ROBITUSSIN MUCUS COUGH AND CONGESTION RELIEF 20 MG 6 MG / ML ORAL SOLUTION, ROBITUSSIN CHESTY COUGH WITH CONGESTION - summary of medicine characteristics

1 NAME OF THE MEDICINAL PRODUCT

Robitussin Chesty Cough with Congestion

Robitussin Mucus Cough and Congestion Relief 20mg, 6mg/ml Oral Solution

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Guaifenesin, 100mg per 5ml

Pseudoephedrine Hydrochloride, 30mg per 5ml

Excipients with known effect

Amaranth (E123): 0.066 mg of Amaranth in each 10 ml dose

Ethanol: 242 mg of alcohol (ethanol) in each 10 ml dose

Maltitol (E965): 484 mg of maltitol in each 10 ml dose

Propylene glycol (E1520): 15.2 mg propylene glycol in each 10 ml dose

Sodium benzoate (E211): 12.0 mg of sodium benzoate in each 10 ml dose

Sodium: 27.5mg sodium in each 10 ml dose

Sorbitol (E420): 2094 g sorbitol in each 10 ml dose

For full list of excipients see section 6.1

Pale pink clear liquid for oral administration

4.1 Therapeutic indications

Nasal decongestant and expectorant for the symptomatic relief of respiratory tract disorders.

4.2 Posology and method of administration

Oral Administration

Adults, the elderly and children over 12 years: 10ml up to four times daily

Children under 12 years: Do not use

4.3 Contraindications

Hypersensitivity to any of the ingredients.

Use in patients with ischaemic heart disease, thyrotoxicosis, glaucoma, diabetes, enlargement of the prostate or urinary retention.

Patients taking a prescription monoamine oxidase inhibitor (MAOI) or for 14 days after stopping the MAOI drug. (See section 4.5).

Use in children under 12 years.

4.4 Special warnings and precautions for use

Sympathomimetics (such as pseudoephedrine hydrochloride) may occasionally cause an increase in blood pressure when used in combination with other sympathomimetics and tricyclic antidepressants (TCAs) and therefore special care is advisable in patients receiving antihypertensive therapy (See section 4.5).

Causes of chronic cough should be excluded if symptoms are persistent. Any accompanying symptoms should be actively sought and appropriately investigated/ treated.

Severe Skin reactions

Severe skin reaction 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 Robitussin Chesty Cough with Congestion / Robitussin Mucus Cough and Congestion Relief should be discontinued and appropriate measures taken if needed.

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.

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.

Stop use and ask your healthcare professional if your cough lasts more than 7 days, comes back or is accompanied by a fever, rash or persistent headache.

Keep out of sight and reach of children.

Do not exceed recommended dose.

Excipient warnings:

– Patients with rare hereditary problems of fructose intolerance should not take this medicine because this product contains sorbitol and maltitol.

– This medicinal product contains 27.5 mg sodium per 10 ml, equivalent to 1.4 % of the WHO recommended maximum daily intake of 2 g sodium for an adult.

– This product contains Amaranth (E123), which may cause allergic reactions.

– This medicine contains 242 mg of alcohol (ethanol) in each 10 ml dose which is equivalent to 24 mg/ml (2.30% w/v). The amount in 10 ml of this medicine is equivalent to less than 6 ml beer or 3 ml wine. Harmful for those suffering from alcoholism. To be taken into account in pregnant or breast-feeding women and high-risk groups such as patients with liver disease, or epilepsy.

– This medicine contains 12.0 mg sodium benzoate in each 10 ml dose which is equivalent to 1.2 mg/ml.

– This medicine contains 15.2 mg propylene glycol in each 10 ml which is equivalent to 1.5 mg/ml.

– This medicine contains 2094 mg sorbitol per 10 ml dose which is equivalent to 209.4 mg/ml. Sorbitol may cause gastrointestinal discomfort and mild laxative effect.

4.5 Interaction with other medicinal products and other forms of interaction

Not to be used in patients taking monoamine inhibitors or within 14 days of stopping treatment as there is a risk of hypertensive crisis when MOAI are taken in combination with sympathomimetics.

An increased risk of cardiac arrhythmias may occur if sympathomimetics are given to patients receiving cardiac glycosides.

Concomitant use of pseudoephedrine-containing products in very high doses with other sympathomimetic agents such as decongestants, inhaled beta-agonists or tricyclic antidepressants may occasionally cause a rise in blood pressure.

Alcohol

A dose of 10ml of this medicine administered to an adult weighing 70 kg would result in exposure to 3.0 mg/kg of ethanol which may cause a rise in blood alcohol concentration (BAC) of about 0.5 mg/100 ml.

A dose of 10ml of this medicine administered to a child over 12 years of age and weighing 40 kg would result in exposure to 5.4 mg/kg of ethanol which may cause a rise in blood alcohol concentration (BAC) of about 0.9 mg/100 ml.

For comparison, for an adult drinking a glass of wine or 500 ml of beer, the BAC is likely to be about 50 mg/100 ml. Co-administration with medicines containing e.g.propylene glycol or ethanol may lead to accumulation of ethanol and induce adverse effects, in particular in young children with low or immature metabolic capacity.

4.6 Fertility, pregnancy and lactation

If pregnant or breastfeeding, consult a healthcare professional before use.

Pregnancy

Guaifenesin:

Although adequate and well-controlled studies in pregnant women have not been done, the Collaborative Perinatal Project monitored 197 mother-child pairs exposed to guaifenesin during the first trimester. An increased occurrence of inguinal hernias was found in the neonates. However, congenital defects were not strongly associated with guaifenesin use during pregnancy in 2 large groups of mother-child pairs.

Pseudoephedrine:

Data on pregnancy outcomes after maternal exposure to pseudoephedrine are limited. Two analyses of health maintenance organisation pharmacy data identified 9 malformed infants among 902 first-trimester pseudoephedrine exposures suggesting no specific association with birth defects overall. However the related compounds epinephrine, ephedrine and phenylephrine have been associated with haemorrhages and cardiovascular and limb malformations in animal models. The vasoconstrictive effects of these drugs may indicate that their use in early pregnancy might increase the risk of vascular disruption defects.

Breastfeeding:

Guaifenesin and pseudoephedrine are excreted in breast milk in small quantities. It is estimated that 0.5% to 0.7% of a single dose of pseudoephedrine ingested by the mother will be excreted in breast milk over 24 hours.

Caution should therefore be exercised by balancing the potential benefit of treatment against any possible risks.

4.7 Effects on ability to drive and use machines

No or negligible influence.

4.8

The following side effects may be associated with the use of guaifenesin and pseudoephedrine:

Immune System Disorders Hypersensitivity reactions

Psychiatric Disorders Agitation (anxiety, excitability, irritability, nervousness, restlessness), insomnia (sleeplessness), hallucinations

Nervous System Disorders Dizziness, headache, hyperactivity (psychomotor hyperactivity), cerebral stimulation

Cardiac Disorders

Palpitation, tachycardia

Vascular Disorders

Increased blood pressure

Gastrointestinal Disorders

Nausea, vomiting, ischaemic colitis

Skin and Subcutaneous

Tissue Disorders

generalized exanthematous pustulosis (AGEP)

Skin rash, urticaria, severe skin reactions, including acute

Renal and urinary

Disorders

Urinary retention

Eye disorders Ischaemic optic neuropathy

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

In case of overdose, discontinue use and seek professional assistance immediately.

Symptoms:

Guaifenesin overdose: Nausea and vomiting.

Pseudoephedrine overdose: Bradycardia, palpitation, tachycardia, nausea, vomiting, convulsion (seizure), dizziness, tremor, agitation, anxiety, insomnia, irritability, nervousness, restlessness, hypertension, increased blood pressure.

Treatment: Appropriate supportive therapy dependent upon individual response to the preparation.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Guaifenesin

Pharmacotherapeutic group: Expectorant

ATC code: RO5CAO3

Guaifenesin has an expectorant action which increases the output of respiratory tract fluid by reducing adhesiveness and surface tension. The increased flow of less viscid secretion promotes ciliary action and facilitates the removal of mucus. This changes a dry unproductive cough to a cough that is more productive and less frequent.

Pseudoephedrine Hydrochloride

Pharmacotherapeutic group: Sympathomimetic

ATC code: R01BA02

Pseudoephedrine is a stereoisomer of ephedrine and has a similar action, but has been stated to have less pressor activity and central nervous system effects.

It is a sympathomimetic agent with indirect and direct effects on adrenergic receptors and is an orally effective upper respiratory tract decongestant. It has alpha- and beta-Adrenergic activity and has pronounced stimulating effects on the central nervous system. In therapeutic doses it raises the blood pressure by increasing cardiac output and also by inducing peripheral vasoconstriction.

5.2 Pharmacokinetic properties

Guaifenesin is well absorbed from the gastro intestinal tract following oral administration. Guaifenesin has a plasma half-life of approximately 1 hour. It is rapidly hydrolyzed (60% within seven hours) and then excreted in the urine, with beta-(2-methoxyphenoxy)-lactic acid as its major urinary metabolite.

Pseudoephedrine is absorbed from the gastro-intestinal tract. It is resistant to metabolism by monoamine oxidase and is largely excreted unchanged (55–75%) in the urine together with small amounts of its hepatic metabolite. It has a half-life of several hours; elimination is enhanced and half-life accordingly shorter in acid urine.

5.3 Preclinical safety data

No relevant information additional to that already contained elsewhere in the SPC

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Glycerol, Sodium Carboxymethyl Cellulose, Disodium Edetate, Sodium Benzoate, Sodium Cyclamate, Amaranth (E123), Ethanol, Levomenthol, Maltitol, Sorbitol Solution 70%, Natural Cherry Flavouring, Citric Acid Anhydrous, Caramel E150, Acesulfame Potassium and Purified Water.

6.2 Incompatibilities

None stated.

6.3 Shelf life

24 months

6.4 Special precautions for storage

Do not store above 25 DC.

6.5 Nature and contents of container

PET bottles containing 100ml with PET lined PP/HDPE screw caps.

A clear polypropylene measuring cap also included.

6.6 Special precautions for disposal

No special requirements.

7 MARKETING AUTHORISATION HOLDER

GlaxoSmithKline Consumer Healthcare (UK) Trading Limited,

Brentford,

TW8 9GS, U.K.

8 MARKETING AUTHORISATION NUMBER(S)

PL 44673/0208

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THEAUTHORISATION

01/09/1993