País: Malta
Idioma: anglès
Font: Malta Medicines Authority
GUAIFENESIN, PSEUDOEPHEDRINE HYDROCHLORIDE
Pfizer Healthcare Ireland 9 Riverwalk, National Digital Park, Citywest Business Campus, Dublin 24, Ireland
R05CA10
GUAIFENESIN 20 mg/ml PSEUDOEPHEDRINE HYDROCHLORIDE 6 mg/ml
ORAL SOLUTION
GUAIFENESIN 20 mg/ml PSEUDOEPHEDRINE HYDROCHLORIDE 6 mg/ml
OTC
COUGH AND COLD PREPARATIONS
Withdrawn
2007-08-20
PLUS ORAL SOLUTION GUAIFENESIN 100 MG/5ML PSEUDOEPHEDRINE HYDROCHLORIDE 30 MG/5ML PAA111359 Read all of this leaflet carefully because it contains important information for you. This medicine is available without prescription. However, you still need to use Robitussin Plus carefully to get the best results from it. • Keep this leaflet. You may need to read it again. • Ask your doctor or pharmacist if you need more information or advice. • If any of the side effects get serious, or if you notice any side effect not listed in this leaflet, please tell your doctor or pharmacist. • You must contact a doctor or pharmacist if symptoms persist. In this leaflet: 1 What Robitussin Plus is and what it is used for 2 Before you take Robitussin Plus 3 How to take Robitussin Plus 4 Possible side effects 5 How to store Robitussin Plus 6 Further information 1 What Robitussin Plus is and what it is used for Robitussin Plus contains the active ingredients guaifenesin and pseudoephedrine hydrochloride. Guaifenesin belongs to a group of medicines called cough expectorants and works by changing an unproductive cough to a cough that is more productive and less frequent. Pseudoephedrine hydrochloride belongs to a group of medicines called nasal decongestants and helps clear nasal congestion (a blocked or stuffy nose). 2 Before you take Robitussin Plus • Do not use in combination with any other medication unless your doctor approves it. Do not take this medicine if: • You are allergic (hypersensitive) to guaifenesin or pseudoephedrine hydrochloride or any of the other ingredients of Robitussin Plus. • You are taking a monoamine oxidase inhibitor (MAOI) or have done so in the last 14 days. • You are taking other medicine for depression (e.g. tricyclic antidepressants). • You are taking sympathomimetics (medicines used to treat nasal congestion that also contain for example pseudoephedrine, phenylephrine or phenylpropanolamine). • You are taking cardiac glycosides (e.g. digoxin). • You are taking any medicine for hea Llegiu el document complet
RESTRICTED Pfizer Consumer Healthcare 1. TRADE NAME OF THE MEDICINAL PRODUCT Robitussin Plus Oral Solution _Guaifenesin 100 mg/5ml _ _Pseudoephedrine HCl 30 mg/5ml _ 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each 5ml of liquid contains: Guaifenesin 100 mg Pseudoephedrine HCl 30 mg Excipients: Each 5ml contains; Ethanol (96%) 107 mg Sodium 12.6 mg Amaranth 0.033 mg Liquid Maltitol 242 mg Sorbitol Solution 70% 1.454 g For a full list of excipients, see 6.1. 3. PHARMACEUTICAL FORM Oral solution. A clear, pale pink-coloured liquid with a cherry flavour. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Fixed combination of sympathomimetic and expectorant for use as a nasal decongestant and expectorant. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Taken orally. ADULTS AND CHILDREN OVER 12 YEARS: 10 ml x 3 daily CHILDREN UNDER 12: Do not use 4.3. CONTRAINDICATIONS 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 RESTRICTED Pfizer Consumer Healthcare Patients currently receiving, or who have received within two weeks, monoamine oxidase inhibitors Patients receiving other sympathominetic agents or tricyclic antidepressants 4.4. SPECIAL WARNINGS AND PRECAUTIONS FOR USE 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. 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 uppe Llegiu el document complet