OLMERTAN COMBI 40/25 olmesartan medoxomil and hydrochlorothiazide 40/25 mg tablet blister pack

Pays: Australie

Langue: anglais

Source: Department of Health (Therapeutic Goods Administration)

Ingrédients actifs:

olmesartan medoxomil, Quantity: 40 mg; hydrochlorothiazide, Quantity: 25 mg

Disponible depuis:

Pharmacor Pty Ltd

forme pharmaceutique:

Tablet

Composition:

Excipient Ingredients: magnesium stearate; stearic acid; hyprolose; lactose monohydrate; microcrystalline cellulose; purified water; titanium dioxide; hypromellose; purified talc; iron oxide yellow; macrogol 6000; iron oxide red; macrogol 400

Mode d'administration:

Oral

Unités en paquet:

30's, 10's

Type d'ordonnance:

(S4) Prescription Only Medicine

indications thérapeutiques:

Olmesartan medoxomil and Hydrochlorothiazide is indicated for:,Treatment of hypertension.,Treatment should not be initiated with this fixed dose combination.

Descriptif du produit:

Visual Identification: Pink coloured, oval shape film coated tablets debossed with A003 on one side and plain on other side.; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Statut de autorisation:

Registered

Date de l'autorisation:

2018-01-29

Notice patient

_OLMERTAN COMBI Ver 04 1 _
OLMERTAN COMBI TABLETS
_ _
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 OLMERTAN COMBI TABLETS?
OLMERTAN
COMBI
TABLETS
contains
the
active
ingredient
Olmesartan
medoxomil
and
hydrochlorothiazide. Olmesartan medoxomil and hydrochlorothiazide is
used to treat high blood pressure
(hypertension). For more information, see Section 1.Why am I using
OLMERTAN COMBI TABLETS?
in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE OLMERTAN COMBI TABLETS?
Do not use if you have ever had an allergic reaction to OLMERTAN COMBI
TABLETS 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
OLMERTAN COMBI TABLETS?
in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with OLMERTAN COMBI TABLETS 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 OLMERTAN COMBI TABLETS?
The dose of OLMERTAN COMBI TABLETS is one tablet to be taken once a
day or talk to your doctor
before taking this medicine. Follow all directions given to you by
your doctor and pharmacist carefully.
More instructions can be found in Section 4. How do I use OLMERTAN
COMBI TABLETS? in the full
CMI.
5.
WHAT SHOULD I KNOW WHILE USING OLMERTAN COMBI TABLETS?
THINGS YOU SHOULD
DO
•
Remind
any
doctor,
dentist
or
pharmacist
you
visit
that
you
are
using
OLMERTAN COMBI TABLETS.
•
If you are about to be started on any new medicine, remind your doctor
and
pharmacist that you are taking OLMERTAN COMBI TABLETS.
•
If you need to have any blood tests, tell your doctor you are taking
OLMERTAN
COMBI TABLETS. OLMERTAN COMBI may affect the results of some
laboratory tests.
T

Résumé des caractéristiques du produit

OLMERTAN COMBI
V04
1
AUSTRALIAN PRODUCT INFORMATION
OLMERTAN COMBI
(OLMESARTAN MEDOXOMIL/HYDROCHLOROTHIAZIDE) TABLETS
1.
NAME OF THE MEDICINE
OLMERTAN COMBI Tablet consists of olmesartan medoxomil and
hydrochlorothiazide
(HCTZ).
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
OLMERTAN COMBI 20/12.5
Each tablet contains 20 mg of olmesartan medoxomil and 12.5 mg of
hydrochlorothiazide.
OLMERTAN COMBI 40/12.5
Each tablet contains 40 mg of olmesartan medoxomil and 12.5 mg of
hydrochlorothiazide.
OLMERTAN COMBI 40/25
Each tablet contains 40 mg of olmesartan medoxomil and 25 mg of
hydrochlorothiazide.
Olmesartan medoxomil is a white to off white, crystalline powder. It
is practically insoluble
in water and in heptane, slightly soluble in ethanol (96%), sparingly
soluble in methanol.
HCTZ is a white or almost white, crystalline powder. It is very
slightly soluble in water,
soluble in acetone, sparingly soluble in ethanol (96%). It dissolves
in dilute solutions of
alkali hydroxides.
Excipients with known effect: contains sugars as lactose.
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
OLMERTAN
COMBI
20/12.5
TABLETS
are
reddish-yellow,
round,
film
coated
tablets
debossed with "A01" on one side & plain on other side.
OLMERTAN
COMBI
40/12.5
TABLETS
are
reddish-yellow,
oval,
film
coated
tablets
debossed with "A002" on one side & plain on other side.
OLMERTAN COMBI 40/25 TABLETS are pink, oval, film coated tablets
debossed with
"A003" on one side & plain on other side.
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
NOTE: OLMERTAN COMBI are only available in the 20/12.5mg, 40/12.5mg
and 40/25mg
strengths. If 20/25mg is required, an alternative brand should be
sought.
ADULTS
OLMERTAN COMBI is administered once daily, with or without food, in
patients whose
blood pressure is not adequately controlled by olmesartan medoxomil or
HCTZ