Beechams Breathe Clear Hot Honey & Lemon Menthol Flavour Powder For Oral Solution
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Beechams Breathe Clear Hot Honey & Lemon Menthol Flavour powder for oral solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Active Constituents mg / 6 g powder
Paracetamol 600.00 Phenylephrine Hydrochloride 10.00 Excipients
Vitamin C (Ascorbic Acid) 40.00 Sucrose 3802
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Powder for Oral Solution.
Off-white to beige, free-flowing, heterogeneous powder with an odour of honey, lemon and menthol.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
The relief of symptoms of influenza, feverishness, chills and feverish colds including headache, sore throat pain, aches and pains, nasal congestion, sinusitis and its associated pain, and acute nasal catarrh.
4.2 Posology and method of administration
Directions for use
Empty contents of sachet into beaker. Half fill with very hot water. Stir well. Add cold water as necessary and sugar if desired.
Recommended Dose and Dosage Schedule
Adults (including elderly) and children aged 12 years and over:
One sachet to be taken every four hours, if necessary, up to a maximum of six sachets in any 24 hours.
Do not take continuously for more than 7 days without medical advice.
Not to be given to children under 12 years of age except on medical advice.
4.3 Contraindications
Hypersensitivity to the active substances or to any of the excipients.
Concomitant use of other sympathomimetic decongestants.
Phaeochromocytoma.
Closed angle glaucoma.
Hypertensive patients or those taking of have taken in the last two weeks monoamine
oxidase inhibitors, tricyclic antidepressants or beta-blockers (see section 4.5).
Hepatic or renal impairment, diabetes, hyperthyroidism and cardiovascular disease.
4.4 Special warnings and precautions for use
Care is advised in the administration of paracetamol to patients with severe renal or severe hepatic impairment. The hazard of overdose is greater in those with noncirrhotic alcoholic liver disease.
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)
This product should not be used by patients taking other sympathomimetics (such as decongestants, appetite suppressants and amphetamine-like psychostimulants).
Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
Contains 3.8 g sucrose per dose. This should be taken into account in patients with diabetes.
This product contains a source of phenylalanine. May be harmful for people with phenylketonuria.
Do not exceed the stated dose.
Patients should be advised not to take other paracetamol-containing or any other cold, flu or decongestant products concurrently.
If symptoms persist consult your doctor.
Keep out of the reach and sight of children.
Special label warnings
Do not take with other flu, cold or decongestant products. 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.
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 speed of absorption of paracetamol may be increased by metoclopramide or domperidone and absorption reduced by colestyramine. The anticoagulant effect of warfarin and other coumarins may be enhanced by prolonged regular daily use of paracetamol with increased risk of bleeding, occasional doses have no significant effect.
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 |
4.6 Fertility, pregnancy and lactation
Due to the phenylephrine content this product should not be used in pregnancy or whilst breast-feeding without medical advice. Phenylephrine may be excreted in breast milk.
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
Undesirable effects Paracetamol Adverse events 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.
|
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 |
* There have been cases of bronchospasm with paracetamol, but these are more likely in asthmatics sensitive to aspirin or other NSAIDs.
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, irritability, restlessness, and excitability |
|
Nervous system disorders |
Headache, dizziness, insomnia |
|
Cardiac disorders |
Increased blood pressure |
|
Gastrointestinal disorders |
Nausea, Vomiting. |
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 that cross-sensitivity may occur with other sympathomimetics |
|
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 24 hours from ingestion should be discussed with the NPIS or a liver unit.
Phenylephrine Hydrochloride 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 arrythmias 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.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Paracetamol provides the analgesic and antipyretic actions.
Phenylephrine Hydrochloride is a sympathomimetic agent and provides relief from nasal congestion due to its vasoconstrictor action.
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.
Phenylephrine Hydrochloride - Due to irregular absorption and first pass metabolism by monoamine oxidase in the gut and liver, phenylephrine has reduced bioavailability from the gastrointestinal tract. It is excreted in the urine almost entirely as the sulphate conjugate.
5.3 Preclinical safety data
None stated.
6.1 List of excipients
Ascorbic acid, Sucrose, Sodium citrate, Citric acid, Maize starch, Menthol, Honey flavour, Honey Flav-o-lok, Lemon flavour, Caramel colour 626 E150A, aspartame (E 951), saccharin sodium.
Incompatibilities
6.2
None stated.
6.3 Shelf life
36 months.
6.4 Special precautions for storage
Store below 25°C.
6.5 Nature and contents of container
The product is packed in laminate sachets comprising paper / polythene / aluminium foil / polythene. Five or ten sachets may be contained in a box board carton.
6.6 Special precautions for disposal
No special requirements.
Any unused product or waste material should be disposed of in accordance with local 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.
8 MARKETING AUTHORISATION NUMBER(S)
PL 00079/0674
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
29/07/2011
10 DATE OF REVISION OF THE TEXT
04/12/2013