TEVETEN PLUS 600/12.5 eprosartan 600mg/hydrochlorothiazide 12.5mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

hydrochlorothiazide, Quantity: 12.5 mg; eprosartan mesilate, Quantity: 735.8 mg (Equivalent: eprosartan, Qty 600 mg)

Available from:

Viatris Pty Ltd

INN (International Name):

Eprosartan,Hydrochlorothiazide

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: crospovidone; microcrystalline cellulose; lactose monohydrate; magnesium stearate; pregelatinised maize starch; titanium dioxide; purified talc; iron oxide yellow; polyvinyl alcohol; macrogol 3350; iron oxide black

Administration route:

Oral

Units in package:

14 tablets, 56 tablets, 28 tablets, 7 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

TEVETEN PLUS is indicated for the treatment of hypertension. Treatment should not be initiated with this fixed dose combination.

Product summary:

Visual Identification: Capsule shaped, butterscotch coloured, film-coated tablet, one side plain, the other side embossed 5147.; Container Type: Blister Pack; Container Material: PVC/PCTFE (Aclar)/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Registered

Authorization date:

2007-08-20

Patient Information leaflet

TEVETEN
® PLUS
T
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E
T
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®
P
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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 PLUS?
TEVETEN PLUS contains the active ingredients eprosartan and
hydrochlorothiazide. TEVETEN PLUS is used to lower high blood
pressure which doctors call hypertension.
For more information, see Section 1. Why am I using TEVETEN PLUS? in
the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE TEVETEN PLUS?
Do not use if you have ever had an allergic reaction to eprosartan,
hydrochlorothiazide 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 PLUS? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with TEVETEN PLUS 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 PLUS?
•
Your doctor will decide what dose you should receive.
•
The usual dose of TEVETEN PLUS is one tablet per day.
More instructions can be found in Section 4. How do I use TEVETEN
PLUS? in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING TEVETEN PLUS?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
TEVETEN PLUS.
•
Tell your doctor immediately if you become pregnant or are
breast-feeding while taking TEVETEN PLUS.
•
Drink enough water during exercise and hot weather when you are taking
TEVETEN PLUS, especially if
you sweat a lot.
THINGS YOU
SHOULD NOT DO
•
Do not take TEVETEN PLUS to treat any other complaints unless your
doctor tells you to.
•
Do not give your medicine to anyone else, even if they have the same
condition as you.
•
Do not stop taking your medicine or lower the dosage without checking

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION
TEVETEN
® PLUS
_Eprosartan mesilate and hydrochlorothiazide tablets _
1
NAME OF THE MEDICINE
Eprosartan mesilate and hydrochlorothiazide
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
TEVETEN PLUS tablets contain eprosartan mesilate equivalent to
eprosartan 600 mg and 12.5 mg
hydrochlorothiazide as the active ingredients.
Excipients with known effect: lactose
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3 PHARMACEUTICAL FORM
Capsule shaped, butterscotch coloured, film-coated tablet, one side
plain, the other side embossed 5147.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of hypertension. Treatment should not be initiated with this
fixed dose combination.
4.2
DOSE AND METHOD OF ADMINISTRATION
TEVETEN PLUS should not be initiated as first line therapy.
TEVETEN PLUS may be used for patients whose blood pressure is not
adequately controlled on either
hydrochlorothiazide or eprosartan alone. Most of the antihypertensive
effect with eprosartan is usually attained
within four weeks of initiation of treatment. Therefore, TEVETEN PLUS
should only be initiated after an
adequate trial period of monotherapy with eprosartan or
hydrochlorothiazide, preferably lasting 4 - 6 weeks.
The recommended dose of TEVETEN PLUS is one tablet daily.
TEVETEN PLUS can be taken with or without food.
Discontinuation of treatment does not lead to rapid rebound increase
in blood pressure.
PATIENTS WHO ARE SALT OR VOLUME DEPLETED OR ON EXISTING DIURETIC
THERAPY
In patients who are salt or volume depleted, for example due to
diuretic therapy, the condition should be
corrected before starting TEVETEN PLUS. Patients on diuretic therapy
should cease the diuretic 2-3 days
before starting TEVETEN PLUS.
ELDERLY, HEPATICALLY OR RENALLY IMPAIRED PATIENTS
Initial dose adjustment is generally not required in the elderly, in
patients with mild to moderate hepatic
impairment or in patients with mild to moderate renal impairment
(creatinine clearance

30 mL/min).
TEVETEN PLUS is not recomm