MOXONIDINE GH moxonidine 400 microgram film-coated tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

moxonidine, Quantity: 400 microgram

Available from:

Lupin Australia Pty Limited

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: magnesium stearate; crospovidone; lactose monohydrate; povidone; titanium dioxide; hypromellose; iron oxide red; macrogol 400

Administration route:

Oral

Units in package:

3X10's

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Moxonidine GH is indicated for the treatment of hypertension

Product summary:

Visual Identification: Dull red, round, biconvex film coated tablets with debossing '0.4' on one side and plain on other side.; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Registered

Authorization date:

2018-07-09

Patient Information leaflet

CONSUMER MEDICINE INFORMATION
MOXONIDINE GH
(MOXONIDINE) FILM-COATED TABLET
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about
Moxonidine GH.
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
Moxonidine GH 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
MEDICATION.
You may want to read it again.
WHAT MOXONIDINE GH IS
USED FOR
Moxonidine GH lowers high
blood pressure, which is
sometimes called hypertension.
Everyone has blood pressure.
This pressure helps to move
your blood around your body.
Your blood pressure may
change at different times of the
day. You have hypertension
when your blood pressure stays
higher than normal, even when
you are calm or relaxed.
There are usually no symptoms
of hypertension. The only way of
knowing if you have
hypertension is to have your
blood pressure checked
regularly. If high blood pressure
is not treated it can lead to
serious health problems,
including stroke, heart disease
and kidney failure.
ASK YOUR DOCTOR IF YOU HAVE
ANY QUESTIONS ABOUT WHY IT
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have
prescribed Moxonidine GH for
another use.
This medicine is only available
with a doctor's prescription.
This medicine is not addictive.
BEFORE YOU TAKE
MOXONIDINE GH
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE MOXONIDINE GH IF
YOU HAVE AN ALLERGY TO:
•
ANY MEDICINE CONTAINING
MOXONIDINE;
•
ANY OF THE INGREDIENTS
LISTED AT THE END OF THIS
LEAFLET.
Some symptoms of an allergic
reaction include skin rash,
itching, shortness of breath or
swelling of the face, lips or
tongue, which may cause
difficulty breathing.
DO NOT TAKE THIS MEDICINE IF
YOU ARE PREGNANT OR THINK YOU
MAY BE PREGNANT.
DO NOT BREASTFEED IF YOU ARE
TAKING THIS MEDICINE.
Moxonidine GH passes into
breast milk. Your doctor will
discuss

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION – MOXONIDINE GH
(MOXONIDINE) FILM-COATED TABLETS
1
NAME OF THE MEDICINE
Moxonidine.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Moxonidine
GH
tablets
are
immediate
release
film-coated
tablets
for
oral
use
containing
200 micrograms or 400 micrograms moxonidine.
Excipients with known effect: sugars as lactose.
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Moxonidine GH 200 micrograms tablets: Light pink, round, biconvex,
film-coated tablet, with debossing
“0.2” on one side and plain on the other side.
Moxonidine GH 400 micrograms tablets: Dull-red, round, biconvex,
film-coated tablet, with debossing
“0.4” on one side and plain on the other side.
4
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Moxonidine GH is indicated for the treatment of hypertension.
4.2 DOSE AND METHOD OF ADMINISTRATION
Treatment should be started with 0.2 mg of moxonidine in the morning.
The dose may be titrated after
two weeks to 0.4 mg given as one dose or as divided doses (morning and
evening) until a satisfactory
response is achieved. If the response is still unsatisfactory after a
further 2 weeks treatment, the dosage
can be increased up to a maximum of 0.6 mg in divided doses (morning
and evening).
A single daily dose of 0.4 mg and a divided daily dose of 0.6 mg of
moxonidine should not be exceeded.
Moxonidine GH may be taken with or without food.
4.3 CONTRAINDICATIONS
•
Hypersensitivity to any of the ingredients (see SECTION 6.1 LIST OF
EXCIPIENTS).
•
Heart failure (NYHA Class I – IV).
•
Patients aged 75 years or older (see SECTION 5.2 PHARMACOKINETIC
PROPERTIES - PHARMACOKINETICS IN
THE ELDERLY).
Moxonidine GH v3.0
Page 2 of 11
(moxonidine) film-coated tablets
•
Bradycardia (HR <50 beats/minute) or severe bradyarrhythmia, including
sick sinus syndrome, or
second or third degree atrioventricular (AV) block.
•
Malignant arrhythmias.
•
Severe renal impairment (GFR <30 mL/min, serum creatinine
concentration >160 µmol/L).
4.4 SPECIAL WARNI