TEVETEN eprosartan 400mg (as mesilate) tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

eprosartan mesilate, Quantity: 400 mg (Equivalent: eprosartan mesilate, Qty 400 mg)

Available from:

Viatris Pty Ltd

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: magnesium stearate; pregelatinised maize starch; microcrystalline cellulose; lactose monohydrate; croscarmellose sodium; titanium dioxide; hypromellose; polysorbate 80; iron oxide yellow; iron oxide red; macrogol 400

Administration route:

Oral

Units in package:

28 Tablets, 56 Tablets, 14 Tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

TEVETEN is indicated for the treatment of essential hypertension.

Product summary:

Visual Identification: Oval light to moderately pink film-coated tablet with 5044 on one side and plain on the other side.; Container Type: Blister Pack; Container Material: PVC/PCTFE (Aclar)/Al; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

1998-06-15

Patient Information leaflet

TEVETEN
®
T
E
V
E
T
E
N
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I USING TEVETEN?
TEVETEN contains the active ingredient eprosartan. TEVETEN is used to
lower blood pressure which doctors call hypertension.
For more information, see Section 1. Why am I using TEVETEN? in the
full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE TEVETEN?
Do not use if you have ever had an allergic reaction to eprosartan or
any of the ingredients listed at the end of the CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
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 use
TEVETEN? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with TEVETEN and affect how it works.
A list of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW DO I USE TEVETEN?
•
Your doctor will decide what dose you should receive.
•
The usual starting dose is one 600 mg tablet per day. However, some
people may need a lower starting dose.
More instructions can be found in Section 4. How do I use TEVETEN? in
the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING TEVETEN?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
TEVETEN.
•
Tell your doctor immediately if you become pregnant or are
breast-feeding while taking TEVETEN.
•
Drink enough water during exercise and hot weather when you are taking
TEVETEN, especially if you
sweat a lot.
THINGS YOU
SHOULD NOT DO
•
Do not stop taking TEVETEN without checking with your doctor.
•
Do not use TEVETEN to treat any other complaints, unless your doctor
tells you to.
•
Do not give TEVETEN to anyone else even if they have the same
condition as you.
DRIVING
OR USING
MACHINES
•
Make sure you know how you react to TEVETEN before you drive a car,
o

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION
TEVETEN
®
_Eprosartan mesilate film coated tablet _
1
NAME OF THE MEDICINE
Eprosartan mesilate
_ _
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
TEVETEN tablets contain eprosartan mesilate equivalent to either 400
mg or 600 mg eprosartan as the active
ingredient.
TEVETEN (eprosartan mesilate) is a non-biphenyl nontetrazole
angiotensin II receptor (AT
1
) antagonist.
Excipient with known effect: lactose.
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS
.
3
PHARMACEUTICAL FORM
TEVETEN 400 mg tablets are light to moderately pink, oval, film coated
tablets marked with “5044” on one
side and plain on the other side.
TEVETEN 600 mg tablets are white, capsule-shaped, film-coated tablets
marked with “5046” on one side
and plain on the other side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
TEVETEN is indicated for the treatment of essential hypertension.
4.2
DOSE AND METHOD OF ADMINISTRATION
The usual starting dose of TEVETEN is 600 mg once-daily. Achievement
of maximal blood pressure reduction
in most patients may take 2 to 3 weeks of treatment.
The safety and efficacy of TEVETEN has been established in combination
with hydrochlorothiazide or
nifedipine.
TEVETEN may be taken with or without food.
Discontinuation of treatment does not lead to a rapid rebound increase
in blood pressure.
HEPATIC OR RENAL IMPAIRMENT
A starting dose of 400 mg once-daily should be considered in patients
with renal or hepatic impairment. The
dose may be increased up to 600 mg once-daily, if further response is
required.
SODIUM/VOLUME DEPLETION
A starting dose of 400 mg once-daily should be considered in patients
who are sodium and/or volume depleted.
The dose may be increased up to 600 mg once-daily, if further response
is required.
USE IN THE ELDERLY
In clinical trials, the efficacy and safety of eprosartan was not
influenced by the age of the patient. However,
based on pharmacokinetic data demonstrating a significant increase in
plasma concentrations of eprosartan in
TEVETEN
®
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