1. NAME OF THE MEDICINAL PRODUCT

Almus Cold & Flu Night Liquid

Boots Night Cold & Flu Relief Oral Solution

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Active ingredient	% w/v	mg/30ml
Paracetamol	3.333	1000.0
Pseudoephedrine hydrochloride	0.200	60.0
Diphenhydramine hydrochloride	0.083	25.0
Pholcodine	0.033	10.0

3. 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 n-acetylcysteine, 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

DATE OF REVISION OF THE TEXT

12/06/2015