Skip to Content

BEECHAMS DECONGESTANT PLUS WITH PARACETAMOL

Active substance(s): CAFFEINE / PARACETAMOL / PHENYLEPHRINE HYDROCHLORIDE

View full screen / Print PDF » Download PDF ⇩
Transcript
Product Summary 1. Trade Name of the Medicinal Product Beechams Powders Capsules / Beechams Decongestant Plus with Paracetamol

2.

Qualitative and Quantitative Composition Active Constituents Paracetamol Ph Eur Caffeine Ph. Eur Phenylephrine Hydrochloride Ph. Eur mg /Capsule 300.00 25.00 5.00

3.

Pharmaceutical Form Capsule

4.1

Therapeutic Indications Symptomatic relief of symptoms of influenza, feverishness, chills and colds including feverish colds. The symptomatic relief of nasal congestion and difficult breathing arising from this, sinusitis and its associated pain, acute nasal catarrh.

4.2

Posology and Method of Administration Recommended Dose and Dosage Schedule Adults (including elderly) and children aged 12 years and over: 2 capsules every 4 to 6 hours as required, but no more than 12 capsules in any 24 hours. Do not take continuously for more than 7 days without medical advice Children under 12 years of age Not to be given under the age of 12

4.3.

Contraindications Concomitant use of other sympathomimetic decongestants Phaeochromocytoma Closed angle glaucoma Known hypersensitivity to paracetamol or any of the other ingredients. Hepatic or severe renal impairment, hypertension, hyperthyroidism, diabetes, and heart disease.

Patients taking tricyclic antidepressants, or beta blocking drugs and those who are taking or who have taken within the last two weeks monoamine oxidase inhibitors (see section 4.5).

4.4

Special warnings and precautions for use
Medical advice should be sought before using 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) (see interactions). Excessive intake of caffeine (e.g. coffee, tea and some canned drinks) should be avoided while taking this product. Keep out of the reach and sight of children Contains Paracetamol Do not exceed the stated dose If symptoms persist consult your doctor If you are under the care of your doctor or receiving prescribed medicines consult your doctor before taking this product. Do not take other flu, cold or decongestant medicines or other paracetamol-containing medicines, with this product. Care is advised in the administration of paracetamol to patients with renal or hepatic impairment. The hazard of overdose is greater in those with non-cirrhotic alcoholic liver disease. 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
Enzyme-inducing drugs may increase hepatic damage, as does excessive intake of alcohol. The speed of absorption of paracetamol may be increased by metoclopramide or domperidone and absorption reduced by colestyramine. These interactions are considered to be of unlikely clinical significance in acute usage at the dosage regimen proposed. Medical advice should be sought before taking paracetamol-caffeine phenylephrine in combination with the following drugs: 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 sympathomimetics amines can increase the risk of cardiovascular side effects (see warnings and precautions). Phenylephrine may reduce the efficacy of beta-blocking drugs and antihypertensive drugs. The risk of hypertension and other cardiovascular side effects may be increased (see contraindications). May increase the risk of cardiovascular side effects with phenylephrine (see contraindications). Concimitant use of phenylephrine with digoxin or cardiac glycosides may increase the ris of irregular heartbeat or heart attack. (ergotamine and methylsergide) increased risk of ergotism The anticoagulant effect of warfarin and other coumarins may be enhanced by prolonged regular daily use of paracetamol with an increased risk of bleeding; occasional doses have no significant effect.

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

Tricyclic antidepressants (eg amitriptyline)

Digoxin and cardiac glycosides

Ergot alkaloids Warfarin and other coumarins

4.6

Pregnancy and lactation
This product is not recommended for use in pregnancy due to the phenylephrine and caffeine content. There is a potential increased risk of lower birth weight and spontaneous abortion associated with caffeine consumption during pregnancy. This product should not be used while breast-feeding without medical advice. Caffeine in breast milk may have a stimulating effect on breast-fed infants. Phenylephrine may be excreted in breast milk.

4.7

Effects on Ability to Drive and to Use Machines Patients should be advised not to drive or operate machinery if affected by dizziness.

4.8

Undesirable effects
Adverse events of paracetamol from historical clinical trial data are both infrequent and from small patient exposure. Accordingly, events reported from extensive post-marketing experience at therapeutic/labelled dose and considered attributable are tabulated below by system 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.

Paracetamol Body System Blood and lymphatic system disorders Undesirable effect Thrombocytopenia Agranulocytosis These are not necessarily causally related to paracetamol. Anaphylaxis Cutaneous hypersensitivity reactions including skin rashes, angiodema and Stevens Johnson syndrome, toxic epidermal necrolysis Bromchospasm*

Immune system disorders

Respiratory, thoracic and mediastinal disorders Hepatobiliary disorders

Hepatic dysfunction

* There have been cases of bronchospasm with paracetamol, but these are more likely in asthmatics sensitive to aspirin or other NSAIDs. Caffeine Adverse reactions identified through post-marketing use with caffeine are listed below. The frequency of these reactions is unknown. Central Nervous system Nervousness and anxiety Irritability, Restlessness and Excitability Dizziness

When the recommended paracetamol-caffeine dosing regimen is combined with dietary caffeine intake, the resulting higher dose of caffeine may increase the potential for caffeinerelated adverse effects such as insomnia, restlessness, anxiety, irritability, headaches, gastrointestinal disturbances and palpitations. Phenylephrine 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 system disorders Cardiac disorders Gastrointestinal disorders Undesirable effect Nervousness Headache, dizziness, insomnia

Increased blood pressure Nausea, vomiting, diarrhoea

Adverse reactions identified during post-marketing use are listed below. The frequency of these reactions is unknown. Eye disorders Mydriasis, acute angle closure glaucoma, most likely to occur in those with closed angle

Cardiac disorders Skin and subcutaneous disorders

glaucoma Tachycardia, palpitations Allergic reactions (e.g. rash, urticaria, allergic dermatitis). Hypersensitivity reactions including crosssensitivity with other sympathomimetics may occur Dysuria, urinary retention. This is most likely to occur in those with bladder outlet obstruction, such as prostatic hypertrophy.

Renal and urinary disorders

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 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 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 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 24h from ingestion should be discussed with the NPIS or a liver unit.
Caffeine Symptoms and signs Overdose of caffeine may result in epigastric pain, vomiting, diurese, tachycardia or cardiac arrhythmia, CNS stimulation (insomnia, restlessness, excitement, agitation, jitteriness, tremors and convulsions). It must be noted that for clinically significant symptoms of caffeine overdose to occur with this product, the amount ingested would be associated with serious paracetamol-related liver toxicity. Treatment No specific antidote is available, but supportive measures may be used. 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 reflex bradycardia. In severe cases confusion, hallucinations, seizures and arrhythmias may occur. However the amount required to produce serious phenylephrine toxicity would be greater than that required to cause paracetamol-related liver toxicity. Treatment Treatment should be as clinically appropriate. Severe hypertension may need to be treated with alpha blocking drugs such as phentolamine. Pharmacological Properties 5.1 Pharmacodynamic Properties Paracetamol: An analgesic and antipyretic. Caffeine: A mild stimulant

Phenylephrine hydrochloride: 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. Caffeine: is absorbed readily after oral administration, maximal plasma concentrations are achieved within one hour and the plasma half-life is about 3.5 hours. 65-80% of administered caffeine is excreted in the urine as 1-methyluric acid and 1-methylxanthine. 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. The toxicity of paracetamol has been extensively studied in numerous animal species. Preclinical studies in rats and mice have indicated single dose oral LD50 values of 3.7 g/kg and 338 mg/kg, respectively. Chronic toxicity in these species at large multiples of the human therapeutic dose, occurs as degeneration and necrosis of hepatic, renal and lymphoid tissue, and blood count changes. The metabolites believed responsible for these effects have also been demonstrated in man. Paracetamol should not, therefore, be taken for long periods of time, and in excessive doses. At normal therapeutic doses, paracetamol is not associated with genotoxic or carcinogenic risk. There is no evidence of embryo-or foetus-toxicity from paracetamol in animal studies.

6. 6.1.

PHARMACEUTICAL PARTICULARS List of excipients Lactose EP Colloidal silica NF Dimeticone BP Shell capsule (G dye/100g capsule part) Amaranth (E123) Erythrosine (E127) Sunset yellow (E110) Titanium dioxide (E171) Gelatin Shell body (G dye/100G capsule part) Gelatin Titanium dioxide (E171)

6.2.

Incompatibilities None known

6.3

Shelf Life

Two years

6.4

Special Precautions for Storage Store below 25C. Store in the original package in order to protect from moisture.

6.5.

Nature and contents of container Opaque blisters of polyvinyl chloride (PVC)/polyvinylidene chloride (PVdC) backed with aluminium foil. Ten or 16 capsules are blistered and packed into boxboard cartons.

6.6.

Instruction for use and handling 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, U.K.

8.

MARKETING AUTHORISATION NUMBER PL 00079/0205

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
06/03/2009

10

DATE OF REVISION OF THE TEXT
08/04/2013

Expand view ⇕

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.

Hide