Jomil 6 mg/0.4 mg modified-release tablets

Land: Malta

Språk: engelsk

Kilde: Medicines Authority

Tilgjengelig fra:

Heaton k.s. Na Pankraci 14, 140 00 Praha 4, Czech Republic

ATC-kode:

G04CA53

INN (International Name):

SOLIFENACIN SUCCINATE 6 mg TAMSULOSIN HYDROCHLORIDE 0.4 mg

Legemiddelform:

MODIFIED-RELEASE TABLET

Sammensetning:

SOLIFENACIN SUCCINATE 6 mg TAMSULOSIN HYDROCHLORIDE 0.4 mg

Resept typen:

POM

Terapeutisk område:

UROLOGICALS

Produkt oppsummering:

Licence number in the source country: NOT APPLICAPABLE

Autorisasjon status:

Authorised

Autorisasjon dato:

2023-05-10

Informasjon til brukeren

PACKAGE LEAFLET: INFORMATION FOR THE USER
JOMIL 6 MG/0.4 MG MODIFIED-RELEASE TABLETS
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 Jomil is and what it is used for
2.
What you need to know before you use Jomil
3.
How to use Jomil
4.
Possible side effects
5.
How to store Jomil
6.
Contents of the pack and other information
1.
WHAT JOMIL IS AND WHAT IT IS USED FOR
Jomil 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.
Jomil 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). Jomil 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.
Solifenacin reduces the undesired contra

Preparatomtale

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Jomil 6 mg/0.4 mg modified-release tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each modified-release tablet contains 6 mg solifenacin succinate,
corresponding to 4.5 mg solifenacin
and 0.4 mg tamsulosin hydrochloride, corresponding to 0.37 mg
tamsulosin.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Modified-release tablet
Each tablet is red film-coated, round, biconvex, approximately 9 mm in
diameter and debossed with
“T7S” on one side.
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
Posology
_Adult males, including elderly _
One Jomil tablet (6 mg/0.4 mg) once daily taken orally with or without
food. The maximum daily dose
is one Jomil tablet (6 mg/0.4 mg).
Special Populations
_Renal impairment _
The effect of renal impairment on the pharmacokinetics of Jomil has
not been studied. However, the
effect on the pharmacokinetics of the individual active substances is
well known (see section 5.2). Jomil
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 Jomil tablet (6
mg/0.4 mg) (see section 4.4).
_Hepatic impairment _
The effect of hepatic impairment on the pharmacokinetics of Jomil has
not been studied. However, the
effect on the pharmacokinetics of the individual active substances is
well known (see section 5.2). Jomil
can be used in patients with mild hepatic impairment (Child-Pugh score
≤ 7). Patients with moderate
hepatic impairment (Child-Pugh score 7-9) should be treated with
caution and the maximum daily dose
in these pat