1. NAME OF THE MEDICINAL PRODUCT

Asda Max Strength Cold and Flu Relief Sachets Benylin Cold and Flu Max Strength Sachets - Lemon Lloyds Pharmacy Max Strength Cold and Flu Relief Sachets Morrisons Max Strength Cold and Flu Relief Sachets Numark Max Strength Cold and Flu Relief Sachets Paramed Max Strength Cold and Flu Relief Sachets Superdrug Max Strength Cold and Flu Relief Sachets Teva Max Strength Cold and Flu Relief Sachets Tesco Max Strength Cold and Flu Relief Sachets

The co-operative Max Strength Cold & Flu Relief Powder for Oral Suspension Wilkinsons Max Strength Cold and Flu Relief Sachets

Boots Max Strength Cold & Flu Relief Lemon Flavour Powder for Oral Suspension Galpharm Max Strength Cold & Flu Lemon Flavour Powder for Oral Suspension Tesco Max Cold & Flu Relief Lemon Flavour powder for oral suspension Morrisons Max Strength Cold and Flu Relief Lemon Flavour Powder for Oral Suspension

Sainsbury’s Healthcare Max Strength Cold and Flu Relief Lemon Flavour Powder for Oral Solution

Health Essentials Max Strength Cold and Flu Relief Lemon Flavour Powder for Oral Suspension

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each sachet contains; 1000 mg Paracetamol Phenylephrine hydrochloride 12.2 mg.

For excipients, see 6.1.

3. PHARMACEUTICAL FORM

Powder for oral suspension. Yellow powder.

4. CLINICAL PARTICULARS

4.1. Therapeutic indications

For relief of symptoms of colds and influenza, including the relief of headaches, aches and pains, sore throat, nasal congestion and lowering of temperature.

4.2. Posology and method of administration

Adults and elderly: For oral administration after dissolution in water.

Contents of one sachet dissolved in hot water. May be repeated after 4 - 6 hours. Maximum of 4 sachets in 24 hours.

Children: Not recommended for children under 12 years of age.

4.3. Contra-indications

Hypersensitivity to any of the ingredients. Avoid in patients with cardiovascular disease, high blood pressure, diabetes mellitus, closed angle glaucoma, hyperthyroidism, prostatic enlargement and phaeochromocytoma. Patients being treated with monoamine oxidase inhibitors or within 14 days of ceasing such treatment (See section 4.5).

4.4. Special Warnings and Special 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.

This medicine should be used with caution in patients with occlusive vascular disease including Raynaud's Phenomenon.

Do not take for longer than 7 days, unless your doctor agrees.

Contains aspartame (E951) a source of phenylalanine equivalent to 14 mg/dosage unit. May be harmful for people with phenylketonuria. The content of sucrose on a daily basis of four doses is 7.75 g.

(Label) Immediate medical advice should be sought in the event of an overdose, even if you feel well.

(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.

Do not exceed the stated dose. Do not take with other paracetamol containing products. If symptoms persist consult your doctor. Keep out of the sight and reach of children. If you are pregnant or are being prescribed medicine by your doctor, seek his advice before taking this product.

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.

These interactions are considered to be of unlikely clinical significance in acute use at the dosage regimen proposed.

This medicine may increase the possibility of arrhythmias in digitalised patients. May enhance the cardiovascular effects of other sympathomimetic amines (e.g. decongestants). This medicine should not be taken together with vasodilators, Beta-blockers or enzyme inducers such as alcohol. Drugs which induce hepatic microsomal enzymes, such as barbiturates and tricyclic antidepressants, may increase the hepatotoxicity of paracetamol, particularly after overdosage. Should not be given to patients being treated with monoamine oxidase inhibitors or within 14 days of stopping such treatment.

4.6.    Pregnancy and lactation

Epidemiological studies in human pregnancy have shown no ill effects due to paracetamol used 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: Due to the vasoconstrictive properties of phenylephrine the product should be used in caution in patients with history of pre-eclampsia. Phenylephrine may reduce placental perfusion and the product should be used in pregnancy only if the benefits outweigh this risk. There is no information on use in lactation.

4.7. Effects on ability to drive and use machines

None known.

Undesirable Effects

Adverse effects of paracetamol are rare (< 1/1000) but hypersensitivity including skin rash may occur. There have been a few reports of blood dyscrasias including thrombocytopenia and agranulocytosis but these were not necessarily causally related to paracetamol.

Adverse effects of phenylephrine hydrochloride include raised blood pressure, tachycardia and occasionally bradycardia, insomnia, restlessness, tremor and anxiety have occasionally occurred, as have urinary retention and hallucinations.

Very rare cases of serious skin reactions have been reported.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

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.

PHENYLEPHRINE HYDROCHLORIDE:

Features of severe overdosage of phenylephrine include haemodynamic changes and cardiovascular collapse with respiratory depression. Treatment includes early gastric lavage and symptomatic and supportive measures. Hypertensive effects may be treated with an IV a-receptor blocking agent.

5. PHARMACOLOGICAL PROPERTIES

5.1. Pharmacodynamic properties

Paracetamol : Paracetamol has both analgesic and antipyretic activity which is believed to be mediated principally through its inhibition of prostaglandin synthesis in the central nervous system.

Phenylephrine hydrochloride: Phenylephrine is a post-synaptic a-receptor agonist with low cardioselective P-receptor affinity and minimal central stimulant activity. It is a recognised decongestant and acts by vasoconstriction to reduce oedema and nasal swelling.

5.2. Pharmacokinetic properties

Paracetamol is absorbed rapidly and completely mainly from the small intestine, producing peak plasma levels after 15- 20 minutes following oral dosing. The systemic availability is subject to first-pass metabolism and varies with dose between 70% and 90%. The drug is rapidly and widely distributed throughout the body and is eliminated from plasma with a half-life of approximately 2 hours. The major metabolites are glucuronide and sulphate conjugates (> 80%) which are excreted in the urine.

Ascorbic acid is readily absorbed from the gastro-intestinal tract and is widely distributed in the body tissues, 25% bound to plasma proteins. Ascorbic acid in excess of the body’s needs is eliminated in the urine as metabolites.

Phenylephrine hydrochloride is readily and rapidly absorbed from the gastrointestinal tract. Presystemic metabolism is high at about 60%, resulting in systemic bioavailability of about 40%. Peak plasma levels occur between 1 and 2 hours and the plasma half-life ranges from 2 - 3 hours. When taken by mouth as a nasal decongestant phenylephrine is usually given at intervals of 4 - 6 hours.

5.3. Preclinical safety data

No preclinical findings of relevance have been reported.

6. PHARMACEUTICAL PARTICULARS

6.1. List of excipients

Sucrose Sodium citrate Citric acid Ascorbic acid

Acesulfame Potassium (E950)

Aspartame (E951),

Quinoline yellow (E104)

Lemon flavours

6.2. Incompatibilities

None known.

6.3. Shelf life

36 months.

6.4. Special precautions for storage

Do not store above 25°C.

6.5 Nature and contents of container

This product is packed in laminate sachets comprising paper/polyethylene/aluminium foil/ polyethylene or paper/polyethylene/aluminium foil/Surlyn.

Five, eight or ten sachets are contained in a boxboard carton.

6.6.    Instruction for use and handling

Not applicable.

7.    MARKETING AUTHORISATION HOLDER

Wrafton Laboratories Limited

Wrafton

Braunton

North Devon EX33 2DL United Kingdom

8.    MARKETING AUTHORISATION NUMBER

PL 12063/0034

9.    DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

19 September 2003

10 DATE OF REVISION OF THE TEXT

07/04/2016