Amiodarone 200mg tablets

Krajina: Spojené kráľovstvo

Jazyk: angličtina

Zdroj: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktívna zložka:

Amiodarone hydrochloride

Dostupné z:

Medreich Plc

ATC kód:

C01BD01

INN (Medzinárodný Name):

Amiodarone hydrochloride

Dávkovanie:

200mg

Forma lieku:

Oral tablet

Spôsob podávania:

Oral

Trieda:

No Controlled Drug Status

Typ predpisu:

Valid as a prescribable product

Prehľad produktov:

BNF: 02030200; GTIN: 05060292740621

Príbalový leták

1
4
50 MM
•
Trembling when you move your arms or legs
•
Blue or grey marks on parts of your skin exposed to sunlight,
especially the face
UNCOMMON
(affects less than 1 in 100 people)
•
Muscle cramps, stiffness or spasm
VERY RARE
(affects less than 1 in 10,000 people)
•
Swelling of the testicles
•
Red, scaly patches of skin, loss of hair or loosening of nails (called
‘exfoliative dermatitis’)
•
Feeling tired, faint, dizzy or having pale skin. These could be signs
of anaemia
•
You may bleed or bruise more easily than usual. This could be because
of a blood disorder (called
‘thrombocytopenia’)
•
Feeling unwell, confused or weak, feeling sick (nausea), loss of
appetite, feeling irritable. This
could be an illness called ‘syndrome of inappropriate anti-diuretic
hormone secretion’ (SIADH)
NOT KNOWN
(frequency cannot be estimated from the available data)
•
Severe stomach pain which may reach through to your back. This could
be a sign of pancreatitis
TELL YOUR DOCTOR OR PHARMACIST IF ANY OF THE FOLLOWING SIDE EFFECTS
GET SERIOUS OR LASTS LONGER THAN
A FEW DAYS:
VERY COMMON
(affects more than 1 in 10 people).
•
Feeling sick (nausea) or being sick (vomiting)
•
Change in the way things taste, often a metallic taste
•
Changes in the amount of liver enzymes at the beginning of treatment.
This can be seen in blood tests
•
Burning more easily in the sun (see ‘Protect your skin from
sunlight’ in Section 2)
COMMON
(affects less than 1 in 10 people)
•
Slightly slower heart beat
•
Nightmares
•
Problems sleeping
•
Constipation
•
Scaly and itchy rash (eczema)
•
Decrease in sex drive
UNCOMMON
(affects less than 1 in 100 people)
•
Dry mouth
VERY RARE
(affects less than 1 in 10,000 people)
•
Headache
•
Balance problems, feeling dizzy (vertigo)
•
Difficulty in getting or maintaining an erection or in ejaculating
•
Hair loss, balding
•
Skin rash
•
Skin redness during radiotherapy
NOT KNOWN
(frequency cannot be estimated from the available data)
•
Hives (itchy, lumpy ras

Súhrn charakteristických

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Amiodarone 200 mg Tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 200mg of amiodarone hydrochloride.
Excipients with known effect:
Each tablet contains 50mg lactose monohydrate
For the full list of the excipients: see 6.1.
3.
PHARMACEUTICAL FORM
Tablet
Diameter: 9.5mm.
Amiodarone 200mg Tablets are round, white, flat tablets with a central
division line
on one face and embossed “200” on the reverse.
The score line is only to facilitate
breaking for ease of swallowing and not to divide into equal doses.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment should be initiated and normally monitored only under
hospital or
specialist supervision. Oral Amiodarone hydrochloride is 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 other 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
wellbeing. 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 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 maintenance
dose. The scored
100 mg tablet should be used to titrate the minimum dosage required to
maintain
control of the arrhythmia. The maintenance dose should be regularly
reviewed,
especially wher