Midodrine HCl Brancaster 2,5 mg tabletten

Land: Nederland

Taal: Nederlands

Bron: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Werkstoffen:

MIDODRINEHYDROCHLORIDE 2,5 mg/stuk SAMENSTELLING overeenkomend met ; MIDODRINE 2,19 mg/stuk

Beschikbaar vanaf:

Brancaster Pharma Ireland Limited Garadice House, 3-4 Fairview D03 XOY5 DUBLIN 3 (IERLAND)

ATC-code:

C01CA17

INN (Algemene Internationale Benaming):

MIDODRINEHYDROCHLORIDE 2,5 mg/stuk SAMENSTELLING overeenkomend met ; MIDODRINE 2,19 mg/stuk

farmaceutische vorm:

Tablet

Samenstelling:

CELLULOSE, MICROKRISTALLIJN (E 460(i)) ; MAGNESIUMSTEARAAT (E 470b) ; MAÏSZETMEEL ; SILICIUMDIOXIDE (E 551), CELLULOSE, MICROKRISTALLIJN (E 460) ; MAGNESIUMSTEARAAT (E 470b) ; MAÏSZETMEEL ; SILICIUMDIOXIDE (E 551),

Toedieningsweg:

Oraal gebruik

Therapeutisch gebied:

Midodrine

Product samenvatting:

Hulpstoffen: CELLULOSE, MICROKRISTALLIJN (E 460); MAGNESIUMSTEARAAT (E 470b); MAÏSZETMEEL; SILICIUMDIOXIDE (E 551);

Autorisatie datum:

1900-01-01

Bijsluiter

PACKAGE LEAFLET: INFORMATION FOR THE USER
MIDODRINE HCL BRANCASTER 2,5 MG TABLETTEN
MIDODRINE HCL BRANCASTER 5 MG TABLETTEN
MIDODRINE HCL BRANCASTER 10 MG TABLETTEN
Midodrine 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 or pharmacist.
-
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 or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Midodrine HCl Brancaster tabletten are and what they are used for
2.
What you need to know before you take Midodrine HCl Brancaster
tabletten
3.
How to take Midodrine HCl Brancaster tabletten
4.
Possible side effects
5.
How to store Midodrine HCl Brancaster tabletten
6.
Contents of the pack and other information
1.
WHAT MIDODRINE HCL BRANCASTER TABLETTEN ARE AND WHAT THEY ARE USED FOR
The name of your medicine is Midodrine HCl Brancaster tabletten. They
contain the medicine
midodrine hydrochloride. This belongs to a group of medicines called
adrenergic and dopaminergic
agents.
Midodrine hydrochloride is a medicine that raises your blood pressure
and is used to treat certain
severe forms of low blood pressure in adults when other treatments
have not worked.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE MIDODRINE HCL BRANCASTER
TABLETTEN
DO NOT TAKE MIDODRINE HCL BRANCASTER TABLETTEN IF:
-
you are allergic to midodrine hydrochloride or any of the other
ingredients of this medicine (listed
in section 6 of this leaflet)
-
you have high blood pressure
-
you have a slow pulse
-
you have difficulty urinating
-
you have certain forms of cardiovascular disease
-
you have elevated pressure in the eye (glaucoma) or poor vision as a
result of diabetes
-
you have an overactive thy

Productkenmerken

1.3. PRODUCT INFORMATION
1.3.1. SPC, LABELLING & PACKAGE LEAFLET
SUMMARY OF PRODUCT CHARACTERISTICS – MIDODRINE HCL BRANCASTER 2,5 MG
TABLETTEN
1.
NAME OF THE MEDICINAL PRODUCT
Midodrine HCl Brancaster 2,5 mg tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 2.5 mg of midodrine hydrochloride.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet.
White, round tablet of diameter 6 mm. Plain on one side with “MID”
debossed above the score line
and “2.5” debossed below the score line on the other side.
The scoreline is only to facilitate breaking for ease of swallowing
and not to divide into equal doses.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Midodrine HCl Brancaster 2,5 mg tabletten are indicated in adults for
the treatment of severe
orthostatic hypotension due to autonomic dysfunction when corrective
factors have been ruled out and
other forms of treatment are inadequate.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Initial dose: 2.5 mg three times a day. Depending on the results of
supine and standing blood pressure
recordings, this dose may be increased weekly up to a dose of 10 mg
three times a day Midodrine HCl
Brancaster 5 mg tabletten are also available). This is the usual
maintenance dosage.
A careful evaluation of the response to treatment and of the overall
balance of the expected benefits
and risks needs to be undertaken before any dose increase and advice
to continue therapy for long
periods.
The last daily dose should be taken at least 4 hours before bedtime in
order to prevent supine
hypertension (see also section 4.4).
Midodrine HCl Brancaster 2,5 mg tabletten may be taken with food (see
section 5.2).
_Paediatric population _
The safety and efficacy of midodrine in children have not been
established. No data are available.
_Elderly population _
_ _
There is limited data on dosing in the elderly and there are no
specific studies which have focused on
a possible dose reduction in the elderly population. Cautious dose
titrat