Hydralazine 25mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Hydralazine hydrochloride

Available from:

Almus Pharmaceuticals Ltd

ATC code:

C02DB02

INN (International Name):

Hydralazine hydrochloride

Dosage:

25mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 02050100; GTIN: 05055382300298

Patient Information leaflet

DIMENSIONS 52 x 101mm
BARCODE 5055382300298
ALMUS CODE A0029a/8
SUPPLIER CODE ART-19160-01
SUPPLIER CODE VTSLB23-1
CLIENT:
PR
OJECT:
ITEM(S):
Almus UK
14179 / UK
Hydralazine Tablets
25mg x 56
Label Leaflet
COLOURS USED:
Queries regarding this artwork,
please contact: Steve Hobbs or
Paul Adams
Date:
6.1.2022
BLACK
PMS
349
PMS
1788
PMS
142
KEYLINE
BRAILLE
VARNISH
FREE
This scale measures 100mm when artwork is 100%
0
10
20
30
40
50
60
70
80
90
100
pmdc design 2016 limited
Lower Test Studios
Sheardley Lane, Droxford
Hampshire SO32 3QY
+44
(
0
)
1489 878780
www.pmdc.co.uk
DIMENSIONS 52 x 101mm
CLIENT:
PROJECT:
ITEM(S):
Almus UK
14179 / UK
Hydralazine Tablets
25mg x 56
Label Leaflet
COLOURS USED:
Queries regarding this artwork,
please contact: Steve Hobbs or
Paul Adams
Date:
6.1.2022
BLACK
KEYLINE
BRAILLE
VARNISH
FREE
This scale measures 100mm when artwork is 100%
0
10
20
30
40
50
60
70
80
90
100
pmdc design 2016 limited
Lower Test Studios
Sheardley Lane, Droxford
Hampshire SO32 3QY
+44
(
0
)
1489 878780
www.pmdc.co.uk
BARCODE 5055382300298
ALMUS CODE A0029a/8
SUPPLIER CODE ART-19160-01
SUPPLIER CODE VTSLB23-1
1
EACH FILM-COATED TABLET CONTAINS:
25 mg hydralazine hydrochloride.
DOSAGE: Oral use. Read the package leaflet before use.
KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.
Do not store above 25°C. Store in the original package
in order to protect from light.
PL 04569/0050
MA Holder:
Mylan, Potters Bar, Hertfordshire, EN6 1TL, U.K.
PEEL HERE BUT DO NOT REMOVE
POM
Almus ® is a registered trademark A0029a/8
56
Film-Coated Tablets
HYDRALAZINE
TABLETS
Film-Coated
Oral use
ART-19160-01 VTSLB23-1
DIMENSIONS 52 x 101mm
BARCODE 5055382300298
ALMUS CODE A0029a/8
SUPPLIER CODE ART-19160-01
SUPPLIER CODE VTSLB23-1
CLIENT:
PROJECT:
ITEM(S):
Almus UK
14179 / UK
Hydralazine Tablets
25mg x 56
Label Leaflet
COLOURS USED:
Queries regarding this artwork,
please contact: Steve Hobbs or
Paul Adams
Date:
6.1.2022
BLACK
PMS
349
PMS
1788
PMS
142
KEYLINE
BRAILLE
VARNISH
FREE
This scale measures 100mm when artwork is 100%
0
10
20
30
40
50

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Hydralazine 25 mg Film-coated Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 25 mg hydralazine hydrochloride.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablets.
Yellow film coated tablet marked “HE 25” on one side and “G”
on the reverse.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Indicated for:
-
Moderate to severe hypertension as an adjunct to other
antihypertensive
agents.
Moderate to severe chronic congestive heart failure along with long
acting nitrates in
patients whose optimal doses of diuretics and cardiac glycosides have
proved
insufficient and ACE inhibitors are unsuitable.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The dosage should be adjusted to the individual requirements of the
patient.
Treatment should commence with low doses which, depending on the
patient’s
response, should be increased stepwise to achieve optimal therapeutic
effect, whilst
minimising unwanted effects.
Due to the complementary mechanism of action, the combination of
hydralazine with
beta-blockers and diuretics may enable antihypertensive efficacy at
lower dose levels
and counteract accompanying hydralazine effects such as reflex
tachycardia and
oedema.
_Adults _
HYPERTENSION: the initial dose is 25 mg twice daily. This may be
increased gradually
to a maximum dose of 200 mg daily. The patient’s acetylator status
must be checked
prior to increasing the daily dose beyond 100 mg.
CHRONIC CONGESTIVE HEART FAILURE: Doses vary greatly between
individual patients
and are generally higher than those used to treat hypertension.
Treatment should be
initiated in hospital where the patient’s individual haemodynamic
values can be
determined with the help of invasive monitoring. Treatment should
continue in
hospital until the patient has been established on the required
maintenance dose. After
progressive titration (initially 25 mg three or four times daily,
increasing every second