METOPROLOL SANDOZ metoprolol tartrate 100mg tablet blister pack

Šalis: Australija

kalba: anglų

Šaltinis: Department of Health (Therapeutic Goods Administration)

Veiklioji medžiaga:

metoprolol tartrate, Quantity: 100 mg

Prieinama:

Sandoz Pty Ltd

Vaisto forma:

Tablet, uncoated

Sudėtis:

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

Vartojimo būdas:

Oral

Vienetai pakuotėje:

60 tablets

Recepto tipas:

(S4) Prescription Only Medicine

Terapinės indikacijos:

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

Produkto santrauka:

Visual Identification: uniform white, round convex tablets with a score notch; Diameter 9.0-9.2mm, Height 3.9-4.1mm.; 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

Autorizacija statusas:

Licence status A

Leidimo data:

1997-12-17

Pakuotės lapelis

METOPROLOL SANDOZ
®
1
METOPROLOL SANDOZ
®
_Metoprolol tartrate tablets _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS
LEAFLET
This leaflet answers some common
questions about Metoprolol Sandoz.
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 risk 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 METOPROLOL
SANDOZ IS USED
FOR
This medicine is used to treat:
•
high blood pressure
(hypertension).
•
heart attack (myocardial
infarction).
•
prevent severe chest pain (angina
pectoris).
•
migraine.
It contains the active ingredient
metoprolol tartrate.
Metoprolol Sandoz belongs to a
group of medicines called beta-
blockers.
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.
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.
There is no evidence that Metoprolol
Sandoz is 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.
BEFORE YOU TAKE
METOPROLOL
SANDOZ
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE THIS MEDICINE IF YOU
HAVE AN ALLERGY TO:
•
metoprolol tartrate, the active
ingredient, or to any of the other
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 breat

Prekės savybės

200617-metoprolol sandoz-pi
Page 1 of 18
AUSTRALIAN PRODUCT INFORMATION
METOPROLOL SANDOZ
® (METOPROLOL TARTRATE) TABLETS
1.
NAME OF THE MEDICINE
Metoprolol tartrate.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Metoprolol Sandoz 50 mg tablet contains metoprolol tartrate 50
mg.
Each Metoprolol Sandoz 100 mg tablet contains metoprolol tartrate 100
mg.
_Excipients with known effect:_
Lactose monohydrate.
For the full list of excipients, see Section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
Metoprolol Sandoz 50 mg tablets: White, round, biconvex, with a score
notch on one side.
Metoprolol Sandoz 100 mg tablets: White, round, biconvex, with a score
notch on one side.
4.
CLINICAL PARTICULARS
4.1.
T
HERAPEUTIC INDICATIONS
•
Hypertension
•
Angina pectoris
•
Suspected or definite myocardial infarction
•
Migraine prophylaxis
4.2.
D
OSE AND METHOD OF ADMINISTRATION
Metoprolol
Sandoz
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.
200617-metoprolol sandoz-pi
Page 2 of 18
_Myocardial infarction _
_Initially:_
Therapy should commence with Metoprolol Sandoz 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.