ALDOMET methyldopa (as sesquihydrate) 250 mg tablet bottle

Χώρα: Αυστραλία

Γλώσσα: Αγγλικά

Πηγή: Department of Health (Therapeutic Goods Administration)

Δραστική ουσία:

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

Διαθέσιμο από:

Aspen Pharmacare Australia Pty Ltd

Φαρμακοτεχνική μορφή:

Tablet, film coated

Σύνθεση:

Excipient Ingredients: Guar Gum; titanium dioxide; purified talc; sodium calcium edetate; iron oxide red; citric acid; quinoline yellow aluminium lake; hypromellose; ethylcellulose; propylene glycol; Carnauba Wax; magnesium stearate; powdered cellulose; colloidal anhydrous silica; citric acid monohydrate

Οδός χορήγησης:

Oral

Μονάδες σε πακέτο:

100

Kατηγορία:

Medicine Registered

Τρόπος διάθεσης:

(S4) Prescription Only Medicine

Θεραπευτικές ενδείξεις:

Hypertension (mild, moderate to severe).

Περίληψη προϊόντος:

Visual Identification: A round, biconvex, yellow, film-coated tablet, debossed "ALDOMET" on one side and "250" on the other side.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius

Καθεστώς αδειοδότησης:

Registered

Ημερομηνία της άδειας:

1991-12-18

Φύλλο οδηγιών χρήσης

ALDOMET
®
_Methyldopa_
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Aldomet. It does not
contain all the available information.
It does not take the place of talking to
your doctor or pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking Aldomet
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 IT IS USED FOR
Aldomet lowers high blood pressure,
which doctors call hypertension.
Everyone has 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. Aldomet helps to
lower your blood pressure.
Aldomet works by controlling
impulses along certain nerve
pathways. As a result, it relaxes and
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 ALDOMET HAS
BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another purpose.
This medicine is only available with
a doctor's prescription.
There is no evidence that it is
addictive.
BEFORE YOU TAKE IT
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE ALDOMET IF:
•
YOU HAVE AN ALLERGY TO ALDOMET
OR ANY OF THE INGREDIENTS LISTED
AT THE END OF THIS LEAFLET
•
YOU HAVE TAKEN ALDOMET IN THE
PAST AND DEVELOPE

Αρχείο Π.Χ.Π.

1
AUSTRALIAN PRODUCT INFORMATION - ALDOMET METHYLDOPA
(AS SESQUIHYDRATE)
1.NAME OF THE MEDICINE
Methyldopa (as sesquihydrate)
2.&3.QUALITATIVE AND QUANTITATIVE COMPOSITION AND
PHARMACEUTICAL FORM
ALDOMET 250mg, yellow, biconvex, circular shaped tablet, film coated.
"250" on one side
and "ALDOMET" on the other.
Each ALDOMET tablet contains 250mg of the active methyldopa (as
sesquihydrate).
For the full list of excipients, see Section 6.1 List of excipients.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Hypertension (mild, moderate to severe).
4.2 DOSE AND METHOD OF ADMINISTRATION
General
Methyldopa is largely excreted by the kidney and patients with
impaired renal function may
respond to smaller doses. Syncope in older patients may be related to
an increased sensitivity
and advanced arteriosclerotic vascular disease. This may be avoided by
lower doses.
Withdrawal of ALDOMET is followed by return of hypertension, usually
within 48 hours. This
is not complicated by an overshoot of blood pressure.
Therapy with ALDOMET may be initiated in most patients already on
treatment with other
antihypertensive agents.
ALDOMET may also be used concomitantly with hydrochlorothiazide or
beta-blocking agents.
When methyldopa is given to patients on other antihypertensives, the
dose of these agents
may need to be adjusted to effect a smooth transition. Terminate these
antihypertensive
medications gradually if required (see manufacturers' recommendations
on stopping these
drugs).
Following such previous antihypertensive therapy, the initial dose of
ALDOMET should be
limited to not more than 500mg daily and increased as required at
intervals of not less than 2
days.
Adults
The usual starting dose of ALDOMET is 250mg two or three times a day
in the first 48 hours.
The daily dosage may then be increased or decreased, preferably at
intervals of not less than
two days, until an adequate response is achieved. The maximum
recommended daily dosage
is 3g.
When ALDOMET 500mg is added to 50mg of hydrochlorothiazide, the two
agents may be