Prucalopride Holsten 2 mg Filmdragerad tablett

Land: Sverige

Språk: svenska

Källa: Läkemedelsverket (Medical Products Agency)

Aktiva substanser:

prukalopridsuccinat

Tillgänglig från:

Holsten Pharma GmbH

ATC-kod:

A06AX05

INN (International namn):

prukalopridsuccinat

Dos:

2 mg

Läkemedelsform:

Filmdragerad tablett

Sammansättning:

laktosmonohydrat Hjälpämne; prukalopridsuccinat 2,64 mg Aktiv substans

Receptbelagda typ:

Receptbelagt

Produktsammanfattning:

Förpacknings: Blister, 14 tabletter (kalenderförpackning); Blister, 28 tabletter (kalenderförpackning); Blister, 84 tabletter (kalenderförpackning)

Bemyndigande status:

Godkänd

Tillstånd datum:

2022-11-21

Bipacksedel

1 PACKAGE LEAFLET: INFORMATION FOR THE USER
PRUCALOPRIDE HOLSTEN 1 MG FILM-COATED TABLETS
PRUCALOPRIDE HOLSTEN 2 MG FILM-COATED TABLETS
prucalopride
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.
WHAT IS IN THIS LEAFLET
1.
What Prucalopride Holsten is and what it is used for
2.
What you need to know before you take Prucalopride Holsten
3.
How to take Prucalopride Holsten
4.
Possible side effects
5.
How to store Prucalopride Holsten
6.
Contents of the pack and other information
1.
WHAT PRUCALOPRIDE HOLSTEN IS AND WHAT IT IS USED FOR
Prucalopride Holsten contains the active substance prucalopride.
Prucalopride Holsten belongs to a group of gut motility enhancing
medicines (gastrointestinal
prokinetics). It acts on the muscle wall of the gut, helping to
restore the normal functioning of the
bowel. Prucalopride is used for the treatment of chronic constipation
in adults in whom laxatives do
not work well enough.
Not for use in children and adolescents younger than 18 years.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE PRUCALOPRIDE HOLSTEN
DO NOT TAKE PRUCALOPRIDE HOLSTEN:
-
if you are allergic to prucalopride or any of the other ingredients of
this medicine (listed in section
6).
-
if you are on renal dialysis,
-
if you suffer from perforation or obstruction of the gut wall, severe
inflammation of the intestinal
tract, such as Crohn’s disease, ulcerative colitis or toxic
megacolon/megarectum.
WARNINGS AND PRECAUTIONS
Talk to your doctor before taking Prucalopride Holsten.
Take special care with Prucalopride Holsten and tell your do

Produktens egenskaper

1
1.
NAME OF THE MEDICINAL PRODUCT
Prucalopride Holsten 1 mg film-coated tablets
Prucalopride Holsten 2 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 1 mg or 2 mg prucalopride (as
succinate).
Excipients with known effect: Each 1 mg film-coated tablet contains
144 mg lactose and 2 mg film-coated tablet
contains 159 mg lactose.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
1 mg: white to off-white, round biconvex, film-coated tablets debossed
with “P1” on one side and no
debossing on the other side. Thickness of tablets is 4 mm and diameter
is 8 mm.
2 mg: pink, round biconvex, film-coated tablets debossed with “P2”
on one side and no debossing on the
other side. Thickness of tablets is 4 mm and diameter is 9 mm.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Prucalopride Holsten is indicated for symptomatic treatment of chronic
constipation in adults in whom
laxatives fail to provide adequate relief.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults_
: 2 mg once daily with or without food, at any time of the day.
Due to the specific mode of action of prucalopride (stimulation of
propulsive motility), exceeding the
daily dose of 2 mg is not expected to increase efficacy.
If the intake of once daily prucalopride is not effective after 4
weeks of treatment, the patient should be
re-examined and the benefit of continuing treatment reconsidered.
The efficacy of prucalopride has been established in double-blind,
placebo-controlled studies for up to 3
months. Efficacy beyond 3 months has not been demonstrated in
placebo-controlled studies (see section
5.1). In case of prolonged treatment, the benefit should be reassessed
at regular intervals.
Special populations
_Older people (>65 years)_
: Start with 1 mg once daily (see section 5.2); if needed the dose can
be
increased to 2 mg once daily.
_Patients with renal impairment_
: The dose for patients with severe renal impairment
(GFR < 30 ml/min/1.73 m
2