Lactulose Sandoz 670 mg/ml, stroop

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

LACTULOSE, VLOEIBAAR 1340 mg/ml SAMENSTELLING overeenkomend met ; LACTULOSE 670 mg/ml

Beschikbaar vanaf:

Sandoz B.V. Veluwezoom 22 1327 AH ALMERE

ATC-code:

A06AD11

INN (Algemene Internationale Benaming):

LACTULOSE, VLOEIBAAR 1340 mg/ml SAMENSTELLING overeenkomend met ; LACTULOSE 670 mg/ml

farmaceutische vorm:

Stroop

Samenstelling:

WATER, GEZUIVERD,

Toedieningsweg:

Oraal gebruik

Therapeutisch gebied:

Lactulose

Product samenvatting:

Hulpstoffen: WATER, GEZUIVERD;

Autorisatie datum:

2012-09-24

Bijsluiter

Sandoz B.V.
Page 1/6
Lactulose Sandoz 670 mg/ml, stroop
RVG 109594
1313-v4
1.3.1.3 Bijsluiter
Mei 2022
PACKAGE LEAFLET: INFORMATION FOR THE USER
LACTULOSE SANDOZ 670 MG/ML, STROOP
lactulose
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 have 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 several days.
_ _
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.
WHAT [NATIONALLY COMPLETED NAME] IS AND WHAT IT IS USED FOR
[Nationally completed name] belongs to a group of medicines known as
laxatives. Lactulose, the
active substance, makes the stool softer and easier to pass by drawing
water into the bowel. It is not
absorbed into your body.
[NATIONALLY COMPLETED NAME] IS USED TO TREAT
•
Symptoms of
CONSTIPATION
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE [NATIONALLY COMPLETED NAME]
DO NOT TAKE [NATIONALLY COMPLETED NAME]
•
if you are allergic to lactulose.
•
if you suffer from
o
galactosaemia (a severe genetic disorder where you cannot digest
galactose).
o
blockage in your gastrointestinal tract (apart from normal
constipation).
o
digestive perforation or a risk of digestive perforation (e.g. acute
inflammatory bowel disease
such as Crohn’s disease or ulcerative colitis).
WARNINGS AND PRECAUTIONS
Talk to your doctor before taking [Nationally completed name] if you
suffer from a

Productkenmerken

Sandoz B.V.
Page 1/5
Lactulose Sandoz 670 mg/ml, stroop
RVG 109595
1313-v4
1.3.1.3 Bijsluiter
Mei 2022
SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Lactulose Sandoz 670 mg/ml, stroop
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
1ml contains 670 mg Lactulose (as lactulose liquid).
3
PHARMACEUTICAL FORM
Oral solution
Clear colourless to pale brownish yellow, viscous solution
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
•
Symptomatic treatment of constipation
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The lactulose solution may be administered diluted or undiluted. The
dose should be titrated according
to the clinical response. Lactulose may be given as a single daily
dose or in two divided doses, using
the measuring cup.
A single dose of lactulose should be swallowed in one and should not
be kept in the mouth for an
extended period of time.
The posology should be adjusted according to the individual needs of
the patient. The starting dose
can be adjusted after adequate treatment effect individually
(maintenance dose). Several days (2-
3 days) of treatment may be needed in some patients before adequate
treatment effect occurs. In case
of single daily dose, this should be taken at the same time of the
day, e.g. during breakfast. During the
therapy with laxatives it is recommended to drink sufficient amounts
of fluids (1.5-2 l/day, equal to
6-8 glasses).
_ _
Starting dose (per day)
Maintenance dose (per day)
Adults and
adolescents over 14 years
15-45 ml
corresponding to
10-30 g
lactulose
15-30 ml
corresponding to
10-20 g
lactulose
Children
(7-14 years)
15 ml
corresponding to
10 g lactulose
10-15 ml
corresponding to
7-10 g lactulose
Children
(1-6 years)
5-10 ml
corresponding to
3-7 g lactulose
5-10 ml
corresponding to
3-7 g lactulose
Infants under 1 year
up to 5 ml
corresponding to
up to 3 g
lactulose
up to 5 ml
corresponding to
up to 3 g
lactulose
If diarrhoea occurs, the dosing regimen should be reduced.
Sandoz B.V.
Page 2/5
Lactulose Sandoz 670 mg/ml, stroop
RVG 109595
1313-v4
1.3