Detrunorm XL 30mg capsules

Страна: Великобритания

Язык: английский

Источник: MHRA (Medicines & Healthcare Products Regulatory Agency)

Активный ингредиент:

Propiverine hydrochloride

Доступна с:

CST Pharma 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; GTIN: 5055946804347

тонкая брошюра

1
Package leaflet: Information for the patient
DETRUNORM
® XL 30MG CAPSULES
(propiverine hydrochloride)
Your medicine is known by the above name, but will be referred to as
Detrunorm
®
throughout this leaflet.
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 leaflet provides a summary of the information available on your
medicine.
- This medicine has been prescribed for you, do not pass it on to
others, it
may harm them, even if their symptoms 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.
IN THIS LEAFLET:
1. What Detrunorm
®
is and what is used for
2. What you need to know before you take Detrunorm
®
3. How to take Detrunorm
®
4. Possible Side Effects
5. How to store Detrunorm
®
6. Contents of the pack and other information
1. WHAT DETRUNORM
®
IS AND WHAT IS USED FOR
Detrunorm
®
is used for the treatment of people who have difficulty in
controlling their bladders due to bladder overactivity. Detrunorm
®
contains
the active substance propiverine hydrochloride. This substance
prevents
the bladder from contracting and increases the amount that the bladder
can hold. Detrunorm
®
is used to treat the symptoms of overactive bladder.
It is a modified-release capsule that needs only be taken once a day.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE DETRUNORM
®
DO NOT TAKE DETRUNORM
® 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).
OR IF YOU ARE SUFFERING FROM ANY OF THE FOLLOWING CONDITIONS:

obstruction of the bowel;

obst

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