Detrunorm XL 30mg capsules

Страна: Великобритания

Язык: английский

Источник: MHRA (Medicines & Healthcare Products Regulatory Agency)

Активный ингредиент:

Propiverine hydrochloride

Доступна с:

Mawdsley-Brooks & Company Ltd

код АТС:

G04BD06

ИНН (Международная Имя):

Propiverine hydrochloride

дозировка:

30mg

Фармацевтическая форма:

Modified-release capsule

Администрация маршрут:

Oral

класс:

No Controlled Drug Status

Тип рецепта:

Valid as a prescribable product

Обзор продуктов:

BNF: 07040200

тонкая брошюра

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
DETRUNORM
® XL 30MG CAPSULES
(propiverine hydrochloride)
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,
pharmacist or nurse.

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, pharmacist or
nurse. This includes any possible side effects not listed in
this leaflet. See section 4.
The name of your medicine is Detrunorm XL 30mg capsules but
will be referred to as Detrunorm XL throughout this leaflet.
WHAT IS IN THIS LEAFLET:
1.
What Detrunorm XL is and what it is used for
2.
What you need to know before you take Detrunorm XL
3.
How to take Detrunorm XL
4.
Possible side effects
5.
How to store Detrunorm XL
6.
Contents of the pack and other information
1. WHAT DETRUNORM XL IS AND WHAT IT IS
USED FOR
Detrunorm XL is used for the treatment of people who have
difficulty in controlling their bladders due to bladder overactivity.
Detrunorm XL contains the active substance propiverine
hydrochloride. This substance prevents the bladder from
contracting and increases the amount that the bladder can hold.
Detrunorm XL is used to treat the symptoms of overactive
bladder. It is a modified-release capsule that needs only to be
taken once a day.
2. WHAT YOU NEED TO KNOW BEFORE YOU
TAKE DETRUNORM XL
DO NOT TAKE DETRUNORM XL:

if you are allergic to propiverine hydrochloride or any of the
other ingredients of this medicine listed in section 6 (allergic
reactions include mild symptoms such as itching and/or rash.
More severe symptoms include swelling of the face, lips,
tongue and/or throat with difficulty in swallowing or
breathing).

if you have obstruction of the bowel;

if you have obstruction to the bladder outlet (difficulty in
passing ur

Характеристики продукта

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Detrunorm XL 30 mg Modified Release Capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 30 mg propiverine hydrochloride (equivalent to
27.28
mg propiverine).
Excipients with known effect:
Lactose monohydrate (5.7 mg/tablet)_ _
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Modified-release capsules, hard.
Orange and white size 3 capsules containing white to off-white
pellets.
4.1
THERAPEUTIC INDICATIONS
Detrunorm XL 30 mg Modified Release Capsules are indicated in adults
for
the symptomatic treatment of urinary incontinence and/or increased
urinary
frequency and urgency in patients with overactive bladder syndrome.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The recommended daily doses are as follows:
Adults: As a standard dose one capsule (= 30 mg
propiverinehydrochloride)
once a day is recommended.
Paediatric population
The safety and efficacy of propiverine in children has not yet been
established. Hence this product should not be used in children.
.
Elderly
Generally there is no special dose regimen for the elderly (see
section 5.2).
Caution should be exercised and physicians should monitor patients
carefully for side
effects in the following dispositions (see sections 4.4, 4.5, 5.2) .
Use in renal impairment
In patients with mild or moderate impairment of renal function no dose
adjustment is required. (see section 5.2).
Use in hepatic impairment
In patients with mildly impaired hepatic function there is no need for
a dose
adjustment however, treatment should proceed with caution . No studies
have
been performed to investigate the use of propiverine in patients with
moderately or severely impaired hepatic function. Its use is therefore
not
recommended in these patients. (see section 5.2).
Patients receiving concomitant treatment with drugs that are potent
inhibitors
of CYP 3A4 combined with methimazole
In patients receiving drugs that are potent flavin-containing
monooxygenase
(FMO)
inhibi