Carbocisteine 375 mg capsules, Mucodyne 375 mg capsules – patient leaflet, side effects, dosage

1) WHAT MUCODYNE CAPSULES ARE AND WHAT THEY ARE USED FOR

Mucodyne 375mg Capsules (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) 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 below) 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.
• 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

Talk to your doctor before taking this medicine if:

• You are pregnant, might become pregnant or think you may be pregnant. This medicine should not be taken during the first three months of your pregnancy
• 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.

Important information about some of the ingredients of Mucodyne Capsules

Mucodyne Capsules contain:

• Lactose. This medicine contains 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.
• Sunset yellow (E110): May cause allergic reactions. Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of the lips, face, throat or tongue

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:

• Vomiting

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

By reporting side effects you can help provide more information on the safety of this medicine.

5) HOW TO STORE MUCODYNE CAPSULES

• Keep out of the sight and reach of children.
• Do not store above 25^oC.
• Store in the original package in order to protect from light.
• Do not use Mucodyne Capsules after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.
• If your capsules become discoloured or show any signs of deterioration, return them to your pharmacist.
• Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6) FURTHER INFORMATION

What Mucodyne Capsules contain

Each capsule contains 375mg of carbocisteine.

The other ingredients are lactose, sodium laurilsulfate, aerosil 200 (E551) and magnesium stearate E572.

The capsule shell contains quinoline yellow (E104), sunset yellow (E110), titanium dioxide (E171) and gelatin.

Printing ink contains iron oxide black.

What Mucodyne Capsules look like and contents of the pack

Mucodyne Capsules are size No. 1 opaque, yellow, hard capsules, having an identification mark printed “Mucodyne 375” in black ink and containing a white to almost white powder.

Mucodyne Capsules come in blister packs of 120 capsules.

Manufactured by

FAMAR HEALTH CARE SERVICES MADRID, S.A.U., Avenida de Leganés, Alcorcon, Madrid, Spain.

Procured from within the EU by the Product Licence holder: MPT Pharma Ltd., Westgate Business Park, Unit 5-7 Tintagel Way, Aldridge, Walsall WS9 8ER.

Repackaged by MPT Pharma Ltd.

PL 33532/0594

Leaflet dated 14^th October 2016

Leaflet coded xxxxxxxx

Mucodyne^® is a registered trademark of Sanofi-Aventis Netherlands B.V.

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.

POM