Amlodipine Heumann 5 mg, tabletten

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

AMLODIPINEBESILAAT 7 mg/stuk SAMENSTELLING overeenkomend met ; AMLODIPINE 5 mg/stuk

Beschikbaar vanaf:

Heumann Pharma GmbH & Co. Generica KG Südwestpark 50 90449 NÜRNBERG (DUITSLAND)

ATC-code:

C08CA01

INN (Algemene Internationale Benaming):

AMLODIPINEBESILAAT 7 mg/stuk SAMENSTELLING overeenkomend met ; AMLODIPINE 5 mg/stuk

farmaceutische vorm:

Tablet

Samenstelling:

CALCIUMWATERSTOFFOSFAAT 0-WATER (E 341) ; CELLULOSE, MICROKRISTALLIJN (E 460(i)) ; CROSPOVIDON (E 1202) ; MAGNESIUMSTEARAAT (E 470b) ; POVIDON (E 1201), CALCIUMWATERSTOFFOSFAAT 0-WATER (E 341) ; CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSPOVIDON (E 1202) ; MAGNESIUMSTEARAAT (E 470b) ; POVIDON (E 1201),

Toedieningsweg:

Oraal gebruik

Therapeutisch gebied:

Amlodipine

Product samenvatting:

Hulpstoffen: CALCIUMWATERSTOFFOSFAAT 0-WATER (E 341); CELLULOSE, MICROKRISTALLIJN (E 460); CROSPOVIDON (E 1202); MAGNESIUMSTEARAAT (E 470b); POVIDON (E 1201);

Autorisatie datum:

1900-01-01

Bijsluiter

Amlodipine Heumann, 5 mg, tablets – NL/H/0776/001
NL pl
Page 1
NL/p/004/22/2
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
AMLODIPINE HEUMANN 5 MG, TABLETTEN
Amlodipine
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, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Amlodipine Heumann is and what it is used for
2.
What you need to know before you take Amlodipine Heumann
3.
How to take Amlodipine Heumann
4.
Possible side effects
5.
How to store Amlodipine Heumann
6.
Contents of the pack and other information
1.
WHAT AMLODIPINE HEUMANN IS AND WHAT IT IS USED FOR
Amlodipine Heumann contains the active substance amlodipine which
belongs to a group of medicines
called calcium antagonists.
Amlodipine Heumann is used to treat high blood pressure (hypertension)
or a certain type of chest pain
called angina, a rare form of which is Prinzmetal’s or variant
angina.
In patients with high blood pressure this medicine works by relaxing
blood vessels, so that blood passes
through them more easily. In patients with angina Amlodipine Heumann
works by improving blood
supply to the heart muscle which then receives more oxygen and as a
result chest pain is prevented. This
medicine does not provide immediate relief of chest pain from angina.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE AMLODIPINE HEUMANN
DO NOT TAKE AMLODIPINE HEUMANN
•
If you are allergic to amlodipine, or any of the other ingredients of
this medicine (listed in section
6), or to any other calcium antagonists. This may be itching,
reddening of the skin or difficulty
in breathing.
•

Productkenmerken

Amlodipine Heumann, 5 mg, tablets – NL/H/0776/001
NL SmPC
NL/s/001/22/2
Page 1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Amlodipine Heumann 5 mg, tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One tablet contains amlodipine besilate equivalent to 5 mg amlodipine.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet
White round tablets.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Hypertension
Chronic stable angina pectoris
Vasospastic (Prinzmetal’s) angina
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
Adults
For both hypertension and angina the usual initial dose is 5 mg
amlodipine once daily which may be
increased to a maximum dose of 10 mg depending on the individual
patient's response.
In hypertensive patients, amlodipine has been used in combination with
a thiazide diuretic, alpha
blocker, beta blocker, or an angiotensin converting enzyme inhibitor.
For angina, amlodipine may be
used as monotherapy or in combination with other antianginal medicinal
products in patients with angina
that is refractory to nitrates and/or to adequate doses of beta
blockers.
No dose adjustment of Amlodipine Heumann is required upon concomitant
administration of thiazide
diuretics, beta blockers, and angiotensin-converting enzyme
inhibitors.
Special populations
_Elderly patients _
Amlodipine used at similar doses in elderly or younger patients is
equally well tolerated. Normal dosage
regimens are recommended in the elderly, but increase of the dosage
should take place with care (see
sections 4.4 and 5.2).
Amlodipine Heumann, 5 mg, tablets – NL/H/0776/001
NL SmPC
NL/s/001/22/2
Page 2
_Patients with hepatic impairment _
Dosage recommendations have not been established in patients with mild
to moderate hepatic
impairment; therefore dose selection should be cautious and should
start at the lower end of the dosing
range (see sections 4.4 and 5.2). The pharmacokinetics of amlodipine
have not been studied in severe
hepatic impairment. Amlodipine should be initia