Solifenacin 10mg tablets

Krajina: Spojené kráľovstvo

Jazyk: angličtina

Zdroj: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktívna zložka:

Solifenacin succinate

Dostupné z:

Krka UK Ltd

ATC kód:

G04BD08

INN (Medzinárodný Name):

Solifenacin succinate

Dávkovanie:

10mg

Forma lieku:

Oral tablet

Spôsob podávania:

Oral

Trieda:

No Controlled Drug Status

Typ predpisu:

Valid as a prescribable product

Prehľad produktov:

BNF: 07040200; GTIN: 5391512455163 5391512456313

Príbalový leták

Package leaflet: Information for the patient
SOLIFENACIN 5 MG FILM-COATED TABLETS
SOLIFENACIN 10 MG FILM-COATED TABLETS
Solifenacin succinate
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 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 is and what it is used for
2.
What you need to know before you take Solifenacin
3.
How to take Solifenacin
4.
Possible side effects
5.
How to store Solifenacin
6.
Contents of the pack and other information
1.
WHAT SOLIFENACIN IS AND WHAT IT IS USED FOR
The active substance of Solifenacin belongs to the group of
anticholinergics. These
medicines are used to reduce the activity of an overactive bladder.
This enables you to wait
longer before having to go to the bathroom and increases the amount of
urine that can be
held by your bladder.
Solifenacin is used to treat the symptoms of a condition called
overactive bladder. These
symptoms include: having a strong, sudden urge to urinate without
prior warning, having to
urinate frequently or wetting yourself because you could not get to
the bathroom in time.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE SOLIFENACIN
DO NOT TAKE SOLIFENACIN
Ÿ
if you are allergic to solifenacin succinate or any of the other
ingredients of this
medicine (listed in section 6).
Ÿ
if you are unable to pass water or to empty your bladder completely
(urinary retention).
Ÿ
if you have a severe stomach or bowel condition (including toxic
megacolon, a
complication associated with ulcerative colitis).
Ÿ
if you suffer from the muscle disease called myasthenia gravis, which
can cause an

Súhrn charakteristických

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Solifenacin succinate 10 mg Film-coated Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Solifenacin succinate 10 mg film-coated tablets
Each tablet contains 10 mg solifenacin succinate.
Excipient(s) with known effect:
lactose monohydrate 102.5 mg
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Film-coated Tablets
Solifenacin succinate 10 mg Film-coated Tablets:
Light pink, round shaped, film coated tablets debossed with "S10" on
one side
and plain on other side. Approximate tablet diameter: 7. 60 mm ± 0.3
mm
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Symptomatic treatment of urge incontinence and/or increased urinary
frequency and
urgency as may occur in patients with overactive bladder syndrome.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults, including the elderly _
The recommended dose is 5 mg solifenacin succinate once daily. If
needed, the dose
may be increased to 10 mg solifenacin succinate once daily._ _
_ _
_Paediatric population _
The safety and efficacy of solifenacin succinate tablets in children
have not yet been
established. Therefore, solifenacin succinate should not be used in
children.
_Patients with renal impairment _
No dose adjustment is necessary for 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 receive no more than 5
mg
once daily (see Section 5.2).
_Patients with hepatic impairment _
No dose adjustment is necessary for patients with mild hepatic
impairment. Patients
with moderate hepatic impairment (Child-Pugh score of 7 to 9) should
be treated with
caution and receive no more than 5 mg once daily (see Section 5.2).
_Potent inhibitors of cytochrome P450 3A4 _
The maximum dose of solifenacin succinate tablets should be limited to
5 mg when
treated simultaneously with ketoconazole or therapeutic doses of other
potent
CYP3A4-inhibitors e