Trusitev SR 4 mg Prolonged-release Capsules, hard

国: アイルランド

言語: 英語

ソース: HPRA (Health Products Regulatory Authority)

有効成分:

Tolterodine tartrate

から入手可能:

Teva Pharma B.V.

ATCコード:

G04BD; G04BD07

INN（国際名）:

Tolterodine tartrate

投薬量:

4 milligram(s)

医薬品形態:

Prolonged-release capsule, hard

処方タイプ:

Product subject to prescription which may be renewed (B)

治療領域:

Drugs for urinary frequency and incontinence; tolterodine

認証ステータス:

Marketed

承認日:

2012-11-16

情報リーフレット

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
TRUSITEV SR 2 MG PROLONGED-RELEASE CAPSULES, HARD
TRUSITEV SR 4 MG PROLONGED-RELEASE CAPSULES, HARD
tolterodine tartrate
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 Trusitev SR is and what it is used for
2.
What you need to know before you take Trusitev SR
3.
How to take Trusitev SR
4.
Possible side effects
5.
How to store Trusitev SR
6.
Contents of the pack and other information
1.
WHAT TRUSITEV SR IS AND WHAT IT IS USED FOR
The active substance in Trusitev SR is tolterodine. Tolterodine
belongs to a class of medicines called
antimuscarinics.
Trusitev SR is used for the treatment of the symptoms of overactive
bladder syndrome. If you have overactive
bladder syndrome, you may find that:
•
you are unable to control urination.
•
you need to rush to the toilet with no advance warning and/or go to
the toilet frequently.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE TRUSITEV SR
DO NOT TAKE TRUSITEV SR
•
if you are allergic to tolterodine or any of the other ingredients of
this medicine (listed in section 6).
•
if you are unable to pass urine from the bladder (urinary retention).
•
if you have an uncontrolled narrow-angle glaucoma (high pressure in
the eyes with loss of eyesight that is
not being adequately treated).
•
if you suffer from myasthenia gravis (excessive weakness of the
muscles).
•
if you suffer from severe ulcerative colitis (ulceration and
inflammation of the colon).
•
if you suffer from a toxic megacolon (acute dilatation of

製品の特徴

Health Products Regulatory Authority
09 December 2020
CRN009Y1C
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Trusitev SR 4 mg Prolonged-release Capsules, hard
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One prolonged-release capsule, hard contains 4 mg tolterodine
tartrate, which is equivalent to 2.74 mg of tolterodine.
Excipient with known effect
Each 4 mg prolonged release capsule, hard contains 65.41-68.99 mg
lactose monohydrate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Prolonged-release capsule, hard
The 4 mg prolonged release capsule, hard is light blue opaque-light
blue opaque size 1 hard gelatin capsule containing four
white, round, biconvex coated tablets.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Trusitev SR is indicated in 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 4 mg once daily except in patients with
impaired liver function or severely impaired renal function
(GFR ≤ 30 ml/min) for whom the recommended dose is 2 mg once daily
(see sections 4.4 and 5.2). In case of troublesome
side-effects the dose may be reduced from 4 mg to 2 mg once daily.
The effect of treatment should be re-evaluated after 2-3 months (see
section 5.1).
Paediatric population
The efficacy of Trusitev SR has not been demonstrated in children (see
section 5.1). Therefore, Trusitev SR is not recommended
for children.
METHOD OF ADMINISTRATION
The prolonged-release capsules, hard can be taken with or without food
and must be swallowed whole.
4.3 CONTRAINDICATIONS
Tolterodine is contraindicated in patients with
– Known hypersensitivity to the active substance or to any of the
excipients
– Urinary retention
– Uncontrolled narrow angle glaucoma
– Myasthenia gravis
– Severe ulcerative colitis
– Toxic megacolon.
4.4 SPECIAL WARNINGS AND PRECAUTIONS