Vesomni 6mg/0.4mg modified-release tablets

Nazione: Regno Unito

Lingua: inglese

Fonte: MHRA (Medicines & Healthcare Products Regulatory Agency)

Principio attivo:

Solifenacin succinate; Tamsulosin hydrochloride

Commercializzato da:

Astellas Pharma Ltd

Codice ATC:

G04CA53

INN (Nome Internazionale):

Solifenacin succinate; Tamsulosin hydrochloride

Dosaggio:

6mg ; 400microgram

Forma farmaceutica:

Modified-release tablet

Via di somministrazione:

Oral

Classe:

No Controlled Drug Status

Tipo di ricetta:

Valid as a prescribable product

Dettagli prodotto:

BNF: 07040100; GTIN: 5013346013530

Foglio illustrativo

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 reduces the undesired contractions of your bladder and
increases
the amount of urine that your bladder can hold. Therefore you can wait
longer before you have to go to the toilet. Tamsulosin enables urine
to pass
more readily through the urethra and facilitates urination.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE VESOMNI
DO NOT USE VESOMNI IF:
-
you are allergic to solifenacin or tamsulosin or any of the other
ingredients
of this medicine (listed in section 6).
-
you are undergoing kidney dialysis.
-
you have a severe liver disease.
-
you suffer from severe kidney disease AND if, at the same time, you
are being treated with medicines that may decrease the removal of
Vesomni from t

Scheda tecnica

OBJECT 1
VESOMNI 6 MG/0.4 MG MODIFIED RELEASE TABLETS
Summary of Product Characteristics Updated 22-May-2018 | Astellas
Pharma Ltd
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).
Vesomn