Hydralazine 25mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Hydralazine hydrochloride

Available from:

Alliance Healthcare (Distribution) 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

Patient Information leaflet

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 symptoms
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 Apresoline Tablets 25 mg are and
what they are used for
2.
What you need to know before you take
Apresoline Tablets 25 mg
3.
How to take Apresoline Tablets 25 mg
4.
Possible side effects
5.
How to store Apresoline Tablets 25 mg
6.
Contents
of
the
pack
and
other
information
1.
WHAT APRESOLINE TABLETS 25 MG ARE
AND WHAT THEY ARE USED FOR
The name of your medicine is Apresoline
Tablets 25 mg.
The
active
ingredient
is
hydralazine
hydrochloride.
Hydralazine hydrochloride belongs to a group
of medicines called antihypertensives.
Apresoline
is
used
to
treat
high
blood
pressure and heart failure.
It
works
by
relaxing
blood
vessels
and
increasing the supply of blood and oxygen
to the heart.
2.
WHAT YOU NEED TO KNOW BEFORE YOU
TAKE APRESOLINE TABLETS 25 MG
DO NOT TAKE APRESOLINE IF YOU:
•
are
ALLERGIC
to
HYDRALAZINE,
DIHYDRALAZINE
or
any
of
the
other
ingredients
in
this
medicine
(allergic
reactions include mild symptoms such
as
itching
and/or
rash.
More
severe
symptoms include swelling of the face,
lips, tongue and/or throat with difficulty
in swallowing or breathing);
•
have or have ever had a condition called
Systemic Lupus Erythematosus (SLE),
an autoimmune condition which causes
joint pain, skin rashes and fever;
•
suffer from severe tachycardia or right
sided
heart
failure
due
to
increased
pressure in the blood vessels of the
lungs (cor pulmonale);
•
suffer from thyrotoxicosis (an excess of
thyroid hormones in the blood that can
cause
a
fast
heartbeat,

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Apresoline Tablets 25 mg
Hydralazine 25 mg Tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
The active ingredient is 1-hydrazinophthalazine hydrochloride
(hydralazine
hydrochloride).
One coated tablet contains 25 mg hydralazine hydrochloride B.P.
Excipient(s) with known effects
Each tablet contains 22.931 mg of sucrose
For the full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Sugar-coated tablets.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For the treatment of moderate to severe hypertension as an adjunct to
other
anti-hypertensive agents.
Due to the complementary mechanism of action the combination of
hydralazine with b-blockers and diuretics may enable antihypertensive
efficacy at lower dose levels and counteract accompanying hydralazine
effects
such as reflex tachycardia and oedema.
_ _
As supplementary medication for use in combination with long-acting
nitrates
in moderate to severe chronic congestive cardiac failure in patients
in whom
optimal doses of conventional therapy have proved insufficient.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
_Elderly: _
Clinical evidence would indicate that no special dosage regime is
necessary.
Advancing age does not affect either blood concentration or systemic
clearance.
Renal elimination may however be affected in so far as kidney function
diminishes with age.
_ _
_Adults: _
_Hypertension: _the dose should be adjusted to the individual
requirements of
the patient. Treatment should begin with low doses of Apresoline
which,
depending on the patient’s response should be increased stepwise to
achieve
optimal therapeutic effect whilst keeping unwanted effects to a
minimum.
Initially 25 mg bid. This can be increased gradually to a dose not
exceeding
200 mg daily. The dose should not be increased beyond 100 mg daily
without
first checking the patient’s acetylator status.
_Chronic congestive heart failure: _Treatment with Apresoline should
always be
initiated in hospital, where the pat