What is Fluimucil 600mg tablets

• 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.

Do not use Fluimucil 600mg 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 Fluimucil 600mg 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 Fluimucil 600mg tablets 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, Fluimucil 600mg tablets must not be used by children under the age of 2.
• Fluimucil 600mg 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 apply to you, or have applied to you in the past.

Other medicines and Fluimucil 600mg tablets

• If you are using other medicines, do not dissolve them together with Fluimucil 600mg tablets.
• If you need to use medicines to control or prevent infections (antibiotics), you are advised to take these two hours before or after Fluimucil 600mg tablets.
• Cough suppressants should not be used at the same time as Fluimucil 600mg tablets, as you must be able to cough up the loosened phlegm.
• Fluimucil 600mg 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 Fluimucil 600mg tablets.
• Tell your doctor or pharmacist if you are taking or have recently taken any other medicines apart from Fluimucil 600mg tablets, including medicines obtained without a prescription.

Pregnancy and breast-feeding

• 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.
• It is not known whether acetylcysteine is excreted in breast milk. Only use Fluimucil 600mg 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.

How to use Fluimucil 600mg 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 Fluimucil 600mg tablets than you should

• Symptoms that may occur are: nausea, vomiting and diarrhoea.
• If you have used too many Fluimucil 600mg tablets, immediately contact your doctor or pharmacist.

If you forget to take Fluimucil 600mg 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 normal. Do not take a double dose to make up for a forgotten dose.

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 Fluimucil 600mg tablets and contact your doctor.

• 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 Fluimucil 600mg tablets. You will require emergency medical care or need be admitted to the hospital.

This very serious side effect is very rare. 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.

• 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.

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.

How to store Fluimucil 600mg 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. 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.

References:

https://www.medicines.org.uk/emc/files/pil.8576.pdf

https://www.mims.com/philippines/drug/info/fluimucil

https://www.practo.com/medicine-info/fluimucil-600-mg-tablet-37070

https://www.fluimucil.it/en/Products/Fluimucil-Mucolitico/Sachets-600-mg-without-sugar

https://www.cathaydrug.com/product/fluimucil-oral/

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