ROBITUSSIN CHESTY COUGH WITH CONGESTION

Active substance: PSEUDOEPHEDRINE HYDROCHLORIDE

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PAA021487

Chesty Cough with Congestion

Liquid For Oral Administration Guaifenesin 100mg And Pseudoephedrine Hydrochloride 30mg Per 5ml
If you take more medicine than you should: If you take too much of this medicine, consult your doctor or hospital immediately. Bring any remaining medicine with you to show the doctor. If you forget to take your medicine: Take a dose when you need to, provided the last dose was taken at least 4 hours ago. Do not take a double dose to make up for the one you have missed. 4. Possible side effects Like all medicines, your medicine can cause side effects, although not everybody gets them. Side effects with guaifenesin or pseudoephedrine are rare. However, susceptible individuals may experience unwanted side effects. If you experience any of the following serious effects then STOP taking this medicine immediately and contact your doctor or pharmacist: - Allergic reactions. Symptoms could include itchy skin or rashes, difficulty breathing, faster heart rate, swelling of the face or throat. - A feeling your heart is beating too fast or palpitations. Other possible side effects If any of the side effects below get serious or you experience any other side effects, stop taking this medicine immediately and consult your doctor: - Feeling sick (nausea) or being sick (vomiting). - Dizziness, headache, feeling restless or overactive. - Feeling anxious, irritable or nervous. - If you cannot sleep, or suffer from hallucinations. - Skin rashes or hives. - An increased blood pressure. - Difficulty passing urine. 5. How to store Robitussin Chesty Cough with Congestion - Do not use this medicine after the expiry date shown on the end of the carton. - Do not store above 25C. - Keep out of the sight and reach of children. 6. Further information What Robitussin Chesty Cough with Congestion contains: Each 5ml contains 100mg of the active substance guaifenesin and 30mg of the active substance pseudoephedrine hydrochloride. Robitussin Chesty Cough also contains: Glycerol, Carmellose Sodium, Disodium Edetate, Sodium Benzoate (E211), Sodium Cyclamate, Amaranth (E123), Ethanol (96%), Levomenthol, Maltitol (E965), Sorbitol Solution 70%, Natural Cherry Flavouring, Citric Acid Anhydrous, Caramel (E150), Acesulfame Potassium and Purified Water. Robitussin Chesty Cough with Congestion is available in packs containing 100ml. Who makes and supplies this medicine: The licence holder for Robitussin Chesty Cough with Congestion is: Pfizer Consumer Healthcare Ltd, Ramsgate Road, Sandwich, Kent, CT13 9NJ, UK. The dosing cup is manufactured by: Humphrey Cosburn Plastics, 89 Union Street, Toronto, Ontario, M6N 3N2, Canada The EU Authorised Representative is: Pfizer Consumer Healthcare Ltd This medicine is manufactured by: John Wyeth and Brother Limited, New Lane, Havant, Hampshire, PO9 2NG, United Kingdom. OR: Wyeth Lederle S.p.A. Via Nettunese 90, 04011 Aprilia (LT) Italy. If you have any queries, comments about this medicine or require information in large print, tape or CD please contact the Careline by phone or write to: Careline, Pfizer Consumer Healthcare Ltd, Vanwall Road, Maidenhead, Berkshire, SL6 4UB, UK. or carelineUK@pfizer.com Leaflet prepared: August 2011 PL 00165/0098 MA111/00401

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 this medicine
carefully to get the best results from it. - Keep this leaflet. You may need to read it again. - Ask your pharmacist if you need more information or advice. - You must contact a doctor if your symptoms worsen or do not improve after 7 days. - 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. In this leaflet: 1. What Robitussin Chesty Cough with Congestion is and what it is used for 2. Before you take Robitussin Chesty Cough with Congestion 3. How to take Robitussin Chesty Cough with Congestion 4. Possible side effects 5. How to store Robitussin Chesty Cough with Congestion 6. Further information 1. What Robitussin Chesty Cough with Congestion is and what it is used for This medicine contains the active ingredients guaifenesin and pseudoephedrine hydrochloride. Every 5ml of liquid contains 100mg of guaifenesin and 30mg of 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 works by providing symptomatic relief of the common cold. 2. Before you take Robitussin Chesty Cough with Congestion Do not take this medicine if: - You are allergic (hypersensitive) to guaifenesin or pseudoephedrine hydrochloride or any of the other ingredients in this medicine. - You are suffering from heart disease, an overactive thyroid gland, increased pressure in your eyes (glaucoma), diabetes, an enlarged prostate gland or have difficulty passing urine. - You are taking a monoamine oxidase inhibitor (MAOI) medicine for depressive illness, such as Moclobemide, or have done so in the last 14 days. Take special care and talk to your doctor or pharmacist before taking this medicine if you have had a cough for a long time, or if you have asthma or are suffering from an asthma attack. Taking other medicines: Talk to your doctor or pharmacist before taking this medicine if: - You are taking digoxin. - You are taking medicines to reduce blood pressure. - You are taking another decongestant product (e.g. sympathomimetics such as phenylepherine or an amphetamine-like psychostimulant such as dextroamphetamine). - You are taking a medicine to control the symptoms of asthma (e.g. an inhaled beta-agonist such as Salbutamol). - You are taking a medicine for depression (e.g. a tricyclic anti-depressant such as amitriptyline). Pregnancy and Lactation Talk to your doctor before taking this medicine if you are pregnant or breast-feeding. Driving and using machines Robitussin will have no or negligible influence on your ability to drive. Important information about some of the ingredients in this medicine: - This product contains amaranth (E123), which may cause allergic reactions. - If you have been told that you have an intolerance to some sugars, contact your doctor before taking this medicine as it contains Sorbitol and Maltitol. - This medicinal product contains 2.7 % v/v alcohol (ethanol) (214 mg per dose). This is equivalent to approximately 2 ml wine per dose which can be harmful for those suffering from alcoholism and should be taken into account if you are pregnant or breast-feeding or have liver disease or epilepsy. 3. How to take Robitussin Chesty Cough with Congestion Adults, the elderly and children over 12 years: Take 10ml up to four times daily, as required. Children under 12 years: Do not use. Do not exceed the stated dose. Not more than four doses should be taken in any 24 hours. Stop using this medicine and ask a healthcare professional if you have had a cough for more than 7 days or if you have any other symptoms which might be related to your cough, for example fever, rash, persistent headache, shortness of breath, weight loss or chest pain.

* Trade Mark
PAA021487

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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