Hydopa 250 mg tablet bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

methyldopa sesquihydrate, Quantity: 283 mg (Equivalent: methyldopa, Qty 250 mg)

Available from:

Alphapharm Pty Ltd

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: ethylcellulose; disodium edetate; magnesium stearate; Guar Gum; sodium starch glycollate; colloidal anhydrous silica; citric acid; titanium dioxide; hypromellose; sunset yellow FCF; quinoline yellow; macrogol 400

Administration route:

Oral

Units in package:

100, 90, 30, 500

Class:

Medicine Registered

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

INDICATIONS AS AT 7 May 1996: Hypertension (mild, moderate to severe)

Product summary:

Visual Identification: 10.2 mm yellow film coated normal convex tablet marked MD 250 on one side, G on the reverse; Container Type: Bottle; Container Material: HDPE; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Licence status A

Authorization date:

1999-06-10

Patient Information leaflet

HYDOPA
_Contains the active ingredient methyldopa (as sesquihydrate)_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Hydopa.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have benefits and
risks. Your doctor has weighed the
risks of you taking Hydopa against
the benefits they expect it will have
for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT HYDOPA IS USED
FOR
Hydopa is used to lower high blood
pressure, also called hypertension.
Everyone had blood pressure. This
pressure helps get your blood all
around your body. Your blood
pressure may be different at different
times of the day, depending on how
busy or worried you are. You have
hypertension (high blood pressure)
when your blood pressure stays
higher than is needed, even when you
are calm and relaxed.
There are usually no symptoms of
hypertension. The only way of
knowing that you have hypertension
is to have your blood pressure
checked on a regular basis. If high
blood pressure is not treated it can
lead to serious health problems. You
may feel fine and have no symptoms,
but eventually hypertension can
cause stroke, heart disease and
kidney failure. Hydopa helps to
lower your blood pressure.
Hydopa works by controlling
impulses along certain nerve
pathways and as a result, widens
blood vessels so that blood passes
through them more easily. This helps
to lower blood pressure.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another reason.
There is no evidence that Hydopa is
addictive.
Hydopa is available only with a
doctor's prescription.
BEFORE YOU TAKE
HYDOPA
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE HYDOPA IF YOU HAVE AN
ALLERGY TO:
•
any medicine containing
methyldopa (as sesquihydrate)
(e.g. Aldomet)
•
any of the

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION
HYDOPA
_Methyldopa (as sesquihydrate) _
1
NAME OF THE MEDICINE
Methyldopa (as sesquihydrate).
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains methyldopa (as sesquihydrate) equivalent to 250
mg of anhydrous methyldopa.
Excipients with known effect:
Hydopa also contains trace amounts of galactose.
For the full list of excipients, see
SECTION 6.1 LIST OF EXCIPIENTS
.
3
PHARMACEUTICAL FORM
HYDOPA 250mg tablets are yellow film-coated, marked MD 250 on one
side, G on the reverse.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Hypertension (mild, moderate to severe).
4.2
DOSE AND METHOD OF ADMINISTRATION
GENERAL
Methyldopa is primarily excreted by the kidneys. Therefore, patients
with impaired renal function may
respond to lower doses. Syncope in older patients may be related to an
increased sensitivity and advanced
arteriosclerotic vascular disease; this may be avoided by smaller
doses.
Cessation of methyldopa therapy is followed by return of hypertension,
usually within 48 hours. This is not
complicated by an overshoot of blood pressure.
Therapy
with
methyldopa
may
be
commenced
in
most
patients
already
on
treatment
with
other
antihypertensive agents.
Methyldopa may also be given concomitantly with hydrochlorothiazide or
beta-blocking agents.
When methyldopa is administered to patients on other
antihypertensives, dosage adjustments of these agents
may be required to effect a smooth transition. Withdraw these
antihypertensive agents gradually if required
(see manufacturers' recommendations on discontinuing these drugs).
Following such previous antihypertensive therapy, the initial dose of
methyldopa should be limited to not
more than 500 mg per day and increased as required at intervals of not
less than 2 days.
ADULTS
The usual starting dose is 250 mg two or three times daily in the
first 48 hours. The daily dosage may then be
increased or reduced, preferably at intervals of not less than 2 days,
until an adequate response is achieved.
The maximum recommended daily dosa