Solifenacin Clonmel 10 mg film-coated tablets
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Patient Information leaflet
(PIL)
27-11-2023
Summary of Product characteristics
(SPC)
16-01-2022
Active ingredient:
Solifenacin succinate
Available from:
Clonmel Healthcare Ltd
ATC code:
G04BD; G04BD08
INN (International Name):
Solifenacin succinate
Dosage:
10 milligram(s)
Pharmaceutical form:
Film-coated tablet
Prescription type:
Product subject to prescription which may be renewed (B)
Therapeutic area:
Drugs for urinary frequency and incontinence; solifenacin
Authorization status:
Marketed
Authorization date:
2017-07-28
Patient Information leaflet
Page 1 of 5
PACKAGE LEAFLET: INFORMATION FOR THE USER
Solifenacin Clonmel 5mg Film-coated Tablets
Solifenacin Clonmel 10mg 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 Clonmel is and what it is used for
2. What you need to know before you take Solifenacin Clonmel
3. How to take Solifenacin Clonmel
4. Possible side effects
5. How to store Solifenacin Clonmel
6. Contents of the pack and other information
1. WHAT SOLIFENACIN CLONMEL IS AND WHAT IT IS USED FOR
The active substance of Solifenacin Clonmel 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.
Solifenacin Clonmel 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 CLONMEL
DO NOT TAKE SOLIFENACIN CLONMEL
•
if you are unable 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
Read the complete document
Summary of Product characteristics
Health Products Regulatory Authority
15 January 2022
CRN00CRDK
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Solifenacin Clonmel 10 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Solifenacin Clonmel 10 mg film-coated tablet contains 10 mg
solifenacin succinate, equivalent to 7.5 mg solifenacin.
Excipient(s) with known effect
Each Solifenacin Clonmel 10 mg film-coated tablet contains 102.5 mg
lactose monohydrate
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
Each 10 mg tablet is light pink, round, biconvex film-coated tablet
with 8 mm diameter.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Solifenacin Clonmel 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.
_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).
_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 Clonmel 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 4.5).
_Paediatric population_
The safety and efficacy of solifenacin in children and adolescent
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