Oxybutynin 2care4 5 mg Tablett

Land: Svíþjóð

Tungumál: sænska

Heimild: Läkemedelsverket (Medical Products Agency)

Virkt innihaldsefni:

oxibutyninhydroklorid

Fáanlegur frá:

2care4 ApS

ATC númer:

G04BD04

INN (Alþjóðlegt nafn):

oxibutyninhydroklorid

Skammtar:

5 mg

Lyfjaform:

Tablett

Samsetning:

oxibutyninhydroklorid 5 mg Aktiv substans; laktosmonohydrat Hjälpämne

Gerð lyfseðils:

Receptbelagt

Vörulýsing:

Förpacknings: Blister, 98 tabletter; Blister, 105 tabletter; Blister, 252 tabletter

Leyfisstaða:

Avregistrerad

Leyfisdagur:

2017-06-28

Upplýsingar fylgiseðill

PACKAGE LEAFLET: INFORMATION FOR THE USER
OXYBUTYNIN ACCORD 2.5 AND 5MG TABLETS
OXYBUTYNIN 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 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 the leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Oxybutynin Accord is and what it is used for
2.
What you need to know before you take Oxybutynin Accord
3.
How to take Oxybutynin Accord
4.
Possible side effects
5.
How to store Oxybutynin Accord
6.
Contents of the pack and other information
1.
WHAT OXYBUTYNIN ACCORD IS AND WHAT IT IS USED FOR
Oxybutynin Accord contains a medicine called Oxybutynin hydrochloride.
This belongs to two groups of
medicines called “anticholinergics and “antispasmodics”. It
works by relaxing the muscles of the bladder and
stops sudden muscle contractions (spasms). This helps control the
release of water (urine).
Oxybutynin Accord can be used to treat:
Adults:
Frequent and severe urinary urgency or Loss of control in passing
urine (urge incontinence) caused by
damage to the nervous system.
Children over 5 years:
-
Loss of control in passing water (urinary incontinence).
-
Increased need or urgency to pass urine (frequent and excessive
urination).
-
Night time bedwetting in children when other treatments have not
worked.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE OXYBUTYNIN ACCORD
DO NOT TAKE OXYBUTYNIN ACCORD AND TELL YOUR DOCTOR IF:
-
You are allergic to Oxybutynin or any of the other ingredients of this
medicine (listed in Section 6).
-
You have a rare condition called “Myasthenia gravis” that makes
the muscles in the body become
weak and tire easily.
-
You

Vara einkenni

Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Oxybutynin Accord 2.5mg tablets
Oxybutynin Accord 5mg tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 2.5 mg tablet contains 2.5mg Oxybutynin hydrochloride
Excipient(s) with known effect: Contains 53.25 mg Lactose monohydrate
per tablet.
For the full list of excipient, see section 6.1.
Each 5 mg tablet contains 5mg Oxybutynin hydrochloride
Excipient(s) with known effect: Contains 106.50 mg Lactose monohydrate
per tablet.
For the full list of excipient, see section 6.1.
3
PHARMACEUTICAL FORM
Tablets
2.5 MG:
White to off white, odourless, 5mm round biconvex, uncoated tablets
with inscription “BS” on one side and
plain on the other side.
5 MG:
White to off white, odourless, 7.9mm round biconvex, uncoated tablets
with inscription “B” and “R” on
either side of score line on one side and plain on the other side.
The 5 mg tablets can be divided into equal halves.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
ADULTS
Treatment of frequency, urgency or urge incontinence as may occur in
bladder overactivity whether due to
neurogenic bladder disorders (detrusor hyperreflexia) or idiopathic
detrusor overactivity.
PAEDIATRIC POPULATION
Oxybutynin hydrochloride is indicated for children over 5 years for:
- Urinary incontinence, urgency and frequency in overactive bladder
conditions caused by idiopathic
overactive bladder or neurogenic bladder dysfunction (detrusor over
activity).
-
Nocturnal enuresis associated with detrusor over activity, in
conjunction with non-drug therapy, when
other treatment not been successful.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
The dosage should be adapted individually. Unless otherwise specified,
the following recommendations
apply:
Page 2 of 8
Adults:
The initial starting dose is 2.5 mg three times daily. Thereafter, the
lowest effective dose should be selected.
The daily dose may vary between 5mg two or three times daily (10 and
15 mg per day) and maximum dose
is 5mg four times dail