ISOPTIN verapamil hydrochloride 80mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

verapamil hydrochloride, Quantity: 80 mg

Available from:

Viatris Pty Ltd

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: calcium hydrogen phosphate dihydrate; microcrystalline cellulose; colloidal anhydrous silica; croscarmellose sodium; magnesium stearate; hypromellose; sodium lauryl sulfate; macrogol 6000; purified talc; titanium dioxide

Administration route:

Oral

Units in package:

10 tablets, 100 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Immediate Release Tablets,ISOPTIN is 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 response

Product summary:

Visual Identification: White, biconvex film coated tablets, embossed "Isoptin 80" on the front and "Knoll" above the score on the back.; Container Type: Blister Pack; Container Material: PVC/PVDC; 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:

1999-03-25

Patient Information leaflet

ISOPTIN
® AND ISOPTIN
® SR
I
S
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T
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N
®
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d
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S
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®
S
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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

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION
ISOPTIN
® AND ISOPTIN
® SR
_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 in ISOPTIN SR 180 mg and 240 mg tablets:
Trace quantities of sulfites.
Excipients with known effect in ISOPTIN 40 mg and 80 mg tablets: 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)
•
Tachyarrhyth