VESICARE solifenacin succinate 10mg tablet blister pack

Nazione: Australia

Lingua: inglese

Fonte: Department of Health (Therapeutic Goods Administration)

Principio attivo:

solifenacin succinate, Quantity: 10 mg

Commercializzato da:

Astellas Pharma Australia Pty Ltd

INN (Nome Internazionale):

Solifenacin succinate

Forma farmaceutica:

Tablet, film coated

Composizione:

Excipient Ingredients: hypromellose; lactose monohydrate; maize starch; magnesium stearate; titanium dioxide; macrogol 8000; purified talc; iron oxide red

Via di somministrazione:

Oral

Confezione:

10 tablets (sample pack), 30 tablets

Tipo di ricetta:

(S4) Prescription Only Medicine

Indicazioni terapeutiche:

Vesicare is indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency or increased urinary frequency.

Dettagli prodotto:

Visual Identification: Round, light pink film coated tablet marked with the Yamanouchi logo and "151" on one side; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius

Stato dell'autorizzazione:

Licence status A

Data dell'autorizzazione:

2006-08-28

Foglio illustrativo

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CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I USING VESICARE?
VESICARE contains the active ingredient solifenacin succinate.
VESICARE is used to treat the symptoms of overactive bladder.
For more information, see Section 1. Why am I using VESICARE? in the
full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE VESICARE?
Do not use if you have ever had an allergic reaction to VESICARE or
any of the ingredients listed at the end of the CMI.
There are a number of circumstances in which a person should not use
this medicine or may need to use caution. It is important to
understand if these apply to you before taking VESICARE (see Section
2. What should I know before I use VESICARE? in the full
CMI for more details)
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with VESICARE and affect how it works.
A list of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW DO I USE VESICARE?
•
The usual dose is 5 to 10 mg of VESICARE once a day. Your doctor will
decide the most suitable dose for you.
•
Talk to your doctor or pharmacist if you feel that the effect of
VESICARE is too strong or too weak.
More instructions can be found in Section 4. How do I use VESICARE? in
the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING VESICARE?
THINGS YOU
SHOULD DO
•
Before starting any new medicine, tell your doctor or pharmacist that
you are taking VESICARE.
•
Tell all the doctors, dentists and pharmacists who are treating you
that you are taking VESICARE.
•
If you become pregnant while taking VESICARE, tell your doctor.
•
Visit your doctor regularly so they can check on your progress.
THINGS YOU
SHOULD NOT DO
•
Do not stop taking VESICARE, or lower the dose, without checking with
your doctor.
•
Do not use VESICARE to treat any other conditions unless your doctor
tells you to.
•
Do not give VESICARE to anyo

Scheda tecnica

1
AUSTRALIAN PRODUCT INFORMATION
VESICARE
® (SOLIFENACIN SUCCINATE) FILM-COATED TABLETS
1
NAME OF THE MEDICINE
solifenacin succinate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Vesicare 5 mg film-coated tablet contains 5 mg solifenacin succinate,
corresponding to 3.8 mg
solifenacin.
Vesicare 10 mg film-coated tablet contains 10 mg solifenacin
succinate, corresponding to 7.5 mg
solifenacin.
List of excipients with known effect
lactose monohydrate
For the full list of excipients, see Section 6.1 - LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Tablet, film-coated.
Vesicare 5 mg film-coated tablet is a round, light-yellow tablet
marked with the
logo and “150”
on the same side.
Vesicare 10 mg film-coated tablet is a round, light-pink tablet marked
with the
logo and “151”
on the same side.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Vesicare is indicated for the treatment of overactive bladder with
symptoms of urge urinary
incontinence, urgency or increased urinary frequency.
4.2
D
OSE AND METHOD OF ADMINISTRATION
DOSAGE
Adults, including the elderly
The recommended dose is 5 mg solifenacin succinate once daily. If
needed, the dose may be
increased to a maximum of 10 mg solifenacin succinate once daily.
2
Children and adolescents
Safety and effectiveness in children have not yet been established.
Therefore, Vesicare 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.
Patients with hepatic impairment
No dose adjustment is necessary for patients with mild hepatic
impairment. Patients with moderate
hepatic impairment (Child-Pugh B) should be treated with caution and
receive no more than 5 mg
once daily. Vesicare is contraindicated in patients with severe
hepatic impairment (Child-Pugh C).
Co-medication
The maximum do