Solifenacin succinate/Tamsulosin hydrochloride Clonmel 6 mg/0.4 mg modified-release tablets

Ország: Írország

Nyelv: angol

Forrás: HPRA (Health Products Regulatory Authority)

Aktív összetevők:

Solifenacin succinate; Tamsulosin hydrochloride

Beszerezhető a:

Clonmel Healthcare Ltd

ATC-kód:

G04CA53

INN (nemzetközi neve):

Solifenacin succinate; Tamsulosin hydrochloride

Gyógyszerészeti forma:

Modified-release tablet

Terápiás terület:

tamsulosin and solifenacin

Engedélyezési státusz:

Not marketed

Engedély dátuma:

2023-07-17

Betegtájékoztató

Page 1 of 6
PACKAGE LEAFLET: INFORMATION FOR THE USER
SOLIFENACIN/TAMSULOSIN CLONMEL 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 Solifenacin/Tamsulosin Clonmel is and what it is used for
2.
What you need to know before you use Solifenacin/Tamsulosin Clonmel
3.
How to use Solifenacin/Tamsulosin Clonmel
4.
Possible side effects
5.
How to store Solifenacin/Tamsulosin Clonmel
6.
Contents of the pack and other information
1.
WHAT SOLIFENACIN/TAMSULOSIN CLONMEL IS AND WHAT IT IS USED FOR
Solifenacin/Tamsulosin Clonmel 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.
Solifenacin/Tamsulosin Clonmel 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). Solifenacin/Tamsulosin Clonmel 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 no

Termékjellemzők

Health Products Regulatory Authority
08 March 2024
CRN00F60M
Page 1 of 11
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Solifenacin succinate/Tamsulosin hydrochloride Clonmel 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 Solifenacin/Tamsulosin Clonmel tablet (6 mg/0.4 mg) once daily
taken orally with or without food. The maximum daily
dose is one Solifenacin/Tamsulosin Clonmel tablet (6 mg/0.4 mg).
Special Populations
_Renal impairment_
The effect of renal impairment on the pharmacokinetics of
Solifenacin/Tamsulosin Clonmel has not been studied. However, the
effect on the pharmacokinetics of the individual active substances is
well known (see section 5.2). Solifenacin/Tamsulosin
Clonmel 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 Solifenacin/Tamsulosin Clonmel tablet (6 mg/0.4
mg) (see section 4.4).
_Hepatic impairment_
The effect of hepatic impairment on the pharmacokinetics of
Solifenacin/Tamsulosin Clonmel has not been studied. However,
the effect on the pharmacokinetics of the individual active su