Pfizer Consumer Healthcare

Robitussin Plus Oral Solution

Guaifenesin 100 mg/5ml

Pseudoephedrine HCl 30 mg/5ml

Each 5ml of liquid contains:

For a full list of excipients, see 6.1.

Oral solution.

A clear, pale pink-coloured liquid with a cherry flavour.

Fixed combination of sympathomimetic and expectorant for use as a nasal decongestant and expectorant.

Taken orally.

Use in children under 12 years of age.

Hypersensitivity to the active substance or to any of the excipients.

Persons with hypertension, acute ischaemic heart disease, glaucoma, thyrotoxicosis or urinary retention, should use this product only as directed by a doctor

Patients currently receiving, or who have received within two weeks, monoamine oxidase inhibitors

Patients receiving other sympathominetic agents or tricyclic antidepressants

Caution should be exercised in patients with:

- High blood pressure, heart disease, diabetes, thyroid disease, or trouble urinating due to enlarged prostate gland.

-A chronic cough as occurs with smoking or chronic lung disease such as asthma or emphysema.

It should be used only cautiously in patients with severe hepatic or renal impairment.

Pregnant of lactating women should consult their doctor before use.

A doctor or healthcare professional should be sought if symptoms get worse or last more than 5 days, come back or are accompanied by fever, rash or persistent headaches. These could be signs of a serious condition.

This medicinal product contains 12.6 mg sodium per 5ml. To be taken into consideration by patients on a controlled sodium diet.

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.

This product contains amaranth (E123) which may cause allergic reactions.

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

Do not exceed recommended dose.

Do not take this product if you are taking a prescription monoamine oxidase inhibitor (MAOI) or for 14 days after stopping the MAOI drug.

Patients receiving cardiac glycosides or antihypertensive agents should use this product only as directed by a doctor.

None.

The following side effects may be associated with the use of these active ingredients and are listed under their corresponding body system organ class:

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 HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517. Website: www.hpra.ie; E-mail: medsafety@hpra.ie.

The following side effects may be associated with an overdose of these actives ingredients:

Gastrointestinal disorders

Nausea, vomiting

Cardiac disorders

Bradycardia, palpitation, tachycardia

Nervous system disorders

Convulsion, dizziness, tremor

Psychiatric disorders

Agitation, anxiety, insomnia, irritability, nervousness, restlessness

Vascular disorders

Hypertension, increased blood pressure

Treatment is by gastric lavage together with appropriate supportive therapy dependent upon individual response to the various constituents of the product.

Guaifenesin is used as an expectorant. It reduces the viscosity of the sputum.

Pseudoephedrine reduces swollen nasal membranes, tissue hyperaemia, oedema and nasal congestion. It increases nasal airway patency and reduces eustachian tube blockage.

Guaifenesin is absorbed from the GI tract. It undergoes metabolism and is excreted in the urine.

Pseudoephedrine is absorbed from the GI tract. It is incompletely metabolised in the liver. It is excreted both as unchanged pseudoephedrine and as metabolites in the urine.

Not Applicable.

Ethanol (96%)

Glycerol

Carmellose Sodium

Sodium Benzoate (E211)

Caramel (E150)

Disodium Edetate

Amaranth (E123)

Citric Acid Anhydrous

Levomenthol

Maltitol Liquid (E965)

Natural Cherry Flavour*

Sorbitol Solution (70%) (E420)

Sodium Cyclamate

Acesulfame Potassium Salt

Purified Water

* contains Ethanol, Propylene Glycol and Natural Cherry Flavour

None known

PET Bottles: 24 months

Do not store above 25°C. Do not refrigerate or freeze.

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

A clear polypropylene measuring cap is also included.

No special requirements.

Pfizer Healthcare Ireland,

9 Riverwalk, National Digital Park,

Citywest Business Campus, Dublin 24,

Ireland.

PA 0822/171/001

Date of first authorisation: 29^th July 1985

Date of last renewal: 29^th July 2010

February 2015