MOXOTENS moxonidine 400 microgram tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

moxonidine, Quantity: 400 microgram

Available from:

Arrotex Pharmaceuticals Pty Ltd

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: crospovidone; magnesium stearate; lactose monohydrate; povidone; titanium dioxide; hypromellose; purified talc; macrogol 6000; iron oxide red

Administration route:

Oral

Units in package:

10 tablets, 98 tablets, 56 tablets, 84 tablets, 14 tablets, 30 tablets, 7 tablets (sample), 28 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

MOXOTENS is indicated for the treatment of hypertension.

Product summary:

Visual Identification: Dull brick red coloured round shaped tablet debossed with MX4 on one side and plain on another side.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Authorization status:

Registered

Authorization date:

2019-07-02

Patient Information leaflet

1
MOXOTENS
®
TABLETS
_moxonidine_
_ _
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Moxotens.
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
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY IT HAS BEEN
PRESCRIBED FOR YOU.
Your doctor may have prescribed
Moxotens for another use.
This medicine is only available with
a doctor's prescription.
This medicine is not addictive.
•
HAVE HEART PROBLEMS SUCH AS
HEART FAILURE OR ABNORMAL
RHYTHM
•
HAVE SEVERE KIDNEY DISEASE
DO NOT TAKE IT AFTER THE EXPIRY DATE
(EXP) PRINTED ON THE PACK OR IF THE
PACKAGING IS TORN OR SHOWS SIGNS OF
TAMPERING.
If it has expired or is damaged return
it to your pharmacist for disposal.
the risks of you taking Moxotens
IF YOU ARE NOT SURE WHETHER YOU
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 MOXOTENS IS
USED FOR
Moxotens 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.
BEFORE YOU TAKE
MOXOTENS
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE MOXOTENS 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,
short

Summary of Product characteristics

Page 1 of 9
AUSTRALIAN PRODUCT INFORMATION
MOXOTENS
(MOXONIDINE)
1 NAME OF THE MEDICINE
Moxonidine.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Moxonidine is a white to almost white powder with a melting point of
197
–
205
◦
C. Moxonidine
is very slightly soluble in water, sparingly soluble in methanol.
200 microgram:
Each tablet contains 200 microgram moxonidine.
400 microgram:
Each tablet contains 400 microgram moxonidine.
List of excipients with known effect: Contains sugars as lactose.
For the full list of excipients, see Section 6.1 List of excipients.
3 PHARMACEUTICAL FORM
Tablet, film coated.
MOXOTENS 200 μg tablets: Pale pink, coloured round shaped tablet
debossed with MX2 on one
side and plain on another side.
MOXOTENS 400 μg tablets: Dull brick red coloured round shaped tablets
debossed with MX4 on
one side and plan on another side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
MOXOTENS is indicated for the treatment of hypertension.
4.2 DOSE AND METHOD OF ADMINISTRATION
Treatment should be started with 200 μg MOXOTENS in the morning. The
dose may be titrated
after two weeks to 400 μg 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 600 μg in
divided doses (morning and
evening).
A single daily dose of 400 μg and a divided daily dose of 600 μg of
MOXOTENS should not
be exceeded.
MOXOTENS may be taken with or without food.
4.3 CONTRAINDICATIONS
Hypersensitivity to any of the ingredients of this product.
Heart failure (NYHA Class I – IV).
Patients aged 75 years or older.
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
µ
mol/L).
Page 2 of 9
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
RENAL IMPAIRMENT
In patients with m