Volutsa 6 mg/0,4 mg tabletten met gereguleerde afgifte

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

SOLIFENACINESUCCINAAT 6 mg/stuk SAMENSTELLING overeenkomend met ; SOLIFENACINE 4,5 mg/stuk ; TAMSULOSINEHYDROCHLORIDE 0,4 mg/stuk SAMENSTELLING overeenkomend met ; TAMSULOSINE 0,37 mg/stuk

Beschikbaar vanaf:

Astellas Pharma Europe B.V. Sylviusweg 62 2333 BE LEIDEN

ATC-code:

G04CA53

INN (Algemene Internationale Benaming):

SOLIFENACINESUCCINAAT 6 mg/stuk SAMENSTELLING overeenkomend met ; SOLIFENACINE 4,5 mg/stuk ; TAMSULOSINEHYDROCHLORIDE 0,4 mg/stuk SAMENSTELLING overeenkomend met ; TAMSULOSINE 0,37 mg/stuk

farmaceutische vorm:

Tablet met gereguleerde afgifte

Samenstelling:

BUTYLHYDROXYTOLUEEN (E 321) ; HYPROMELLOSE (E 464) ; IJZEROXIDE ROOD (E 172) ; MACROGOL 7000000 ; MACROGOL 8000 ; MAGNESIUMSTEARAAT (E 470b) ; MALTOSE 0-WATER ; MANNITOL (D-) (E 421) ; SILICIUMDIOXIDE (E 551),

Toedieningsweg:

Oraal gebruik

Therapeutisch gebied:

Tamsulosin and solifenacin

Product samenvatting:

Hulpstoffen: BUTYLHYDROXYTOLUEEN (E 321); HYPROMELLOSE (E 464); IJZEROXIDE ROOD (E 172); MACROGOL 7000000; MACROGOL 8000; MAGNESIUMSTEARAAT (E 470b); MALTOSE 0-WATER; MANNITOL (D-) (E 421); SILICIUMDIOXIDE (E 551);

Autorisatie datum:

2013-12-17

Bijsluiter

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
VOLUTSA 6 MG/0,4 MG TABLETTEN MET GEREGULEERDE AFGIFTE
solifenacin succinate/tamsulosin hydrochloride
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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 Volutsa is and what it is used for
2.
What you need to know before you use Volutsa
3.
How to use Volutsa
4.
Possible side effects
5.
How to store Volutsa
6.
Contents of the pack and other information
1.
WHAT VOLUTSA IS AND WHAT IT IS USED FOR
Volutsa is a combination of two different medicines called solifenacin
and tamsulosin in one tablet.
Solifenacin belongs to a group of medicines called anticholinergics
and tamsulosin belongs to a
group of medicines called alpha-blockers.
_ _
Volutsa is used in men to treat both moderate to severe storage
symptoms and voiding symptoms of
the lower urinary tract which are caused by bladder problems and an
enlarged prostate (benign
prostatic hyperplasia). Volutsa is used when previous treatment with a
monoproduct for this
condition did not relieve symptoms adequately.
As the prostate grows, it can lead to urinary problems (voiding
symptoms) such as hesitancy
(difficulty to start urinating), difficulty urinating (poor stream),
dribbling and feeling of incomplete
bladder emptying. At the same time, the bladder is also affected and
contracts spontaneously at times
you do not want to void. This causes storage symptoms such as changes
in bladder sensation, urgency
(having a strong, sudden desire to urinate without prior warning), and
having to urinate more
frequently.
Solife

Productkenmerken

1
1.
NAME OF THE MEDICINAL PRODUCT
Volutsa 6 mg/0,4 mg tabletten met gereguleerde afgifte
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains a layer of 6 mg solifenacin succinate,
corresponding to 4.5 mg solifenacin free
base and a layer of 0.4 mg tamsulosin hydrochloride, corresponding to
0.37 mg of tamsulosin free
base.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Modified release tablet
Each tablet is round, approximately 9 mm in diameter, red film-coated
and debossed with “6/0.4”.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of moderate to severe storage symptoms (urgency, increased
micturition frequency) and
voiding symptoms associated with benign prostatic hyperplasia (BPH) in
men who are not adequately
responding to treatment with monotherapy.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_Adult_ _males, including older people _
One Volutsa tablet (6 mg/0.4 mg) once daily taken orally with or
without food. The maximum daily
dose is one Volutsa tablet (6 mg/0.4 mg).
The tablet must be swallowed whole, intact without biting or chewing.
Do not crush the tablet._ _
_Patients with renal impairment _
The effect of renal impairment on the pharmacokinetics of Volutsa has
not been studied. However,
the effect on the pharmacokinetics of the individual active substances
is well known (see section 5.2).
Volutsa can be used in patients with mild to moderate renal impairment
(creatinine clearance
> 30 mL/min). Patients with severe renal impairment (creatinine
clearance ≤ 30 mL/min) should be
treated with caution and the maximum daily dose in these patients is
one Volutsa tablet
(6 mg/0.4 mg) (see section 4.4).
_Patients with hepatic impairment _
The effect of hepatic impairment on the pharmacokinetics of Volutsa
has not been studied. However,
the effect on the pharmacokinetics of the individual active substances
is well known (see section 5.2).
Volutsa can be used in patients with mild hepatic impairment
(Child-Pugh score ≤ 7). Patients with
moderate hepatic