Amiodarone 100mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

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Patient Information leaflet (PIL)

21-04-2020

Summary of Product characteristics (SPC)

05-05-2020

Public Assessment Report (PAR)

20-04-2020

Active ingredient:

Amiodarone hydrochloride

Available from:

IVAX Pharmaceuticals UK Ltd

ATC code:

C01BD01

INN (International Name):

Amiodarone hydrochloride

Dosage:

100mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 02030200

Patient Information leaflet

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Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Amiodarone hydrochloride 100mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Amiodarone Hydrochloride 100mg tablet contains 100mg amiodarone
hydrochloride.
Excipients with known effect:
This medicinal product contains lactose monohydrate.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablet.
_AMIODARONE HYDROCHLORIDE 100MG TABLETS: _
Amiodarone Tablets 100mg are white, flat, with a breakline and marked
with "100"
on one side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment should be initiated and normally monitored only under
hospital or
specialist supervision. Amiodarone Tablets are indicated only for the
treatment of
severe rhythm disorders not responding to other therapies or when
other treatments
cannot be used.
Tachyarrhythmias associated with Wolff-Parkinson-White Syndrome.
Atrial flutter and fibrillation when drugs cannot be used.
All types of tachyarrhythmias of paroxysmal nature including:
supraventricular, nodal
and ventricular tachycardias, ventricular fibrillation; when other
drugs cannot be
used.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_ADULTS _
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 generally effective.
_INITIAL STABILISATION _
Treatment should be started with 200mg, three times a day and may be
continued for
1 week. The dosage should then be reduced to 200mg, twice daily for a
further week.
_MAINTENANCE _
After the initial period the dosage should be reduced to 200mg daily,
or less if
appropriate. Rarely, the patient may require a higher maintenance
dose. The scored
100mg tablet should be used to titrate the minimum dosage required to
maintain
control of the arrhythmia. The maintenance dose should be regularly
reviewed,
especially where this exceeds 200mg daily.
_ _
_GENERAL CONSIDERATIONS_
Initial dosing
A high dos

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Amiodarone 100mg tablets

Active ingredient:

Available from:

ATC code:

INN (International Name):

Dosage:

Pharmaceutical form:

Administration route:

Class:

Prescription type:

Product summary:

Patient Information leaflet

Summary of Product characteristics

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