Pikopil druppels voor oraal gebruik, oplossing, 7,5 mg/ml

Land: Nederland

Språk: nederlandsk

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

Aktiv ingrediens:

NATRIUMPICOSULFAAT 1-WATER SAMENSTELLING overeenkomend met ; NATRIUMPICOSULFAAT 0-WATER

Tilgjengelig fra:

Vital Pharma GmbH Schaberweg 28b 61348 BAD HOMBURG (DUITSLAND)

ATC-kode:

A06AB08

INN (International Name):

NATRIUMPICOSULFAAT 1-WATER COMPOSITION corresponding to ; NATRIUMPICOSULFAAT 0-WATER

Legemiddelform:

Druppels voor oraal gebruik, oplossing

Sammensetning:

CITROENZUUR 1-WATER (E 330) ; NATRIUMBENZOAAT (E 211) ; SORBITOL (D-)(E 420) ; TRINATRIUMCITRAAT 2-WATER (E 331) ; WATER VOOR INJECTIE,

Administreringsrute:

Oraal gebruik

Terapeutisk område:

Sodium Picosulfate

Produkt oppsummering:

Hulpstoffen: CITROENZUUR 1-WATER (E 330); NATRIUMBENZOAAT (E 211); SORBITOL (D-)(E 420); TRINATRIUMCITRAAT 2-WATER (E 331); WATER VOOR INJECTIE;

Autorisasjon dato:

2016-02-02

Informasjon til brukeren

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
PIKOPIL DRUPPELS VOOR ORAAL GEBRUIK, OPLOSSING, 7.5 MG/ML
Sodium picosulfate
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
Always use 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 3 days.
WHAT IS IN THIS LEAFLET
1.
What Pikopil is and what it is used for
2.
What you need to know before you take Pikopil
3.
How to take Pikopil
4.
Possible side effects
5.
How to store Pikopil
6.
Contents of the pack and other information
1.
WHAT PIKOPIL IS AND WHAT IT IS USED FOR
Pikopil contains an active substance called sodium picosulfate.
Pikopil belongs to a group of medicines
called laxatives.
Pikopil works by stimulating your bowel movements. It also increases
the amount of water in your bowel.
Pikopil is used for short-term relief of prolonged or recurrent
constipation.
You must talk to a doctor if you do not feel better or if you feel
worse after 3 days.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE PIKOPIL
DO NOT TAKE PIKOPIL, IF YOU ARE/HAVE:
-
allergic
to
sodium
picosulfate,
other
substances
belonging
to
a
group
of
triarylmethane
(e.g.,
bisacodyl) or any of the other ingredients of this medicine (listed in
section 6).
-
severe dehydration (i.e., lost too much water from your body)
-
a blocked bowel (intestinal obstruction)
-
a serious abdominal problem such as appendicitis
-
acute inflammatory bowel disease
-
severe abdominal pain whith makes you feel or be sick
-
sudden, severe abdominal pain just before intake
-
a bowel problem called “ileus” where your small intestine is
blocked.
Do not take Pikopil if any o

Preparatomtale

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Pikopil druppels voor oraal gebruik, oplossing, 7.5 mg/ml
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml contains sodium picosulfate monohydrate equivalent to 7.5 mg
sodium picosulfate anhydrous
(1 ml = 15 drops).
Excipient with known effect: 1 ml oral solution contains 450 mg
sorbitol
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Oral drops, solution
Clear colorless or yellowish solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Short term relief of chronic or habitual constipation.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
It is recommended to start with the lowest dose. The dose may be
adjusted up to the maximum
recommended dose to produce regular stools.
The maximum recommended daily dose should not be exceeded.
The selected dose of Pikopil should not be taken more than once a day.
_ _
Unless otherwise prescribed by the doctor, the usual dose is:
Adults: 8 to 12 drops (4 – 6 mg) at once.
_ _
If necessary, the number of drops can be increased or reduced, so that
the dose is found that it is most
suitable.
_ _
_Paediatric population _
Children over 6 years: 8 to 12 drops (4 – 6 mg) at once.
Children 4 to 6 years: 6 drops (3 mg) at once.
In children younger than 4 years Pikopil is less effective as in these
children the intestinal microflora is
not sufficiently developed yet to convert sodium picosulfate into its
active metabolite.
_ _
Method of administration
Pikopil should be taken in the evening so that at the following
morning defecation occurs. Pikopil is
liquid, has a neutral taste and can be taken with or without
additional liquid. Pikopil is delivered in a
dropper bottle allowing to adjust the required amount.
_ _
As for all intestinal irritants, Pikopil should basically not be taken
longer than three subsequent days.
The maintenance of an adequate fluid intake during treatment is
essential, especially for younger patients
and the elderly who are more susceptible to the effects of
dehy