Bisolaclar 600 mg bruistabletten

Land: Nederland

Taal: Nederlands

Bron: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Werkstoffen:

ACETYLCYSTEÏNE 600 mg/stuk

Beschikbaar vanaf:

sanofi-aventis Netherlands B.V. Paasheuvelweg 25 1105 BP AMSTERDAM

ATC-code:

R05CB01

INN (Algemene Internationale Benaming):

ACETYLCYSTEÏNE 600 mg/stuk

farmaceutische vorm:

Bruistablet

Samenstelling:

ASCORBINEZUUR (L-) (E 300) ; CITROENSMAAKSTOF AU ; CITROENZUUR 0-WATER (E 330) ; GLUCONOLACTON (E 575) ; LACTOSE 0-WATER ; MALTODEXTRINE ; MANNITOL (D-) (E 421) ; NATRIUMCARBONAAT 0-WATER (E 500 (I)) ; NATRIUMCYCLAMAAT (E 952) ; NATRIUMWATERSTOFCARBONAAT (E 500 (II)) ; NATUURLIJKE EN KUNSTMATIGE SMAAKSTOFFEN ; SACCHAROIDE NATRIUM X-WATER (E 954) ; SILICIUMDIOXIDE (E 551) ; SORBITOL (D-)(E 420) ; TRINATRIUMCITRAAT 2-WATER (E 331),

Toedieningsweg:

Oraal gebruik

Therapeutisch gebied:

Acetylcysteine

Product samenvatting:

Hulpstoffen: ASCORBINEZUUR (L-) (E 300); CITROENSMAAKSTOF AU; CITROENZUUR 0-WATER (E 330); GLUCONOLACTON (E 575); LACTOSE 0-WATER; MALTODEXTRINE; MANNITOL (D-) (E 421); NATRIUMCARBONAAT 0-WATER (E 500 (I)); NATRIUMCYCLAMAAT (E 952); NATRIUMWATERSTOFCARBONAAT (E 500 (II)); NATUURLIJKE EN KUNSTMATIGE SMAAKSTOFFEN; SACCHAROIDE NATRIUM 0-WATER (E 954); SILICIUMDIOXIDE (E 551); SORBITOL (D-)(E 420); TRINATRIUMCITRAAT 2-WATER (E 331);

Autorisatie datum:

2015-08-03

Bijsluiter

310523
PACKAGE LEAFLET: INFORMATION FOR THE USER
BISOLACLAR 600 MG BRUISTABLETTEN
Acetylcysteine
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
Always take this medicine exactly as described in this leaflet or as
your doctor, or pharmacist has
told 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 8 to 10 days.
WHAT IS IN THIS LEAFLET
1.
What
Bisolaclar
is and what it is used for
2.
What you need to know before you take
Bisolaclar
3.
How to take
Bisolaclar
4.
Possible side effects
5.
How to store
Bisolaclar
6.
Contents of the pack and other information
1.
WHAT BISOLACLAR IS AND WHAT IT IS USED FOR
Acetylcysteine breaks down and loosens thick mucus making it runny and
easy to cough up.
Acetylcysteine is indicated in adults for the treatment of airway
diseases in which a reduction in
the viscosity of the bronchial secretions is required to facilitate
expectoration, especially during
periods of acute bronchitis.
You must talk to a doctor if you do not feel better or if you feel
worse after 8 to 10 days.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE BISOLACLAR
DO NOT TAKE BISOLACLAR
-
if you are allergic to acetylcysteine or any of the other ingredients
of this medicine (listed
in section 6).
-
Children aged under 2 years must not use this medicine.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Bisolaclar.
If you have asthma or experienced episodes of bronchospasm (narrowing
/ cramping of the
airways) in the past Bisolaclar should be taken with special caution
as your condition can
aggravate under the treatment with Bisolaclar. If this happens, a
doctor has to be consulted
immediately.
If you have a stomach ulcer or a history

Productkenmerken

Bisolaclar 600 mg- SPC-310523
SUMMARY OF PRODUCT CHARACTERISTICS
Bisolaclar 600 mg- SPC-310523
1.
NAME OF THE MEDICINAL PRODUCT
Bisolaclar 600 mg bruistabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each effervescent tablet contains 600 mg acetylcysteine.
Excipients with known effect:
Each effervescent tablet contains 6.03 mmol of sodium, which is
equivalent to 138.8 mg of
sodium.
Each effervescent tablet contains 70 mg lactose.
Each effervescent tablet contains the maximum of 40 mg sorbitol.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Effervescent tablet.
Round, white tablets with faultless surface, a score line on one side
and diameter of 20 mm.
The score line is only to facilitate breaking for ease of dissolving
and not to divide into equal
doses.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Acetylcysteine is indicated in adults for the treatment of airway
diseases 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
One 600 mg effervescent tablet once daily.
_Paediatric population _
Bisolaclar 600 mg effervescent tablets are contraindicated for use in
children aged under 2 years
(see section 4.3) and are not suitable for use in children and
adolescents.
Method of administration
The effervescent tablet has to be dissolved in half a glass of water.
Once the tablet has dissolved,
the liquid can be drunk immediately.
Acetylcysteine is used for symptomatic treatment and should not be
used longer than 8 to 10 days
without seeking for medical advice.
4.3
CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1.
Bisolaclar 600 mg- SPC-310523
Children aged under 2 years.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Administer with caution to asthmatic patients, or those with a history
of bronchospasm. If a
bronchospasm occurs, use of Bisolaclar should be stopped immediately.
C