Hydralazine 50mg tablets

Land: Storbritannien

Språk: engelska

Källa: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiva substanser:

Hydralazine hydrochloride

Tillgänglig från:

Sigma Pharmaceuticals Plc

ATC-kod:

C02DB02

INN (International namn):

Hydralazine hydrochloride

Dos:

50mg

Läkemedelsform:

Oral tablet

Administreringssätt:

Oral

Klass:

No Controlled Drug Status

Receptbelagda typ:

Valid as a prescribable product

Produktsammanfattning:

BNF: 02050100

Bipacksedel

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v1/May 2015
24 Aug 2016
1/1
15:58
Hydralazine Hydrochloride 50 mg 56
Label Leaflet
901896
584721
901896
04569/0051
N/A
LL0436AG
17
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287807
2
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UK
N/A
5016695080048
4
Black
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306
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Process Blue
PMS
298
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Myriad Pro
52 x 101mm
7.5 pt
4 pt
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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 Hydralazine is and what it is used for
2. What you need to know before you
take Hydralazine
3. How to take Hydralazine
4. Possible side effects
5. How to store Hydralazine
6. Contents of the pack and other information
1.
WHAT HYDRALAZINE IS AND WHAT IT IS USED FOR
Hydralazine belongs to a group of medicines called
antihypertensives.
Hydralazine can be used along with other medicines:
•
to reduce high blood pressure (hypertension)
•
to treat moderate and serious heart failure.
Anti-hypertensives work by lowering blood pressure.
High blood pressure increases the workload of the
heart and arteries (blood vessels) and if left untreated,
can lead to damage of the blood vessels of the brain,
heart and kidneys.
2. WHAT YOU NEED TO KNOW BEF

Produktens egenskaper

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