Solifenacin Teva 10mg film-coated Tablets

Negara: Malta

Bahasa: Inggris

Sumber: Medicines Authority

Bahan aktif:

SOLIFENACIN SUCCINATE

Tersedia dari:

Teva Pharma B.V. (utrecht) Swensweg 5, 2031 GA Haarlem, Netherlands

Kode ATC:

G04BD08

INN (Nama Internasional):

SOLIFENACIN SUCCINATE 10 mg

Bentuk farmasi:

FILM-COATED TABLET

Komposisi:

SOLIFENACIN SUCCINATE 10 mg

Jenis Resep:

POM

Area terapi:

UROLOGICALS

Status otorisasi:

Withdrawn

Tanggal Otorisasi:

2011-12-15

Selebaran informasi

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Solifenacin Teva 5 mg film-coated tablets
Solifenacin Teva 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 Teva is and what it is used for
2.
What you need to know before you take Solifenacin Teva
3.
How to take Solifenacin Teva
4.
Possible side effects
5.
How to store Solifenacin Teva
6.
Contents of the pack and other information
1.
WHAT SOLIFENACIN TEVA IS AND WHAT IT IS USED FOR
The active substance of Solifenacin Teva 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 Teva 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 TEVA
DO NOT TAKE SOLIFENACIN TEVA
–
if you have an inability to pass water or to empty your bladder
completely (urinary retention).
–
if you have a severe stomach or bowel condition (including toxic
megacolon, a complication
associated with ulcerative colitis).
–
if you suffer from the muscle disease called myasthenia gravis, which
can cause an extreme
weakness of certain muscles.
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Karakteristik produk

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Solifenacin Teva 5 mg film-coated tablets
Solifenacin Teva 10 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Solifenacin Teva 5 mg film-coated tablet contains 5 mg
solifenacin succinate, equivalent to 3.8 mg
solifenacin.
Each Solifenacin Teva 10 mg film-coated tablet contains 10 mg
solifenacin succinate, equivalent to 7.5 mg
solifenacin.
Excipient with known effect
Lactose monohydrate 109.0 mg
Lactose monohydrate 104.0 mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet
Each 5 mg tablet is a round, light-yellow tablet of approximately 8 mm
in length, debossed with “390” on one
side of the tablet.
Each 10 mg tablet is a round, light-pink tablet of approximately 8 mm
in length, debossed with “391” on one
side of the tablet.
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 in children have not yet been
established. Therefore, solifenacin should
not be used in children.
_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
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caution and receive no more than 5 mg once daily (see section 5.2).
_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