Patient leaflet - ACETYLCYSTEINE 600MG TABLETS

1. WHAT ACETYLCYSTEINE TABLETS ARE AND WHAT THEY ARE USED FOR

Acetylcysteine 600mg 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 ACETYLCYSTEINE TABLETS

Do NOT take Acetylcysteine Tablets if you:

! Are allergic (hypersensitive) to

acetylcysteine or any of the other ingredients of this medicine (listed in section 6) ! Are under 14 years of age.

Warnings and precautions

Talk to your doctor, pharmacist or nurse before taking Acetylcysteine Tablets:

! If you have asthma; in the event of narrowing of

the airways (bronchospasms), use must be stopped immediately and appropriate treatment started.

! If you have difficulty coughing up mucus in your

airways, the airways must be cleared with physiotherapy (postural drainage) or, if necessary, kept clear by suction (aspiration). ! If you suffer from, or have suffered from,

stomach ulcers, or are at risk of gastrointestinal bleeding, particularly when you are simultaneously using other medicines known to irritate the gastric mucosa

! If you are allergic to histamines, as symptoms

of intolerance may occur with prolonged use of this medicine (headache, inflammation of the nasal mucosa, itching).

! If you have liver or kidney problems.

! If you experience vomiting (acetylcysteine may

increase the intensity of vomiting)

! If you experience allergic symptoms, including

hives (urticaria) (discontinue use if the symptoms cannot be medically controlled). ! If you are taking other medicines. Please also

read the section 'Other medicines and Acetylcysteine'

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).

Other medicines and Acetylcysteine 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. It is best

to avoid simultaneous use of cough suppressants with mucolytic medications, such as acetylcysteine, as this reduces the cough reflex and could lead to a buildup of mucus. ! Antibiotics: some antibiotics may not work as

well when taken at the same time as Acetylcysteine Tablets. All antibiotics should be given at a different time to Acetylcysteine Tablets at least 2 hours apart

! Medicines to treat angina attacks, (tightness in

your chest, neck and arm), Acetylcysteine Tablets may increase the blood pressure-lowering effect of nitroglycerin (a medicine used to treat angina) and you may experience headaches. Your doctor will need to monitor your blood pressure if you use nitroglycerin and Acetylcysteine Tablets at the same time. ! Simultaneous use of acetylcysteine and

carbamazepine could lead to reduced efficacy of carbamazepine.

! Activated charcoal can reduce the effect of

acetylcysteine.

! Acetylcysteine Tablets and heavy metal salts,

such as gold, iron, or calcium salts, can influence each other's action. It is therefore better to leave a time interval between the intake of Acetylcysteine and these salts, or to choose a different route of administration.

Acetylcysteine Tablets with food, drink and alcohol

Acetylcysteine Tablets should be taken after food.

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.

Acetylcysteine Tablets should not be taken during pregnancy or breast-feeding.

If you are unsure you should talk to your doctor before taking these tablets.

Driving and using machines

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

Acetylcysteine Tablets contains sodium

This medicine contains less than 1 mmol sodium (23mg) per tablet, that is to say essentially 'sodium-free'.

3. HOW TO TAKE ACETYLCYSTEINE TABLETS

Always take Acetylcysteine Tablets exactly as your doctor has told you . You should check with your doctor or pharmacist if you are unsure. For oral administration only. Acetylcysteine Tablets should be swallowed with a drink of water and taken after food. Do not chew the tablet.

Adults and children aged 14 years and over:

The usual dose is 1 tablet, once daily.

Children under the age of 14

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

If you take more Acetylcysteine Tablets than you should

If you take more Acetylcysteine 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.

If you forget to take Acetylcysteine 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.

If you stop taking Acetylcysteine Tablets

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

4. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everyone gets them.

Stop taking Acetylcysteine 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 and loss of consciousness. 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, itching, 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.

Very rare (affects less than 1 person in 10,000)

! Bleeding in the upper respiratory tract. ! Dizziness

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.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 ACETYLCYSTEINE TABLETS

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

Store below 25°C.

Store in a cool dry place.

Check the expiry date found on the blister and carton. 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 of the tablets.

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. CONTENTS OF THE PACK AND OTHER INFORMATION

What Acetylcysteine Tablets contain:

Acetylcysteine Tablets contain the active substance acetylcysteine 600mg in each tablet. The other ingredients are: Microcrystalline Cellulose, Macrogol 6000, Lemon Flavour, Saccharin Sodium, Magnesium Stearate.

What Acetylcysteine Tablets look like and contents of the pack

Acetylcysteine Tablets are white, round convex tablets, about 13 mm in diameter.

They are available as follows:

Cartons containing 30 tablets packed in Aluminium foil/PVC blisters.

Marketing Authorisation Holder

Ennogen IP Ltd

Unit G4, Riverside Industrial Estate,

Riverside Way, Dartford, DA1 5BS, UK

Manufacturer

Ennogen Healthcare Limited