Coldrex Hotrem Lemon
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Coldrex HotRem Lemon
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5.0 g sachet of powder for oral solution contains Paracetamol 750 mg and Phenylephrine Hydrochloride 10 mg.
3 PHARMACEUTICAL FORM
Powder for Oral Solution
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Short term symptomatic relief of influenza, feverishness, chills and 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
For oral administration, dissolved in hot water.
Dosage:
Adults (including elderly) and children aged 12 years and over:
One sachet in a tumbler full of hot water to be taken every four to six hours up to four times a day.
Children:
Not recommended for children under 12 years of age.
Do not take continuously for more than 5 days without medical advice.
4.3 Contraindications
Hypersensitivity to paracetamol or any of the other constituents. Concomitant use of other sympathomimetic decongestants. Phaeochromocytoma.
Closed angle glaucoma.
Hepatic or severe renal impairment, hypertension, hyperthyroidism, diabetes, heart disease. Patients 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
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.
Medical advice should be sought before taking this product in patients with these conditions:
• An enlargement of the prostate gland
• Occulusive 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).
Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
Concomitant use of other flu, cold or decongestant medicines, or other paracetamol-containing medicines should be avoided.
Consult your doctor if you are taking warfarin.
Do not exceed the stated dose.
If symptoms persist consult your doctor.
Keep out of the reach and sight of children.
Pack Label:
Immediate medical advice should be sought in the event of an overdose, even if you feel well. Do not take with any other paracetamol-containing products.
Patient Information Leaflet
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 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 Pregnancy and lactation
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
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 postmarketing 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, diarrhoea |
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 crosssensitivity 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 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).
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 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 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 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 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.
Ascorbic acid
Symptoms and signs
High doses of ascorbic acid (>3000 mg) may cause transient osmotic diarrhoea and gastrointestinal effects such as nausea and abdominal discomfort. Effects of overdose of ascorbic acid would be subsumed by severe liver toxicity caused by paracetamol overdose.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Paracetamol - an analgesic and antipyretic.
Phenylephrine hydrochloride - a sympathomimetic agent with mainly direct effects on adrenergic receptors predominantly alpha-adrenergic activity producing nasal congestion.
The active ingredients are not known to cause sedation.
5.2 Pharmacokinetic properties
No relevant pharmacokinetic particulars are available on this formulation.
5.3 Preclinical safety data
There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Ascorbic acid
Castor sugar
Citric acid (anhydrous)
Saccharin sodium
Sodium citrate
Lemon Flavour 610399E
Honey Flavour PFW 610507E
Honey Flavour Felton F7624P Caramel Colour 626 Aspartame
Maize Starch
6.2 Incompatibilities
None known.
6.3 Shelf life
36 months.
6.4 Special precautions for storage
None.
6.5 Nature and contents of container
The product is packed into laminate sachets of paper/aluminium foil/polyethylene containing 5 g of powder for oral solution. Five or ten sachets are packed into a cardboard carton.
6.6 Special precautions for disposal
None.
7 MARKETING AUTHORISATION HOLDER
SmithKline Beecham (SWG) Limited
980 Great West Road
Brentford
Middlesex
TW8 9GS
United Kingdom
Trading as:
GlaxoSmithKline Consumer Healthcare, Brentford, TW8 9GS, U.K.
8 MARKETING AUTHORISATION NUMBER(S)
PL 00071/0438
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
9 March 2001
DATE OF REVISION OF THE TEXT
10/01/2012