What is a Patient Information Leaflet and why is it useful?

The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.

Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.

The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL 00165/0098.


Robitussin Mucus Cough and Congestion Relief 20mg, 6mg/ml Oral Solution

PATIENT INFORMATION LEAFLET

Robitussin® MUCUS COUGH AND CONGESTION RELIEF 20mg, 6mg/ml Oral Solution

Guaifenesin and Pseudoephedrine

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.

After taking the medicine:

If you develop a feverish generalised erythema (redness of the skin) associated with pustules, stop taking Robitussin Mucus Cough and Congestion Relief and contact your doctor or seek medical attention immediately. See section 4.

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:

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.
  • Sudden onset of fever, reddening of the skin, or many small pustules (possible symptoms of Acute Generalized Exanthematous Pustulosis - AGEP) may occur within the first 2 days of treatment with Robitussin Mucus Cough and Congestion Relief. See section 2.

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 or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Robitussin Mucus Cough and Congestion Relief

  • Do not use this medicine after the expiry date shown on the top end of the carton.
  • Do not store above 25°C.
  • Keep out of the sight and reach of children.

6. Further information

What Robitussin Mucus Cough and Congestion Relief contains:

Each 5 ml contains 100 mg of the active substance guaifenesin and 30 mg of the active substance pseudoephedrine hydrochloride.

Robitussin Mucus Cough and Congestion Relief 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 Mucus Cough and Congestion Relief is a liquid, supplied in a 100 ml botle.

Who makes and supplies this medicine:

The Marketing Authorisation holder for Robitussin Mucus Cough and Congestion Relief 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:

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 or CD please contact the Careline by phone or write to:

Careline
Pfizer Consumer Healthcare Ltd
Walton Oaks
Surrey
KT20 7NS
UK

or [email protected]

Leaflet prepared: June 2018

PL 00165/0098

MA111/00401

SUB-INS-00029