Solifenacin succinate Aristo 5 mg film-coated tablets

Država: Irska

Jezik: angleščina

Source: HPRA (Health Products Regulatory Authority)

Aktivna sestavina:

Solifenacin succinate

Dostopno od:

Aristo Pharma GmbH

Koda artikla:

QG04BD08

INN (mednarodno ime):

Solifenacin succinate

Farmacevtska oblika:

Film-coated tablet

Terapevtsko območje:

solifenacin

Status dovoljenje:

Not marketed

Datum dovoljenje:

2023-01-27

Navodilo za uporabo

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
SOLIFENACIN SUCCINATE ARISTO 5 MG FILM-COATED TABLETS
SOLIFENACIN SUCCINATE ARISTO 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 succinate Aristo is and what it is used for
2.
What you need to know before you take Solifenacin succinate Aristo
3.
How to take Solifenacin succinate Aristo
4.
Possible side effects
5.
How to store Solifenacin succinate Aristo
6.
Contents of the pack and other information
1.
WHAT SOLIFENACIN SUCCINATE ARISTO IS AND WHAT IT IS USED FOR
The active substance of Solifenacin succinate Aristo 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 succinate Aristo 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 SUCCINATE ARISTO
DO NOT TAKE SOLIFENACIN SUCCINATE ARISTO:
-
if you are allergic to solifenacin or any of the other ingredients of
this medicine (listed in
section 6)
-
if you have an inability to pass water or to empty your bladder
completely (urinary retention)
-
if you have a severe sto

Lastnosti izdelka

Health Products Regulatory Authority
02 February 2023
CRN00CX8W
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Solifenacin succinate Aristo 5 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 5 mg solifenacin succinate, corresponding to 3.8
mg solifenacin.
Excipient(s) with known effect: lactose, anhydrous
Each tablet contains 104.6 mg lactose, anhydrous.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablets
Round, light pink film-coated tablets.
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 succinate Aristo in children
have not yet been established. Therefore, Solifenacin
succinate Aristo should not be used 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) 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 succinate Aristo should be limited to
5 mg when treated simultaneously with ketoconazole
or therapeutic doses of other potent CYP3A4-inhibitors e.g. ritonavir,
nelfinavir, itraconazole (see Section 4