Acetylcysteïne Sandoz 600 mg, poeder voor oraal gebruik in sachet

Country: Netherlands

Language: Dutch

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

Active ingredient:

ACETYLCYSTEÏNE

Available from:

Sandoz B.V. Veluwezoom 22 1327 AH ALMERE

ATC code:

R05CB01

INN (International Name):

Acetyl cysteine

Pharmaceutical form:

Poeder voor oraal gebruik

Composition:

ASPARTAAM (E 951) ; BRAMENSMAAKSTOF ; CARMELLOSE NATRIUM (E 466) ; CITROENZUUR 0-WATER (E 330) ; GLUCONOLACTON (E 575) ; MAGNESIUMCARBONAAT (E 504 (I)) ; MAGNESIUMCITRAAT 0-WATER ; MAGNESIUMSTEARAAT (E 470b) ; MALTODEXTRINE ; MANNITOL (D-) (E 421) ; NATRIUMDIWATERSTOFCITRAAT (E 331) ; POLYSORBAAT 65 (E 436) ; SILICIUMDIOXIDE (E 551) ; SORBITOL (D-)(E 420) ; TRIPALMITINE ; VANILLINE ; XYLITOL (E 967),

Administration route:

Oraal gebruik

Therapeutic area:

Acetylcysteine

Product summary:

Hulpstoffen: ASPARTAAM (E 951); BRAMENSMAAKSTOF; CARMELLOSE NATRIUM (E 466); CITROENZUUR 0-WATER (E 330); GLUCONOLACTON (E 575); MAGNESIUMCARBONAAT (E 504 (I)); MAGNESIUMCITRAAT 0-WATER; MAGNESIUMSTEARAAT (E 470b); MALTODEXTRINE; MANNITOL (D-) (E 421); NATRIUMDIWATERSTOFCITRAAT (E 331); POLYSORBAAT 65 (E 436); SILICIUMDIOXIDE (E 551); SORBITOL (D-)(E 420); TRIPALMITINE; VANILLINE; XYLITOL (E 967);

Authorization date:

2017-12-04

Patient Information leaflet

Sandoz B.V.
Page 1/8
Acetylcysteïne Sandoz
®
600 mg, poeder voor oraal gebruik in sachet
RVG 119475
1313-V5
1.3.1.3 Bijsluiter
September 2020
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ACETYLCYSTEÏNE SANDOZ 600 MG, POEDER VOOR ORAAL GEBRUIK IN SACHET
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.
•
[NATIONALLY COMPLETED NAME] SHOULD NOT BE TAKEN FOR MORE THAN 14 DAYS
WITHOUT ANY
MEDICAL ADVISE.
•
You must talk to a doctor if you do not feel better or if you feel
worse after 4-5 days.
FOR RX PRODUCTS
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.
- If you have any further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
- If you get any side effects, talk to your doctor. This includes any
possible side effects not listed
in this leaflet. See section 4.
WHAT IS THIS LEAFLET
1.
What [Nationally completed name]
is and what it is used for
2.
What you need to know before you take [Nationally completed name]
3.
How to take [Nationally completed name]
4.
Possible side effects
5.
How to store [Nationally completed name]
6.
Contents of the pack and other information
1. WHAT [NATIONALLY COMPLETED NAME] IS AND WHAT IT IS USED FOR
[Nationally completed name] contains the active substance
acetylcysteine and liquefies viscous mucus
in the airways.
[Nationally completed name] is used

Summary of Product characteristics

Sandoz B.V.
Acetylcysteine Sandoz 600 mg, poeder voor
oraal gebruik in sachet
Page
1/10
RVG 119475
1311-V4
1.3.1.1 Samenvatting van de Productkenmerken
Augustus 2020
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Acetylcysteïne Sandoz 600 mg, poeder voor oraal gebruik in sachet
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each sachet contains 600 mg of acetylcysteine.
Excipients with known effect
Each sachet contains 0.5mg of aspartame and up to 527 mg of sorbitol.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Oral powder.
White to slightly yellowish powder, easily disaggregating agglomerates
if any with an odour like
blackberry, possibly slightly sulfuric.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Secretolytic therapy in acute and chronic bronchopulmonary diseases
where a reduction in the
viscosity of the bronchial mucus is required in order to facilitate
expectoration in adults.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The following dosage is recommended for [Nationally completed name]:
For adults only
1 sachet once daily (equivalent to 600 mg acetylcysteine per day)
[Nationally completed name] is not suitable for use in adolescents and
children. But other appropriate
pharmaceutical forms are available.
Method of administration
Sandoz B.V.
Acetylcysteine Sandoz 600 mg, poeder voor
oraal gebruik in sachet
Page
2/10
RVG 119475
1311-V4
1.3.1.1 Samenvatting van de Productkenmerken
Augustus 2020
The oral powder of one sachet should be placed directly on the tongue.
The oral powder stimulates the
salivation so the oral powder can be swallowed easily. The oral powder
should not be chewed before
swallowing.
Can be taken without water.
Elderly and weakened patients
Patients with a reduced cough reflex (elderly and weakened patients)
should take the oral powder
preferably in the morning.
Duration of use
[Nationally completed name] should not be taken for more than -14 days
without medical advice.
The patient should consult a doctor in case that the sympt