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: PL04425/0203.


Mucodyne 375mg Capsules

PACKAGE LEAFLET: INFORMATION FOR THE USER

Mucodyne 375mg Capsules, Hard

Carbocisteine

Is this leaflet hard to see or read? Phone 0800 035 2525 for help

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. See section 4.

What is in this leaflet:

1. What Mucodyne Capsules are and what they are used for
2. What you need to know before you take Mucodyne Capsules
3. How to take Mucodyne Capsules
4. Possible side effects
5. How to store Mucodyne Capsules
6. Contents of the pack and other information

1. What Mucodyne Capsules are and what they are used for

Mucodyne 375mg Capsules, Hard (called Mucodyne Capsules in this leaflet) contain a medicine called carbocisteine. This belongs to a group of medicines called ‘mucolytics’.

It works by making mucus (phlegm) less sticky. This makes the mucus easier to cough up.

Mucodyne Capsules are used for problems with the breathing passages (respiratory tract). These problems happen when too much mucus is made or the mucus is too sticky.

2. What you need to know before you take Mucodyne Capsules

Do not take this medicine and tell your doctor if:

  • You are allergic (hypersensitive) to carbocisteine or any of the other ingredients of Mucodyne Capsules (listed in section 6).
    Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of the lips, face, throat or tongue.
  • You have an ulcer in your stomach or gut.

Do not take this medicine if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Mucodyne Capsules.

Warnings and precautions

Talk to your doctor before taking this medicine if:

  • You are elderly.
  • You have had an ulcer in your stomach or gut.
  • You are taking other medicines known to cause bleeding in the stomach.

Pregnancy and breast-feeding

Mucodyne is not recommended during pregnancy or breast-feeding.

Talk to your doctor before taking this medicine if:

  • You are pregnant, might become pregnant or think you may be pregnant.
  • You are breast-feeding or planning to breast-feed.

Ask your doctor or pharmacist for advice before taking any medicine if you are pregnant or breast-feeding.

Mucodyne Capsules contain:

  • Lactose: This is a type of sugar. If you have been told by your doctor that you cannot tolerate some sugars, talk to your doctor before taking Mucodyne Capsules.

3. How to take Mucodyne Capsules

Always take Mucodyne Capsules exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Taking this medicine

  • Take this medicine by mouth.
  • If you feel that this medicine is too weak or too strong, do not change the dose yourself, but ask your doctor.

How much to take

Adults (including the elderly)

  • Usual dose is two capsules, 3 times each day.
  • If your symptoms improve, your dose should be lowered to one capsule, 4 times, each day.

Children

  • Mucodyne Capsules are not recommended for children. A syrup form of this medicine called 'Mucodyne Paediatric 125mg/5ml Syrup' is available for use in children.

If you take more Mucodyne Capsules than you should

If you take more Mucodyne Capsules than you should, tell a doctor or go to a hospital casualty department straight away. Take the medicine pack with you. This is so the doctor knows what you have taken. If you take too many Mucodyne Capsules, it is likely that you will get an upset stomach (gastrointestinal disturbance).

If you forget to take Mucodyne Capsules

If you forget a dose, do not worry. Just wait until the next dose is due. Do not take a double dose to make up for a forgotten dose.

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

4. Possible side effects

Like all medicines, Mucodyne Capsules can cause side effects, although not everybody gets them.

Stop taking Mucodyne Capsules and see a doctor or go to a hospital straight away if:

  • You have an allergic reaction. The signs may include: a rash, swallowing or breathing problems, swelling of the lips, face, throat or tongue.
  • You have blistering or bleeding of the skin, including around your lips, eyes, mouth, nose and genitals. You may also have flu-like symptoms and fever. This may be something called ‘Stevens-Johnson Syndrome’.
  • You have blood in your vomit or black tarry stools.

Tell your doctor or pharmacist if any of the following side effects get serious or lasts longer than a few days:

  • Feeling sick (nausea) or being sick (vomiting)
  • Diarrhoea
  • Stomach pain

Reporting of side effects

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

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

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

Store below 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.

6. Contents of the pack and other information

What Mucodyne Capsules contain

  • Each gelatin capsule contains 375mg of the active substance, carbocisteine.
  • The other ingredients are magnesium stearate (E572), anhydrous colloidal silica (E551), lactose monohydrate, sodium lauril sulfate, titanium dioxide (E171) and yellow iron oxide (E172).

What Mucodyne Capsules look like and contents of the pack

Mucodyne Capsules are yellow and printed ‘Mucodyne 375’ in black. They are available in blister packs containing 6, 18, 30 or 120 capsules.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Sanofi
410 Thames Valley Park Drive
Reading
Berkshire
RG6 1PT
UK
Tel: 0800 035 2525

Manufacturer

FAMAR HEALTH CARE SERVICES MADRID, S.A.U.
Avda. Leganés, 62
Alcorcón 28923 Madrid
Spain

This leaflet does not contain all the information about your medicine. If you have any questions or are not sure about anything, ask your doctor or pharmacist.

This leaflet was last revised in 06/2020

© Sanofi, 1981 – 2020

11502005-12