MOXONIDINE GX moxonidine 400 microgram tablet blister pack

País: Austràlia

Idioma: anglès

Font: Department of Health (Therapeutic Goods Administration)

ingredients actius:

moxonidine, Quantity: 400 microgram

Disponible des:

Viatris Pty Ltd

formulario farmacéutico:

Tablet, film coated

Composición:

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

Vía de administración:

Oral

Unidades en paquete:

30 tablets

tipo de receta:

(S4) Prescription Only Medicine

indicaciones terapéuticas:

For the treatment of hypertension.

Resumen del producto:

Visual Identification: Dull red, round, biconvex, film-coated tablet, imprinted with 0.4 on one side.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Estat d'Autorització:

Registered

Data d'autorització:

2018-01-25

Informació per a l'usuari

MOXONIDINE GX
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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 GX?
MOXONIDINE GX contains the active ingredient moxonidine. MOXONIDINE GX
is used to lower high blood pressure. For more
information, see Section 1. Why am I taking MOXONIDINE GX? in the full
CMI.
2.
WHAT SHOULD I KNOW BEFORE I TAKE MOXONIDINE GX?
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 GX? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with MOXONIDINE GX and affect how it
works or may be affected by MOXONIDINE GX. 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 GX?
•
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
GX? in the full CMI.
5.
WHAT SHOULD I KNOW WHILE TAKING MOXONIDINE GX?
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 GX to treat any other complaints unless your
doctor or pharmacist tells you to.
Do

Fitxa tècnica

AUSTRALIAN PRODUCT INFORMATION
MOXONIDINE GX
_moxonidine film-coated tablet _
1
NAME OF THE MEDICINE
Moxonidine
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
MOXONIDINE GX 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 GX 200 micrograms tablets: Pale pink, round, biconvex,
film-coated tablet, imprinted 0.2 on
one side.
MOXONIDINE GX 400 micrograms tablets: Dull red, round, biconvex,
film-coated tablet, imprinted 0.4 on one
side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
MOXONIDINE GX is indicated for the treatment of hypertension.
4.2
DOSE AND METHOD OF ADMINISTRATION
Treatment should be started with 200 micrograms MOXONIDINE GX 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 GX should
not be exceeded.
MOXONIDINE GX 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.
Malignant arrhythmias.
Severe renal impairment (GFR < 30 mL/min, serum creatinine
concentration >160

mol/L).
MOXONIDINE GX – PRODUCT INFORMATION
2
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
CESSATION OF COMBINATION THERAPY WITH BETA-BLOCKERS
Abrupt