Skip to Content

NACSYS 600 MG EFFERVESCENT TABLETS

Active substance(s): ACETYLCYSTEINE / ACETYLCYSTEINE

View full screen / Print PDF » Download PDF ⇩

PDF Transcript

Package leaflet: Information for the user
NACSYS 600 mg EFFERVESCENT TABLETS
Acetylcysteine
Read all of this leaflet carefully because it contains important information
This medicine is available without prescription. However, you still need to use NACSYS 600 mg effervescent tablets
carefully to get the best results from it.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- You must talk to your doctor if you do not feel better or
if you feel worse after 14 days.
- 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
1. WHAT NACSYS 600 MG EFFERVESCENT TABLETS IS AND WHAT IT IS USED FOR
Acetylcysteine breaks down and loosens thick phlegm, making it runny and easy to cough up.
Acetylcysteine is used in the treatment of airway diseases such as bronchitis (inflammation of the mucous membrane in
the airways), emphysema, mucoviscidosis (cystic fibrosis) and bronchiectasis (chronic widening of an airway passage).
NACSYS 600 mg Effervescent tablets is indicated only for adult.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE NACSYS 600 MG EFFERVESCENT TABLETS
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.
3. HOW TO USE NACSYS 600 MG EFFERVESCENT TABLETS
Adults:
1 effervescent tablet once daily.
Patients who have difficulty coughing up phlegm (elderly and weakened patients), are advised to take the effervescent
tablet in the mornings.
Dissolve the effervescent tablet in half a glass of water. Drink the solution immediately.
Always use this medicine exactly as prescribed. Check with your doctor or pharmacist if you are not sure.
Do not use this medicine for longer than 14 days without consulting a doctor.
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.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If any of the following side effects occur, immediately stop using NACSYS 600 mg effervescent tablets and contact your
doctor or go the emergency room of a nearby hospital.
 Shock (severe drop in blood pressure, paleness, restlessness, weak pulse, clammy skin, decreased consciousness) due
to a sudden widening of the blood vessels as a result of severe hypersensitivity to certain ingredients (anaphylactic
shock).
 Sudden fluid accumulation in the skin and mucous membranes (e.g. throat or tongue), breathing difficulties and/or
itching and skin rash, often as a result of an allergic reaction (angioedema).
The above mentioned reactions are very serious side effects. If you experience any of these reactions it is possible that
you have a hypersensitivity reaction to NACSYS 600 mg effervescent tablets. You will require emergency medical care
or need be admitted to the hospital.
This very serious side effect is very rare (occurs in fewer than 1 in 10,000 users). Bleedings are also very rare.
Inform you doctor if you experience any of the following side effects:
 Shortness of breath due to muscle cramping of the airways (bronchospasms).
 Difficulty breathing, shortness of breath or breathlessness (dyspnoea).
 Impaired digestion with symptoms of fullness in the upper abdomen, gastric pain, belching, nausea and heartburn
(dyspepsia).
These side effects are rare (occurring in 1 to 10 in every 10,000 users).


Hypersensitivity
This may manifests itself as bronchospasms and dyspnoea (see above) rapid heart rate (tachycardia), itching
(pruritus), skin rash with severe itching and small bumps (urticaria) and angioedema.
 Headache
 Ringing in the ears (tinnitus)
 Inflammation of the oral mucous lining (stomatitis)
 Diarrhoea
 Fever (pyrexia)
 Low blood pressure
 Abdominal pain
 Nausea
 Vomiting
These side effects are uncommon (occurring in 1 to 10 in every 1,000 users).
If you suffer from gastric or duodenal ulcers or have had these in the past, acetylcysteine may have an unfavourable
effect on your gastrointestinal mucous membrane.
If any of the side effects become serious, or you notice any side effects not mentioned in this leaflet, contact your doctor
or pharmacist.
Consult with your doctor or pharmacist if you notice that the effect of NACSYS 600 mg effervescent tablets is too strong
or not strong enough.
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.
5. HOW TO STORE NACSYS 600 MG EFFERVESCENT TABLETS
Keep this medicine out of the sight and reach of children.
Store in the original package to protect against moisture.
Shelf life
Do not use this medicine after the expiry date, which is stated on the package after "Do not use after" or "exp". The
expiry date refers to the last day of that month.
After first opening the product may be used for a maximum of 10 days in tube with 10 effervescent tablets or 20 days in
tube with 20 effervescent tablets.
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 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
Marketing Authorisation Holder:
Alpex Pharma (UK) Ltd
25a Becher Close,
Renhold, Bedford
MK41 0LP-UK
Manufacturer:
Kymos Pharma Services, S.L.
Ronda de Can Fatjó, 7B
(Parque Tecnológico del Vallès),
Cerdanyola del Vallès, 08290 Barcellona
Distributor:
Atlantic Pharma Ltd
25a Becher Close
Renhold, Bedford
MK41 0LP-UK
This medicinal product is authorised in the Member States of the EEA under the
following names:
The Netherlands: Acetylcysteïne Alpex 600 mg, bruistabletten
Ireland: NACSYS 600 mg effervescent tablets
United Kingdom: NACSYS 600 mg effervescent tablets
This leaflet was last revised in June 2017

Expand Transcript

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide