DILATREND carvedilol 25mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

carvedilol, Quantity: 25 mg

Available from:

Pharmaco Australia Ltd

Pharmaceutical form:

Tablet, uncoated

Composition:

Excipient Ingredients: lactose monohydrate; sucrose; magnesium stearate; colloidal anhydrous silica; povidone; crospovidone

Administration route:

Oral

Units in package:

60 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

DILATREND is indicated for the treatment for the treatment of mild to moderate hypertension. Data have not been provided to support the use of this drug in severe hypertension or renovascular disease. DILATREND is indicated for the treatment of patients with symptomatic mild to moderate (NYHA class II & III) congestive heart failure, as an adjunct to conventional treatments (e.g diuretics, digoxin, ACE inhibitors and vasodilators). INDICATIONS AS AT 24 JANUARY 2002: DILATREND is indicated for the treatment of mild to moderate hypertension. Data have not been provided to support the use of this drug in severe hypertension or renovascular disease. DILATREND is indicated for the treatment of patients with symptomatic mild to severe (NYHA Class II - IV) congestive heart failure (CHF) as an adjunct to conventional treatments (e.g. diuretics, digoxin, ACE inhibitors and vasodilators). INDICATIONS AS AT 3 MARCH 2003: DILATREND is indicated for the treatment of hypertension. Data have not been provided to support the use of this drug in renovascular disease. DILATREND is indicated for the treatment of patients with symptomatic mild to severe (NYHA Class II - IV) congestive heart failure (CHF) as an adjunct to conventional treatments (e.g. diuretics, digoxin, ACE inhibitors and vasodilators).

Product summary:

Visual Identification: white to pale-yellowish beige, round, biconvex tablet, with bilateral scoreline engraved BM/D5.; Container Type: Blister Pack; Container Material: PA/Al/PVC/Al - polyamide-aluminium foil-polyvinylchloride/aluminium foil; Container Life Time: 5 Years; Container Temperature: Store below 30 degrees Celsius

Authorization status:

Licence status A

Authorization date:

1998-01-21

Patient Information leaflet

DILATREND® - Consumer Medicines Information 2022-03 v3.0
1
DILATREND®
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 DILATREND®?
DILATREND® contains the active ingredient carvedilol. DILATREND® is
used to treat heart failure and high blood pressure
(hypertension).
For more information, see Section 1. Why am I using DILATREND®? in
the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE DILATREND®?
Do not use if you have ever had an allergic reaction to carvedilol 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
DILATREND®? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with DILATREND® 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 DILATREND®?
•
Take DILATREND® exactly as your doctor has prescribed.
•
Your doctor will tell you how many DILATREND® tablets to take each
day. This depends on your condition and whether or not
you are taking other medicines.
More instructions can be found in Section 4. How do I use DILATREND®?
in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING DILATREND®?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist, pharmacist, surgeon or anaesthetist you
visit that you are using
DILATREND®, especially if you are going to have any laboratory tests
or surgery.
•
Drink enough water during exercise and hot weather.
•
Tell your doctor if you haven’t taken your medicine or if you feel
it is not helping your condition.
THINGS YOU
SHOULD NOT DO
•
Do not stop using this medicine suddenly.
•
Do not change the dose without first checking with your doctor.
•
Do not run out of medicine over

Summary of Product characteristics

2022-03 v3.0
1
AUSTRALIAN PRODUCT INFORMATION – DILATREND
®
(CARVEDILOL) TABLETS
1
NAME OF THE MEDICINE
Carvedilol.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
DILATREND tablets contain 6.25 mg, 12.5 mg or 25 mg of carvedilol.
Excipients of known effect: lactose, sucrose.
DILATREND tablets also contain povidone, crospovidone, colloidal
anhydrous silica, magnesium
stearate, iron oxide yellow (6.25 mg and 12.5 mg tablets only), iron
oxide red (12.5 mg tablets only)
as excipients.
3
PHARMACEUTICAL FORM
DILATREND 6.25 MG
: Yellow, round, biconvex tablet, diameter 7.0 mm, with bilateral
scoreline,
engraved with BM on one side and F1 on the other.
DILATREND 12.5 MG
: Light brown, round, biconvex tablet, diameter 7.0 mm, with bilateral
scoreline, engraved with BM on one side and H3 on the other.
DILATREND 25 MG
: White to pale yellowish beige, round, biconvex tablet, diameter 7.0
mm, with
bilateral scoreline, engraved with BM on one side and D5 on the other.
The tablet(s) can be divided into equal doses.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
DILATREND is indicated for the treatment of hypertension. Data have
not been provided to support
the use of this drug in renovascular disease.
DILATREND IS INDICATED FOR THE TREATMENT OF PATIENTS WITH SYMPTOMATIC
MILD TO SEVERE (NYHA
CLASS II - IV) CONGESTIVE HEART FAILURE (CHF) AS AN ADJUNCT TO
CONVENTIONAL TREATMENTS (E.G.
DIURETICS, DIGOXIN, ACE INHIBITORS AND VASODILATORS).
4.2
D
OSE AND METHOD OF ADMINISTRATION
HYPERTENSION:
Once daily dosing is recommended.
Adults: The recommended dose for initiation of therapy is 12.5 mg once
a day for the first 2
days. Thereafter the recommended dosage is 25 mg once a day. If
necessary, the
2022-03 v3.0
2
dosage may subsequently be increased at intervals of at least two
weeks up to the
recommended maximum daily dose of 50 mg given once or twice daily.
Elderly:
The recommended dose for initiation of therapy is 12.5 mg once daily,
which has
provided satisfactory control in some patients. If the response is
inadequate, the dose