PARACETAMOL AND PHENYLEPHRINE HYDROCHLORIDE 750/10 MG POWDER FOR ORAL SOLUTION - Summary of medicine characteristics

1 NAME OF THE MEDICINAL PRODUCT

Paracetamol and Phenylephrine Hydrochloride 750/10 mg Powder for Oral Solution

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each 5.0 g sachet of powder for oral solution contains:

Active ingredients:

Paracetamol 750 mg

Phenylephrine Hydrochloride 10 mg.

Excipients with known effect:

Aspartame (E951) 50mg

Sodium            45.80mg

Sucrose            2470 mg

Benzoic Acid       5.25mg

Sulphites            0.0075mg

For the full list of excipients, see section 6.1

3 PHARMACEUTICAL FORM

Powder for oral solution.

Pale yellow coloured powder.

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

Posology

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.

Method of administration

For oral administration, dissolved in hot water.

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 noncirrhotic 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, glucosegalactose 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.

This medicinal product contains 45.80mg sodium per 5g, equivalent to 2.29 % of the WHO recommended maximum daily intake of 2g sodium for an adult.

This medicine contains 50mg aspartame in each 5g dose which is equivalent to 0.7mg/Kg/dose. Aspartame is a source of phenylalanine. It may be harmful if you have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine builds up because the body cannot remove it properly.

This medicine contains 5.25mg benzoic acid in each 5gm dose.

This medicine contains Sulphites which may rarely cause severe hypersensitivity reactions and bronchospasm.

Pack Label:

Do not take anything else containing paracetamol while taking this medicine. Talk to a doctor at once if you talk too much of this medicine, even if you feel well.

Do not take anything else containing paracetamol while taking this medicine.

Patient Information Leaflet:

Do not take more medicine than the label tells you to. If you do not get better, talk to your doctor.

Talk to a doctor at once if you take too much of this medicine, even if you feel well. This is because too much paracetamol can cause 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.

4.6 Fertility, 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.

*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.

Adverse reactions identified during post-marketing use are listed below. The frequency of these reactions is unknown but likely to be rare.

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 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).

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 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

ATC code: N02BE51

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

Sucrose

Citric acid (anhydrous)

Saccharin sodium

Sodium citrate

Lemon Flavour

Honey Flavours (“contains (Sodium, Benzoic Acid, Sulphites)”)

Honey Flavour

Caramel Colour

Aspartame (E 951)

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.