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

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Document: leaflet MAH BRAND 2_PL 00165-0098 change

Robitussin*

Guaifenesin and

MUCUS COUGH

AND CONGESTION RELIEF

20mg, 6mg/ml Oral Solution

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 Mucus Cough and Congestion Relief is and what it is used for

2.    Before you take Robitussin Mucus Cough and Congestion Relief

3.    How to take Robitussin Mucus Cough and Congestion Relief

4.    Possible side effects

5.    How to store Robitussin Mucus Cough and Congestion Relief

6.    Further information

1.    What Robitussin Mucus Cough and Congestion Relief 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 Mucus Cough and Congestion Relief 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 breastfeeding.

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 10 ml 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 Mucus Cough and Congestion Relief

For oral use only.

Adults, the elderly and children over 12 years: Take 10 ml 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. No 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:

Takeadosewhen you need to, prtvifef the last ftse was taken at least 4 hours ago. Dt not take a double dose to make up for the one you have missef.

4.    Possibleuide effects

Like all mef icinen, your medieine 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 tsking this medicine immediately and contact your doctor or pharmacist:

-    AMergic reactions. Symptoms coul id include itchy okin or rashes, difficulty breathing, faster heart rate, swelling sf the face os throat.

-    A feeling your heart is beating too fast or palpitations.

Other possible hide effects

If any of the side effucts bolow get serious or you experience any other side effects, stop taking this medicine immediately and consult your doctor:

-    Feeling sick (nausea) or bei ng sick (vomiting).

-    Dizzinessn oeadache, feeling restless or overaktive.

-    Feeli ng anxi ou s, irritable or nervous.

-    If you cannot sleep, or^ ^uffee from hallucinations.

-    Dkin rashes or hives.

-    /An increased blood pressure.

e    Difficulty passing srine.

If you get any side effucts, talOto your doctor, pharmscist 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.mhea.eov.ukeyellowcurU. Byrepgrtinnsidenffecdt an^icenhulp provide more information on the safety of this medicine.

5.    HDW/^^si^^eeF^^e itussi n Mucuh Cough and Congestion Relief

-    Do not use this medicine after the expiry date shown on the top end of the carton.

-    Do no0stcuaabove25°C.

-    Keep out of the sight an d reach of chi ldren.

6iFuutherinfokmation

Went Robituddi n Mucuh Cough and Congestion Relief contains:

Rach U ml contains 100 mg of the active sul}stance guoifenesin and 30mg of the active substance Fseudoe phsodne hydeochloriddi

Robituhhin Mucus Cough and Congestion Relief also container GlyceroL Carmellose Andyum, Disodmm Edetate, Sodium Benzoate (Et11 ), Sodium Cyclamate, Amaranth (E1t3), Ethanol WO'ycO, Levomenthol, Maltad (C96U), Sorbitol So lutk>n 70%, Natural Cherry Flavouring, Citric Acid Anhydrous, Caramel (E1U0), Acesulfame Potassium and durified Water.

Robitussin Mucus Couah and Congestion Relief is a MusiC, supplied ina100 ml botle.

Who makes and supplies this mecHcine:

The Marheting /\uthorisstioll holder Os bobitussin Mucus Cough and Congestion Relief is:

Hfizer Consumer Heolthcare Ltd, Ramsgate Road, Sandwical Kent, NT13 9NJ, UK.

The dosing cup is manufactnred by:

Humphrey Cosburn Plastics, 89 Union Street, Toronto, Ontario, M6N 3Nt, Canada.

Whe EUJ Authorised Representative re: Pfizer Consumer Healthcare Ltd.

This medicine is manufactured by:

Wyeth Pharmaceuticals, New Lane, Havant, Hampsai(L, JO9 tNG, United Kingdom.

Wyou have any queries, comments about this medicine or raquire information in large print, tape or CD please contact the Careline by phone or write to:

C arelinev Pfizer Consumer Healthcare Ltd,

Walton Oaks, Surrey, KTa0 7NS, UK. or carelineOK@pfizer.com



Meaflet prepared: April 2015 PL 0016U/0098 MA111/00401

PAA049041