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PRIMACARE COLD & FLU RELIEF LEMON POWDER FOR ORAL SOLUTION

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SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT PrimaCare Cold & Flu Relief Lemon Powder for Oral Solution

2.

QUALITATIVE AND QUANTITATIVE COMPOSITION Each sachet contains: Paracetamol Phenylephrine hydrochloride For excipients see Section 6.1

650mg 10mg

3.

PHARMACEUTICAL FORM Powder for oral solution The powder is a creamy-yellow white granule.

4

CLINICAL PARTICULARS
Therapeutic indications
For the relief of nasal congestion and congestion of mucous membranes of the upper respiratory tract associated with common cold.

4.1.

4.2.

Posology and method of administration Powder for solution for oral administration. Adults, including the elderly and children over 12 years of age: One sachet should be dissolved in a tumbler of hot (not boiling water) One sachet up to four times daily. 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 hydrochloride or any component of the preparation Concominant use of other sympathomimetic decongestants Cardiovascular disease including hypertension Diabetes mellitus Phaeochromocytoma Hyperthyroidism Closed angle glaucoma Monoamine oxidase inhibitors (MAOIs, or within 14 days of stopping treatment, see section 4.5) Beta-blockers- (see section 4.5)

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. 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 you feel 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. Caution is also required when Phenylephrine hydrochloride is given to patients with diabetes mellitus or closed angle glaucoma. Phenylephrine hydrochloride may increase blood pressure and therefore special care is advisable in individuals receiving antihypertensive treatment. Caution should also be exercised by individuals taking beta-adrenergic blocking agents. 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. Use with caution in occlusive vascular disease If any of the following occur, Primacare Cold & Flu relief Lemon Powder for Oral Solution should be stopped. Hallucinations Restlessness Sleep disturbances

4.5.

Interactions with other medicinal products and other forms of interaction

Liver microsomal inducing agents such as barbiturates, tricyclic antidepressants and alcohol may increase paracetamol hepatotoxicity. Anticonvulsants or oral steroid contraceptives may induce liver enzymes and prevent attainment of therapeutic paracetamol levels. The absorption of paracetamol may be decreased by cholestyramine. Metoclopramide and domperidone may accelerate the absorption of paracetamol. Hypertension may occur when phenylephrine hydrochloride is given concurrently with antidepressants of both monoamine oxidase and tricyclic types, ganglionblocking agents, adrenergic-blocking drugs, rauwolfia alkaloids and methyldopa. Paracetamol may delay the elimination of chloramphenicol. 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. MAOIs and/or RIMAs: should not be given to patients treated with MAOIs or within 14 days of stopping treatment: increased risk of hypertensive crisis Moclobemide: risk of hypertensive crisis Antihypertensives (including adrenergic neurone blockers & beta blockers): Primacare Cold & Flu relief Lemon Powder for Oral Solution may block the hypotensive effects Cardiac glycosides: increased risk of dysrhythmias Ergot alkaloids (ergotamine &methysergide): increased risk of ergotism Appetite suppressants and amphetamine-like psychostimulants: risk of hypertension Oxytocin- risk of hypertension Enhances effects of anticholinergic drugs (such as TCAs)

4.6.

Pregnancy and lactation There is epidemiological evidence for the safety of paracetamol in pregnancy, but patients should follow medical advice about its use. Although phenylephrine hydrochloride may not cross the placenta there are pharmacological reasons why it should be avoided in pregnancy i.e. potential stimulation of uterine contractility and peripheral vasoconstriction, with the possibility of foetal hypoxia. Excretion of phenylephrine hydrochloride in breast milk appears to be minimal. However, the product should only be used during pregnancy and lactation when it is considered essential by the physician. Paracetamol is excreted in breast milk but not in a clinically significant amount. Available published data do not contraindicate breast feeding.

4.7.

Effects on ability to drive and use machines

None known.

4.8.

Undesirable effects
Side-effects of paracetamol are rare and usually mild. However, allergic or hypersensitivity reactions may occur very rarely. There have been a few reports of blood dyscrasias including thrombocytopenia and agranulocytosis but these were not necessarily causally related to paracetamol. Phenylephrine hydrochloride may rarely produce Cardiovascular effects Tachycardia/palpitations Other cardiac dysrhythmias and hypertension CNS effects Irritability Anxiety Restlessness Excitability Insomnia Hallucinations and paranoid delusions Skin reactions including rash Hypersensitivity reactions-including that cross-sensitivity may occur with other sympathomimetics Other reactions Nausea and/or vomiting Headache Urinary retension

4.9.

Overdose 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 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. 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 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. Overdose of phenylephrine hydrochloride may produce hypertension and associated reflex bradycardia. However the amount required to produce toxicity would be greater than that producing paracetamol toxicity.

5.
5.1.

PHARMACOLOGICAL PROPERTIES
Pharmacodynamic properties ATC code : N02BE51

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 hydrochloride is a relatively selective 1-adrenoceptor agonist. It has a weak 2-adrenoceptor agonist activity and some activity as a 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 (Nacetyl-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 hydrochloride 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 hydrochloride 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 In large toxic doses paracetamol causes acute centrilobar hepatic necrosis in animals and man. There are considerable species differences in susceptibility and acute hepatotoxic doses in hamsters, man, mice and rats are about 150, 250, 300 and 3000 mg/kg respectively. Paracetamol causes methaemoglobinaemia and oxidative haemolysis in dogs and cats but not

normally in man, even after overdosage. In chronic toxicity studies, paracetamol has less potential for nephrotoxicity (renal papillary necrosis) than aspirin and the non-steroidal anti-inflammatory analgesics. Straindependent cataract formation and other ocular abnormalities have been described in induced mice. There is no evidence to indicate mutagenic potential of phenylephrine hydrochloride. There is no reported carcinogenicity.

6.
6.1.

PHARMACEUTICAL PARTICULARS
List of excipients Sucrose Sodium citrate Citric acid Tartaric acid Maize starch Lemon juice Ascorbic acid Aspartame (E951) Natural colour (E100) Lemon flavour

6.2.

Incompatibilities None.

6.3.

Shelf life Two years.

6.4.

Special precautions for storage Do not store above 25C.

6.5.

Nature and contents of container

The immediate container for PrimaCare Cold & Flu Relief Lemon Powder for Oral Solution 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.

Instruction for use and handling None

7.

MARKETING AUTHORISATION HOLDER Bristol Laboratories Limited Unit 3, Canalside, Northbridge Road, , Berkhamsted HP4 1EG

8.

MARKETING AUTHORISATION NUMBER PL 17907/0165

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
08/03/2011

10

DATE OF REVISION OF THE TEXT
08/03/2011

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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.

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