APO-MOXONIDINE moxonidine 200 microgram film-coated tablet blister pack

Nazione: Australia

Lingua: inglese

Fonte: Department of Health (Therapeutic Goods Administration)

Principio attivo:

moxonidine, Quantity: 200 microgram

Commercializzato da:

Southern Cross Pharma Pty Ltd

Forma farmaceutica:

Tablet, film coated

Composizione:

Excipient Ingredients: magnesium stearate; lactose monohydrate; crospovidone; povidone; titanium dioxide; hypromellose; iron oxide yellow; macrogol 6000; iron oxide red; macrogol 400

Via di somministrazione:

Oral

Confezione:

30, 10, 14, 28, 100, 98, 84, 56, 60

Tipo di ricetta:

(S4) Prescription Only Medicine

Indicazioni terapeutiche:

APO-MOXONIDINE (moxonidine tablets) is indicated for the treatment of hypertension.

Dettagli prodotto:

Visual Identification: Pink round biconvex film coated tablets 5 mm in diameter; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius

Stato dell'autorizzazione:

Registered

Data dell'autorizzazione:

2018-01-16

Foglio illustrativo

APO-MOXONIDINE
1
APO-MOXONIDINE
TABLETS
_moxonidine _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about APO-Moxonidine. 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 APO-
Moxonidine 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 APO-MOXONIDINE
IS USED FOR
APO-Moxonidine is used to lower
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 THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another reason.
This medicine is not addictive.
This medicine is available only with
a doctor's prescription.
There is not enough information to
recommend the use of this medicine
for children under the age of 16
years.
BEFORE YOU TAKE APO-
MOXONIDINE
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE APO-MOXONIDINE IF
YOU HAVE AN ALLERGY TO:
•
any medicine containing
moxonidine
•
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

Scheda tecnica

AUSTRALIAN PRODUCT INFORMATION
APO-MOXONIDINE
®
TABLETS
_ _
1. NAME OF THE MEDICINE
Moxonidine
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
APO-MOXONIDINE tablets are immediate release film-coated tablets for
oral use containing 0.2 mg or
0.4 mg moxonidine.
Excipient with known effect: Sugars (as lactose monohydrate).
For the full list of excipients, see Section 6.1 List of excipients.
3. PHARMACEUTICAL FORM
APO-MOXONIDINE 0.2 mg tablets: pink round biconvex film coated tablets
5 mm in diameter.
APO-MOXONIDINE 0.4 mg tablets: pink round biconvex film coated tablets
7 mm in diameter.
4. CLINICAL PARTICULARS
4.1. THERAPEUTIC INDICATIONS
APO-MOXONIDINE is indicated for the treatment of hypertension.
4.2. DOSE AND METHOD OF ADMINISTRATION
Treatment should be started with 0.2 mg APO-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
APO-MOXONIDINE should not be
exceeded.
APO-MOXONIDINE may be taken with or without food.
RENAL IMPAIRMENT
In patients with moderate renal impairment (GFR 30 – 60 mL/min), the
single dose should not exceed 0.2 mg
and the daily dose should not exceed 0.4 mg of moxonidine.
USE IN ELDERLY
See Sections 4.3 Contraindications and 5.2 Pharmacokinetic Properties
- Pharmacokinetics in the Elderly.
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).
APO- MOXONIDINE – AUSTRALIAN PRODUCT INFORMATION
2
Bradycardia (HR < 50 beats/minute) or severe bradyarrhythmia,
including sick sinus syndrome, or second
or third degree atrioventricular (AV) b