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Robitussin Mucus Cough And Congestion Relief 20mg 6mg/Ml Oral Solution

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Document: leaflet MAH BRAND_PL 00165-0098 change

m1-3-1 -leaflet-clean 0098 PIL 15 149 v1

Robitussin® Chesty Cough with Congestion

Guaifenesin 100mg and Pseudoephedrine 30mg per 5ml Liquid for Oral Administration

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.

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, used to treat some heart conditions.

-You are taking medicines to reduce blood pressure.

-You are taking another decongestant product (e.g. sympathomimetics such as phenylephrine.

-    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 breastfeeding

Talk to your doctor before taking this medicine if you are pregnant or breast-feeding.

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 medicine contains 25.2 mg of sodium per 10 ml dose. This should be taken into account by those who are on a controlled sodium diet.

-    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 breastfeeding or have liver disease or epilepsy. This will have no or negligible influence on your ability to drive.

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.

Use the dosing cup provided with the pack.

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 or shortness of breath.

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.

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

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 25°C.

-    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 with Congestion 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 a liquid, supplier in a 100 ml bottle.

Who makes and supplies this medicine:

The Marketing Authorisation 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 This medicine is manufactured by:

Wyeth Pharmaceuticals, New Lane, Havant, Hampshire, PO9 2NG, United Kingdom.

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,

Walton Oaks, Surrey, KT20 7NS, UK or carelineUK@pfizer.com

Leaflet prepared: December 2015 PL 00165/0098 MA111/00401