Beechams All-In-One
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Beechams All-In-One Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains paracetamol 250mg, guaifenesin 100mg and phenylephrine hydrochloride 5mg
Contains lactose
For full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Tablets
White, film-coated tablets embossed with a ‘B’ on one side.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Short term symptomatic relief of colds, chills and influenza including chesty coughs.
4.2 Posology and method of administration
Adults and children 12 years and over
Two tablets. Repeat every four hours as necessary.
Do not take more than 8 tablets in 24 hours.
Not to be given to children under 12 years except on medical advice.
Elderly
The normal adult dose may be taken.
Do not take continuously for more than 5 days without medical advice
4.3 Contraindications
Known hypersensitivity to any of the ingredients.
Concomitant use of other sympathomimetic decongestants. Phaeochromocytoma.
Closed angle glaucoma.
Hepatic or severe renal impairment, hypertension, hyperthyroidism, diabetes, heart disease or those taking tricyclic antidepressants or beta-blocking drugs
and those patients who are taking or have taken, within the last two weeks, monoamine oxidase inhibitors (see section 4.5).
4.4 Special warnings and precautions for use
Patients suffering from chronic cough or asthma should consult a physician before taking this product.
Patients should stop using the product and consult a health care professional if cough lasts for more than 5 days or comes back, or is accompanied by a fever, rash or persistent headache.
Do not take with a cough suppressant.
Medical advice should be sought before taking this product in patients with these conditions:
An enlargement of the prostate gland
Occlusive vascular disease (e.g. Raynaud’s Phenomenon)
Cardiovascular disease
This product should not be used by patients taking other sympathomimetics (such as decongestants, appetite suppressants and amphetamine-like psychostimulants)
Concomitant use of other paracetamol-containing products should be avoided. If symptoms persist consult your doctor.
Keep out of the reach and sight of children.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactose deficiency or glucose-galactose malabsorption should not take this medicine.
Special label warnings
Do not take with any other paracetamol-containing products. Do not take with other flu, cold or decongestant products.
Immediate medical advice should be sought in the event of an overdose, even if you feel well.
Special leaflet warnings
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.
4.5 Interaction with other medicinal products and other forms of interaction
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. The hepato-toxicity of paracetamol may be potentiated by excessive intake of alcohol. The speed of absorption of paracetamol may be increased by metoclopramide or domperidone and absorption reduced by colestyramine. Pharmacological interactions involving paracetamol with a number of other drugs have been reported. These are considered to be of unlikely clinical significance in acute use at the dosage regimen proposed.
Phenylephrine should be used with caution in combination with the following drugs as interactions have been reported:
|
Monoamine oxidase inhibitors (including moclobemide) |
Hypertensive interactions occur between sympathomimetic amines such as phenylephrine and monoamine oxidase inhibitors (see contraindications). |
|
Sympathomimetic amines |
Concomitant use of phenylephrine with other sympathomimetic amines can increase the risk of cardiovascular side effects. |
|
Beta-blockers and other antihypertensives (including debrisoquine, guanethidine, reserpine, methyldopa) |
Phenylephrine may reduce the efficacy of beta-blocking drugs and antihypertensive drugs. The risk of hypertension and other cardiovascular side effects may be increased. |
|
Tricyclic antidepressants (e.g. amitriptyline) |
May increase the risk of cardiovascular side effects with phenylephrine. |
|
Ergot alkaloids (ergotamine and methylsergide) |
Increased risk of ergotism |
|
Digoxin and cardiac glycosides |
Increase the risk of irregular heartbeat or heart attack |
If urine is collected within 24 hours of a dose of this product, a metabolite may cause a colour interference with laboratory determinations of 5 hydroxyindoleacetic acid (5-HIAA) and vanillymandelic acid (VMA).
4.6 Fertility, pregnancy and lactation
This product should not be used during pregnancy without medical advice. Epidemiological studies in human pregnancy have shown no ill effects due to paracetamol used in the recommended dosage, but patients should follow the advice of their doctor regarding its use. The safety of guaifenesin and phenylephrine during pregnancy has not been established.
Paracetamol and phenylephrine are excreted in breast milk but not in a clinically significant amount. This product should not be used in breast feeding without medical advice.
4.7 Effects on ability to drive and use machines
Patients should be advised not to drive or operate machinery if affected by dizziness.
4.8 Undesirable effects
Adverse events from historical clinical trial data are both infrequent and from small patient exposure. Events reported from extensive post-marketing experience at therapeutic/labelled dose and considered attributable are tabulated below by MedDRA System Organ Class. Due to limited clinical trial data, the frequency of these adverse events is not known (cannot be estimated from available data), but post-marketing experience indicates that adverse reactions to paracetamol are rare and serious reactions are very rare.
|
Body System |
Undesirable effect |
|
Blood and lymphatic system disorders |
Thrombocytopenia Agranulocytosis These are not necessarily causally related to paracetamol |
|
Immune system disorders |
Anaphylaxis Cutaneous hypersensitivity reactions including skin rashes, angiodema and Stevens Johnson syndrome, toxic epidermal necrolysis |
|
Respiratory, thoracic and mediastinal disorders |
Bronchospasm* |
|
Hepatobiliary disorders |
Hepatic dysfunction |
|
Gastrointestinal disorders |
Acute pancreatitis |
* There have been cases of bronchospasm with paracetamol, but these are more likely in asthmatics sensitive to aspirin or other NSAIDs.
The following adverse events have been observed in clinical trials with phenylephrine and may therefore represent the most commonly occurring adverse events.
|
Body System |
Undesirable effect |
|
Psychiatric disorders |
Nervousness, irritability, restlessness, and excitability |
|
Nervous system disorders |
Headache, dizziness, insomnia |
|
Cardiac disorders |
Increased blood pressure |
|
Gastrointestinal disorders |
Nausea, Vomiting, diarrhoea |
Adverse reactions identified during post-marketing use are listed below. The frequency of these reactions is unknown but likely to be rare.
Eye disorders
Mydriasis, acute angle closure glaucoma, most likely to occur in those with closed angle glaucoma
|
Cardiac disorders |
Tachycardia, palpitations |
|
Skin and subcutaneous disorders |
Allergic reactions (e.g. rash, urticaria, allergic dermatitis). Hypersensitivity reactions including cross-sensitivity with other sympathomimetics may occur. |
|
Renal and urinary disorders |
Dysuria, urinary retention. This is most likely to occur in those with bladder outlet obstruction, such as prostatic hypertrophy. |
Guaifenesin
The frequency of these events is unknown but considered likely to be rare.
|
Body system |
Undesirable effect |
|
Immune system disorders |
Allergic reactions, angioedema, anaphylactic reactions |
|
Respiratory, thoracic and mediastinal disorders |
Dyspnoea* |
|
Gastrointestinal disorders |
Nausea, vomiting, abdominal discomfort |
|
Skin and subcutaneous disorders |
Rash, urticaria |
4.9 Overdose
Paracetamol
Liver damage is possible in adults who have taken 10g or more of paracetamol. Ingestion of 5g 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 oedema, 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 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). Treatment with N-acetylcysteine may be used up to 24 hours after ingestion of paracetamol, however, the maximum protective effect is obtained up to 8 hours post-ingestion. 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 hospital. Management of patients who present with serious hepatic dysfunction beyond 24h from ingestion should be discussed with the NPIS or a liver unit.
Phenylephrine
Symptoms and signs
Phenylephrine overdosage is likely to result in effects similar to those listed under adverse reactions. Additional symptoms may include hypertension and possibly reflux bradycardia. In severe cases confusion, hallucinations, seizures and arrhythmias may occur. However the amount required to produce serious phenylephrine toxicity would be greater than required to cause paracetamol-related toxicity.
Treatment
Treatment should be as clinically appropriate. Severe hypertension may need to be treated with an alpha blocking drug such as phentolamine.
Guaifenesin
Symptoms and signs
Very large doses of guaifenesin cause nausea and vomiting.
Treatment
Vomiting would be treated by fluid replacement and monitoring of electrolytes if indicated.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
ATC Code: N02BE 51 Paracetamol combinations excluding psycholeptics. Paracetamol is an analgesic and antipyretic.
Guaifenesin is an expectorant.
Phenylephrine Hydrochloride is a sympathomimetic decongestant. The active ingredients are not known to cause sedation.
5.2 Pharmacokinetic properties
Paracetamol is readily absorbed from the gastrointestinal tract. It is metabolised in the liver and excreted in the urine, mainly as glucuronide and sulphate conjugates.
Guaifenesin is rapidly absorbed after oral administration. It is rapidly metabolised by oxidation to £-(2 methoxy-phenoxy) lactic acid, which is excreted in the urine.
Phenylephrine hydrochloride is irregularly absorbed from the gastrointestinal tract and undergoes first-pass metabolism by monoamine oxidase in the gut and liver; orally administered phenylephrine has reduced bioavailability. It is excreted in the urine almost entirely as the sulphate conjugate.
5.3 Preclinical safety data
Preclinical safety data on these active ingredients in the literature have not revealed any pertinent and conclusive findings which are of relevance to the recommended dosage and use of the product and which have not already been mentioned elsewhere in this SPC.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Tablets
Lactose
Microcrystalline cellulose Maize starch Stearic acid
Colloidal anhydrous silica Purified talc Povidone Potassium sorbate Pregelatinised starch
Film coating
Hypromellose E464 Titanium dioxide E171 Polyethylene glycol 4000 Lactose monohydrate
6.2 Incompatibilities
None known
6.3 Shelf life
Three years
6.4 Special precautions for storage
Do not store above 25°C
6.5 Nature and contents of container
Blister of 250pm PVC/ 25pm LDPE/ 90gsm PVdC/ 30pm Aluminium foil containing 8, 12 or 16 tablets
6.6 Special precautions for disposal
Not applicable
7 MARKETING AUTHORISATION HOLDER
Beecham Group plc 980 Great West Road Brentford Middlesex TW8 9GS United Kingdom
Trading as: GlaxoSmithKline Consumer Healthcare, Brentford, TW8 9GS
8 MARKETING AUTHORISATION NUMBER(S)
PL 00079/0630
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
03/07/2008
10 DATE OF REVISION OF THE TEXT
22/10/2012