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

Each 5ml contains Guaiphenesin PhEur, 100mg Pseudoephedrine Hydrochloride BP, 30mg

3 PHARMACEUTICAL FORM

Pale pink clear liquid for oral administration 4.    CLINICAL PARTICULARS

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.

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 25.2 mg sodium per 10ml dose. This should be taken into consideration by patients on a controlled sodium diet.

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

-    This medicinal product contains 2.7 % w/v ethanol (alcohol), up to 214 mg per dose (equivalent to approx 2 ml wine per dose). 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.

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.

4.6    Pregnancy and lactation

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 organsation 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 Undesirable Effects

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

Skin and Subcutaneous

Tissue Disorders    Skin rash, urticaria

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

Symptoms:

Guaifenesin overdose: nausea and vomiting.

Pseudoephedrine overdose: Bradycardia, palpitation, tachycardia, nausea, vomiting, convulsion (seizure), dizziness, tremor, agitation, anxiety, insomnia, irritability, nervousness, restlessness, 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 °C.

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.

No special requirements.

7_MARKETING AUTHORISATION HOLDER

Pfizer Consumer Healthcare Ltd

Ramsgate Road

Sandwich

Kent

CT13 9NJ United Kingdom

8. MARKETING AUTHORISATION NUMBER(S)

PL 00165/0098

9. DATE OF FIRST AUTHORISATION / RENEWAL OF THE AUTHORISATION

01 September 1993

10 DATE OF REVISION OF THE TEXT

30/01/2014