Package leaflet: Information for the user

Carbocisteine

750mg/10ml sugar-free oral solution in sachet Carbocisteine

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

-    Keep this leaflet. You may need to read it again.

-    If you have any further questions, ask your doctor or pharmacist.

-    This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

-    If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

What is in this leaflet

1.    What Carbocisteine oral solution in sachet is and what it is used for

2.    What you need to know before you take Carbocisteine oral solution in sachet

3.    How to take Carbocisteine oral solution in sachet

4.    Possible side effects

5.    How to store Carbocisteine oral solution in sachet

6.    Contents of the pack and other information

1. What Carbocisteine oral solution in sachet is and what it is used for

This medicine belongs to a group of medicines called "mucolytics". It is an expectorant for bronchial secretions, or sputum. It makes the sputum easier to cough up.

This medicine is indicated in adults and children over 15 years for recent respiratory disorder with expectoration difficulties (difficulty rejecting by spitting out sputum).

2. What you need to know before you take Carbocisteine oral solution in sachet

Do not take Carbocisteine oral solution in sachet:

- if you are allergic to carbocisteine or any of the other ingredients contained in Carbocisteine oral solution in sachet.

When in doubt, you should always consult a doctor or pharmacist.

Please take special care with Carbocisteine oral solution in sachet:

Consult your doctor immediately:

•    if you have thick, purulent sputum or fever,

•    if you suffer from chronic illness (long-term) of the bronchi or lungs

•    if you have a peptic or duodenal ulcer. Precautions for use

This medicine should always be accompanied by voluntary efforts to cough, which help expectoration.

Do not take cough medicine (to stop coughing) or medicine that dries out bronchial secretions during the treatment period with carbocisteine.

CONSULT A DOCTOR IF NO IMPROVEMENT IS SEEN.

Other medicines and Carbocisteine oral solution in sachet

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, even if it is medication obtained without a prescription.

This medicine contains carbocisteine. Other medications also contain carbocisteine. Please do not take them at the same time in order to avoid exceeding the maximum doses advised (see 3. HOW TO TAKE Carbocisteine oral solution in sachet)

Pregnancy and breast-feeding

Pregnancy

This medicine should only be used during pregnancy if advised by your doctor.

If you discover that you are pregnant while taking this medicine, please contact your doctor as only he/she will be able to tell you if you should continue taking it or not.

Ask your doctor or pharmacist before taking any medication.

Breast-feeding

It is possible to breast feed your child while taking this medicine.

Ask your doctor or pharmacist before taking any medication.

Important information about some of the ingredients in Carbocisteine oral solution in sachet:

This medicine contains the following excipients with known effects:

•    Sodium

•    Sodium methyl para-hydroxybenzoate (E 219)

•    Maltitol

•    Sorbitol

•    Ethanol (alcohol, present in caramel/vanilla flavouring)

This medicine contains sodium. This medicine contains 97.5 mg (4.24 mmol) of sodium per sachet. This should be taken into account in patients following strict low sodium diets.

This medicine contains sodium methyl para-hydroxybenzoate and can cause allergic reactions.

This medicine contains maltitol and sorbitol. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

This medicine contains small quantities of ethanol (alcohol), less than 100 mg per sachet.

When in doubt, please ask your doctor or pharmacist.

5. How to store Carbocisteine oral solution in sachet

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.

Do not store above 25°C.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

3. How to take Carbocisteine oral solution in sachet

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Mode of administration

Oral route.

FOR ADULTS AND CHILDREN OVER 15 YEARS ONLY Do not use this medicine in children under 15 years.

Posoloqy

The standard dose is 750 mg of carbocisteine 3 times a day, or one 10 ml sachet 3 times a day. This medicine is appropriate for patients following a low sugar or low calorie diet.

If you feel that the effects of Carbocisteine oral solution in sachet are too strong or not strong enough, please talk to your doctor or pharmacist.

Treatment duration

Do not exceed 5 days of treatment without medical advice.

If symptoms (cough) persist, consult your doctor.

If you take more Carbocisteine oral solution in sachet than you should:

Contact your doctor or pharmacist.

If you forget to take Carbocisteine oral solution in sachet:

Do not take a double dose to make up for a forgotten dose.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

6. Contents of the pack and other information

4. Possible side effects

Like all medicines, Carbocisteine oral solution in sachet can cause side effects, although not everybody gets them.

•    Gastrointestinal disorders

Very comm on stomach pains, nausea, diarrhoea. In such cases, it is advised to reduce the dosage.

•    Skin and subcutaneous tissue disorders

Rarettching, rash, erythematous rash, or swelling in the face

If you get any side effects not listed in this leaflet, or if certain side effects become serious, talk to your doctor or pharmacist.

What Carbocisteine oral solution in sachet contains

The active substance is carbocisteine. Each 10 ml oral solution contains 750 mg of carbocisteine .

The other ingredients are:

Saccharin sodium, sodium methyl para-hydroxyben-zoate (E 219), hydroxyethylcellulose, caramel/vanil-la flavouring (contains alcohol), sorbitol liquid (non-crystallising), maltitol liquid, sodium hydroxide'¹, purified water.

* sodium hydroxide pellets or sodium hydroxide 30 % solution

What Carbocisteine oral solution in sachet looks like and contents of the sachet

This medicine is available in 10 ml sachets and comes in boxes of 10,12 or 15 sachets.

It is a limpid, viscous, light brown solution.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

UNITHER PHARMACEUTICALS 151 rue Andre Durouchez Espace Industriel Nord 80084 Amiens cedex 2

Distributor in UK:

Intrapharm Laboratories Limited,

The Courtyard Barns,

Choke Lane, Cookham Dean,

Maidenhead, Berks. SL6 6PT,

United Kingdom

Manufacturer

UNITHER LIQUID MANUFACTURING

1-3 allee de la Neste Zl d'En Sigal 31770 COLOMIERS

This leaflet was last revised in January 2015.

Detailed information on this medicine is available on the web site of UK Medicines and Healthcare products Regulatory Agency (www.mhra.gov.uk/).