Fluimucil acetylcysteine 600 mg effervescent tablets

Land: Malta

Taal: Engels

Bron: Malta Medicines Authority

Beschikbaar vanaf:

Zambon Spa Via Lillo del Duca, 10, 20091 Bresso (Milan), Italy

ATC-code:

R05CB01

INN (Algemene Internationale Benaming):

ACETYLCYSTEINE 600 mg

farmaceutische vorm:

EFFERVESCENT TABLET

Samenstelling:

ACETYLCYSTEINE 600 mg

Prescription-type:

OTC

Therapeutisch gebied:

COUGH AND COLD PREPARATIONS

Product samenvatting:

Licence number in the source country: NOT APPLICAPABLE

Autorisatie-status:

Authorised

Autorisatie datum:

2022-08-10

Bijsluiter

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
Fluimucil
600 MG EFFERVESCENT TABLETS
Acetylcysteine
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.
-
Ask your pharmacist if you need more information or advice .
-
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.
-
You must talk to a doctor if you do not feel better or if you feel
worse after 10 days
WHAT IS IN THIS LEAFLET
1.
What Fluimucil is and what it is used for
2.
What you need to know before you take Fluimucil
3.
How to take Fluimucil
4.
Possible side effects
5.
How to store Fluimucil
6.
Contents of the pack and other information
1.
WHAT FLUIMUCIL IS AND WHAT IT IS USED FOR
Fluimucil 600mg effervescent tablets contains a medicine called
acetylcysteine.
Acetylcysteine breaks down and loosens thick mucus, making it runny
and easy to cough up.
Acetylcysteine is used in the treatment of airway diseases associated
with an excess of mucus,
especially acute bronchitis (inflammation of the air tubes of the
lungs).
You must talk to a doctor if you do not feel better or if you feel
worse after 5 days.
Do not take the product for longer than 10 days without contacting
your doctor.
Fluimucil is intended for adults only.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE FLUIMUCIL
DO NOT TAKE FLUIMUCIL:
-
if you are allergic to acetylcysteine or any of the other ingredients
of this medicine (listed in
section 6).
-
if your child is under 2 years of age.
-
if you are a child or a pregnant woman suffering with phenylketonuria.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Fluimucil
-
If you have stomach ulcers or history of them.
-
If you suffer from bronchial asthma, as you may need to be monitored
closely whilst taking
this medicine. If you experience difficulty in breathing, immediately
stop taking Fluimucil and
contact your docto

Productkenmerken

SUMMARY OF PRODUCT CHARACTERISTICS
1
Page 2 of 8
1.
NAME OF THE MEDICINAL PRODUCT
Fluimucil acetylcysteine 600 mg effervescent tablets.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each effervescent tablet contains 600mg Acetylcysteine.
Excipient(s) with known effect:
Sodium bicarbonate, aspartame, lemon flavour (contains glucose).
This medicinal product contains 157.9 mg sodium per effervescent
tablet, equivalent to 7.9% of the
WHO recommended maximum daily intake of 2 g sodium for an adult.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Effervescent tablets.
White circular effervescent tablets of approximately 18 mm.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Fluimucil is indicated in adults for the treatment of airway secretion
in which a reduction in the
viscosity of the bronchial secretions is required to facilitate
expectoration, especially during periods of
acute bronchitis.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults: _
600 mg of acetylcysteine (1 tablet) once a day.
_Paediatric population _
Fluimucil 600 mg effervescent tablets is not indicated in children
less than 18 years old.
Fluimucil 600 mg effervescent tablets is contraindicated for use in
children aged under 2 years (see
section 4.3) and is not suitable for use in children and adolescents.
Method of administration
For oral use.
Dissolve one effervescent tablet in a small volume of water.
Once the tablet has completely dissolved, the liquid can be drunk
immediately
.
The solution can be taken independent of food intake.
Patients are advised not to take this medicine for longer than 10 days
without consulting a doctor.
If patient’s symptoms worsen or do not improve after 5 days from the
treatment initiation, they
should stop taking the product and contact a doctor.
It is recommended for elderly and for fragile patients to take the
effervescent tablet in the morning.
Page 3 of 8
4.3
CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1.
Children