Detrunorm XL 45mg capsules

מדינה: הממלכה המאוחדת

שפה: אנגלית

מקור: MHRA (Medicines & Healthcare Products Regulatory Agency)

מרכיב פעיל:

Propiverine hydrochloride

זמין מ:

Consilient Health Ltd

קוד ATC:

G04BD06

INN (שם בינלאומי):

Propiverine hydrochloride

כמות:

45mg

טופס פרצבטיות:

Modified-release capsule

מסלול נתינה (של תרופות):

Oral

סיווג:

No Controlled Drug Status

סוג מרשם:

Valid as a prescribable product

leaflet_short:

BNF: 07040200; GTIN: 5060064171943

מאפייני מוצר

OBJECT 1
DETRUNORM XL 45 MG MODIFIED-RELEASE CAPSULES
Summary of Product Characteristics Updated 12-Dec-2014 | Concordia
International - formerly AMCo
1. Name of the medicinal product
Detrunorm XL 45 mg Modified-Release Capsules
2. Qualitative and quantitative composition
Each capsule contains 45 mg propiverine hydrochloride (equivalent to
40.92 mg propiverine).
Excipients: Lactose monohydrate (8.5 mg), for a full list of
excipients, see section 6.1
3. Pharmaceutical form
Modified-release capsule, hard
Orange size 2 capsules containing white to off-white pellets.
4. Clinical particulars
4.1 Therapeutic indications
Symptomatic treatment of urinary incontinence and/or increased urinary
frequency and urgency in
patients with overactive bladder syndrome or neurogenic detrusor
overactivity (detrusor hyperreflexia)
from spinal cord injuries.
4.2 Posology and method of administration
Capsules for oral use.
Do not crush or chew the capsules.
The recommended daily doses are as follows:
Adults: One capsule (= 45 mg propiverine hydrochloride) once daily.
As a standard treatment, one modified-release capsule Detrunorm XL 30
mg once a day or one tablet of
Detrunorm (= 15 mg propiverine hydrochloride) twice a day is
recommended, this may be increased to
one tablet of Detrunorm (= 15 mg propiverine hydrochloride) three
times a day. Some patients may
already respond to a dosage of 15 mg propiverine hydrochloride a day.
In patients whom Detrunorm (= 15 mg propiverine hydrochloride) tablet
three times daily is indicated, the
15 mg tablet three times daily regimen could be replaced by Detrunorm
XL 45 mg Modified-Release
Capsules once a day.
The maximum daily dose is one Detrunorm XL 45 mg Modified-Release
Capsule daily.
Elderly: Generally there is no special dosage regimen for the elderly
(see section 5.2).
Paediatric population: Due to a lack of data, this product should not
be used in children.
Caution should be exercised and clinicians should monitor patients
carefully for side effects in the
following dispositions (see sections