Tolterodin Paranova 2 mg Depotkapsel, hård

Country: Шведска

Језик: Шведски

Извор: Läkemedelsverket (Medical Products Agency)

Активни састојак:

tolterodintartrat

Доступно од:

Paranova Läkemedel AB

АТЦ код:

G04BD07

INN (Међународно име):

tolterodine tartrate

Дозирање:

2 mg

Фармацеутски облик:

Depotkapsel, hård

Састав:

laktosmonohydrat Hjälpämne; natriumlaurilsulfat Hjälpämne; propylenglykol Hjälpämne; tolterodintartrat 2 mg Aktiv substans

Тип рецептора:

Receptbelagt

Резиме производа:

Förpacknings: Blister, 30 kapslar; Blister, 60 kapslar

Статус ауторизације:

Avregistrerad

Датум одобрења:

2022-03-01

Информативни летак

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
TOLTERODIN RIVOPHARM 2 MG PROLONGED-RELEASE CAPSULES, HARD
TOLTERODIN RIVOPHARM 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 Tolterodin Rivopharm is and what it is used
for
2.
What you need to know before you take Tolterodin Rivopharm
3.
How to take Tolterodin Rivopharm
4.
Possible side
effects
5.
How to store Tolterodin Rivopharm
6.
Contents of the pack and other
information
1.
WHAT TOLTERODIN RIVOPHARM IS AND WHAT IT IS USED
FOR
The active substance in Tolterodin Rivopharm is tolterodine.
Tolterodine belongs to a class
of medicines
called
antimuscarinics.
Tolterodin Rivopharm 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 TOLTERODIN RIVOPHARM
DO NOT TAKE TOLTERODIN RIVOPHARM
•
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 (ulcerat

Карактеристике производа

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Tolterodin Rivopharm 2 mg, prolonged-release capsules, hard
Tolterodin Rivopharm 4 mg, prolonged-release capsules, hard
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One prolonged-release capsule, hard contains 2 mg tolterodine
tartrate, which is equivalent to 1.37 mg of
tolterodine.
One prolonged-release capsule, hard contains 4 mg tolterodine
tartrate, which is equivalent to 2.74 mg of
tolterodine.
Excipient with known effect
Each 2 mg prolonged release capsule, hard contains 32.70-34.50 mg
lactose monohydrate.
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 2 mg prolonged release capsule, hard is opaque green-opaque green
size 1 hard gelatin capsule
containing two white, round, biconvex coated tablets.
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
Tolterodin Rivopharm 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 safety and efficacy of tolterodine has not been demonstrated in
children (see section 5.1). Therefore,
tolterodine is not recommended for children.
2
Method of administration
The prolonged-release capsules, hard ca