Fluimucil mucolytic 100 ml / 5 ml - syrup - 200 ml bottle

Product Description

BEFORE USE, READ ALL THE INFORMATION CONTAINED IN THE INFORMATION LEAFLET CAREFULLY

This is a SELF-MEDICATION medicine that you can use to treat mild and transient ailments that are easily recognizable and resolvable without resorting to medical help.
It can therefore be purchased without a prescription but must be used correctly to ensure its effectiveness and reduce side effects.
• For more information and advice, contact your pharmacist.
• consult your doctor if the disorder does not resolve after a short period of treatment.

FLUIMUCIL MUCOLYTIC 100mg/5ml
Syrup
N-Acetylcysteine

WHAT IT IS
Fluimucil Mucolitico is a mucus thinner.

WHY? IT IS USED
Fluimucil Mucolitico is used for the treatment of respiratory conditions characterized by thick and viscous hypersecretion.

WHEN IT SHOULD NOT BE USED
Hypersensitivity to the active ingredient or to any of the excipients.
The drug is contraindicated in children under 2 years of age.
Pregnancy and breastfeeding (see "what to do during pregnancy and breastfeeding").

PRECAUTIONS FOR USE
Mucolytics can induce bronchial obstruction in children under 2 years of age. In fact, the capacity to drain bronchial mucus is limited in this age group, due to the physiological characteristics of the airways. They should therefore not be used in children under 2 years of age (see the section "When it should not be used").
The administration of N-acetylcysteine, especially at the beginning of treatment, can thin bronchial secretions and simultaneously increase their volume.

WHICH MEDICINES OR FOODS CAN ALTER THE EFFECT OF THE MEDICINAL PRODUCT
Inform your doctor or pharmacist if you have recently taken any other medicines, even those obtained without a prescription.

Drug-drug interaction
Antitussive drugs and N-acetylcysteine ​​should not be taken at the same time as the reduction of the cough reflex could lead to an accumulation of bronchial secretions. Activated charcoal can reduce the effect of N-acetylcysteine.
It is advisable not to mix other medicines with the Fluimucil Mucolitico solution. The available information regarding the antibiotic-N-acetylcysteine ​​interaction refers to in vitro tests, in which the two substances were mixed, which showed a reduced activity of the antibiotic. However, as a precaution, it is recommended to take oral antibiotics at least two hours after the administration of N-acetylcysteine. Concomitant administration of nitroglycerin and N-acetylcysteine ​​has been shown to cause significant hypotension and dilation of the temporal artery with possible onset of headache.
If you are taking other medicines, ask your doctor or pharmacist for advice.

Drug-laboratory test interactions
N-acetylcysteine ​​may cause interference with the colorimetric assay method for the determination of salicylates. N-acetylcysteine ​​may cause interference with the colorimetric assay method for the determination of salicylates. interfere with the urine ketone test.

IT IS IMPORTANT TO KNOW THAT
The possible presence of a sulphurous odor does not indicate alterations of the preparation but is typical of the active ingredient it contains.

When can should be used only after consulting your doctor.
Patients suffering from bronchial asthma must be closely monitored during therapy. If bronchospasm occurs, treatment must be stopped immediately.
It is also advisable to consult your doctor if such disorders have occurred in the past.
Particular caution is required when using the medicine in patients suffering from peptic ulcers or with a history of peptic ulcers, especially if they are taking other drugs known to cause gastro-damage at the same time.

What to do during pregnancy and breastfeeding
Ask your doctor or pharmacist for advice before taking any medicine.
During pregnancy and breastfeeding, Fluimucil Mucolitico should be used only after consulting your doctor and evaluating the risk/benefit ratio in your case. Consult your doctor if you suspect you are pregnant or are planning to become pregnant.

Effects on the ability to drive and use machines
Fluimucil Mucolitico does not affect the ability to drive or use machines.

Important information about some of the excipients
The product contains parahydroxybenzoates which can cause delayed allergic reactions and, more rarely, immediate reactions with bronchospasm and urticaria. The product contains 16.6 mg of sodium per dose, which should be taken into account in patients with reduced kidney function or on a low-sodium diet.

HOW TO USE THIS MEDICINE
How much
Adults: 10 ml of syrup (one measuring spoon) equal to 200 mg of N-acetylcysteine, 2-3 times a day.
Children over two years of age: 5 ml of syrup (1/2 measuring spoon), equal to 100 mg of N-acetylcysteine, 2 to 4 times a day depending on age.
Caution: do not exceed the indicated doses without medical advice.
When and for how long
The duration of therapy is 5-10 days. Consult your doctor if the disorder occurs repeatedly or if you have noticed any recent changes in its characteristics.
How
Shake the syrup before use. Once opened, the syrup has a shelf life of 15 days.

WHAT TO DO IF YOU HAVE TAKEN AN EXCESSIVE DOSE OF THE MEDICINE
Overdose can cause gastrointestinal symptoms such as nausea, vomiting and diarrhea.
In case of accidental ingestion/intake of an excessive dose of Fluimucil Mucolitico, inform your doctor immediately or go to the nearest hospital.
If you have any doubts about the use of Fluimucil Mucolitico, ask your doctor or pharmacist.

SIDE EFFECTS
Like all medicines, Fluimucil Mucolitico can cause side effects such as nausea, vomiting and diarrhea. cause side effects, although not everybody gets them.
Below is a table showing the frequency of adverse reactions reported after taking oral N-acetylcysteine:

In very rare cases, the appearance of serious skin reactions in temporal connection with the intake of N-acetylcysteine, such as Stevens-Johnson syndrome and Lyell's syndrome, has occurred.
Although in most cases at least one other more suspect drug has been identified, probably involved in the genesis of the aforementioned mucocutaneous syndromes. In case of mucocutaneous alterations, it is advisable to contact your doctor and the use of N-acetylcysteine ​​must be stopped immediately.
Some studies have confirmed a reduction in platelet aggregation during the use of N-acetylcysteine. The clinical significance of this finding has not yet been defined.
Following the instructions in the package leaflet reduces the risk of side effects. These side effects are generally transitory.
If any of the side effects worsen, or if you notice the appearance of any side effects not listed in this package leaflet, inform your doctor or pharmacist.
Request and complete the side effect reporting form available at your pharmacy (form B).

EXPIRY AND STORAGE
See the expiry date indicated on the package. This date applies to the product in its intact packaging and stored correctly.
Caution: do not use the medicine after the expiry date indicated on the package.
Once opened, the syrup has a shelf life of 15 days.

KEEP THE MEDICINE OUT OF THE REACH AND SIGHT OF CHILDREN.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer used. These measures will help protect the environment.
It is important to always have the information on the medicine available, so keep both the box and the package leaflet.

COMPOSITION
One bottle contains: Active ingredient: N-acetylcysteine ​​4 g (corresponding to 20 mg per ml of syrup). Excipients: methyl parahydroxybenzoate, sodium benzoate, sodium edetate, sodium carboxymethylcellulose, sodium cyclamate, sucralose, raspberry flavoring, sodium saccharinate, sodium hydroxide, purified water.