Summary of medicine characteristics - ALMUS COLD AND FLU NIGHT LIQUID
1 NAME OF THE MEDICINAL PRODUCT
1 NAME OF THE MEDICINAL PRODUCTAlmus Cold & Flu Night Liquid
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.
Caution is needed in patients with a history of drug abuse. Pholcodine is an opioid and addiction is observed with opioids as a class.
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).
Severe Skin reactions
Severe skin reactions such as acute generalized exanthematous pustulosis (AGEP) may occur with pseudoephedrine-containing products. This acute pustular eruption may occur within the first 2 days of treatment, with fever, and numerous, small, mostly non-follicular pustules arising on a widespread oedematous erythema and mainly localized on the skin folds, trunk, and upper extremities. Patients should be carefully monitored. If signs and symptoms such as pyrexia, erythema, or many small pustules are observed, administration of Almus Cold & Flu Night Liquid should be discontinued and appropriate measures taken if needed.
Ischaemic colitis
Some cases of ischaemic colitis have been reported with pseudoephedrine. Pseudoephedrine should be discontinued and medical advice sought if sudden abdominal pain, rectal bleeding or other symptoms of ischaemic colitis develop.
Cases of ischaemic optic neuropathy have been reported with pseudoephedrine.
Almus Cold & Flu Night Liquid should be discontinued if sudden loss of vision or decreased visual acuity such as scotoma occurs.
Severe cutaneous adverse reactions (SCARs) including acute generalized exanthematous pustulosis (AGEP), which can be life-threatening or fatal, have been reported in patients treated with pholcodine, most likely in the first week. Patients should be advised of the signs and symptoms and monitored closely for skin reactions. If signs and symptoms suggestive of these reactions appear, Almus Cold & Flu Night Liquid should be withdrawn immediately.
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 Fertility, Pregnancy and lactation
Pregnancy
A large amount of data on pregnant women indicate neither malformative, nor feto/neonatal toxicity. Epidemiological studies on neurodevelopment in children exposed to paracetamol in utero show inconclusive results. If clinically needed, paracetamol can be used during pregnancy however it should be used at the lowest effective dose for the shortest possible time and at the lowest possible frequency
There are limited amount of data on the use of pseudoephedrine in pregnant women. The use of pseudoephedrine during the first trimester of pregnancy has been associated with an increased frequency of gastroschisis (a developmental defect in the abdominal wall with intestinal herniation) and of small intestinal atresia (congenital obstruction of small intestine). Due to the vasoconstrictive properties of pseudoephedrine, it may induce a reduction in uteroplacental circulation.
Pseudoephedrine is not recommended in pregnancy..
In view of the possible association of foetal abnormalities with first trimester exposure to diphenhydramine, use of the product during pregnancy should be avoided.
Breastfeeding
Paracetamol is excreted in breast milk but not in a clinically significant amount. Available published data do not contraindicate breastfeeding.
Pseudoephedrine has been detected in human milk with a small percentage of the maternal dose potentially administered to the breastfed infant. Irritability and disturbed sleep have been reported in breastfed infants. Pseudoephedrine may suppress lactation.
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.
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.
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 pseudoephedrine (particularly in children).
Acute generalized exanthematous pustulosis (see section 4.4).
Eye Disorders: Frequency unknown – Ischaemic optic neuropathy Gastrointestinal disorders – Frequency unknown: Ischaemic colitis
Immune system disorders: hypersensitivity reactions, anaphylaxis.
Skin and subcutaneous tissue disorders: Frequency unknown – Severe skin reactions, including acute generalized exanthematous pustulosis (AGEP)
Harmful in high doses. Can cause headache, stomach upset and diarrhoea (Glycerin).
May cause diarrhoea (Maltitol/Polyols).
4.9 Overdose
Paracetamol
Liver damage is possible in adults who have taken 10G or more of paracetamol.
Ingestion of 5 g or more of paracetamol may lead to liver damage if the patient has risk factors (see below).
Risk Factors
If the patient
a) Is on long term treatment with carbamazepine, phenobarbitone, phenytoin, primidone, rifampicin, St John’s Wort or other drugs that induce liver enzymes OR
b) Regularly consumes ethanol in excess of recommended amounts OR
c) Is likely to be glutathione deplete e.g. eating disorders, cystic fibrosis, HIV infection, starvation, cachexia
Symptoms
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, haemorrhage, hypoglycaemia, cerebral odema and death. Acute renal failure with acute tubular necrosis, strongly suggested by loin pain, haematuria and proteinuria, may develop even in the absence of severe liver damage. Cardiac arrhythmias and pancreatitis have been reported.
Management
Immediate treatment is essential in the management of paracetamol overdose. Despite a lack of significant early symptoms, patients should be referred to hospital urgently for immediate medical attention. Symptoms may be limited to nausea or vomiting and may not reflect the severity of the overdose or the risk of organ damage. Management should be in accordance with established treatment guidelines, see BNF overdose section. Treatment with activated charcoal should be considered if the overdose has been taken within 1 hour. Plasma paracetamol concentration should be measured at 4 hours or later after ingestion (earlier concentrations are unreliable) but results should not delay initiation of treatment beyond 8 hours after ingestion, as the effectiveness of the antidote declines sharply after this time. If required the patient should be given intravenous N-acetylcysteine, in line with the established dosage schedule. If vomiting is not a problem, oral methionine may be a suitable alternative for remote areas, outside of hospital.
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 arrhythmias.
General supportive measures must be available including the administration of a betablocker if supraventricular tachycardia supervenes and the administration of the specific narcotic antagonist naloxone.
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
5.3 Preclinical safety dataPseudoephedrine
There are no preclinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC
Paracetamol
Conventional studies using currently accepted standard for the evaluation of toxicity to reproduction and development are not available.
6.1 List of Excipients
6.1 List of ExcipientsAcesulfame 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
6.4. Special Precautions for StorageDo not store above 25°C.
6.5 Nature and contents of container
6.5 Nature and contents of containerA 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)
8. MARKETING AUTHORISATION NUMBER(S)PL 00014/0571
9. DATE OF FIRST AUTHORISATION/RENEWAL OF AUTHORISATION
24 November 2000