TRANALPHA trandolapril 2 mg capsules blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

trandolapril, Quantity: 2 mg

Available from:

Alphapharm Pty Ltd

INN (International Name):

Trandolapril

Pharmaceutical form:

Capsule, hard

Composition:

Excipient Ingredients: dimeticone 350; microcrystalline cellulose; lactose monohydrate; pregelatinised maize starch; silicon dioxide; magnesium stearate; titanium dioxide; sunset yellow FCF; purified water; erythrosine; Gelatin; sodium lauryl sulfate

Administration route:

Oral

Units in package:

28 capsules blister pack

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Treatment of hypertension. Data to support the usage of trandolapril in renovascular hypertension are, at present, not available. Trandolapril is also indicated for patients with left ventricular dysfunction post myocardial infarction (ejection fraction less than or equal to 35% or WMI (wall motion index) less than or equal to 1.2).

Product summary:

Visual Identification: red-oranget size 2 capsule; Container Type: Blister Pack; Container Material: PVC/PE/PVDC/Al; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2012-08-28

Patient Information leaflet

TRANALPHA
_trandolapril_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Tranalpha.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have benefits and
risks. Your doctor has weighed the
risks of you taking Tranalpha against
the benefits expected for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, TALK TO YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH YOUR
MEDICINE.
You may need to read it again.
WHAT TRANALPHA IS
USED FOR
Tranalpha is used to treat:
•
high blood pressure
(hypertension)
•
some heart conditions
There are usually no symptoms of
hypertension. The only way of
knowing that you have hypertension
is to have your blood pressure
checked on a regular basis. If high
blood pressure is not treated it can
lead to serious health problems. You
may feel fine and have no symptoms,
but eventually hypertension can lead
to serious health problems, including
stroke, heart disease and kidney
failure. Tranalpha helps to lower
your blood pressure.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY TRANALPHA
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed
Tranalpha for another purpose.
_HOW TRANALPHA WORKS_
Tranalpha belongs to a group of
medicines called angiotensin
converting enzyme (ACE) inhibitors.
ACE inhibitors lower blood pressure
by widening and relaxing your blood
vessels, making it easier for the heart
to pump blood around the body.
Widening of the blood vessels also
increases the supply of blood and
oxygen to the heart. By increasing
the supply of oxygen to your heart,
your heart does not have to work as
hard.
Tranalpha is available only with a
doctor's prescription.
There is no evidence that Tranalpha
is addictive.
Tranalpha is not recommended for
use in children as there have been no
studies of its effects in children.
BEFORE YOU TAKE
TRANALPHA
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE TRANALPHA IF YOU:
•
are allergic (sensitive) reaction to
t

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION
TRANALPHA
_trandolapril _
1
NAME OF THE MEDICINE
Trandolapril
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Trandolapril is a long acting, highly lipophilic, non-peptide,
angiotensin converting enzyme (ACE) inhibitor
with a carboxyl group but without a sulphydryl group.
Each Tranalpha capsule contains 0.5 mg, 1 mg, 2 mg or 4 mg of
trandolapril as the active ingredient.
Excipients with known effect: Contains sugars (as lactose) and
sulfites.
For the full list of excipients, see
SECTION 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Tranalpha 0.5 mg
A hard capsule with a light scarlet body and a rich yellow cap
Tranalpha 1 mg
A hard capsule with a light scarlet body and a light orange cap
Tranalpha 2 mg
A hard capsule with a light scarlet body and a light scarlet cap
Tranalpha 4 mg
A hard capsules with a swedish orange body and a scarlet cap
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of hypertension. Data to support the usage of trandolapril
in renovascular hypertension are, at
present, not available.
Trandolapril is also indicated for patients with left ventricular
dysfunction post myocardial infarction (ejection
fraction ≤35% or WMI (wall motion index) ≤1.2).
4.2
DOSE AND METHOD OF ADMINISTRATION
Trandolapril has a duration of action greater than 24 hours and should
not be administered at intervals of less
than 24 hours. Monitoring of trough blood pressure should be done
initially to ensure that control lasts over
the dosing period. Should daily doses of more than one capsule be
required, they should be administered
together as a single daily dose.
Since there is no clinically significant effect of food on the
absorption of trandolapril, the capsules may be
taken before, during or after a meal.
HYPERTENSION
The usual starting dose is one 1 mg capsule once daily. Maximum
response is usually achieved within two to
four weeks.
Some patients not responding to 1 mg once daily may respond to 2 mg
once daily. An alternative to increasing
the dose is to add a calcium chann