Prodopa

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Methyldopa sesquihydrate 566mg equivalent to to 500 mg methyldopa anhydrous

Available from:

Viatris Limited

INN (International Name):

Methyldopa sesquihydrate 566 mg (equiv. to 500 mg methyldopa anhydrous)

Dosage:

500 mg

Pharmaceutical form:

Tablet

Composition:

Active: Methyldopa sesquihydrate 566mg equivalent to to 500 mg methyldopa anhydrous Excipient: Citric acid   Colloidal silicon dioxide Disodium edetate dihydrate Ethylcellulose Guar gum Magnesium stearate Opadry yellow OY-8462 Purified water Sodium starch glycolate

Units in package:

Bottle, plastic, HDPE with PP child resistant cap, 100 tablets, 100 tablets

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Sicor (Societa Italiana Corticosteroidi) Srl

Therapeutic indications:

Hypertension (mild, moderate or severe).

Product summary:

Package - Contents - Shelf Life: Bottle, plastic, HDPE with PP child resistant cap - 100 tablets - 36 months from date of manufacture stored at or below 25°C protect from light

Authorization date:

1981-10-15

Patient Information leaflet

Page 1 of 4
NEW ZEALAND CONSUMER MEDICINE INFORMATION
METHYLDOPA VIATRIS
_METHYLDOPA 250 MG, FILM COATED TABLET_
WHAT IS IN THIS LEAFLET
Please read this leaflet carefully
before you start taking
METHYLDOPA VIATRIS.
This leaflet answers some common
questions about METHYLDOPA
VIATRIS.
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
METHYLDOPA VIATRIS 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 METHYLDOPA
VIATRIS IS USED FOR
Your METHYLDOPA VIATRIS
tablets contain the active ingredient
methyldopa.
METHYLDOPA VIATRIS is used to
lower high blood pressure, also
called hypertension. It works by
widening blood vessels so that
blood passes through them more
easily. This helps to lower blood
pressure.
There is no evidence that
METHYLDOPA VIATRIS is
addictive.
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.
This medicine is available only with
a doctor’s prescription.
BEFORE YOU TAKE
METHYLDOPA
VIATRIS
_WHEN YOU MUST NOT TAKE _
_IT_
DO NOT TAKE METHYLDOPA
VIATRIS IF YOU HAVE AN ALLERGY TO:

any medicine containing
methyldopa

any of the ingredients listed
at the end of this leaflet.
Some of the symptoms of an
allergic reaction may include:
shortness of breath; wheezing or
difficulty breathing; swelling of the
face, lips, tongue or other parts of
the body; rash, itching or hives on
the skin.
Do not take METHYLDOPA
VIATRIS if you:

have liver disease such as
hepatitis or cirrhosis

take a monoamine oxidase
inhibitor (MAOI), a medicine
used to treat depression
and Parkinson’s disease

are being treated for
depression

have phaeochromocytoma
or paranganglioma (rare
tumours of the adren

Summary of Product characteristics

Page 1 of 8
NEW ZEALAND DATA SHEET
METHYLDOPA VIATRIS
1. PRODUCT NAME
Methyldopa Viatris, 250 mg, film coated tablet.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film coated tablet contains 250 mg of methyldopa (as anhydrous).
Excipients with known effect: contains sulfites and galactose.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
250 mg tablet: Yellow film coated normal convex tablets, 10.2 mm in
diameter, imprinted ‘MD’ over
‘250’ on one side and ‘G’ on the other.
4. CLINICAL PARTICULARS
_4.1 _
_THERAPEUTIC INDICATIONS_
Hypertension (mild, moderate or severe).
_4.2_
_DOSE AND METHOD OF ADMINISTRATION_
DOSE
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 methyldopa 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 initiated in most patients already on
treatment with other
antihypertensive agents.
Methyldopa may also be used concomitantly with
amiloride/hydrochlorothiazide tablets or beta-
blocking agents. such as timolol maleate. Many patients can be
controlled with one tablet of
amiloride 5 mg/hydrochlorothiazide 50 mg and 500 mg of methyldopa
administered once daily.
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 medicines).
Following such previous antihypertensive therapy, the initial dose of
methyldopa should be limited
to not more than 500 mg daily and increased as required at intervals
of not less than 2 days.
Page 2 of 8
_ADULTS_
The usual starting dosage of methyldopa is 250 mg two or three times a
day in the