Solifenacin 5mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Solifenacin succinate

Available from:

Genus Pharmaceuticals Ltd

ATC code:

G04BD08

INN (International Name):

Solifenacin succinate

Dosage:

5mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 07040200; GTIN: 05011309007213

Patient Information leaflet

Itemcode: PT 3179-02
Substrate: 40gsm Bible paper
Version No: 02
Reason for Issue: Wave Pharma added as batch release site
Pharmacode: 3500
Product: Solifenacin Film-coated Tabs
Market: Ascend, UK
Component: Insert
Barcode: NA
Mfg Location: Amaliya
Superseed No: PT 3179-01
Folding Size: 160 x 30 mm
Size: (L x H) 160 x 480 mm
Change Part No: NA
Style: folded
Pack Size: NA
Change Control No: NA
Date of Initiation: 23/07/2019
Modification Date:
Final approval of artwork:
BLACK
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 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.

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Solifenacin 5 mg film-coated tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 5 mg solifenacin succinate,
corresponding to 3.8 mg
solifenacin.
Excipients with known effect: each film-coated tablet contains 50 mg
lactose
monohydrate
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Film-coated tablets.
The tablet is a light yellow coloured, round, biconvex, film-coated
tablet of
approximately 5.6 mm diameter, debossed with ‘D5’ on one side and
plain on the
other side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Solifenacin is indicated in adults for the 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 _
Safety and effectiveness in children have not yet been established.
Therefore,
Solifenacin should not be used in children.
Special Populations
_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 should be limited to 5 mg when treated
simultaneously with ketoconazole or therapeutic doses of other potent
CYP3A4 inhibitors e.g. ritonavir