Solifenacin 10mg tablets

Country: যুক্তরাজ্য

ভাষা: ইংরেজি

সূত্র: MHRA (Medicines & Healthcare Products Regulatory Agency)

সক্রিয় উপাদান:

Solifenacin succinate

থেকে পাওয়া:

Zentiva Pharma UK Ltd

এটিসি কোড:

G04BD08

INN (International Name):

Solifenacin succinate

ডোজ:

10mg

ফার্মাসিউটিকাল ফর্ম:

Oral tablet

প্রশাসন রুট:

Oral

শ্রেণী:

No Controlled Drug Status

প্রেসক্রিপশন টাইপ:

Valid as a prescribable product

পণ্য সারাংশ:

BNF: 07040200; GTIN: 8594739231092

তথ্য লিফলেট

PACKAGE LEAFLET: INFORMATION FOR THE USER
SOLIFENACIN SUCCINATE 5 MG FILM-COATED TABLETS
SOLIFENACIN SUCCINATE 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 Solefenacin 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 IF YOU:
• are allergic to solifenacin or any of the other ingredients of
this medicine (listed in section 6).
• have an inability to pass water or to empty your bladder
completely (urinary retention).
• have a severe stomach or bowel condition (including toxic
megacolon, a complication associated with
ulcerative colitis).
• suffer from the muscle disease called myasthenia gravis, which can
ca

পণ্য বৈশিষ্ট্য

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