Osolfenacare 5mg film-coated Tablets

Land: Malta

Språk: engelska

Källa: Medicines Authority

Aktiva substanser:

SOLIFENACIN SUCCINATE

Tillgänglig från:

Adamed Sp. Z.o.o. Pieńków 149, 05-152 Czosnów, Poland

ATC-kod:

G04BD08

INN (International namn):

SOLIFENACIN SUCCINATE 5 mg

Läkemedelsform:

FILM-COATED TABLET

Sammansättning:

SOLIFENACIN SUCCINATE 5 mg

Receptbelagda typ:

POM

Terapiområde:

UROLOGICALS

Bemyndigande status:

Withdrawn

Tillstånd datum:

2011-12-15

Bipacksedel

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PACKAGE LEAFLET: INORMATION FOR THE USER
Osolfenacare 5 mg film-coated tablets
Osolfenacare 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. Do not pass it on to
others. It may harm
them, even if their symptoms 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.
IN THIS LEAFLET
1.
What Osolfenacare is and what it is used for
2.
What you need to know before you take Osolfenacare
3.
How to take Osolfenacare
4.
Possible side effects
5.
How to store Osolfenacare
6.
Contents of the pack and other information
1.
WHAT OSOLFENACARE IS AND WHAT IT IS USED FOR
The active substance of Osolfenacare belongs to the group called
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.
Osolfenacare 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 OSOLFENACARE
DO NOT TAKE OSOLFENACARE
–
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.
-
if you suffer from increased pressure in the eyes, with gradual

Produktens egenskaper

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Osolfenacare 5 mg film-coated tablets
Osolfenacare 10 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Osolfenacare 5 mg film-coated tablet contains 5 mg solifenacin
succinate, equivalent to 3.8 mg
solifenacin.
Each Osolfenacare 10 mg film-coated tablet contains 10 mg solifenacin
succinate, equivalent to 7.5 mg
solifenacin.
Excipient(s) with known effect
Lactose monohydrate 109.0 mg 104.0 mg
For a 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
_ _
Osolfenacare is indicated in adults for 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 Osolfenacare in children have not yet been
established. Therefore, Osolfenacare
should not be used in children.
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_Patients with renal impairment_
_ _
No dosage 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 dosage 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