AMIOCARD

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

AMIODARONE HYDROCHLORIDE

Available from:

CTS CHEMICAL INDUSTRIES LTD, ISRAEL

ATC code:

C01BD01

Pharmaceutical form:

TABLETS

Composition:

AMIODARONE HYDROCHLORIDE 200 MG

Administration route:

PER OS

Prescription type:

Required

Manufactured by:

CTS CHEMICAL INDUSTRIES LTD

Therapeutic group:

AMIODARONE

Therapeutic area:

AMIODARONE

Therapeutic indications:

Coronary insufficiency arrhythmias resistant to other treatments.

Authorization date:

2020-11-30

Patient Information leaflet

PATIENT LEAFLET IN ACCORDANCE WITH THE
PHARMACISTS’ REGULATIONS (PREPARATIONS) – 1986
THE MEDICINE IS DISPENSED WITH A DOCTOR'S
PRESCRIPTION ONLY
AMIOCARD TABLETS 200 MG
Each tablet contains: Amiodarone Hydrochloride 200 mg
For inactive ingredients and allergens in the preparation –
see section 2 “Important information about some ingredients
of the medicine” and section 6 “Additional information”.
READ THE ENTIRE LEAFLET CAREFULLY BEFORE USING THE
MEDICINE. This leaflet contains concise information about the
medicine. If you have any other questions, refer to the doctor
or the pharmacist.
This medicine has been prescribed for treatment of your
illness. Do not pass it on to others. It may harm them even if it
seems to you that their medical condition is similar.
This medicine is not intended for babies and children.
1. WHAT IS THE MEDICINE INTENDED FOR?
The medicine is intended for treatment of coronary
insufficiency and arrhythmias resistant to other treatments.
THERAPEUTIC CLASS: Antiarrhythmic drugs.
The mechanism of action of this medicine controls irregular
heartbeats (a phenomenon called arrhythmia). Taking the
tablet helps the heartbeats to return to normal.
2. BEFORE USING THE MEDICINE:
DO NOT USE THIS MEDICINE IF:
•
You are sensitive (allergic) to the active ingredient
amiodarone, to iodine or to any of the additional
components the medicine contains. Symptoms of an
allergic reaction include: rash, swallowing or breathing
difficulties, swelling of the lips, face or tongue.
•
You have or have had in the past slower than usual
heartbeats (a phenomenon called ‘sinus bradycardia’) or
an illness called ‘sino-atrial’ heart block.
•
You have other types of arrhythmias and you DO NOT
have an implanted pacemaker.
•
You suffer or have suffered in the past from thyroid
dysfunction. Your doctor should check your thyroid
function before beginning treatment with the medicine.
•
You are taking other medicines that may cause
arrhythmias (see section “Drug interactions”).
•
You are ta

Summary of Product characteristics

1
SUMMARY OF PRODCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
AMIOCARD
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
AMIOCARD contain 200mg of Amiodarone Hydrochloride. For
excipients, see 6.1
3
PHARMACEUTICAL FORM
Tablets
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Coronary insufficiency arrhythmias resistant to other treatments.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_INITIAL TREATMENT _
The usual dosage regimen is 3 tablets per day, for 8 to 10 days.
In some cases, the initial treatment has involved higher doses (4 to 5
tablets per day), always for
short periods and under electrocardiographic monitoring.
_MAINTENANCE TREATMENT _
Seek the minimum effective dose, which varies depending on the
patient, ranging from 1/2
tablet per day (1 tablet every 2 days) to 2 tablets every day.
4.3
CONTRAINDICATIONS
Hypersensitivity
to the active substance or to any of the excipients listed in section
6.1.
Sinus bradycardia and sino-atrial heart block. In patients with severe
conduction
disturbances (high grade AV block, bifascicular or trifascicular
block) or sinus node
disease, AMIOCARD should be used only in conjunction with a pacemaker.
Evidence or history of thyroid dysfunction. Thyroid function tests
should be performed
in all patients prior to therapy.
Known hypersensitivity to iodine or to amiodarone, or to any of the
excipients (One
200mg tablet contains approximately 75mg iodine).
The combination of AMIOCARD with drugs which may induce torsades de
pointes is
contra-indicated (see section 4.5).
Pregnancy - except in exceptional circumstances (see section 4.6)
Lactation (see section 4.6)
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Amiodarone can cause serious adverse reactions affecting the eyes,
heart, lung, liver, thyroid gland,
skin and peripheral nervous system (
_see section 4.8_
). Because these reactions may be delayed,
2
patients on long-term treatment should be carefully supervised and
reviewed regularly. As
undesirable effects are usually dose-related, the minimum effective
maintenance dose shou