Hot Lemon Cold Relief Powders
Out of date information, search anotherSUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Hot Lemon Cold Relief Powders
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Paracetamol 650 mg
Phenylephrine hydrochloride 10 mg
3 PHARMACEUTICAL FORM
Powder for oral solution.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
For the relief of sinus pain and congestion and the symptoms of cold and influenza including headache, sore throat and “feverishness”.
4.2 Posology and method of administration
Adults, including the elderly and children over 12 years of age:
One sachet up to four times daily. Dissolve the contents of one sachet in a tumbler of hot (not boiling) water.
Not more than four sachets to be taken in 24 hours. The dose should not be repeated more frequently than every four hours.
Children under 12 years:
Not recommended for children under 12 years of age except on medical advice.
4.3 Contraindications
Hypersensitivity to paracetamol, phenylephrine or any other constituents of the formulation.
Phenylephrine hydrochloride
Do not give to hyper susceptible patients or those with severe hyperthyroidism, aneurysm, hypertension, arteriosclerosis, phaeochromocytoma and prostatic enlargement.
Concomitant use with monoamine oxidase inhibitors, including moclobemide, is contraindicated.
4.4 Special warnings and precautions for use
Paracetamol
Care is advised in the administration of paracetamol to patients with renal or hepatic impairment. The hazards of overdose are greater in those with alcoholic liver disease. Paracetamol should be given with care to patients with alcoholic dependence.
Paracetamol is well tolerated by the majority of people with asthma. However, a small percentage of aspirin sensitive asthmatics are also sensitive to paracetamol. The likelihood of a reaction to paracetamol increases with a patient’s level of sensitivity to aspirin (see also 4.8 Undesirable Effects).
Phenylephrine hydrochloride
Care is advised in the administration of phenylephrine in patients with cardiovascular conditions such as Prinzmetal’s angina, thromboembolic disorders, following myocardial infarction or a history of ischaemic heart disease.
Care should be taken in administration of phenylephrine in patients with hyperthyroidism (see also section 4.3 Contraindications) or diabetes mellitus.
Generally
Contains a source of phenylalanine. May be harmful for people with phenylketonuria.
Patients with rare hereditary problems of fructose intolerance, glucose- galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
This medicinal product contains 1.7mmol of sodium per dose. To be taken into consideration by patients on a sodium controlled diet.
Patients should be advised not to exceed the recommended dose.
Patients should be advised not to take with any other paracetamol-containing products concurrently.
Immediate medical advice should be sought in the event of an overdose, even if the patient feels well, because of the risk of delayed, serious liver damage.
If symptoms persist, patients should consult a doctor.
Keep out of the sight and reach of children
4.5 Interaction with other medicinal products and other forms of interaction
Paracetamol
Alcohol: Paracetamol should be given with care to patients with alcohol dependence (see Section 4.4).
Analgesics: Diflunisal increases blood concentrations of paracetamol.
Anion-exchange resins: Absorption reduced by colestyramine; administration should be separated by at least 1 hour.
Antibacterials: Isoniazid may increase the risk of hepatotoxicity with therapeutic doses of paracetamol.
Anticoagulants: 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.
Antiepileptics: Carbamazepine, phenobarbital, phenytoin and primidone can reduce the effects of paracetamol and increase the risk of hepatotoxicity. Paracetamol may increase lamotrigine metabolism.
Motility stimulants: The speed of absorption of paracetamol may be increased by metoclopramide or domperidone.
Oral Contraceptives: Paracetamol is cleared from the body more quickly in women taking oral contraceptives and the analgesic effects may be reduced.
Uricosurics: Probenecid can reduce the loss of paracetamol from the body.
Phenylephrine hydrochloride
Adrenergic neurone blockers: may enhance the hypertensive effect of phenylephrine.
Antidepressants: Concomitant use of monoamine oxidase inhibitors (MAOIs), including moclobemide, is contraindicated (see section 4.3 Contraindications). There is an increased risk of hypertension when used with tricyclic antidepressants e.g. imipramine.
Atropine: There is an increased risk of hypertension when used with atropine.
Ergot alkaloids: increased risk of vasoconstriction and hypertension.
Oxytocin: potential increased risk of hypertension with oxytocin.
Sympathomimetics: concomitant use with other sympathomimetics can increase the hypertensive effect.
4.6 Pregnancy and lactation
Paracetamol
Epidemiological studies in human pregnancy have shown no ill effects due to paracetamol use in the recommended dosage, but patients should follow the advice of their doctor regarding its use.
Paracetamol is excreted in breast milk but not in a clinically significant amount. Available published data do not contraindicate breast-feeding.
Phenylephrine hydrochloride
The safety of phenylephrine during pregnancy has not been established but there is some evidence suggesting a possible association of foetal abnormalities with first trimester exposure to phenylephrine. As an alpha-adrenoceptor stimulant, it might provoke uterine changes, which can result in foetal asphyxia.. There is no information on the excretion of phenylephrine into breast milk; however no clinical problems have been documented.
In view of the above, Hot Lemon Cold Relief Powder should be avoided during pregnancy and lactation unless prescribed by a doctor.
4.7 Effects on ability to drive and use machines
Paracetamol
None
Phenylephrine hydrochloride
May cause dizziness, if affected, do not drive or operate machinery.
4.8 Undesirable effects
Paracetamol
Adverse effects of paracetamol are rare.
Haematological: There have been reports of blood dyscrasias including thrombocytopenia and agranulocytosis but these were not necessarily causally related to paracetamol.
Immune system: Hypersensitivity including skin rashes may occur. A small percentage of aspirin-sensitive asthmatics are also sensitive to paracetamol. In such cases, the deterioration in respiratory function induced by paracetamol is milder and shorter than with aspirin (see also 4.4 Special warnings and precautions for use).
Renal: Nephropathy has been associated with chronic high dose use.
Phenylephrine hydrochloride
Hypertension with headache, vomiting, dizziness, reflex bradycardia, difficulty in micturition and urinary retention. Rarely reports of palpitations, and allergic reactions.
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, phenobarbital, 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.
Treatment
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.
Phenylephrine hydrochloride
Severe hypertension is possible. If overdose is suspected, consult a doctor immediately.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
In therapeutic doses, paracetamol has antipyretic and mild analgesic actions together with some anti-inflammatory activity. These effects are thought to be related to inhibition of prostaglandin synthesis.
Phenylephrine is a relatively selective ^-adrenoceptor agonist. It has a weak a2-adrenoceptor agonist activity and some activity as a P-adrenoceptor. It is also termed a sympathomimetic vasoconstrictor. Its efficacy as a decongestant results from its vasoconstrictor properties. Vasoconstriction within the nasal mucosa decreases the volume of mucosal tissue and decreases the resistance to air flow through the nasal passages.
5.2 Pharmacokinetic properties
Paracetamol is readily absorbed from the gastro-intestinal tract with peak plasma concentrations occurring about 10 to 60 minutes after oral ingestion. Paracetamol is distributed into most body tissues. It crosses the placenta and is present in breast milk. Plasma-protein binding is negligible at usual therapeutic concentrations but increases with increasing concentrations. The elimination half-life of paracetamol varies from about 1 to 3 hours.
Paracetamol is metabolised predominantly in the liver and excreted in the urine, mainly as the glucuronide and sulphate conjugates. Less than 5% is excreted as unchanged paracetamol. A minor hydroxylated metabolite (N-acetyl-p-benzoquinoneimine) which is usually produced in very small amounts by mixed-function oxidases in the liver and which is usually detoxified by conjugation with liver glutathione may accumulate following paracetamol overdosage and cause tissue damage.
Phenylephrine is readily absorbed after oral administration but is subject to extensive presystemic metabolism much of which occurs in the enterocytes. As a consequence, systemic bioavailability is only about 40%. Following administration, peak plasma concentrations are achieved in 1-2 hours. The mean plasma half-life is in the range of 2-3 hours. Penetration into the brain appears to be minimal.
Following absorption, the drug is extensively biotransformed in the liver. Both phenylephrine and its metabolites are excreted in urine, with <20% as unchanged drug. There is no evidence that any of the metabolites are pharmacologically active.
The volume of distribution is between 200 and 500l, but there are no data on the extent of plasma protein binding.
5.3 Preclinical safety data
There is no pre-clinical data of relevance to the prescriber that are additional to those already included in other sections.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Caster sugar Sodium citrate Citric acid Tartaric acid Maize starch Lemon juice Ascorbic acid Aspartame
Natural colour (E100)
Lemon flavour
6.2 Incompatibilities
None.
6.3 Shelf life
Two years from the date of manufacture.
6.4 Special precautions for storage
Store below 25 °C.
6.5 Nature and contents of container
The immediate container for Hot Lemon Cold Relief Powder is a laminated sachet. The sachets are packaged in an outer carton, with a patient information leaflet. The pack size is 5 or 10 sachets per carton.
Specification:
40 gsm gloss coated paper 12 gsm polyethylene 8 micron aluminium 23 gsm polyethylene
6.6 Special precautions for disposal
The product should be dissolved in hot water before administration.
7 MARKETING AUTHORISATION HOLDER
Wockhardt UK Ltd Ash Road North Wrexham LL13 9UF United Kingdom
8 MARKETING AUTHORISATION NUMBER(S)
PL 29831/0168
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
1st December 2007
10 DATE OF REVISION OF THE TEXT
1st December 2007