Solifenacin Viatris

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Solifenacin succinate 10mg;  

Available from:

Viatris Limited

INN (International Name):

Solifenacin succinate 10 mg

Dosage:

10 mg

Pharmaceutical form:

Film coated tablet

Composition:

Active: Solifenacin succinate 10mg   Excipient: Hypromellose   Iron oxide red Iron oxide yellow Lactose Magnesium stearate Maize starch Propylene glycol Purified talc Titanium dioxide

Prescription type:

Prescription

Manufactured by:

Megafine Pharma (P) Limited

Therapeutic indications:

Solifenacin Viatris is indicated for the treatment of unstable bladder with symptoms of increased urinary urgency, frequent microurination, and/or urge incontinence.

Product summary:

Package - Contents - Shelf Life: Blister pack, PVC-Al - 30 tablets - 36 months from date of manufacture stored at or below 25°C protect from light - Bottle, HDPE - 500 tablets - 36 months from date of manufacture stored at or below 25°C protect from light

Authorization date:

2014-08-27

Patient Information leaflet

Page 1 of 4
NEW ZEALAND CONSUMER MEDICINE INFORMATION
SOLIFENACIN VIATRIS
_SOLIFENACIN SUCCINATE, 5 MG AND 10 MG, FILM COATED TABLET_
WHAT IS IN THIS LEAFLET
Please read this leaflet carefully
before you start taking Solifenacin
Viatris.
This leaflet answers some common
questions about Solifenacin Viatris.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking Solifenacin
Viatris against the benefits they
expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE
MEDICINE. You may need to read it
again.
WHAT SOLIFENACIN
VIATRIS IS USED FOR
Solifenacin Viatris is used to treat
symptoms of overactive bladder.
These symptoms include needing to
rush to the toilet to urinate without
warning, needing to urinate
frequently, or wetting yourself
because you did not get to the toilet
in time.
Solifenacin Viatris contains the
active ingredient solifenacin
succinate. It belongs to a group of
medicines called anticholinergic
medicines.
It works on specialised cells to
reduce the activity of your bladder
and help you control your bladder.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it for
another reason.
This medicine is not addictive.
This medicine is available only with
a doctor’s prescription.
BEFORE YOU TAKE
SOLIFENACIN VIATRIS
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE SOLIFENACIN VIATRIS IF
YOU HAVE AN ALLERGY TO:

any medicine containing
solifenacin succinate.

any of the ingredients listed
at the end of this leaflet.

Some of the symptoms of
an allergic reaction may
include: shortness of
breath; wheezing or
difficulty breathing; swelling
of the face, lips, tongue or
other parts of the body;
rash, itching or hives on the
skin.
DO NOT GIVE THIS MEDICINE TO
CHILDREN.
Safety and effectiveness in children
h

Summary of Product characteristics

Page 1 of 14
NEW ZEALAND DATA SHEET
SOLIFENACIN VIATRIS
1. PRODUCT NAME
Solifenacin Viatris 5 mg and 10 mg, film coated tablet.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film coated tablet contains 5 mg or 10 mg of solifenacin
succinate.
Excipients of known effect: Contains sugars as lactose.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Solifenacin Viatris 5 mg tablets: yellow film-coated, round, biconvex
tablet debossed with M on one
side of the tablet and SF over 5 on the other side.
Solifenacin Viatris 10 mg tablets: pink film-coated, round, biconvex
tablet debossed with M on one
side of the tablet and SF over 10 on the other side.
4. CLINICAL PARTICULARS
_4.1 _
_THERAPEUTIC INDICATIONS_
Solifenacin Viatris is indicated for the treatment of unstable bladder
with symptoms of increased
urinary urgency, frequent micturition, and/or urge incontinence.
_4.2_
_DOSE AND METHOD OF ADMINISTRATION_
DOSE
_ADULTS_
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.
_SPECIAL POPULATIONS_
CHILDREN
Safety and effectiveness in children has not yet been established.
Solifenacin Viatris is not
recommended for use 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)
Page 2 of 14
should be treated with caution and receive not more than 5 mg once
daily. Pharmacokinetics in
patients undergoing haemodialysis has not been studied.
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 not more than 5 mg
once daily. Solifenacin Viatris is contraindicated in patients with
severe hepatic impairment (Child-
Pugh C).
STRONG INHIBITORS OF CYTOCHROME P450 3A4
The maximum do