VICKS MEDINITE - summary of medicine characteristics

1 NAME OF THE MEDICINAL PRODUCT

Vicks Medinite.

Vicks Cold & Flu Care MEDINITE Complete Syrup

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

ACTIVE INGREDIENTS

Excipient(s) with known effect

Ethanol 96%                 18 % v/v (equivalent to 4.1 g per 30 mL dose)

Sodium benzoate (E 211)      0.10% w/v

Sucrose                    2­7.5% w/v

Each 30 ml dose contains 75 mg sodium.

For the full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Syrup.

A clear, slightly viscous green liquid

4.1 Therapeutic indications

Vicks Cold & Flu Care Medinite Complete Syrup is indicated in adults and children aged 16 years and over for the treatment of symptoms of the common cold, accompanied by runny nose, sneezing, headache, body ache, sore throat, cough and nasal congestion.

4.2 Posology and method of administrationPosology

Adults

30 ml in measuring cup at bedtime.

Paediatric population

The adult dose is applicable to children aged 12 years and over. Contraindicated in children aged 12 years and under (see section 4.3).

Elderly

Adult dose applies.

Method of administration

Oral administration.

4.3 Contraindications

Hypersensitivity to the active substances or to any of the excipients listed in section 6.1

Cardiovascular disorders (hypertension, heart disease)

Hyperthyroidism disease

While currently taking MAOIs (monoamine oxidase inhibitors) or within 14 days of stopping taking MAOIs (see section 4.5) Severe hepatic or renal insufficiency

Closed or narrow angle glaucoma

Pheochromocytoma

Patients taking selective serotonin reuptake inhibitors (SSRIs, see section 4.5) Concomitant use of other sympathomimetic decongestants

Patients taking beta blockers (see section 4.5)

Not to be used in Children under 12 years of age

4.4 Special warnings and precautions for use

Do not exceed the recommended dose.

Do not take any other cough and cold medicine

Contains paracetamol. Patients should be advised not to take other paracetamol-containing products concurrently. Care is advised in the administration of paracetamol to patients with impaired hepatic function including those with non-cirrhotic alcoholic liver disease. The hazards of overdose are greater in those with alcoholic liver disease.

This product should be used with caution if the patient is suffering from the following conditions:

occlusive vascular disease

prostatic hypertrophy or urinary retention

susceptibility to angle-closure associated with glaucoma

diabetes mellitus

Ask a doctor before use if you have the following:

a cough accompanied by excessive phlegm (mucus)

a chronic or persistent cough such as occurs with smoking, asthma or emphysema

Drug dependence, tolerance and potential for abuse

For all patients, prolonged use of this product may lead to drug dependence (addiction), even at therapeutic doses. The risks are increased in individuals with current or past history of substance misuse disorder (including alcohol misuse) or mental health disorder (e.g., major depression).

Drug withdrawal syndrome

The drug withdrawal syndrome is characterised by some or all of the following: restlessness, lacrimation, rhinorrhoea, yawning, perspiration, chills, myalgia, mydriasis and palpitations. Other symptoms may also develop including irritability, agitation, anxiety, hyperkinesia, tremor, weakness, insomnia, anorexia, abdominal cramps, nausea, vomiting, diarrhoea, increased blood pressure, increased respiratory rate or heart rate.

Serotonin Syndrome

Serotonergic effects, including the development of a potentially lifethreatening serotonin syndrome, have been reported for dextromethorphan with concomitant administration of serotonergic agents, such as selective serotonin re-uptake inhibitors (SSRIs), drugs which impair metabolism of serotonin (including monoamine oxidase inhibitors (MAOIs)) and CYP2D6 inhibitors.

Serotonin syndrome may include mental-status changes, autonomic instability, neuromuscular abnormalities, and/or gastrointestinal symptoms.

If serotonin syndrome is suspected, treatment with Vicks Cold & Flu Care Medinite Complete Syrup should be discontinued.

Severe Skin reactions

Severe skin reactions such as acute generalized exanthematous pustulosis (AGEP) may occur with pseudoephedrine-containing products. This acute pustular eruption may occur within the first 2 days of treatment, with fever, and numerous, small, mostly non-follicular pustules arising on a widespread oedematous erythema and mainly localized on the skin folds, trunk, and upper extremities. Patients should be carefully monitored. If signs and symptoms such as pyrexia, erythema, or many small pustules are observed, administration of pseudoephedrine containing products should be discontinued and appropriate measures taken if needed

Dextromethorphan is metabolised by hepatic cytochrome P450 2D6. The activity of this enzyme is genetically determined. About 10% of the general population are poor metabolisers of CYP2D6. Poor metabolisers and patients with concomitant use of CYP2D6 inhibitors may experience exaggerated and/or prolonged effects of dextromethorphan. Caution should therefore be exercised in patients who are slow metabolizers of CYP2D6 or use CYP2D6 inhibitors (see also section 4.5).

Ischaemic colitis

Some cases of ischaemic colitis have been reported with pseudoephedrine. Pseudoephedrine should be discontinued and medical advice sought if sudden abdominal pain, rectal bleeding or other symptoms of ischaemic colitis develop.

Ischaemic optic neuropathy

Cases of ischaemic optic neuropathy have been reported with pseudoephedrine. Pseudoephedrine should be discontinued if sudden loss of vision or decreased visual acuity such as scotoma occurs.

If you are under the care of your doctor or are receiving prescribed medication or if you are pregnant, consult your doctor before using this product.

If any of the following occur, Vicks Cold & Flu Care Medinite Complete Syrup should be stopped:

hallucinations

restlessness

sleep disturbances

If symptoms persist, consult your doctor.

Keep out of the sight and reach of children.

Prolonged use without medical supervision is not advisable.

Excipient warnings:

Ethanol 96%

Contains alcohol. May cause drowsiness. If affected do not drive or operate machinery. Avoid alcoholic drink and other CNS depressants.

The amount of alcohol in a dose may be harmful for those suffering from alcoholism and should be taken into account in pregnant or breastfeeding women, children and high-risk groups such as patients with liver disease or epilepsy. Alcohol may alter the effects of other medicines.

Sodium

This medicinal product contains 75 mg sodium per 30 ml, equivalent to 4% of the WHO recommended maximum daily intake of 2 g sodium for an adult.

Sucrose

Each dose contains 8.25 g of sucrose. This should be taken into account in patients with diabetes mellitus.

Patients with rare hereditary problems of fructose intolerance, glucosegalactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

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 use of paracetamol with increased risk of bleeding.

Paracetamol may cause a marginal increase in blood levels of chloramphenicol, monoamine oxidase inhibitors, antihypertensives, betablockers.

Do not use for patients currently receiving or within 14 days of stopping therapy with monoamine oxidase inhibitors (MAOI) and/ or reversible inhibitors of monoamine oxidase (RIMA) and moclobemide due to the risk of serotonin syndrome

Drugs which induce liver enzymes (e.g. alcohol, anticonvulsants etc) may increase the hepatotoxicity of paracetamol, particularly after overdose.

Pseudoephedrine may reduce the efficacy of beta-blocking drugs, methyl dopa or other anti-hypertensive drugs including adrenergic neurone blockers.

There is a possible increased risk of hypertension and arrhythmias when tricyclic antidepressants, appetite suppressants and amphetamine-like psychostimulants are given with sympathomimetics such as pseudoephedrine.

Possible additive cardiovascular toxicity may occur when sympathomimetics are given with antiparkinsonian drugs such as bromocriptine

There is an increased risk of dysrhythmias when cardiac glycosides are given with sympathomimetics such as pseudoephedrine.

There is an increased risk of ergotism when ergot alkaloids (ergotamine & methysergide) are given with sympathomimetics such as pseudoephedrine.

CYP2D6 inhibitors:

There is a possibility of interactions between dextromethorphan and drugs that inhibit the CYP2D6 isoenzyme such as SSRIs (e.g. fluoxetine, paroxetine). Dextromethorphan is metabolised by CYP2D6 and has an extensive first-pass metabolism. Concomitant use of potent CYP2D6 enzyme inhibitors can increase the dextromethorphan concentrations in the body to levels multifold higher than normal. This increases the patient's risk for toxic effects of dextromethorphan (agitation, confusion, tremor, insomnia, diarrhoea and respiratory depression) and development of serotonin syndrome.

Potent CYP2D6 enzyme inhibitors include fluoxetine, paroxetine, quinidine and terbinafine. In concomitant use with quinidine, plasma concentrations of dextromethorphan have increased up to 20-fold, which has increased the CNS adverse effects of the agent.

Amiodarone, flecainide and propafenone, sertraline, bupropion, methadone, cinacalcet, haloperidol, perphenazine and thioridazine also have similar effects on the metabolism of dextromethorphan.

If concomitant use of CYP2D6 inhibitors and dextromethorphan is necessary, the patient should be monitored and the dextromethorphan dose may need to be reduced.

Dextromethorphan and doxylamine might exhibit additive CNS depressant effects with alcohol, antihistamines, psychotropics, and other CNS depressant drugs e.g., barbiturates, hypnotics, opioid analgesics and anxiolytic sedatives.

4.6 Fertility, pregnancy and lactation

A large amount of data on pregnant women indicate neither malformative, nor feto/neonatal toxicity

Epidemiological studies on neurodevelopment in children exposed to paracetamol in utero show inconclusive results.

If clinically needed, paracetamol can be used during pregnancy, however it should be used at the lowest effective dose for the shortest possible time and at the lowest possible frequency.

Paracetamol is excreted in breast milk but not in a clinically significant amount. Available published data do not contraindicate breast feeding.

Due to insufficient evidence on the use of the product in pregnancy and lactation, use of the product should be avoided unless on the advice of a physician.

4.7 Effects on ability to drive and use machines

The amount of alcohol in this medicinal product may impair the ability to drive or use machines.

May cause drowsiness. Those affected should not drive or operate machinery. 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

In general no severe undesirable effects are expected.

Tabulated list of adverse reactions

The table below presents undesirable effects listed by system organ class and grouped by frequency of occurrence. The frequency of occurrence of undesirable effect is usually classified as follows:

Very common (> 1/10)

Common (> 1/100 to < 1/10)

Uncommon (> 1/1,000 to < 1/100)

Rare (> 1/10,000 to < 1/1,000)

Very rare (< 1/10,000)

Not known (cannot be estimated from the available data).

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 or search for MHRA Yellow Card in the Google Play or Apple App Store.

4.9 Overdose

4.9.1 Symptoms

Paracetamol:

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, coma and death. Acute renal failure with acute tubular necrosis may develop even in the absence of severe liver damage. Cardiac arrhythmias have been reported.

Other symptoms may include CNS depression, cardiovascular effects and renal damage.

Dextromethorphan:

Dextromethorphan overdose may be associated with nausea, vomiting, dystonia, agitation, confusion, somnolence, stupor, nystagmus, cardiotoxicity (tachycardia, abnormal ECG including QTc prolongation), ataxia, toxic psychosis with visual hallucinations, hyperexcitability.

In the event of massive overdose, the following symptoms may be observed: coma, respiratory depression, convulsions.

It is thought to be of low toxicity, but the effects in dextromethorphan overdosage will be potentiated by simultaneous ingestion of alcohol and psychotropic drugs.

Doxylamine:

Symptoms such as excitation, mental confusion, convulsions and respiratory depression may occur after overdose with doxylamine.

Pseudoephedrine:

Central nervous and cardiovascular symptoms may occur with overdose. These may include agitation, insomnia, tremors or convulsions, hypertension and cardiac arrhythmias

4.9.1 Treatment of overdose

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 and any patient who has 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.

Treatment of other symptoms is by symptomatic management.

Treatment of dextromethorphan overdose should be symptomatic and supportive.

Activated charcoal can be administered to asymptomatic patients who have ingested overdoses of dextromethorphan within the preceding hour.

For patients who have ingested dextromethorphan and are sedated or comatose, naloxone, in the usual doses for treatment of opioid overdose, can be considered. Naloxone has been used successfully to reverse central or peripheral opioid effects of dextromethorphan in children (0.01mg/kg body weight).

Benzodiazepines for seizures and benzodiazepines and external cooling measures for hyperthermia from serotonin syndrome can be used.

5.1 Pharmacodynamic properties

Paracetamol: N02BE51

Other analgesics and antipyretics

Dextromethorphan:N07XX59

Cough suppressants

Antihistamine for systemic use Sympathomimetic agent – nasal

Doxylamine:R06AA59

Pseudoephidrine hydrochloride: decongestant

5.2 Pharmacokinetic properties

Paracetamol:

Dextromethorphan: pass

Genetically main determinant in human volunteers.

oxidation

pharmacokinetics between

Metabolised in the liver and excreted in the urine as

glucuronide and sulphate conjugates.

Dextromethorphan undergoes rapid and extensive first-metabolism in the liver after oral administration.

controlled O-demethylation (CYD2D6) is the of dextromethorphan pharmacokinetics

It appears that there are distinct phenotypes for this process resulting in highly variable subjects. Unmetabolised

dextromethorphan, together with the                      t­hree demethylated

morphinan metabolites dextrorphan (also                       ­known as 3–

hydroxy-N-methylmorphinan), 3

hydroxymorphinan and 3-methoxymorphinan have been

identified as conjugated products in the urine.

Dextrorphan, which also has antitussive action, is the

main                             ­metabolite. In some individuals metabolism

proceeds more                                 ­slowly and unchanged

dextromethorphan predominates in the                          b­lood and urine

Doxylamine succinate: Is believed to be metabolised in the liver and

excreted mainly as metabolites in the urine.

Pseudoephedrine Is resistant to metabolism by monoamine oxidase and

is largely excreted unchanged in the urine.

5.3 Preclinical safety data

Conventional studies using the currently accepted standards for the evaluation of toxicity to reproduction and development are not available.

6.1 List of excipients

Ethanol 96%

Sodium citrate

Citric acid monohydrate

Sodium benzoate (E 211)

Polyethylene glycol 6000

Sucrose

Glycerol (E 422)

Anethole

Quinoline yellow (E104)

Indigotin blue (E132)

Water, purified

6.2 Incompatibilities

Not applicable

6.3 Shelf-life

3 years

6.4 Special precautions for storage

Do not store above 25oC.

6.5 Nature and content of container

6.6    Special precautions for disposal

7.   MARKETING AUTHORISATION HOLDER

8.   MARKETING AUTHORISATION NUMBER

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THEAUTHORISATION

25/02/2009