SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Boots Pharmacy Cold & Flu Day Capsules Boots Day Cold & Flu Relief Capsules

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Active ingredient    mg/cap

Paracetamol    500

Pseudoephedrine hydrochloride    30

Pholcodine    5

3    PHARMACEUTICAL FORM

Capsule, hard (capsule)

The capsule has an orange cap and yellow body printed axially in black ink 'BOOTS' on the cap and '0580' on the body.

4    CLINICAL PARTICULARS

4.1 Therapeutic indications

Combination product for the relief of the major symptoms of cold 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.

Posology and method of administration

Take during the day.

Adults and children over 12 years: Two capsules 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 Boots Night Cold & Flu Relief Capsules are taken before bedtime.

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

Children under 12 years: Not to be given to children under 12 years of age.

For oral administration.

Warning: Do not exceed the stated dose.

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

4.3. Contraindications

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 hyperexcitability, prostatic enlargement or liver 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).

Patients taking beta-blockers - (see section 4.5).

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

Not to be used in children under the age of 12 years.

4.4 Special warnings and precautions for use

Paracetamol

Should be given with caution to patients with renal or hepatic impairment. 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.

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.

Do not take with other flu, cold or decongestant products.

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.

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.

Do not take with any other cough and cold medicine.

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

Pseudoephedrine

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

Hallucinations

Restlessness

Sleep disturbances

Caution in moderate to severe renal impairment.

4.5. Interaction with other medicinal products and other forms of interaction

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

Pseudoephedrine may diminish the antihypertensive effects of hypotensive drugs and increase the possibility of arrhythmias in digitalised patients.

MAOIs and/or reversible inhibitors of monoamine oxidase A 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 on anticholinergic drugs (such as tricyclic antidepressants). 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.

4.6. Fertility, pregnancy and lactation

Pregnancy

This product should not be used in pregnancy.

Epidemiological studies in human pregnancy have shown no ill effects due to paracetamol used in the recommended dosage. The safety of pholcodine during pregnancy has not been established, but there is no direct evidence of teratogenicity.

However, in view of the possible association of foetal abnormalities with first trimester exposure to pseudoephedrine, use of the product during pregnancy should be avoided.

Lactation

The use of this medicine during lactation is not recommended.

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

4.7 Effects on ability to drive and use machines

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

Paracetamol

Immune system disorders: adverse effects of paracetamol are rare but anaphylaxis and cutaneous 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.

Respiratory, thoracic and mediastinal disorders: bronchospasm has been reported, this is more likely in asthmatics with aspirin or NSAID sensitivity. Hepatobility disorders: hepatic dysfunction.

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 dizziness, excitation, confusion. Respiratory, thoracic and mediastinal disorders: sputum retention.

Skin and subcutaneous tissue disorders: skin reactions including rash.

Pseudoephedrine

Cardiovascular disorders: tachycardia, palpitations, dry mouth. Gastrointestinal disorders: nausea and/or vomiting, diarrhoea or constipation, epigastric pain.

Immune system disorders: hypersensitivity reactions, including crosssensitivity.

Metabolism and nutrition disorders: anorexia.

Nervous system disorders: dizziness, headache, tinnitus, tremor, anxiety, excitability, irritability, hallucinations, lassitude.

Psychiatric disorders: nightmares, nervousness, insomnia, blurred vision, agitation, restlessness, hallucinations (particularly in children), paranoid delusions, sleep disturbances.

Renal and urinary disorders: dysuria, difficulty in micturition including urinary retention.

Skin and subcutaneous tissue disorders: skin reactions including rash, sweating allergic dermatitis.

Vascular disorders: hypertension.

Can cause allergic type reactions including asthma. Allergy is more common in those people who are allergic to aspirin. Allura Red E129 may cause allergic type reactions.

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

Paracetamol

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.

Other symptoms of overdosage may include drowsiness, headache, tachycardia, arrhythmias, urinary retention, hallucinations, stupor, coma, hyperreflexia, tremor, excitement and hypertension, dry mouth, disorientation, staggering gait, nystagmus hyperthermia, convulsions and respiratory depression.

Immediate treatment is essential in the management of paracetamol overdosage.

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. In addition symptomatic and supportive therapy may be necessary including the administration of a beta-blocker if supraventricular tachycardia supervenes and the administration of the specific narcotic antagonist naloxone.

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, restlessness, excitement, ataxia and respiratory depression.

Management: Treatment of overdose should be symptomatic and supportive. Gastric lavage may be of use. In addition symptomatic and supportive therapy may be necessary, including the administration of the specific narcotic antagonist naloxone.

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

Symptomatic and supportive therapy may be necessary, including the administration of a beta-blocker if supraventricular tachycardia supervenes.

Pseudoephedrine

Symptoms: symptoms of overdosage include abdominal discomfort, excitation, confusion, hallucinations, ataxia, irritability, restlessness, palpitations, hypertension, difficulty in micturition and thirst.

Management: in severe overdosage gastric lavage and aspiration should be performed. Symptomatic and supportive measures should be undertaken, particularly with regard to the cardiovascular and respiratory systems. Chlorpromazine may be used to control marked excitement and hallucinations. Severe hypertension may need to be treated with an alpha-adrenoreceptor blocking drug such as phentolamine. A beta-blocker may be required to control cardiac arrhythmias.

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.

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 at about 4 to 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.

Preclinical Safety Data

There are no preclinical data of relevance to the prescriber which are additional to that already included.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Sodium lauryl sulphate Sodium starch glycolate Magnesium stearate Hard gelatin capsule

(containing; Quinoline yellow E104, Allura red E129, Titanium dioxide E171) Printing Ink:

(containing: Shellac, Iron oxide black E172, Propylene glycol)

6.2. Incompatibilities

Not applicable.

6.3. Shelf life

36 months.

6.4. Special precautions for storage

Do not store above 25°C. Store in the original package.

6.5 Nature and contents of container

A child-resistant push through pack of opaque 250 micron PVC/40gsm PVdC blisters, heat sealed to 35gsm Glassine paper/9 micron soft temper aluminium foil.

Pack sizes: 8/ 10/ 12/ 16/ 20/ 24

Instruction for use and handling

Not applicable.

7.    MARKETING AUTHORISATION HOLDER

The Boots Company PLC 1 Thane Road West Nottingham NG2 3AA United Kingdom

Trading as: BCM

Trading as Boots Pharmacy

8.    MARKETING AUTHORISATION NUMBER

PL 00014/0580

9    DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

03/03/2009

10    DATE OF REVISION OF THE TEXT

18/03/2015