DOLAPRIL 1 trandolapril 1 mg capsule blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

trandolapril, Quantity: 1 mg

Available from:

Arrotex Pharmaceuticals Pty Ltd

INN (International Name):

Trandolapril

Pharmaceutical form:

Capsule

Composition:

Excipient Ingredients: titanium dioxide; croscarmellose sodium; Gelatin; erythrosine; povidone; sunset yellow FCF; lactose monohydrate; sodium stearylfumarate; maize starch; brilliant blue FCF; allura red AC; propylene glycol; ethanol; butan-1-ol; isopropyl alcohol; purified water; Shellac; strong ammonia solution; iron oxide black; potassium hydroxide

Administration route:

Oral

Units in package:

28 capsules

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 dysfuntion 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: A hard gelatin, peach/scarlet opaque capsule with "TN" over "1" on the cap and no markings on the body.; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2007-07-10

Patient Information leaflet

DOLAPRIL- Consumer Medicine Information
Page 1 of 5
DOLAPRIL
trandolapril
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about DOLAPRIL.
It does not contain all of 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 DOLAPRIL
against the benefits they expect it
will have for you.
TALK TO YOUR DOCTOR OR
PHARMACIST IF YOU HAVE ANY
CONCERNS ABOUT TAKING THIS
MEDICINE.
Keep this leaflet with your medicine.
You may need to read it again.
WHAT DOLAPRIL IS USED
FOR
DOLAPRIL 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.
DOLAPRIL helps to lower your blood
pressure.
DOLAPIRL belongs to a group of
medicines called Angiotensin
Converting Enzyme (ACE) inhibitors.
It works by relaxing your blood
vessels, making it easier for blood
to move around your body. This
helps lower blood pressure and
increase the supply of blood and
oxygen to the heart.
Your doctor may have prescribed
DOLAPRIL for another reason. Ask
your doctor if you have any
questions about why DOLAPRIL has
been prescribed for you.
DOLAPRIL is not addictive.
This medicine is available only with
a doctor's prescription.
DOLAPRIL is not recommended for
use in children as there have been
no studies of its effects in children.
BEFORE YOU TAKE
DOLAPRIL
WHEN YOU MUST NOT TAKE IT
DO NOT TAKE DOLAPRIL IF YOU:
•
Are allergic (sensitive) to
trandolapril or any of the
ingredients in DOLAPRIL capsules
listed at the end of this leaflet
Symptoms of an allergic reaction
may i

Summary of Product characteristics

1
AUSTRALIAN PI – DOLAPRIL (TRANDOLAPRIL)
1
NAME OF THE MEDICINE
Trandolapril.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
DOLAPRIL 0.5 capsules contain 0.5 mg of trandolapril.
DOLAPRIL 1 capsules contain 1 mg of trandolapril.
DOLAPRIL 2 capsules contain 2 mg of trandolapril.
DOLAPRIL 4 capsules contain 4 mg of trandolapril.
EXCIPIENTS WITH KNOWN EFFECT:
The capsules contain sugars as lactose. For the full list of
excipients, see _SECTION 6.1 LIST OF _
_EXCIPIENTS_.
3
PHARMACEUTICAL FORM
DOLAPRIL 0.5 capsules: White opaque capsule with ‘TN’ over ‘5’
on the cap.
DOLAPRIL 1 capsules: Peach and scarlet opaque capsule with ‘TN’
over ‘1’ on the cap.
DOLAPRIL 2 capsules: Scarlet opaque capsule with ‘TN’ over ‘2’
on the cap
DOLAPRIL 4 capsules: White opaque capsule with ‘TN’ over ‘4’
on the cap.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Treatment of hypertension. Data to support the usage of DOLAPRIL in
renovascular hypertension
are, at present, not available.
DOLAPRIL 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).
2
4.2
D
OSE AND METHOD OF ADMINISTRATION
DOLAPRIL 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 channel blocker or di