NOUMED METOPROLOL metoprolol tartrate 50mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

metoprolol tartrate, Quantity: 50 mg

Available from:

AVALLON PHARMACEUTICALS PTY LTD

Pharmaceutical form:

Tablet, uncoated

Composition:

Excipient Ingredients: colloidal anhydrous silica; maize starch; calcium hydrogen phosphate dihydrate; lactose monohydrate; crospovidone; hyprolose; magnesium stearate; microcrystalline cellulose

Administration route:

Oral

Units in package:

100 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Hypertension; angina pectoris; suspected or definite myocardial infarction; migraine prophylaxis

Product summary:

Visual Identification: uniform white, round convex tablets with a score notch; Diameter: 7.0-7.2mm, Height: 2.9-3.1mm.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Authorization status:

Registered

Authorization date:

2018-02-26

Patient Information leaflet

NOUMED METOPROLOL
1
NOUMED METOPROLOL
_metoprolol tartrate tablets _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about NOUMED
METOPROLOL.
It does not contain all of 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 this medicine
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 NOUMED
METOPROLOL IS USED
FOR
NOUMED METOPROLOL tablets
contain the active ingredient
metoprolol tartrate.
Metoprolol tartrate belongs to a
group of medicines called beta-
blockers, which are used to:
•
lower high blood pressure
(hypertension).
•
prevent severe chest pain (angina
pectoris).
•
prevent heart attack (myocardial
infarction) or its complications.
•
prevent migraine headaches.
It works by affecting the body's
response to some nerve impulses,
especially in the heart. As a result, it
decreases the heart's need for blood
and oxygen and therefore reduces the
amount of work the heart has to do. It
also widens the blood vessels in the
body, causing blood pressure to fall.
This medicine is available only with
a doctor's prescription.
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.
BEFORE YOU TAKE IT
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE THIS MEDICINE IF YOU
HAVE AN ALLERGY TO:
•
metoprolol tartrate, the active
ingredient, or any of the inactive
ingredients listed at the end of
this leaflet under Product
Description.
•
any other similar medicines such
as other beta-blockers.
Some of the symptoms of an allergic
reaction may include shortness of
breath; wheezing or difficulty in
breathing; swelling of the face, lips
tongue or other parts of the body;
r

Summary of Product characteristics

Product Information - Australia
Page 1 of 14
AUSTRALIAN PRODUCT INFORMATION – NOUMED
METOPROLOL 50MG AND 100 MG TABLETS
(METOPROLOL TARTRATE)
1. NAME OF THE MEDICINE
Metoprolol tartrate
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Noumed Metoprolol tablet contain 50mg or 100 mg of metoprolol
tartrate.
List of excipients with known effect: lactose monohydrate.
For the full list of excipients, see _section 6.1 List of excipients_.
3. PHARMACEUTICAL FORM
Noumed Metoprolol 50 mg Tablets: White, round, biconvex, with a score
notch on one side.
Noumed Metoprolol 100 mg Tablets: White, round, biconvex, with a score
notch on one side.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Hypertension; angina pectoris; suspected or definite myocardial
infarction; migraine prophylaxis.
4.2 DOSE AND METHOD OF ADMINISTRATION
Noumed Metoprolol is recommended for oral therapy in hypertension,
angina pectoris, suspected or definite
myocardial infarction and migraine prophylaxis.
_HYPERTENSION _
_Initially: _
Mild hypertension: 50 or 100 mg once daily for one week.
Severe hypertension: 50 or 100 mg twice daily for one week.
_Maintenance: _
50 or 100 mg once or twice daily.
Some patients will respond to 50 mg once daily. However, a large
number of patients will respond to 100 mg once
daily as initial and maintenance therapy. Response is rarely improved
by increasing the dose beyond 200 mg daily.
The maximum daily dose should not exceed 400 mg. Although twice daily
dosage is optimal in patients where
maintenance dosage is 150 mg daily or less, it may be administered as
a single dose.
_ANGINA PECTORIS _
50 to 100 mg two or three times daily.
_MYOCARDIAL INFARCTION _
_Initially: _
Therapy should commence with Noumed Metoprolol 50 mg tablets twice
daily and be continued
for 48 hours._ _
_Maintenance: _
The oral maintenance dose is generally 100 mg twice daily._ _
_MIGRAINE PROPHYLAXIS _
100 to 150 mg given in divided doses morning and evening.
Product Information - Australia
Page 2 of 14
4.3 CONTRAINDICATIONS
•
Severe bronchial