SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT

Fedril Night Cold and Flu, Oral Solution

Lloyds Pharmacy Night Cold and Flu Relief, Oral Solution

Numark Night Cold and Flu, Oral Solution

Tesco Night Cold and Flu, Oral Solution

Vantage Night Cold and Flu, Oral Solution

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Active Constituents    mg/20 ml

Paracetamol    1000.0

Promethazine Hydrochloride    20.0

Dextromethorphan Hydrobromide    15.0

For excipients, see 6.1.

3 PHARMACEUTICAL FORM

Oral Solution

Clear green, mint flavoured, sugar free oral solution.

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

For the symptomatic night time relief of colds, chills and influenza consisting of headache, shivers, sore throat pain, tickly cough, runny nose, aches and pains.

4.2    Posology and method of administration

Route of administration

For oral use. Shake the bottle before use

Adults and children aged 12 years and over:

One measured 20 ml dose to be taken just before going to bed.

Not to be given to children under 12 years.

Elderly:

The normal adult dose can be used.

4.3 Contraindications

Hypersensitivity to paracetamol or any of the other constituents. Hepatic or renal impairment.

4.4 Special warnings and precautions for use

Patients suffering from asthma or other respiratory disorders, epilepsy, glaucoma, urinary retention, prostatic hypertrophy, or cardiovascular problems, should only take the product after consulting a doctor.

Patients with rare hereditary problems of fructose intolerance should not take this medicine.

The hazards of overdose are greater in those with non-cirrhotic alcoholic liver disease.

Do not exceed the stated dose. Always use the measuring cup supplied with the pack. Patients should be advised not to take other paracetamol-containing products or decongestant-containing medicines concurrently.

If symptoms persist consult your doctor.

Keep all medicines out of reach and sight of children.

Warning: May cause drowsiness. If affected, do not drive or operate machinery. Avoid alcoholic drink.

Special label warnings

Do not take with any other paracetamol-containing products.

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

Special leaflet warnings

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.

This medicinal product contains ethanol (alcohol), i.e. up to 3.5ml per 20ml dose, equivalent to 70 ml of beer, 29 ml of wine per dose.

Harmful for those suffering from alcoholism.

To be taken into account in pregnant or breast-feeding women, children and high-risk groups such as patients with epilepsy.

Each 20ml dose contains up to 23.52mg of sodium. This should be taken into account by patients on a controlled sodium diet.

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 cholestyramine. 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.

The hepatotoxicity of paracetamol may be potentiated by excessive intake of alcohol. Promethazine may potentiate the action of alcohol and other centrally acting depressants, hypnotics and anxiolytics. MAOIs may enhance the antimuscarinic effects of antihistamines. Antihistamines have an added antimuscarinic effect with other antimuscarinic drugs including tricyclic antidepressants. Promethazine may interfere with immunologic urine pregnancy test to produce false results.

Use of dextromethorphan in patients taking monoamine oxidase inhibitors should be avoided as severe reactions have been reported.

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 does not contraindicate breast feeding.

There are also no known contraindications to the use of Promethazine or Dextromethorphan during pregnancy and lactation. Hence, as with all medicines, the advice of a doctor should be sought before use of the product in pregnancy and lactation, and it should only be used when considered essential by the doctor.

4.7 Effects on ability to drive and use machines

This medicine can impair cognitive function and can affect a patient’s ability to drive safely. This class of medicine is in the list of drugs included in regulations under 5a of the Road Traffic Act 1988. When prescribing this medicine, patients should be told:

•    The medicine is likely to affect your ability to drive

•    Do not drive until you know how the medicine affects you

•    It is an offence to drive while under the influence of this medicine

•    However, you would not be committing an offence (called ‘statutory defence’) if:

o The medicine has been prescribed to treat a medical or dental problem and o You have taken it according to the instructions given by the prescriber and in the information provided with the medicine and o It was not affecting your ability to drive safely

4.8 Undesirable effects

Adverse effects of paracetamol are rare but hypersensitivity including skin rash may occur. Very rare cases of serious skin reactions have been reported. There have been very rare reports of blood dyscrasias including thrombocytopenia and agranulocytosis but these were not necessarily causality related to paracetamol.

Drowsiness, psychomotor impairment, antimuscarinic effects (such as urinary retention, dry mouth, and blurred vision), disorientation, restlessness and gastrointestinal disturbances may occasionally occur with promethazine. Hypersensitivity reactions including rash and photosensitivity reactions have been reported.

Adverse effects with dextromethorphan are rare, but gastrointestinal disturbances and dizziness have been reported occasionally.

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

Immediate treatment is essential in the management of paracetamol overdosage. Despite a lack of significant early symptoms, patients should be referred to hospital urgently for immediate medical attention and any patient who had ingested around 7.5g or more of paracetamol in the preceding 4 hours should undergo gastric lavage. Administration of oral methionine or intravenous N-acetylcysteine which may have a beneficial effect up to at least 48 hours after the overdose may be required. General supportive measures must be available.

Symptoms of paracetamol overdose in the first 24 hours are pallor, nausea, vomiting, anorexia and abdominal pain. Liver damage may become apparent 12-48 hours after ingestion. Abnormalities of glucose metabolism and metabolic acidosis may occur. In severe poisoning, hepatic failure may progress to encephalopathy, coma and death. Acute renal failure with acute tubular necrosis may develop even in the absence of severe liver damage. Cardiac arrhythmias and pancreatitis have been reported. Liver damage is possible in adults who have taken 10 g or more of paracetamol. It is considered that excess quantities of a toxic metabolite (usually adequately detoxified by glutathione when normal doses of paracetamol are ingested); become irreversibly bound to liver tissue.

In children, Promethazine overdose can cause CNS stimulation and antimuscarinic effects. In severe cases in both adults and children, CNS depression with coma and convulsions may occur. Cardiorespiratory depression is uncommon. If the patient is seen soon enough after ingestion, it should be possible to induce vomiting with ipecacuanha despite the antiemetic effect of promethazine; alternatively gastric lavage may be used. Treatment otherwise supportive with attention to maintenance of adequate respiratory and circulatory status. Convulsions should be treated with diazepam or other suitable anticonvulsants.

Symptoms of Dextromethorphan overdose would be dizziness, excitation, mental confusion and gastrointestinal disturbances, and at very high doses, respiratory depression. Intravenous Naloxone is a specific antidote.

5    PHARMACOLOGICAL PROPERTIES

5.1    Pharmacodynamic properties

Paracetamol: other analgesics and antipyretics, anilides.

Pharmacotherapeutic Group: Analgesics and Antipyretics, Anilides ATC Code:    N02B E01

Promethazine Hydrochloride: an antihistamine with anticholinergic activity.

Pharmacotherapeutic Group: Antihistamines for Systemic Use, Phenothiazine derivatives

ATC Code:    R06A D02

Dextromethorphan Hydrobromide: an antitussive Pharmacotherapeutic Group:    Cough and Cold Preparations, Opium

Alkaloids and derivatives ATC Code:    R05D A09

5.2 Pharmacokinetic properties

Paracetamol is readily absorbed from the upper gastrointestinal tract. It is metabolised predominantly in the liver and excreted in the urine, mainly as glucuronide and sulphate conjugates.

Promethazine Hydrochloride is readily absorbed from the gastrointestinal tract, but undergoes extensive first pass metabolism in the liver, with only 25% of the oral dose reaching the systemic circulation unchanged. After oral therapy, therapeutic effects are identifiable at 15-30 minutes and peak plasma concentrations at 2 to 3 hours. Estimates of terminal half life in blood plasma are in the range of 4-6 hours. It is extensively plasma protein bound. It is eliminated mainly as metabolites,

predominantly by the faecal (via biliary) route, with < 1% of the patient compound and ca. 10% as the sulphoxide metabolite being excreted in the urine over a 72 hour period.

Dextromethorphan Hydrobromide is well absorbed from the gastrointestinal tract. It is metabolised in the liver and excreted as demethylated metabolites including dextrorphan, and as a minor proportion of unchanged dextromethorphan. In a small proportion of individuals, metabolism proceeds more slowly and dextromethorphan predominates in blood and urine.

5.3    Preclinical safety data

Preclinical safety data on these active ingredients in the literature have not revealed any pertinent and conclusive findings which are of relevance to the recommended dosage and use of the product and which have not already been mentioned elsewhere in this summary.

6    PHARMACEUTICAL PARTICULARS

6.1    List of excipients

ethanol

propylene glycol

liquid maltitol (hydrogenated glucose syrup)

sodium citrate

ascorbic acid

acesulfame k

citric acid monohydrate

natural mint flavour

patent blue v (E131)

quinoline yellow (E104)

purified water

6.2    Incompatibilities

None known.

6.3    Shelf life

36 months

Shelf life after first opening: 1 month

6.4    Special precautions for storage

Do not store above 25^oC. Store in the original container. Keep the bottle in the outer carton.

6.5    Nature and contents of container

Clear glass bottles - 200 ml with polypropylene child resistant closures.

6.6    Special precautions for disposal

Not applicable.

7    MARKETING AUTHORISATION HOLDER

Pinewood Laboratories Limited

Ballymacarbry

Clonmel

Co. Tipperary

Ireland

8    MARKETING AUTHORISATION NUMBER(S)

PL 04917/0053

9    DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

05/11/2009

10    DATE OF REVISION OF THE TEXT

05/03/2015