Beechams Decongestant Plus With Paracetamol
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Beechams Powders Capsules/Beechams Decongestant Plus With Paracetamol/Beechams Cold & Flu Capsules
2. Qualitative and Quantitative Composition
mg /Capsule
Active Constituents
Paracetamol Ph Eur 300.00
Caffeine Ph. Eur 25.00
Phenylephrine Hydrochloride Ph. Eur 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. 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) (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 noncirrhotic 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). |
|
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 (see contraindications). |
|
Tricyclic antidepressants (eg amitriptyline) |
May increase the risk of cardiovascular side effects with phenylephrine (see contraindications). |
|
Digoxin and cardiac glycosides |
Concimitant use of phenylephrine with digoxin or cardiac glycosides may increase the ris of irregular heartbeat or heart attack. |
|
Ergot alkaloids |
(ergotamine and methylsergide) increased risk of ergotism |
|
Warfarin and other coumarins |
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. |
Pregnancy and lactation
4.6
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 |
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 |
Bromchospasm* |
|
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 |
Nervousness and anxiety |
|
system |
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 caffeine-related 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 |
Undesirable effect |
|
Psychiatric disorders |
Nervousness |
|
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.
|
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. |
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.
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. PHARMACEUTICAL PARTICULARS
6.1. 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 25°C. 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, UK.
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
03/07/2013