BEECHAMS ALL-IN-ONE - summary of medicine characteristics

1 NAME OF THE MEDICINAL PRODUCT

Beechams All-in-One

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each 20 ml dose contains Paracetamol Ph Eur 500.0 mg, Guaifenesin Ph Eur

200.0 mg, Phenylephrine Hydrochloride Ph Eur 10.0 mg.

Also contains:                                          p­er 20 ml

Sorbitol (E420)                                       ­4,700 mg

Sunset Yellow FCF                                0­.7 mg

Sodium (as sodium cyclamate, sodium citrate)           42 mg

Ethanol 96%                                       ­4.012 ml

For a full list of excipients, see section 6.1

3 PHARMACEUTICAL FORM

Oral solution

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 aged 16 years and over:

One 20 ml measured dose (or four 5 ml spoonfuls). Repeat every four hours as necessary. Do not exceed four doses per 24 hours.

Do not exceed the stated dose.

Minimum dosing interval: 4 hours.

The lowest dose necessary to achieve efficacy should be used for the shortest duration of treatment.

Maximum daily dose: Four doses (2000 mg paracetamol, 800 mg guaifenesin, 40 mg phenylephrine HCl) in any 24 hour period.

Not to be given to children under 16 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.

An enlargement of the prostate gland

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

The concomitant use with other products containing paracetamol may lead to an overdose. Paracetamol overdose may cause liver failure which may require liver transplant or lead to death.

Concomitant use of decongestants and other cough and cold medicines should be avoided.

Medical advice should be sought before taking this product in patients with:

Occlusive vascular disease (e.g. Raynaud’s Phe­nomenon)

Glutathione depletion due to metabolic deficiencies

Chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema.

Use with caution in patients taking the following medications (see Interactions)

vasoconstrictor agents such as ergot alkaloids (e.g. ergotamine and methysergide)

digoxin and cardiac glycosides

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.

This product should not be used by patients taking other sympathomimetics (such as decongestants, appetite suppressants and amphetamine-like psychostimulants)

Concomitant use with alcohol, should be avoided.

If symptoms persist consult your doctor.

Do not exceed the recommended dose.

Keep out of the sight and reach of children.

Special label warnings

Contains paracetamol. Do not take anything else containing paracetamol whilst taking this medicine. Do not take more medicine than the label tells you to. Talk to a doctor at once if you take too much of this medicine, even if you feel well. If you do not get better, talk to your doctor.

Special leaflet warnings

Contains paracetamol. 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.

Contains sunset yellow (E110) which may cause allergic-type reactions.

Contains sorbitol (E420): Patients with rare hereditary problems of fructose intolerance should not take this medicine.

This medicinal product contains 31 mg of sodium per dose. To be taken into consideration by patients on a controlled sodium diet.

This medicinal product contains 19% v/v ethanol (alcohol) i.e. 3.8 ml per 20 ml dose, equivalent to 76 ml beer or 31.6 ml wine.

Harmful for those suffering from alcoholism.

To be taken into account in pregnant or breast-feeding women, children and high-risk groups such as patients with liver disease, or epilepsy.

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:

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 whilst breastfeeding 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

5   PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Paracetamol is an analgesic and antipyretic.

Guaifenesin is an expectorant.

Phenyleplrrine hydrochloride is a sympathomimimetic 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 ß-(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 thus 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 Summary.

6.1 List of Excipients

Sorbitol (non-crystallising, E420), glycerol, ethanol (96%), propylene glycol, sodium cyclamate, acesulfame potassium, sodium citrate, xanthan gum, citric acid monohydrate, coughsweet flavour, sunset yellow FCF (E110), patent blue V (E131), water.

6.2 Incompatibilities

None known

6.3 Shelf-life

3 years

6.4 Special precautions for storage

Store below 25°C

6.5 Nature and contents of container

Amber glass bottle fitted with a PP 28mm child resistant, tamper-evident polypropylene/HDPE closure fitted with a polyester-coated, aluminium faced boxboard wad.

Each bottle is packed in a boxboard carton. Contents 160ml.

6.6 Special precautions for disposal

Not applicable

7 MARKETING AUTHORISATION HOLDER

GlaxoSmithKline Consumer Healthcare (UK) Trading Limited, 980 Great West Road

Brentford

Middlesex

TW8 9GS

United Kingdom

8 MARKETING AUTHORISATION NUMBER(S)

PL 44673/0021

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

19/10/1994 / 30/06/2003