GOPTEN 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:

Viatris Pty Ltd

Pharmaceutical form:

Capsule, hard

Composition:

Excipient Ingredients: erythrosine; sodium lauryl sulfate; sodium stearylfumarate; povidone; iron oxide yellow; titanium dioxide; Gelatin; lactose monohydrate; maize starch

Administration route:

Oral

Units in package:

7, 10, 14, 15, 28, 30 capsules

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

GOPTEN is indicated for the treatment of hypertension. Data to support the usage of GOPTEN in severe hypertension or renovascular hypertension is, at present, not available. GOPTEN is also indicated for patients with left ventricular dysfunction post myocardial infarction [ejection fraction less than or equal to 35%) or Wall Motion Index (WMI) less than or equal to 1.2],GOPTEN is indicated for the treatment of hypertension. Data to support the usage of GOPTEN in renovascular hypertension is, at present, not available. GOPTEN 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: White to off white granules filled in Size 4 hard gelatin capsules with orange opaque cap and red opaque body.; Container Type: Blister Pack; Container Material: PVC/PVDC/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:

Licence status A

Authorization date:

1994-01-24

Patient Information leaflet

GOPTEN
®
G
O
P
T
E
N
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 GOPTEN?
GOPTEN contains the active ingredient trandolapril. GOPTEN is used to
treat high blood pressure (hypertension) and also to treat
some heart conditions.
For more information, see Section 1. Why am I using GOPTEN? in the
full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE GOPTEN?
Do not use if you have ever had an allergic reaction to trandolapril
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
GOPTEN? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with GOPTEN 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 GOPTEN?
•
The usual dosage is one or two capsules taken once daily, up to a
maximum of 4mg (two 2mg capsules) once daily.
More instructions can be found in Section 4. How do I use GOPTEN? in
the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING GOPTEN?
THINGS YOU SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
trandolapril.
•
Have your blood pressure checked when your doctor says, to make sure
GOPTEN is
working.
•
If you become pregnant while taking GOPTEN tell your doctor
immediately.
•
If you feel light-headed or dizzy after taking your first dose of
GOPTEN, or when your dose is
increased, tell your doctor immediately.
•
Tell your doctor if you have excessive vomiting and/or diarrhoea while
taking GOPTEN.
THINGS YOU SHOULD NOT DO
•
Do not give GOPTEN to anyone else, even if they have the same
condition as you.
•
Do not take GOPTEN to treat any other complaints unless your doctor
tells you to.
•
Do not

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION
GOPTEN
®
_Trandolapril Capsules _
1
NAME OF THE MEDICINE
Trandolapril
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each GOPTEN capsule contains 0.5 mg, 1 mg, 2 mg or 4 mg of
trandolapril as 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
GOPTEN 0.5 mg
White to off white granules filled in Size 4 hard gelatin capsules
with yellow
opaque cap and red opaque body.
GOPTEN 1 mg
White to off white granules filled in Size 4 hard gelatin capsules
with orange
opaque cap and red opaque body.
GOPTEN 2 mg
White to off white granules filled in Size 4 hard gelatin capsules
with red opaque
cap and red opaque body.
GOPTEN 4 mg
White to off white granules filled in Size 2 hard gelatin capsules
with maroon
opaque cap and red opaque body.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
GOPTEN is indicated for the treatment of hypertension. Data to support
the usage of GOPTEN in
renovascular hypertension is, at present, not available.
GOPTEN 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
GOPTEN has a duration of action of greater than 24 hours and should
not be administered at intervals of less
than 24 hours. Monitoring of trough BP should be done initially to
ensure 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 GOPTEN, 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 2 - 4
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