Barnidipine HCl Sigillata 20 mg, harde capsules met gereguleerde afgifte

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

BARNIDIPINEHYDROCHLORIDE 20 mg/stuk SAMENSTELLING overeenkomend met ; BARNIDIPINE 18,6 mg/stuk

INN (Algemene Internationale Benaming):

BARNIDIPINEHYDROCHLORIDE 20 mg/stuk SAMENSTELLING overeenkomend met ; BARNIDIPINE 18,6 mg/stuk

farmaceutische vorm:

Capsule met gereguleerde afgifte, hard

Samenstelling:

AMMONIA (E 527) ; CARMELLOSE (E 466) ; ETHYLCELLULOSE (E 462) ; GELATINE (E 441) ; IJZEROXIDE GEEL (E 172) ; IJZEROXIDE ZWART (E 172) ; KALIUMHYDROXIDE (E 525) ; MAÏSZETMEEL ; POLYSORBAAT 80 (E 433) ; PROPYLEENGLYCOL (E 1520) ; SACCHAROSE ; SCHELLAK (E 904) ; SUIKERMAÏSBOLLETJES ; TALK (E 553 B) ; TITAANDIOXIDE (E 171) ; ZWARTE INKT, AMMONIA (E 527) ; CARMELLOSE (E 466) ; ETHYLCELLULOSE (E 462) ; GELATINE (E 441) ; IJZEROXIDE GEEL (E 172) ; IJZEROXIDE ZWART (E 172) ; KALIUMHYDROXIDE (E 525) ; MAÏSZETMEEL ; POLYSORBAAT 80 (E 433) ; PROPYLEENGLYCOL (E 1520) ; SACCHAROSE ; SCHELLAK (E 904) ; SUGAR SPHERES ; TALK (E 553 B) ; TITAANDIOXIDE (E 171) ; ZWARTE INKT

Toedieningsweg:

Oraal gebruik

Autorisatie datum:

2022-04-26

Bijsluiter

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
Barnidipine HCl Sigillata 10 mg, harde capsules met gereguleerde
afgifte
Barnidipine HCl Sigillata 20 mg, harde capsules met gereguleerde
afgifte
_ _
barnidipine 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 [Product Name] is and what it is used for
2.
What you need to know before you take [Product Name]
3.
How to take [Product Name]
4.
Possible side effects
5.
How to store [Product Name]
6.
Contents of the pack and other information
1.
WHAT [PRODUCT NAME] IS AND WHAT IT IS USED FOR
The active substance of [Product Name] belongs to the group of
medicines called calcium antagonists.
[Product Name] causes blood vessels to dilate thereby lowering blood
pressure. [Product Name]
capsules are made in a ‘prolonged-release’ form. This means that
the active substance gets absorbed
into your system gradually and has a longer lasting effect. That is
why taking the dose once daily is
sufficient.
[Product Name] is used to treat high blood pressure.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE [PRODUCT NAME]
DO NOT TAKE [PRODUCT NAME]:
-
if you are allergic to barnidipine or any of the other ingredients of
this medicine (listed in
section 6)
-
if you are allergic to dihydropyridines (found in medicines to treat
high blood pressure)
-
if you suffer from liver disease
-
if you suffer from severe kidney disease
-
if you suffer from these specific heart diseases: untreated heart
failure, certain forms of pain on
the chest (unstable angina pectoris) o

Productkenmerken

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAAM VAN HET GENEESMIDDEL
Barnidipine HCl Sigillata 10 mg, harde capsules met gereguleerde
afgifte
Barnidipine HCl Sigillata 20 mg, harde capsules met gereguleerde
afgifte
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
[Product Name] 10 mg hard modified-release capsules
Each capsule contains 10 mg of barnidipine hydrochloride, equivalent
to 9.3 mg barnidipine.
[Product Name] 20 mg hard modified-release capsules
Each capsule contains 20 mg of barnidipine hydrochloride, equivalent
to 18.6 mg barnidipine.
Excipients with known effect
Each 10 mg capsule contains approximately 87 mg of sucrose
Each 20 mg capsule contains approximately 174 mg of sucrose
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Modified-release capsule, hard
[Product Name] 10 mg hard modified-release capsules
Size No.3 hard gelatin capsules filled with yellow to pale yellow
pellets. Capsule cap: yellow with
black ″1000″ imprinting. Body: yellow with black ″0010″
imprinting.
[Product Name] 20 mg hard modified-release capsules
Size No.1 hard gelatin capsules filled with yellow to pale yellow
pellets. Capsule cap: yellow with
black ″1000″ imprinting. Body: yellow with black ″0020″
imprinting.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Mild to moderate essential hypertension.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The recommended starting dosage is 10 mg once daily, in the morning.
It may be increased to 20 mg
once daily if necessary. The decision to increase the dosage should
only be taken after complete
stability is achieved on the initial dosage. This usually takes at
least 3-6 weeks.
_ _
_Paediatric population _
As there are no data in children (under 18 years) barnidipine should
not be administered to children.
_Elderly patients _
The dosage need not be adjusted in elderly patients. Extra care at the
start of treatment is advisable.
_Patients with renal impairment _
2
In patients with mild to moderate renal impairment, care should be
taken when inc