RYTHMODAN disopyramide 150 mg capsule blister pack

Valsts: Austrālija

Valoda: angļu

Klimata pārmaiņas: Department of Health (Therapeutic Goods Administration)

Aktīvā sastāvdaļa:

disopyramide, Quantity: 150 mg

Pieejams no:

Pharmaco Australia Ltd

Zāļu forma:

Capsule, hard

Kompozīcija:

Excipient Ingredients: magnesium stearate; maize starch; purified talc; Gelatin; titanium dioxide; pregelatinised maize starch

Ievadīšanas:

Oral

Vienības iepakojumā:

100 capsules

Klase:

Medicine Registered

Receptes veids:

(S4) Prescription Only Medicine

Ārstēšanas norādes:

Management of documented ventricular arrhythmias, e.g. sustained ventricular tachycardia, which are judged to be life threatening. Because of its proarrhythmic potential, the use of disopyramide is not recommended for lesser arrhythmias. Treatment of asymptomatic ventricular premature contractions should be avoided. In patients with structural heart disease, proarrhythmia and cardiac decompensation are a special risk associated with antiarrhythmic drugs. Special caution should be exercised when prescribing disopyramide for these patients. (See Precautions.)

Produktu pārskats:

Visual Identification: Size No 2 hard gel cap containing white pdr. Cap &body opaque white. Printed RY on one part and 150 on the other, in black; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 2 Years; Container Temperature: Store below 30 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Autorizācija statuss:

Registered

Autorizācija datums:

1991-08-30

Lietošanas instrukcija

Rythmodan®
1
RYTHMODAN®
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 RYTHMODAN®?
Rythmodan® contains the active ingredient disopyramide. Rythmodan®
is used to treat and prevent ventricular arrhythmias
(irregular heartbeat).
For more information, see Section 1. Why am I using Rythmodan®? in
the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE RYTHMODAN®?
Do not use if you have ever had an allergic reaction to Rythmodan 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
Rythmodan®? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Rythmodan® 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 RYTHMODAN®?
•
The dose of Rythmodan may be different for each person. Your doctor
will decide the right dose for you.
•
The daily dose of Rythmodan is usually taken in three equally divided
doses.
More instructions can be found in Section 4. How do I use Rythmodan®?
in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING RYTHMODAN®?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
Rythmodan.
•
Inform your doctor if you become pregnant while taking Rythmodan.
THINGS YOU
SHOULD NOT DO
•
Do not stop using this medicine suddenly or lower the dosage.
•
Do not take Rythmodan to treat any other complaints unless your doctor
or pharmacist tells you to.
DRIVING OR USING
MACHINES
•
Be careful driving or operating machinery until you know how Rythmodan
affects you.
•
Rythmodan may cause izziness, light- headedness or fainting in some
people.
DRINKING
ALCOHOL
•
The effects of alcohol

Produkta apraksts

rythmodan-ccdsv6-piv7-21aug20
Page 1 of 15
AUSTRALIAN PRODUCT INFORMATION – RYTHMODAN
(DISOPYRAMIDE)
1
NAME OF THE MEDICINE
Disopyramide
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Rythmodan 100mg capsule contains 100mg of disopyramide.
Each Rythmodan 150mg
#
capsule contains 150mg of disopyramide.
#
Not marketed
EXCIPIENTS WITH KNOWN EFFECT:
The gelatin capsule contains sulfites.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Hard capsule.
100 mg capsules: Size no 2 two toned gel caps containing white powder.
The cap is opaque
green and the body opaque beige, printed with RY one part and RL on
other in black.
150 mg capsules
#
: Size No 2 hard gel cap containing white powder. The cap and body are
opaque white, printed with RY on one part and 150 on the other in
black.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Rythmodan capsules are indicated for the management of documented
ventricular
arrhythmias, such as sustained ventricular tachycardia, which are
judged to be life
threatening. Because of its proarrhythmic potential, the use of
disopyramide is not
recommended for lesser arrhythmias.
Treatment of asymptomatic ventricular premature contractions should be
avoided.
In patients with structural heart disease, proarrhythmia and cardiac
decompensation are a
special risk associated with antiarrhythmic medicines. Special caution
should be exercised
rythmodan-ccdsv6-piv7-21aug20
Page 2 of 15
when prescribing disopyramide for these patients (See Section 4.4
Special warnings and
precautions for use).
4.2
DOSE AND METHOD OF ADMINISTRATION
The daily dose of Rythmodan capsules must be administered as no less
than 3 equal divided
doses.
ADULTS WITH NORMAL HEPATIC AND RENAL FUNCTION
The recommended dosage in adults with normal hepatic and renal
functions is 300 to 800 mg
daily.
Treatment should be initiated at 400 - 600 mg per day. The effective
maintenance dose is
then reached by progressively reducing the starting dose by no more
than 100 mg per day to
reach a final