration of the specific narcotic antagonist naloxone.
Symptoms of paracetamol overdosage in the first 24 hours are pallor, nausea,
vomiting, anorexia and abdominal pain. Liver damage may become apparent
12 to 48 hours after ingestion. Abnormalities of glucose metabolism and
metabolic acidosis may occur. In severe poisoning, hepatic failure may
progress to encephalopathy, coma and death. Acute renal failure with acute
tubular necrosis may develop even in the absence of severe liver damage.
Cardiac arrhythmias and pancreatitis have been reported. Liver damage is
possible in adults who have taken l0g or more of paracetamol. It is considered
that excess quantities of a toxic metabolite (usually adequately detoxified by
glutathione when normal doses of paracetamol are ingested) become
irreversibly bound to liver tissue.
Other symptoms of overdose may include drowsiness, dryness of the mouth,
headache, tachycardia, urinary retention, disorientation, staggering gait,
hallucinations, stupor, hyperreflexia, tremor, excitement, nystagmus,
hyperthermia, convulsions, respiratory depression, hypertension and
arrhymias.

5.

PHARMACOLOGICAL PROPERTIES

5.1.

Pharmacodynamic Properties
Paracetamol has analgesic and antipyretic actions. Pseudoephedrine is a
sympathomimetic agent with both direct and indirect effects on adrenergic receptors.
Pholcodine is a cough suppressant with little analgesic activity. Diphenydramine is an
antihistamine with anticholinergic properties.

5.2.

Pharmacokinetic Properties
Paracetamol is readily absorbed from the gastrointestinal tract with peak
plasma concentrations occurring about 30 minutes to 2 hours after oral
administration. Paracetamol is distributed into most body tissues. It crosses the
placenta and is present in breast milk. Plasma protein binding is negligible at
usual therapeutic concentrations. Paracetamol is metabolised predominantly
in the liver and excreted in the urine mainly as the glucuronide and sulphate
conjugates with about 10% as glutathione conjugates. Less than 5% is
excreted as unchanged paracetamol. The elimination half life varies from
about 1 to 4 hours.

Pseudoephedrine is absorbed from the gastrointestinal tract. It is resistant to
metabolism and is excreted largely unchanged in the urine. It has a half life of
several hours but elimination is enhanced and half life shortened in acid urine.
Pholcodine is rapidly absorbed after oral administration and maximum plasma
concentrations are attained in about 4-8 hours. The elimination half life ranged
from 32 to 43 hours. The drug has a large volume of distribution and is only
23.5 % protein bound. Pholcodine is metabolised in the liver but undergoes
little conjugation with glucuronide and sulphate.
Diphenhydramine hydrochloride is well absorbed from the gastrointestinal
tract, though high first-pass metabolism appears to affect systemic availability.
Peak plasma concentrations are achieved abut 1 to 4 hours after administration
by mouth. Diphenhydramine is widely distributed throughout the body
including the CNS. It crosses the placenta and has been detected in breast
milk. Diphenhydramine is highly protein bound. Metabolism is extensive and
diphenhydramine is excreted mainly in the urine as metabolites, little being
excreted as unchanged drug. Excretion is almost complete within 24 hours of
administration.

5.3.

Preclinical Safety Data
There are no preclinical data of relevance to the prescriber which are
additional to that already included in other sections of the SPC.

6.1

List of Excipients
Acesulfame K
Citric acid monohydrate
Sodium benzoate
Sodium citrate
Propylene glycol
Alcohol 96%
Glycerol
Maltitol liquid
Aniseed flavour
Mint oil
Quinoline yellow (E104)
Patent Blue V (E131)
Purified water

6.2.

Incompatibilities

None.

6.3.

Shelf Life
24 months.

6.4.

Special Precautions for Storage
Do not store above 25°C.

6.5

Nature and contents of container
A bottle of amber polyethylene terephthalate fitted with a child resistant
closure cap of polypropylene with an expanded polyethylene liner.
Pack sizes: 120ml, 210ml, 240ml, 300ml.

6.6.

Instruction for Use/Handling
Not applicable.

7.

MARKETING AUTHORISATION HOLDER
The Boots Company PLC
Nottingham
NG2 3AA
United Kingdom
Trading as: Boots Pharmacy

8.

MARKETING AUTHORISATION NUMBER(S)
PL 00014/0571

9.
DATE OF FIRST AUTHORISATION/RENEWAL OF
AUTHORISATION
24 November 2000

10

DATE OF REVISION OF THE TEXT
12/06/2015

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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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