TARKA 4/240 trandolapril 4mg & verapamil hydrochloride 240mg tablet

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

trandolapril, Quantity: 4 mg; verapamil hydrochloride, Quantity: 240 mg

Available from:

Viatris Pty Ltd

INN (International Name):

Trandolapril,Verapamil hydrochloride

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: maize starch; lactose monohydrate; povidone; hypromellose; sodium stearylfumarate; microcrystalline cellulose; sodium alginate; magnesium stearate; hyprolose; macrogol 400; macrogol 6000; purified talc; colloidal anhydrous silica; titanium dioxide; iron oxide red; iron oxide yellow; iron oxide black; docusate sodium

Administration route:

Oral

Units in package:

50 tablets, 280 tablets, 7 tablet sample pack, 14 tablets, 28 tablets, 30 tablets, 98 tablets, 56 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

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

Product summary:

Visual Identification: Red-brown, oval, film coated tablet embossed with '244' on one face. Other face has no embossing.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Licence status A

Authorization date:

2005-10-24

Patient Information leaflet

TARKA
®
T
A
R
K
A
®
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 TARKA
TARKA contains the active ingredients trandolapril and verapamil
hydrochloride. TARKA is used to treat hypertension (high blood
pressure).
For more information, see Section 1. Why am I using TARKA in the full
CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE TARKA
Do not use if you have ever had an allergic reaction to any medicine
containing trandolapril (or any other ACE inhibitor), any
medicine containing verapamil 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
TARKA in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with TARKA 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 TARKA
•
The usual dosage for TARKA is one tablet daily. The maximum dose of
TARKA is one 4/240 mg tablet once daily.
More instructions can be found in Section 4. How do I use TARKA in the
full CMI.
5.
WHAT SHOULD I KNOW WHILE USING TARKA
THINGS YOU SHOULD
DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
TARKA.
•
Have your blood pressure checked when your doctor says, to make sure
TARKA is working for you
•
If you feel light-headed or dizzy after taking your first dose of
TARKA, or when your dose is
increased, tell your doctor immediately.
•
Tell your doctor if you have excessive vomiting and/or diarrhoea while
taking TARKA.
THINGS YOU SHOULD
NOT DO
•
Do not take eat grapefruit or drink grapefruit juice whilst taking
TARKA.
•
Do not use TARKA to treat any other complaints unless your doctor or
pharmacist tells you to.
•
Do not give this medicin

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION
TARKA
® 2/180
TARKA
® 4/240
_Trandolapril/verapamil hydrochloride _
1
NAME OF THE MEDICINE
Trandolapril/verapamil hydrochloride
_ _
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
TARKA 2/180 contains trandolapril 2 mg and verapamil 180 mg modified
release as the active ingredients in
pink, oval, film coated tablets. TARKA 2/180 also contain 107.00 mg
lactose monohydrate.
TARKA 4/240 contains trandolapril 4 mg and verapamil 240 mg modified
release as the active ingredients in
red-brown, oval, film coated tablets. TARKA 4/240 also contain 110.37
mg lactose monohydrate.
Excipients with known effect: Contains sugars as lactose.
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
TARKA 2/180 are pink, oval, film coated tablets embossed with
‘182’ on one face.
TARKA 4/240 are red-brown, oval, film coated tablets embossed with
‘244’ on one face.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
TARKA is indicated for the treatment of hypertension. Treatment should
not be initiated with this fixed dose
combination.
_ _
4.2
DOSE AND METHOD OF ADMINISTRATION
The product should be swallowed whole with water ideally in the
morning with or after food.
ADULTS
The usual dosage is one tablet daily. The maximum dose of TARKA is
4/240 mg once daily.
ELDERLY
TARKA has been studied in a limited number of elderly hypertensive
patients only. Pharmacokinetic data
show that the systemic availability of TARKA is higher in elderly
compared to younger hypertensives. Some
elderly patients might experience a more pronounced blood pressure
lowering effect than others.
CHILDREN
TARKA has not been studied in children and adolescents, therefore use
in this age group is not recommended.
ANGINA
The safety and efficacy of TARKA has not been evaluated in the
treatment of angina.
TARKA
®
– PRODUCT INFORMATION
2
4.3
CONTRAINDICATIONS
TARKA is contraindicated in:
•
Patients
who
are
hypersensitive
to trandolapril
or
any
other
ACE
inhibitor
or
to
verapamil
hydrochloride or