Boots Cold and Flu Day

Almus Cold and Flu Day Liquid

Boots Day Cold & Flu Relief Oral Solution

For a full list of excipients see section 6.1

Oral solution.

Combination product for the relief of the symptoms of colds and influenza. Decongestant for the relief of nasal congestion and congestion of mucous membranes of the upper respiratory tract associated with the common cold. Cough suppressant for the relief of acute non-productive cough associated with upper respiratory tract infection. Analgesic for the relief of aches, pains and fever associated with colds and influenza.

Take during the day.

Adults and children over 16 years: 30ml every four hours, up to a maximum of 4 doses in 24 hours if needed, or up to a maximum of three doses within any 24 hour period if a night liquid is taken before bedtime.

Elderly: There is no specific requirement for dosage reduction in the elderly.

This medicine is contraindicated in children under 16 years of age (see section 4.3).

Warning: Do not exceed the stated dose.

Keep all medicines out of the sight and reach of children.

Hypersensitivity to the active substances or any of the excipients.

Severe renal impairment.

Cardiovascular disease including hypertension and peripheral vascular disease.

Diabetes mellitus.

Phaeochromocytoma.

Hyperthyroidism.

Closed angle glaucoma.

Avoid in patients with prostatic enlargement or liver failure.

Pholcodine should not be given to subjects in, or at risk of developing respiratory failure.

Patients with chronic bronchitis, COPD, bronchiolitis or bronchiectasis due to sputum retention.

Concomitant use of other sympathomimetic decongestants.

Patients taking monoamine oxidase inhibitors (MAOIs) or within 14 days of stopping such treatment (see also section 4.5).

Beta-blockers – (see section 4.5).

Not to be used in children under the age of 16 years.

Pholcodine

Should be used with caution by patients with liver or renal disease.

Ask a doctor before use if you suffer from a chronic or persistent cough, if you have asthma or are suffering from an acute asthma attack or where cough is accompanied by excessive secretions.

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-containing products, 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 and Flu Day Liquid/Boots Day Cold & Flu Relief Oral Solution should be withdrawn immediately

Do not take with any other cough and cold medicine.

Use of pholcodine with alcohol or other CNS depressants may increase the effects of the CNS and cause toxicity in relatively smaller doses.

Caution is needed in patients with a history of drug abuse. Pholcodine is an opioid and addiction is observed with opioids as a class.

Cross-reactivity leading to serious allergic reactions (anaphylaxis) have been reported between pholcodine and NMBAs (Neuromuscular Blocking Agents). A precise at-risk period of time between the exposures of pholcodine and NMBAs has not been determined. Clinicians should be aware of this potential in case of future anaesthetic procedures involving NMBAs

Pseudoephedrine

If any of the following occur, this medicine should be stopped

Hallucinations

Restlessness

Sleep disturbances

Caution in moderate to severe renal impairment.

Ischaemic optic neuropathy

Cases of ischaemic optic neuropathy have been reported with pseudoephedrine. Pseudoephedrine should be discontinued if sudden loss of vision or decreased visual acuity such as scotoma occurs.

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 this medicine 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.

Paracetamol

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.

Caution is advised if paracetamol is administered concomitantly with flucloxacillin due to increased risk of high anion gap metabolic acidosis (HAGMA), particularly in patients with severe renal impairment, sepsis, malnutrition and other sources of glutathione deficiency (e.g. chronic alcoholism), as well as those using maximum daily doses of paracetamol. Close monitoring, including measurement of urinary 5-oxoproline, is recommended.

Warning: Do not exceed the stated dose.

Do not use this product for longer than 5 days unless your doctor agrees.

If symptoms persist consult your doctor.

Do not take with any other paracetamol-containing products.

Label:

Immediate medical advice should be sought in the event of an overdose, even if you feel well.

Leaflet or combined Label/Leaflet:

Immediate medical advice should be sought in the event of an overdose, even if you feel well, because of the risk of delayed, serious liver damage.

This medicinal product contains 35 mg sodium per 30 ml dose, equivalent to 1.75% of the WHO recommended daily intake of 2 g sodium for an adult.

This medicine contains 30 mg sodium benzoate in each 30 ml which is equivalent to 1 mg/ 1ml. Increase in bilirubinaemia following its displacement from albumin may increase neonatal jaundice which may develop into kernicterus (non-conjugated bilirubin deposits in the brain tissue).

This medicinal product contains 1157 mg of ethanol per 30 ml dose which is equivalent to 29 ml of beer or 12 ml of wine. A dose of 30 ml administered to an adult weighing 70 kg would result in exposure of 17 mg/kg of ethanol which may cause a rise in blood alcohol concentration (BAC) of about 1.74 mg/100ml.

Co-administration with medicines containing e.g. propylene glycol or ethanol may lead to accumulation of ethanol and induce adverse effects, in particular in young children with low or immature metabolic capacity.

The alcohol in this preparation is likely to affect children. These effects may include feeling sleepy and changes in behaviour. It may also affect their ability to concentrate and take part in physical activities. The amount of alcohol in this medicine can affect your ability to drive or use machines. This is because it may affect your judgement and how fast you react. If you have epilepsy or liver problems, talk to your doctor or pharmacist before taking this medicine. The amount of alcohol in this medicine may alter the effects of other medicines. Talk to your doctor or pharmacist if you are taking other medicines. If you are pregnant or breast-feeding, talk to your doctor or pharmacist before taking this medicine. If you are addicted to alcohol, talk to your doctor or pharmacist before taking this medicine.

This medicine contains 7781 mg propylene glycol in each 30ml dose which is equivalent to 259 mg/ 1 ml.

If you are pregnant or breast feeding, do not take this medicine unless recommended by your doctor. Your doctor may carry out extra checks while you are taking this medicine. Medical monitoring is required in patients with impaired renal or hepatic functions because various adverse events attributed to propylene glycol have been reported such as renal dysfunction (acute tubular necrosis), acute renal failure and liver dysfunction.

This medicinal product contains 5.4g sucrose per 30 ml dose and 1.8g of glucose per 30 ml dose. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

This medicinal product contains glycerol which may be harmful to the teeth

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).

Pseudoephedrine

MAOIs and/or RIMAs: should not be given to patients treated with MAOIs or within 14 days of stopping treatment: increased risk of hypertensive crisis.

Moclobemide: risk of hypertensive crisis.

Antihypertensives: (including adrenergic neurone blockers, diuretics & beta-blockers): this medicine may block the hypotensive effects.

Cardiac glycosides: increased risk of dysrhythmias.

Ergot alkaloids (ergotamine & methysergide): increased risk of ergotism.

Appetite suppressants and amphetamine-like psychostimulants: risk of hypertension.

Oxytocin: risk of hypertension.

Enhances effects of anticholinergic drugs (such as TCAs).

Paracetamol

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 use of paracetamol with increased risk of bleeding; occasional doses have no significant effect.

Caution should be taken when paracetamol is used concomitantly with flucloxacillin as concurrent intake has been associated with high anion gap metabolic acidosis, especially in patients with risks factors (see section 4.4)

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.

Breast-feeding

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. The use of pseudoephedrine should be avoided during breastfeeding as lactation may be suppressed, and 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.

The safety of the combined ingredients in this product during lactation has not been established. The use of this medicine during lactation is not recommended.

Patients should be advised not to drive or operate machinery if affected by dizziness or drowsiness.

Paracetamol

Immune system disorders: Adverse effects of paracetamol are rare but hypersensitivity including skin rash may occur.

Blood and lymphatic system disorders: Very rarely there have been reports of blood dyscrasias including thrombocytopaenia and agranulocytosis, but these were not necessarily causally related to paracetamol.

Skin and subcutaneous tissue disorders: very rare cases of serious skin reactions have been reported.

Pholcodine

The following side effects may be associated with the use of pholcodine:

Gastrointestinal disorders: Gastrointestinal disturbances (nausea and constipation), vomiting, diarrhoea, upset stomach, epigastric pain.

Immune system disorders: Hypersensitivity reactions and anaphylaxis.

Nervous system disorders: Occasional drowsiness, dizziness

Psychiatric disorders: Excitation, confusion.

Respiratory, thoracic and mediastinal disorders: Sputum retention.

Skin and subcutaneous tissue disorders: Skin reactions including rash and acute generalized exanthematous pustulosis (AGEP) (see section 4.4) (frequency unknown)

Pseudoephedrine

Cardiovascular disorders: Tachycardia, palpitations, other cardiac dysrhythmias.

Ear and labyrinth disorders: Tinnitus.

Eye disorders: Blurred vision. Ischaemic optic neuropathy (frequency unknown)

Gastrointestinal disorders: nausea and/or vomiting, anorexia.

Frequency unknown: Ischaemic colitis

General disorders and administration site conditions: Irritability.

Immune system disorders: Hypersensitivity reactions including cross-sensitivity that may occur with other sympathomimetics.

Nervous system disorders: Headache, tremor,

Psychiatric disorders: Sleep disturbance, nightmares, anxiety, restlessness, excitability, insomnia, hallucinations (particularly in children) and paranoid delusions.

Renal and urinary disorders: Difficulty in micturition including urinary retention.

Skin and subcutaneous tissue disorders: Skin reactions including rash, sweating. Severe skin reactions, including acute generalised exanthematous pustulosis (AGEP) – frequency unknown.

Vascular disorders: Hypertension.

Harmful in high doses. Can cause headache, stomach upset and diarrhoea. (Glycerin)

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 or search for MHRA Yellow Card in the Google Play or Apple App Store.

Immediate treatment is essential in the management of paracetamol 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.

Ingestion of lower doses equivalent to 5g or more of paracetamol may lead to liver damage if the patient has risk factors. These include if:

• They are undergoing long-term treatment with drugs that induce liver enzymes

• They regularly consume ethanol in excess of advised amounts

• They are likely to be glutathione deplete e.g. as in cystic fibrosis, eating disorders, HIV infection, starvation, cachexia

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. In addition symptomatic and general supportive therapy 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 10g 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.

Pholcodine

It is thought to be of low toxicity, but the effects in overdosage will be potentiated by simultaneous ingestion of alcohol and psychotropic drugs.

Symptoms: These include nausea, drowsiness, restlessness, excitement, ataxia and respiratory depression.

Management: Treatment of overdose should be symptomatic and supportive. Gastric lavage may be of use. In cases of severe poisoning the specific narcotic antagonist nalaxone may be used.

Information for children:

Naloxone has been used successfully to reverse central or peripheral opioid effects in children (0.01mg/kg body weight). Other treatment option is activated charcoal (1g/kg body weight) if more than 4mg/kg has been ingested within 1 hour, provided the airway can be protected.

Other symptoms of overdosage may include headache, tachycardia, urinary retention, hallucinations, coma, hyperreflexia, tremor, hypertension and arrhythmias.

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.

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 at about 4-8 hours. The elimination half life ranges 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.

Pseudoephedrine

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.

Acesulfame K

Citric Acid Monohydrate

Sodium Benzoate

Sodium Citrate

Levomenthol

Propylene Glycol

Alcohol 96%

Glycerol

Liquid Sugar

Liquid Glucose

Peach Flavour

Pear drop Flavour

Lime Flavour

Riboflavin-5-Phosphate Sodium (E101)

Purified water

Not applicable

36 months

Do not store above 25°C.

Bottle of amber polyethylene terephthalate fitted with a child resistant closure of polypropylene with expanded polyethylene liner.

Pack size: 210ml, 240ml, 300ml.

Not applicable.

The Boots Company PLC

Nottingham NG2 3AA

Trading as BCM

Trading as Boots Pharmacy

PL 00014/0565

25/02/2009

21/07/2022