Detrunorm 15mg tablets

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:

15mg

טופס פרצבטיות:

Oral tablet

מסלול נתינה (של תרופות):

Oral

סיווג:

No Controlled Drug Status

סוג מרשם:

Valid as a prescribable product

leaflet_short:

BNF: 07040200; GTIN: 5060064170359

עלון מידע

(Propiverine hydrochloride)
Detrunorm
®
15 mg Coated Tablets
Package leaflet: information for the patient
200552/LF/2
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 15 mg coated tablets are and what they are used for
2.
What you need to know before you take Detrunorm 15 mg Coated Tablets
3.
How to take Detrunorm 15 mg Coated Tablets
4.
Possible Side Effects
5.
How to store Detrunorm 15 mg Coated Tablets
6.
Contents of the pack and other information
1.
WHAT DETRUNORM 15 MG COATED TABLETS ARE AND WHAT
THEY ARE USED FOR
The name of your medicine is Detrunorm 15 mg Coated Tablets (to be
referred
to as Detrunorm throughout the leaflet).
Detrunorm is used for the treatment of people who have difficulty in
controlling
their bladders due to bladder overactivity or, in some cases, problems
with the
spinal cord. 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.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE DETRUNORM 15 MG
COATED TABLETS
DO NOT TAKE DETRUNORM IF:
•
You are allergic (hypersensitive) to propiverine hydrochloride or any
of
the other ingredients of Detrunorm 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

מאפייני מוצר

OBJECT 1
DETRUNORM 15 MG TABLETS
Summary of Product Characteristics Updated 03-Dec-2018 | ADVANZ Pharma
•
1. Name of the medicinal product
•
2. Qualitative and quantitative composition
•
3. Pharmaceutical form
•
4. Clinical particulars
•
4.1 Therapeutic indications
•
4.2 Posology and method of administration
•
4.3 Contraindications
•
4.4 Special warnings and precautions for use
•
4.5 Interaction with other medicinal products and other forms of
interaction
•
4.6 Fertility, pregnancy and lactation
•
4.7 Effects on ability to drive and use machines
•
4.8 Undesirable effects
•
4.9 Overdose
•
5. Pharmacological properties
•
5.1 Pharmacodynamic properties
•
5.2 Pharmacokinetic properties
•
5.3 Preclinical safety data
•
6. Pharmaceutical particulars
•
6.1 List of excipients
•
6.2 Incompatibilities
•
6.3 Shelf life
•
6.4 Special precautions for storage
•
6.5 Nature and contents of container
•
6.6 Special precautions for disposal and other handling
•
7. Marketing authorisation holder
•
8. Marketing authorisation number(s)
•
9. Date of first authorisation/renewal of the authorisation
•
10. Date of revision of the text
1. Name of the medicinal product
Detrunorm
®
15 mg Coated Tablets
Propiverine Hydrochloride 15mg Coated Tablets
2. Qualitative and quantitative composition
Each coated tablet contains 15 mg propiverine hydrochloride equivalent
to 13.64 mg propiverine.
Excipients with known effect:
Lactose monohydrate
(63.4 mg/ tablet)
Sucrose
(49.0 mg/ tablet)
Glucose monohydrate
(0.6 mg/ tablet)
Cochineal red A (E124, lake)
(0.2 mg/ tablet)
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Coated tablets
Rose-coloured, lenticular glazing coated tablets.
4. Clinical particulars
4.1 Therapeutic indications
Detrunorm 15 mg Coated Tablets are indicated in adults for the
symptomatic treatment of urinary
incontinence and/or increased urinary frequency and urgency in
patients with overactive bladder
syndrome or neurogenic detrusor overactivity (detrusor