NACSYS 600mg Effervescent Tablets

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 NACSYS 600 mg effervescent tablets is and what it is used for
2. What you need to know before you use NACSYS 600 mg effervescent tablets
3. How to use NACSYS 600 mg effervescent tablets
4. Possible side effects
5. How to store NACSYS 600 mg effervescent tablets
6. Other information

Do not use NACSYS 600 mg effervescent tablets

• If you are allergic to acetylcysteine or any of the other ingredients of this medicine.
• Children under 2 years of age may not use this medicine.

Warnings and precautions

• If you suffer of bronchial asthma then you should not take this medicine.
• If you have or have had a peptic ulcer, as NACSYS 600 mg effervescent tablets may irritate your gastric wall.
  In particular if you use other drugs known to irritate the gastric wall.
• There have been very rare reports of serious hypersensitivity reactions with (high) fever, skin redness, joint pains and/or eye infection (Stevens-Johnson syndrome), and acute hypersensitivity reactions accompanied by fever and blisters on the skin or peeling of the skin (Lyell syndrome) which were associated with the use of NACSYS 600 mg effervescent tablets. However, in most cases, at least one other medicine was used, which was most likely the cause for this reaction.
• If new changes to the skin or mucous membranes occur, you must immediately consult a doctor and stop using acetylcysteine. As the thick phlegm becomes more fluid, its volume will increase, especially at the beginning of the treatment. If you are unable to efficiently cough up this fluid phlegm, you must consult a doctor so that adequate measures can be taken to remove the phlegm.
• Medicines, such as NACSYS that dissolve phlegm (mucolytics) may block the airways of children under the age of 2, due to the characteristics of the airways in this age group. This may limit their ability to cough up phlegm.
  Therefore, NACSYS must not be used by children under the age of 2.
• NACSYS 600 mg effervescent tablets are not suitable for use in children and adolescent younger than 18.
• When opening the package you may perceive a mild sulfur odour (smell of rotten eggs). This is a property of the active ingredient and is normal. It does not indicate that the medicine has changed.

Consult your doctor if any of the abovementioned warnings are apply to you, or have applied to you in the past.

Other medicines and NACSYS 600 mg effervescent tablets

If you are using other medicines, do not dissolve them together with NACSYS 600 mg effervescent tablets.

If you need to use medicines to control or prevent infections (antibiotics), you are advised to take these two hours before or after NACSYS 600 mg effervescent tablets.

Cough suppressants should not be used at the same time as NACSYS 600 mg effervescent tablets, as you must be able to cough up the loosened phlegm.

NACSYS 600 mg effervescent tablets may increase the blood pressure-lowering effect of nitroglycerin (a medicine used against tight painful feeling in the chest (angina pectoris)). Caution is advised.

If you use activated charcoal (a medicine against traveller's diarrhoea), it may decrease the effect of NACSYS 600 mg effervescent tablets.

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines apart from NACSYS 600 mg effervescent tablets, including medicines obtained without a prescription.

Pregnancy and breast-feeding

Pregnancy

There is a limited amount of data from the use of acetylcysteine in pregnant women.

Animal studies do not indicate direct or indirect harmful effects on the pregnancy, or the development of the child, before, during or after birth. Only use NACSYS 600 mg effervescent tablets after careful consideration of the benefits and risks during pregnancy.

Breast-feeding

It is not known whether acetylcysteine is excreted in breast milk. Only use Acetylcysteine Alpex 600 mg effervescent tablets after careful consideration of the benefits and risks during breast-feeding.

If you are pregnant or breast-feeding, contact your doctor or pharmacist before any medicine.

Driving and using machines

There are no data available on the effect of acetylcysteine on the ability to drive. An effect is, however, not likely.

Ingredients of this medicine you should take into account

This medicinal product contains 115 mg sodium per dose. To be taken into consideration by patients on a controlled sodium diet.

If you use more NACSYS 600 mg effervescent tablets than you should

Symptoms that may occur are: nausea, vomiting and diarrhoea.

If you have used too many NACSYS 600 mg effervescent tablets, immediately contact your doctor or pharmacist.

If you forget to take NACSYS 600 mg effervescent tablets

If you have forgotten to take a dose and it is almost time for the next dose, do not take the 'forgotten' dose, but continue the schedule as given under "How to use NACSYS 600 mg effervescent tablets ". Do not take a double dose to make up for a forgotten dose.

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 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.

What NACSYS 600 mg effervescent tablets contains

The active substance is acetylcysteine.

The other ingredients are sodium hydrogen carbonate (E500) (equivalent to 115 mg sodium), citric acid (E330), sucralose (E955), and orange flavour (contains Orange Essential Oil, Orange Essential Oil terpenless, gum arabic (E414), butylated hydroxyanisole (E320), citric acid monohydrate (E330), and maltodextrin).

What NACSYS 600 mg effervescent tablets looks like and contents of the pack

NACSYS 600 mg effervescent tablets are round, flat, white to yellowish effervescent tablets. The tablets are packaged in a propylene tube with a polyethylene cap and a desiccant. A tablet container contains 6, 10, or 20 effervescent tablets.

You may sometimes smell a mild sulfur odour when opening the package. This is normal and harmless.

Marketing Authorisation Holder and Manufacturer

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