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BEECHAMS ALL-IN-ONE LIQUID POCKET PACKS

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SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT

Beechams All-in-One Liquid Pocket Packs

2

QUALITATIVE AND QUANTITATIVE COMPOSITION

Each 20 ml dose contains Paracetamol 500 mg, Guaifenesin 200 mg and Phenylephrine Hydrochloride 10 mg. For full list of excipients, see section 6.1.

3

PHARMACEUTICAL FORM

Oral solution. Clear, bright amber liquid.

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 For oral use. Adults and children aged 12 years and over: One 20 ml single unit dose sachet. Repeat every four hours as necessary. Do not exceed four doses per 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

Hypersensitivity to the active ingredients (or drug substances) or to any of the excipients. 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 in the last two weeks, monoamine oxidase inhibitors (see section 4.5).

4.4

Special warnings and precautions for use
The hazards of overdose are greater in those with non-cirrhotic alcoholic liver disease. 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. Raynauds 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, or with alcohol, should be avoided. If symptoms persist consult your doctor. Do not exceed the recommended dose. Keep out of the reach and sight of children. Special label warnings Contains paracetamol. Do not take with any other paracetamol-containing products. Immediate medical advice should be sought in the event of an overdose, even if you feel well. Do not take with other flu, cold or decongestant products. Special leaflet warnings Contains paracetamol. 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.

Patients with rare hereditary problems of fructose intolerance should not take this medicine. 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: Monoamine oxidase inhibitors (including moclobemide) Hypertensive interactions occur between sympathomimetic amines such as phenylephrine and monoamine oxidase inhibitors (see contraindications). Concomitant use of phenylephrine with other sympathomimetic amines can increase the risk of cardiovascular side effects. Phenylephrine may reduce the efficacy of beta-blocking drugs and antihypertensive drugs. The risk of hypertension and other cardiovascular side effects may be increased. May increase the risk of cardiovascular side effects with phenylephrine. Increased risk of ergotism

Sympathomimetic amines

Beta-blockers and other antihypertensives (including debrisoquine, guanethidine, reserpine, methyldopa)

Tricyclic antidepressants (e.g. amitriptyline)

Ergot alkaloids (ergotamine and methylsergide) 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 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 guaiphenesin 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 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 postmarketing experience indicates that adverse reactions to paracetamol are rare and serious reactions are very rare. Body System Undesirable effect

Blood and Thrombocytopenia lymphatic system Agranulocytosis disorders These are not necessarily causally related to paracetamol Immune system Anaphylaxis disorders Cutaneous hypersensitivity reactions including skin rashes, angiodema and Stevens Johnson syndrome, toxic epidermal

necrolysis

Respiratory, thoracic mediastinal disorders Hepatobiliary disorders

Bronchospasm* and

Hepatic dysfunction

Gastrointestinal Acute pancreatitis disorders * 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 Psychiatric disorders Nervous disorders Undesirable effect Nervousness, irritability, restlessness, and excitability

system Headache, dizziness, insomnia

Cardiac disorders Gastrointestinal disorders

Increased blood pressure 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. Mydriasis, acute angle closure glaucoma, most likely to occur in those with closed angle glaucoma Cardiac disorders Tachycardia, palpitations Skin and Allergic reactions (e.g. rash, urticaria, subcutaneous allergic dermatitis). disorders Hypersensitivity reactions including crosssensitivity with other sympathomimetics may occur. Renal and urinary Dysuria, urinary retention. This is most disorders 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 Undesirable effect system Immune system Allergic reactions, angioedema, anaphylactic disorders reactions Eye disorders

Respiratory, thoracic mediastinal disorders

Dyspnoea* and

Gastrointestinal disorders

Nausea, vomiting, abdominal discomfort,

Skin and Rash, urticaria subcutaneous disorders

4.9

Overdose Paracetamol Liver damage is possible in adults who have taken 10 g 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 Johns 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 overdose 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 arrythmias 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). 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 Nacetylcysteine, 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 24 h 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 advserse reactions. Additional symptoms may include irritability, restless, hypertension and possibly reflux bradycardia. In severe cases confusion, hallucinations, seizures and arrythmias may occir. 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: N0 2BE 51 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 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

PHARMACEUTICAL PARTICULARS

6.1 List of excipients Sorbitol liquid (crystallising) (E420) Glycerol Ethanol (96%) Propylene glycol Sodium cyclamate Acesulfame potassium Sodium citrate Citric acid monohydrate Xanthan gum Cough sweet flavour Sunset yellow FCF (E110) Patent blue V (E131) Purified water.

6.2 Incompatibilities None Known

6.3 Shelf life 24 months.

6.4 Special precautions for storage Do not store above 25C.

6.5

Nature and contents of container

Polyethylene/Polyester/Aluminium/Polyethylene sachets with a tear-off top, each containing 20 ml. The sachets are packed into a boxboard carton containing 2, 3, 4, 5 or 6 sachets.

6.6 Special precautions for disposal No special requirements.

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, UK

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MARKETING AUTHORISATION NUMBER(S)

PL 00079/0405

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DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
23/06/2006

10

DATE OF REVISION OF THE TEXT
06/07/2010

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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