MOXONIDINE VIATRIS moxonidine 200 microgram tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

moxonidine, Quantity: 200 microgram

Available from:

Viatris Pty Ltd

Pharmaceutical form:

Tablet, film coated

Composition:

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

Administration route:

Oral

Units in package:

30 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

For the treatment of hypertension.

Product summary:

Visual Identification: Pale pink, round, biconvex, film-coated tablet, imprinted with 0.2 on one side.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Registered

Authorization date:

2018-01-25

Patient Information leaflet

MOXONIDINE VIATRIS
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CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about taking this medicine, speak to your doctor or pharmacist.
1.
WHY AM I TAKING MOXONIDINE VIATRIS?
MOXONIDINE VIATRIS contains the active ingredient moxonidine.
MOXONIDINE VIATRIS is used to lower high blood pressure.
For more information, see Section 1. Why am I taking MOXONIDINE
VIATRIS? in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I TAKE MOXONIDINE VIATRIS?
Do not use if you have ever had an allergic reaction to moxonidine or
any of the ingredients listed at the end of the CMI.
TALK TO YOUR DOCTOR IF YOU HAVE OTHER MEDICAL CONDITIONS, TAKE OTHER
MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME PREGNANT
OR ARE BREASTFEEDING. For more information, see Section 2. What should
I know before I take MOXONIDINE VIATRIS? in the full
CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with MOXONIDINE VIATRIS and affect how it
works or may be affected by MOXONIDINE VIATRIS.
A list of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW DO I TAKE MOXONIDINE VIATRIS?
•
The usual starting dose is one 200 micrograms tablet once per day.
Depending on how your blood pressure responds, your
dosage may be increased by your doctor.
•
Swallow the tablets whole with a full glass of water or another
liquid. Do not chew the tablets.
More instructions can be found in Section 4. How do I take MOXONIDINE
VIATRIS? in the full CMI.
5.
WHAT SHOULD I KNOW WHILE TAKING MOXONIDINE VIATRIS?
THINGS YOU
SHOULD DO
•
Remind any doctor, surgeon, dentist or pharmacist you visit that you
are taking this medicine.
•
Drink enough water during exercise and hot weather when you are taking
this medicine.
•
TELL YOUR DOCTOR IF: you become pregnant, you are about to have any
blood tests or you have excessive
vomiting and/or diarrhoea while taking this medicine.
THINGS YOU
SHOULD NOT DO
•
Do not use MOXONIDINE VIATRIS to t

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION
MOXONIDINE VIATRIS
_moxonidine film-coated tablet _
1
NAME OF THE MEDICINE
Moxonidine
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
MOXONIDINE
VIATRIS
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 VIATRIS 200 micrograms tablets: Pale pink, round, biconvex,
film-coated tablet, imprinted 0.2
on one side.
MOXONIDINE VIATRIS 400 micrograms tablets: Dull red, round, biconvex,
film-coated tablet, imprinted 0.4
on one side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
MOXONIDINE VIATRIS is indicated for the treatment of hypertension.
4.2
DOSE AND METHOD OF ADMINISTRATION
Treatment should be started with 200 micrograms MOXONIDINE VIATRIS in
the morning. The dose may be
titrated after two weeks to 400 micrograms 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 micrograms in divided
doses (morning and evening).
A single daily dose of 400 micrograms and a divided daily dose of 600
micrograms of MOXONIDINE VIATRIS
should not be exceeded.
MOXONIDINE VIATRIS 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).
Bradycardia (HR < 50 beats/minute) or severe bradyarrhythmia,
including sick sinus syndrome, or second or
third degree atrioventricular (AV) block.
MOXONIDINE VIATRIS – PRODUCT INFORMATION
2
Malignant arrhythmias.
Severe renal impairment (GFR < 30 mL/min, serum creatinine
concentration >160

mol/L).
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
CESSATION OF C