Macrogol en elektrolyten naturel Sandoz 13,7 g, poeder voor drank

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

KALIUMCHLORIDE (E 508) 0,0466 g/stuk ; MACROGOL 3350 13,125 g/stuk ; NATRIUMCHLORIDE 0,3507 g/stuk ; NATRIUMWATERSTOFCARBONAAT (E 500 (II)) 0,1785 g/stuk ; SAMENSTELLING overeenkomend met CHLORIDE (CL-) 53 mmol/l ; KALIUM (K+) 5 mmol/l ; NATRIUM (NA+) 65 mmol/l ; WATERSTOFCARBONAAT (HCO3-) 17 mmol/l

Beschikbaar vanaf:

Sandoz B.V. Veluwezoom 22 1327 AH ALMERE

ATC-code:

A06AD65

INN (Algemene Internationale Benaming):

KALIUMCHLORIDE (E 508) 0,0466 g/stuk ; MACROGOL 3350 13,125 g/stuk ; NATRIUMCHLORIDE 0,3507 g/stuk ; NATRIUMWATERSTOFCARBONAAT (E 500 (II)) 0,1785 g/stuk ; SAMENSTELLING overeenkomend met CHLORIDE (CL-) 53 mmol/l ; KALIUM (K+) 5 mmol/l ; NATRIUM (NA+) 65 mmol/l ; WATERSTOFCARBONAAT (HCO3-) 17 mmol/l

farmaceutische vorm:

Poeder voor oraal gebruik

Samenstelling:

SILICIUMDIOXIDE (E 551)

Toedieningsweg:

Oraal gebruik

Therapeutisch gebied:

Macrogol, Combinations

Autorisatie datum:

1900-01-01

Bijsluiter

Sandoz B.V.
Page 1/7
Macrogol en elektrolyten naturel Sandoz
®
13,7 g,
poeder voor drank
RVG 123358
1313-v6
1.3.1.3 Bijsluiter
November 2021
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
MACROGOL EN ELEKTROLYTEN NATUREL SANDOZ
® 13,7 G, POEDER VOOR DRANK
macrogol 3350 / sodium chloride / sodium hydrogen carbonate /
potassium chloride
_ _
[For medicines available only on prescription:] [To be completed
nationally]
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 or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
[For medicines available without a prescription:] [To be completed
nationally]
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 14 days for chronic
constipation, or after 3 days for faecal impaction. [For faecal
impaction indication only]
WHAT IS IN 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. WH

Productkenmerken

Sandoz B.V.
Page 1/7
Macrogol en elektrolyten naturel Sandoz 13,7 g,
poeder voor drank
RVG 123358
1311-v6
1.3.1.1 Samenvatting van de Productkenmerken
December 2023
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Macrogol en elektrolyten naturel Sandoz 13,7 g, poeder voor drank
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each sachet contains the following quantitative composition of active
ingredients:
Macrogol 3350
13.125 g
Sodium Chloride
0.3507 g
Sodium Hydrogen Carbonate
0.1785 g
Potassium Chloride
0.0466 g
The content of electrolyte ions per sachet following reconstitution in
125 ml of water is
equivalent to:
Sodium
65 mmol/l
Chloride
53 mmol/l
Hydrogen Carbonate (Bicarbonate)
17 mmol/l
Potassium
5 mmol/l
Excipient(s) with known effect
Each sachet contains 8.2 mmol (188 mg) sodium and 0.6 mmol (24.4 mg)
potassium.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder for oral solution.
Single-dose sachet containing a white crystalline powder.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For the treatment of chronic constipation. [Nationally completed name]
is also effective in
resolving faecal impaction, defined as refractory constipation with
faecal loading of the rectum
and/or colon.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
_Chronic constipation:_
_ _
A course of treatment for chronic constipation with_ _[Nationally
completed name] does not
normally exceed 2 weeks, although this can be repeated if required.
Sandoz B.V.
Page 2/7
Macrogol en elektrolyten naturel Sandoz 13,7 g,
poeder voor drank
RVG 123358
1311-v6
1.3.1.1 Samenvatting van de Productkenmerken
December 2023
As for all laxatives, prolonged use is not usually recommended.
Extended use may be necessary
in the care of patients with severe chronic or resistant constipation,
secondary to multiple
sclerosis or Parkinson's disease, or induced by regular constipating
medicinal products in
particular opioids and antimuscarinics.
Adults, adolescents and elderly: 1-3 sachets daily in divided do