nogen Healthcare

PACKAGE LEAFLET: INFORMATION FOR THE USER

Mucolight 600mg Effervescent Tablets

(Acetylcysteine)

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 or nurse.

•    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 or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

1.    What Mucolight Effervescent Tablets are and what they are used for

2.    What you need to know before you take Mucolight Effervescent Tablets

3.    How to take Mucolight Effervescent Tablets

4.    Possible side effects

5.    How to store Mucolight Effervescent Tablets

6.    Contents of the pack and other information

1. WHAT MUCOLIGHT EFFERVESCENT TABLETS ARE AND WHAT THEY ARE USED FOR

Mucolight Effervescent Tablets contain a medicine called Acetylcysteine. This belongs to a group of medicines called mucolytics. It works by making the mucus (phlegm) less sticky which makes the mucus easier to cough up.

Acetylcysteine is used for problems with the breathing passages (respiratory tract).

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE MUCOLIGHT EFFERVESCENT TABLETS

Do NOT take Mucolight Effervescent Tablets if

you:

•    Are allergic (hypersensitive) to acetylcysteine or any of the other ingredients of this medicine (listed in section 6)

•    Areunder14yearsofage.

Warnings and precautions

Talk to your doctor, pharmacist or nurse before

taking Mucolight Effervescent Tablets:

•    If you have asthma

•    If you have a history of stomach ulcers

•    If you are allergic to histamines

•    If you are on a restricted salt diet (see Mucolight Effervescent Tablets contain sodium)

•    If you have hereditary problems with some sugars (see Mucolight Effervescent Tablets contain sorbitol)

•    If you have liver or kidney problems.

If you notice any changes to your skin or mucus membranes such as the inside of your nose, mouth and lips, you should STOP taking these tablets IMMEDIATELY and seek medical advice

(see section 4 Possible side effects).

Effervescent tablets can be a choking hazard if swallowed whole, especially in the elderly. Ensure that tablet is fully dissolved before you take it.

Other medicines and Mucolight Effervescent Tablets:

Please tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. In particular:

•    Antitussives: cough-relieving agents

•    Antibiotics: some antibiotics may not work as well when taken at the same time as Mucolight Effervescent Tablets.

All antibiotics should be given at a different time to Mucolight Effervescent Tablets at least 2 hours apart

•    Glyceryl trinatrate: used to treat angina (chest pain).

Mucolight Effervescent Tablets with food, drink and alcohol

Mucolight Effervescent Tablets should be taken afterfood.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

Mucolight Effervescent Tablets should not affect your ability to drive or use machinery.

Mucolight Effervescent Tablets contain sodium

Mucolight Effervescent Tablets contain 356.8 mg of sodium per tablet. This should be taken into consideration if you are on a controlled salt diet. Sodium is part ofsalt (sodium chloride).

Mucolight Effervescent Tablets contain 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.

3. HOW TO TAKE MUCOLIGHT EFFERVESCENT TABLETS

Always take Mucolight Effervescent Tablets exactly as your doctor has told you. You should check with your doctor or pharmacist ifyou are unsure.

For oral administration only. Mucolight Effervescent Tablets should be dissolved completely in a glass of water before use and taken after food.

Adults and children aged 14 years and over:

The usual dose is 1 tablet, once daily.

Dissolve the tablet in a glass ofwater and take afterfood.

This medicine can be taken for up to 5 days for acute respiratory problems. Longer-term treatment may be needed for chronic respiratory disorders.

Children under the age of 14 years

Mucolight Effervescent Tablets are not suitable for children under the age of 14.

Ifyou take more Mucolight Effervescent Tablets than you should

If you take more Mucolight Effervescent Tablets than you should, talk to your doctor or contact your nearest hospital casualty department immediately. Take your tablet pack with you. You may have diarrhoea, heartburn, stomach ache or feel sick.

Ifyou forget to take Mucolight Effervescent Tablets

If you have forgotten to take a dose, leave out that dose completely. Take your next dose at the normal time, do not take a double dose. If you have trouble remembering to take your tablets, tell your doctor or pharmacist.

Ifyou stop taking Mucolight Effervescent Tablets

You should talk to your doctor or pharmacist before stopping taking these tablets.

Very rare (affects less than 1 person in

10,000)

•    Bleeding in the upper respiratory tract.

Frequency unknown

•    Swelling of the face.

Laboratory tests:

Your doctor may want to perform some laboratory tests while you are taking these tablets.

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.aov.uk/vellowcard.

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

5. HOW TO STORE MUCOLIGHT EFFERVESCENT TABLETS

4. POSSIBLE SIDE EFFECTS

Like all medicines, Mucolight Effervescent Tablets can cause side effects, although not everyone gets them.

Stop taking Mucolight Effervescent Tablets and see a doctor or contact your nearest hospital casualty department immediately:

•    If you have swelling of the lips, throat or tongue, difficulty in swallowing or breathing. This could be a sign of an allergic reaction

•    Any changes to the skin or mucus membranes (such as your nose, mouth, lips and genitals) including skin rashes, blistering or peeling of the skin. These may be accompanied by flu-like symptoms. These could be signs of serious skin reactions such as Stevens Johnson Syndrome or Lyell's Syndrome.

Other side effects reported with this medicine are shown below:

Uncommon (affects less than 1 person in 100)

•    Headache

•    Ringing in the ears (Tinnitus)

•    Increased heart rate

•    Feeling sick and being sick

•    Diarrhoea

•    Stomach pains

•    Swelling in the mouth and swelling of the lips

•    Skin rashes and itching

•    Fever

•    Low blood pressure.

Rare (affects less than 1 person in 1,000)

•    Indigestion

•    Shortness of breath.

Keep out of the sight and reach of children.

Store below 25°C. Store in the original package to protect from moisture and light. Keep the tube tightly closed.

Check the expiry date found on the blister and carton or label. The expiry date refers to the last day of that month. Do not use after the expiry date stated.

Do not use this medicine if you notice discolouration ofthe tablets.

Medicines should not be disposed ofvia wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Mucolight Effervescent Tablets contain:

Mucolight Effervescent Tablets contain the active substance acetylcysteine 600mg in each tablet.

The other ingredients are: Ascorbic acid (Vitamin C), Citric acid, Sodium hydrogen carbonate, Sodium carbonate, Sorbitol (E420), Macrogol 6000, Sodium citrate, Sodium saccharin, Flavour (Lemon).

What Mucolight Effervescent Tablets look like and contents of the pack

Mucolight Effervescent Tablets are white flat-faced tablets with bevelled edges 25mm in diameter.

They are available as follows:

Tubes containing 12 tablets with tamper evident plastic caps with inbuilt dessicant.

A carton containing 10 tablets packed into individual sachets.

A carton containing 20 tablets packed into individual sachets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Ennogen Healthcare Limited Unit G4, Riverside Industrial Estate,

Riverside Way, Dartford, DA1 5BS, UK

This leaflet was last revised in May 2016