Pikopil tabletten 7,5 mg

País: Països Baixos

Idioma: neerlandès

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

ingredients actius:

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

Disponible des:

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

Codi ATC:

A06AB08

Designació comuna internacional (DCI):

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

formulario farmacéutico:

Tablet

Composición:

LACTOSE 1-WATER ; MAGNESIUMSTEARAAT (E 470b) ; MAÏSZETMEEL ; MAÏSZETMEEL, GEPREGELATINEERD ; SILICIUMDIOXIDE (E 551),

Vía de administración:

Oraal gebruik

Área terapéutica:

Sodium Picosulfate

Resumen del producto:

Hulpstoffen: LACTOSE 1-WATER; MAGNESIUMSTEARAAT (E 470b); MAÏSZETMEEL; MAÏSZETMEEL, GEPREGELATINEERD; SILICIUMDIOXIDE (E 551);

Data d'autorització:

2016-02-02

Informació per a l'usuari

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
PIKOPIL TABLETTEN 7,5 MG
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 in adults and children over 4 years
old.
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 which 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

Fitxa tècnica

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Pikopil tabletten 7,5 mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
[PIKOPIL 7.5 MG TABLETS]
Each tablet contains sodium picosulfate monohydrate equivalent to 7.5
mg sodium picosulfate
anhydrous.
Excipient with known effect: 1 tablet contains 145.5 mg lactose
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet
[PIKOPIL 7.5 MG TABLETS]
White to off-white, round, flat bevelled-edge tablets with a score
line, diameter 8 mm, height 2.4 mm.
The tablet can be divided into equal doses.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Short term relief of chronic or habitual constipation.
Pikopil is indicated in adults and in children aged from 4 years.
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.
_Adults _
5 – 7.5 mg (Starting with a similar medicinal product of lower
strength, increased to 1 Pikopil 7.5 mg
tablet) swallowed at bedtime.
Dosage can be titrated individually. Once regularity has re-started
dosage should be reduced and can
usually be stopped.
_ _
_Paediatric population _
_Children from 10 years of age _
5 – 7.5 mg ( Starting with a similar medicinal product of lower
strength, increased to 1 Pikopil 7.5 mg
tablet) swallowed at bedtime.
_Children from 4 to less than 10 years of age _
Pikopil tablets 7.5 mg should not be used in children below 10 years
of age. For these children please
refer to the Pikopil oral drops Summary of Product Characteristics.
The safety and efficacy of Pikopil tablets in children below 4 years
of age have not been established. No
data are available.
_ _
Method of administration
The tablet should be swallowed with adequate fluid.
As for all intestinal irritants, Pikopil should basically not be taken
longer than three subsequent days.
The maintenance of an adequate fluid intake during t