ARATAC 100 Tablet

País: Austràlia

Idioma: anglès

Font: Department of Health (Therapeutic Goods Administration)

ingredients actius:

amiodarone hydrochloride, Quantity: 100 mg

Disponible des:

Alphapharm Pty Ltd

formulario farmacéutico:

Tablet, uncoated

Composición:

Excipient Ingredients: crospovidone; microcrystalline cellulose; purified talc; povidone; lactose monohydrate; magnesium stearate; colloidal anhydrous silica

Vía de administración:

Oral

Unidades en paquete:

30 tablets

tipo de receta:

(S4) Prescription Only Medicine

indicaciones terapéuticas:

Severe cases of tachyarrhythmias (e.g. Wolff-Parkinson-White syndrome; supraventricular, nodal and ventricular tachycardias; atrial flutter and fibrillation; ventricular fibrillation) not responding to other therapy. Treatment should be initiated in hospital. It is recommended that the patient should be regularly monitored for possible toxicity (e.g. thyroid function, chest X-ray, ophthalmological examination, liver function etc.) during the entire course of therapy and for several months after discontinuation.

Resumen del producto:

Visual Identification: Normal convex white uncoated tablets marked "AM" breakline "100" on one side and "G" on the reverse.; 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

Estat d'Autorització:

Registered

Data d'autorització:

1991-10-30

Informació per a l'usuari

ARATAC
_amiodarone hydrochloride_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Aratac.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have benefits and
risks. Your doctor has weighed the
risks of you taking Aratac against the
benefits expected for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, TALK TO YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH YOUR
MEDICINE.
You may need to read it again.
WHAT ARATAC IS USED
FOR
Aratac is used to control a fast or
irregular heart beat.
Aratac belongs to a group of
medicines called antiarrhythmics. It
works by lengthening the gap
between one heartbeat and the next,
helping to bring the heart rate to a
slower and more regular pace.
ASK YOUR DOCTOR OR PHARMACIST IF
YOU HAVE ANY QUESTIONS ABOUT WHY
ARATAC HAS BEEN PRESCRIBED FOR
YOU.
Your doctor may have prescribed
Aratac for another reason.
Aratac is not recommended for use in
children, as its safety and
effectiveness in children has not been
established.
Aratac is available only with a
doctor's prescription.
There is no evidence that Aratac is
addictive.
BEFORE YOU TAKE
ARATAC
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE ARATAC IF YOU ARE
ALLERGIC TO:
•
AMIODARONE HYDROCHLORIDE (EG.
CORDARONE X)
•
IODINE
•
ANY OF THE INGREDIENTS LISTED AT
THE END OF THIS LEAFLET.
Some of the symptoms of an allergic
reaction may include skin rash,
itching or hives, swelling of the face,
lips or tongue which may cause
difficulty in swallowing or breathing,
coughing, an asthma attack or
hayfever.
DO NOT TAKE ARATAC IF YOU HAVE OR
HAVE HAD ANY THYROID PROBLEMS.
DO NOT TAKE ARATAC IF YOU HAVE
HEART PROBLEMS THAT MAY CAUSE YOU
TO FAINT.
If you have a pacemaker, your doctor
may allow the use of it.
DO NOT TAKE ARATAC IF YOU HAVE ANY
IF THE FOLLOWING:
•
low blood pressure
•
heart disease or failure.
•
severe problems in breathing
respiratory failure
•
shock
DO NOT TAKE ARATAC IF YOU ARE
P

Fitxa tècnica

AUSTRALIAN PRODUCT INFORMATION
ARATAC
_Amiodarone hydrochloride _
1
NAME OF THE MEDICINE
Amiodarone hydrochloride
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Amiodarone hydrochloride is a Class III antiarrhythmic agent.
Aratac 100 and Aratac 200 tablets contain 100 mg and 200 mg amiodarone
hydrochloride, as the active
ingredient, respectively.
List of excipients with known effect:
Aratac also contains sulfites and sugars as lactose.
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Aratac 100: White, marked "AM" breakline "100" on one side and "G" on
other.
Aratac 200: White, marked "AM" breakline "200" on one side and "G" on
other.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Severe cases of tachyarrhythmias (e.g. Wolff-Parkinson-White syndrome;
supraventricular, nodal and
ventricular tachycardias; atrial flutter and fibrillation; ventricular
fibrillation) not responding to other therapy.
Treatment should be initiated in hospital. It is recommended that the
patient should be regularly monitored for
possible toxicity (e.g. thyroid function, chest X-ray,
ophthalmological examination, liver function etc.) during
the entire course of therapy and for several months after
discontinuation.
4.2
DOSE AND METHOD OF ADMINISTRATION
Due to poor absorption and wide inter-patient variability of
absorption, the initial loading and subsequent
maintenance dosage schedules of the drug in clinical use has to be
individually titrated. It is particularly
important that the minimum effective dose be used. In all cases the
patient's management must be judged on
the individual response and well being. The following dosage regimen
is usually effective.
ADULTS
Initial Stabilisation. Treatment should be started with 200 mg three
times daily and may be continued for 1
week. The dosage should then be reduced to 200 mg twice daily for a
further week.
Maintenance. After the initial period the dosage should be reduced to
200 mg daily, or less if appropriate.
Rarely, the patient may require a higher