Pikopil tabletten 5 mg

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

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

Beschikbaar vanaf:

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

ATC-code:

A06AB08

INN (Algemene Internationale Benaming):

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

farmaceutische vorm:

Tablet

Samenstelling:

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

Toedieningsweg:

Oraal gebruik

Therapeutisch gebied:

Sodium Picosulfate

Product samenvatting:

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

Autorisatie datum:

2016-02-02

Bijsluiter

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
PIKOPIL TABLETTEN 5 MG
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

Productkenmerken

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Pikopil tabletten 5 mg
Pikopil tabletten 7,5 mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
[PIKOPIL 5 MG TABLETS]
Each tablet contains sodium picosulfate monohydrate equivalent to 5 mg
sodium picosulfate
anhydrous.
Excipient with known effect: 1 tablet contains 97.0 mg lactose
[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 5 MG TABLETS]
White to off-white, round, flat bevelled-edge tablets with a score
line, diameter 7 mm,height 2.4 mm.
The tablet can be divided into equal doses.
[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 (corresponding to 1 – 1.5 Pikopil 5 mg tablets or 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 (corresponding to 1 – 1.5 Pikopil 5 mg tablets or 1
Pikopil 7.5 mg tablet) swallowed at
bedtime.
_Children from 4 to less than 10 years of age _
_2.5 – 5 mg (_corresponding to ½ – 1 Pikopil 5 mg tablet)
swallowed at bedtime.
Pikopil tablets 5 mg should not be used in children below 4 years of
age. Pikopil tablets 7.5 mg should
not be used