Vesomni 6 mg/0.4 mg modified-release tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Solifenacin succinate; Tamsulosin hydrochloride

Available from:

Astellas Pharma Co. Limited

ATC code:

G04BD; G04BD08

INN (International Name):

Solifenacin succinate; Tamsulosin hydrochloride

Dosage:

6 mg/0.4 milligram(s)

Pharmaceutical form:

Modified-release tablet

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Drugs for urinary frequency and incontinence; solifenacin

Authorization status:

Marketed

Authorization date:

2014-01-06

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
VESOMNI 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 Vesomni is and what it is used for
2.
What you need to know before you use Vesomni
3.
How to use Vesomni
4.
Possible side effects
5.
How to store Vesomni
6.
Contents of the pack and other information
1.
WHAT VESOMNI IS AND WHAT IT IS USED FOR
Vesomni 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.
_ _
Vesomni 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). Vesomni 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 redu

Summary of Product characteristics

Health Products Regulatory Authority
10 February 2023
CRN00DC31
Page 1 of 12
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Vesomni 6 mg/0.4 mg modified release tablets
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 Vesomni tablet (6 mg/0.4 mg) once daily taken orally with or
without food. The maximum daily dose is one Vesomni 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 Vesomni has
not been studied. However, the effect on the
pharmacokinetics of the individual active substances is well known
(see section 5.2). Vesomni 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 Vesomni tablet (6 mg/0.4
mg) (see section 4.4).
_Patients with hepatic impairment_
The effect of hepatic impairment on the pharmacokinetics of Vesomni
has not been studied. However, the effect on the
pharmacokinetics of the individual active substances is well known
(see section 5.2). Vesomni can be used in patien