Hydralazine 50mg tablets
Country: United Kingdom
Language: English
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Patient Information leaflet
(PIL)
12-11-2021
Summary of Product characteristics
(SPC)
12-11-2021
Active ingredient:
Hydralazine hydrochloride
Available from:
Viatris UK Healthcare Ltd
ATC code:
C02DB02
INN (International Name):
Hydralazine hydrochloride
Dosage:
50mg
Pharmaceutical form:
Oral tablet
Administration route:
Oral
Class:
No Controlled Drug Status
Prescription type:
Valid as a prescribable product
Product summary:
BNF: 02050100; GTIN: 5016695080048
Patient Information leaflet
DIMENSIONS 52 x 101mm
HYDRAL-
AZINE
#50 MG
TABLETS
HYDRAL-
AZINE
#50 MG
TABLETS
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Prompt words (
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Standard font size is 2.0mm for online printed batch data.
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Keep this flap blank and varnish free for online printing.
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*PC: 00000000000000
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Lot: 0000000000
EXP: MM/YYYY
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printing - United Kingdom
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Variable Data area will be left blank for online printing.
Version: 1422541
DIMENSIONS 52 x 101mm
1
EACH FILM-COATED TABLET CONTAINS:
50 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 04569/0051
MA Holder:
Mylan, Potters Bar, Hertfordshire, EN6 1TL, U.K.
PEEL HERE BUT DO NOT REMOVE
Almus ® is a registered trademark A0030a/7
56
Film-Coated Tablets
HYDRALAZINE
TABLETS
Film-Coated
Oral use
50
MG
2280616 LL0508AH
POM
DIMENSIONS 52 x 101mm
2
EACH FILM-COATED TABLET CONTAINS:
50 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 04569/0051
MA Holder: Mylan, Potters Bar, Hertfordshire, EN6 1TL, U.K.
POM
56
Film-Coated Tablets Oral use
HYDRALAZINE TABLETS
Film-Coated
Almus ® is a registered trademark A0030a/7
2280616 LL0508AH
50
MG
3
PACKAGE LEAFLET: INFORMATION FOR THE
PATIENT
HYDRALAZINE 25 MG
FILM-COATED TABLETS
HYDRALAZINE 50 MG
FILM-COATED TABLETS
(hydralazine hydrochloride)
R
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Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Hydralazine 50 mg Film-coated Tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 50 mg hydralazine hydrochloride.
Excipient(s) with known effect:
Each tablet contains 867 mg lactose and 21.9 mg Sunset yellow.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Film-coated tablets
Pink film coated tablets marked “HE 50” on one side and “G”
logo on 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. Af
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