ISOPTIN SR verapamil hydrochloride 240mg tablet blister pack

Страна: Австралия

Език: английски

Източник: Department of Health (Therapeutic Goods Administration)

Активна съставка:

verapamil hydrochloride, Quantity: 240 mg

Предлага се от:

Viatris Pty Ltd

Лекарствена форма:

Tablet, film coated

Композиция:

Excipient Ingredients: sodium alginate; powdered cellulose; purified water; magnesium stearate; hypromellose; purified talc; titanium dioxide; povidone; macrogol 400; macrogol 6000; quinoline yellow; indigo carmine; glycol/butylene glycol montanate

Начин на приложение:

Oral

Броя в опаковка:

15 tablets, 30 tablets, 7 tablet patient starter pack

Вид предписание :

(S4) Prescription Only Medicine

Терапевтични показания:

Isoptin SR (verapamil hydrochloride) is indicated for the management of essential hypertension and angina pectoris.

Каталог на резюме:

Visual Identification: Light green, oblong film-coated tablet (curved tooling). Score and 2 logos on one face and score on the other face.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Статус Оторизация:

Registered

Дата Оторизация:

1991-10-08

Листовка

ISOPTIN
®
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®
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 ISOPTIN?
In most parts of this leaflet, the name ISOPTIN is used to refer to
both ISOPTIN tablets and ISOPTIN SR tablets. Where there is
information specific to the type of ISOPTIN, separate names are used.
ISOPTIN contains the active ingredient verapamil hydrochloride.
ISOPTIN and ISOPTIN SR are used for high blood pressure
(hypertension) and angina (chest pain). ISOPTIN is also used to treat
irregular heartbeats, also called arrhythmias.
For more information, see Section 1. Why am I using ISOPTIN? in the
full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE ISOPTIN?
Do not use if you have ever had an allergic reaction to ISOPTIN 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
ISOPTIN? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with ISOPTIN 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 ISOPTIN?
ISOPTIN is usually taken two or three times a day. The usual dose of
ISOPTIN SR is once daily or they may be taken twice daily.
More instructions can be found in Section 4. How do I use ISOPTIN? in
the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING ISOPTIN?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
ISOPTIN.
•
Tell your doctor if you become pregnant while taking ISOPTIN.
•
If you are being treated for angina, tell your doctor if the medicine
is not helping.
•
Visit your doctor regularly so that they can check on your progress.
THINGS YOU
SHOULD NOT DO
•
Do not stop using this medicine or lower the dos

Данни за продукта

AUSTRALIAN PRODUCT INFORMATION
ISOPTIN
®
_Verapamil hydrochloride tablets _
1
NAME OF THE MEDICINE
Verapamil hydrochloride
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Verapamil hydrochloride is a calcium ion influx inhibitor (slow
channel blocker or calcium ion antagonist).
Each ISOPTIN SR film-coated tablet contains 180 mg or 240 mg of
verapamil hydrochloride as the active
ingredient.
Each ISOPTIN (immediate release formulation) tablet contains 40 mg or
80 mg of verapamil hydrochloride
as the active ingredient.
Excipients with known effect: None
For the full list of excipients, see
SECTION 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
ISOPTIN SR is available for oral administration as light green, oblong
shaped, scored, film-coated tablets
(score and 2 logos on one face and score on the other face) containing
240 mg verapamil hydrochloride and
as old rose, oval shaped, scored, film-coated tablets (‘KNOLL’ on
one face and ‘SR’; score; ‘180’ on the
other face) containing 180 mg verapamil hydrochloride. The tablets are
designed for sustained release of
the drug in the gastrointestinal tract; sustained release
characteristics are not altered when the tablet is
divided in half.
ISOPTIN 40 mg tablets are available for oral administration as white,
biconvex, film coated tablets,
embossed "40" on one side and the Knoll triangle on the other side.
ISOPTIN 80 mg tablets are available for oral administration as white,
biconvex, film coated tablets,
embossed "Isoptin 80" on the front and “Knoll” above the score on
the back.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
ISOPTIN SR is indicated for the management of hypertension and angina
pectoris.
ISOPTIN Tablets 40 mg or 80 mg (immediate release) are indicated for:
•
Hypertension
•
Angina of effort
•
Angina at rest
•
Vasospastic angina (including Prinzmetal’s variant angina)
•
Tachyarrhythmias including paroxysmal supra-ventricular tachycardia
•
Atrial fibrillation with rapid ventricular response
•
Atrial flutter with rapid ventricular