‫רופא‬
‫בעלון ללרופא‬
‫בטיחות) בעלון‬
)‫מידע בטיחות‬
‫החמרה (( מידע‬
‫על החמרה‬
‫הודעה על‬
‫הודעה‬
2011 ‫ דצמבר‬6 :‫תאריך‬
Prandase 50/100 :‫שם תכשיר באנגלית‬
00 125 29 30520 00/ 125 30 30521 :‫מספר רישום‬
Bayer Israel Ltd :‫שם בעל הרישום‬
‫השינויים בעלון מסומנים על רקע צהוב‬
‫ים‬/‫ים המבוקש‬/‫פרטים על השינוי‬
‫טקסט חדש‬
Asymptomatic
liver
enzyme
elevations may occur in individual
cases. Therefore liver enzyme
monitoring should be considered
during the first 6 to 12 months of
treatment. In evaluable cases these
changes
were reversible on
discontinuation
of
Prandase
therapy.
‫טקסט נוכחי‬
Hypoglycaemia: When administered alone, Prandase does not cause hypoglycaemia. It
may, however, act to potentiate the hypoglycaemic effects of insulin and sulphonylurea
drugs, and the dosages of these agents may need to be modified accordingly. In individual
cases hypoglycaemic shock may occur (i.e. clinical sequelae of glucose levels < 1 mmol/L
such as altered conscious levels, confusion or convulsions).
Episodes of hypoglycaemia occurring during therapy must, where appropriate, be treated
by the administration of glucose, not sucrose. This is because acarbose will delay the
digestion and absorption of disaccharides, but not monosaccharides.
Transaminases: Patients treated with acarbose may, on rare occasions, experience an
idiosyncratic response with either symptomatic or asymptomatic hepatic dysfunction. In the
Safety and efficacy of Prandase in majority of cases this dysfunction is reversible on discontinuation of acarbose therapy. It is
patients under 18 years of age have recommended that liver enzyme monitoring is considered during the first six to twelve
not been established.
months of treatment. If elevated transaminases are observed, withdrawal of therapy may be
‫פרק בעלון‬
Warnings
warranted, particularly if the elevations persist. In such circumstances, patients should be
monitored at weekly intervals until normal values are established.
The administration of antacid preparations containing magnesium and aluminium salts, e.g.
hydrotalcite, has been shown not to ameliorate the acute gastrointestinal symptoms of
Prandase in higher dosage and should, therefore, not be recommended to patients for this
purpose.
Dosage
The dosage must be adjusted by the
doctor to suit each patient, because
efficacy and tolerability vary from
one
individual
to
another.
Treatment should begin with:
3x 1 tablet 50 mg Prandase/day
or 3x ½ tablet 100 mg Prandase /day
(corresponds to 150 mg
acarbose/day).
In some patients, a gradual increase
in the dosage of Prandase has
helped to reduce gastrointestinal
side effects, starting with:
1x to 2x 1 tablet 50 mg Prandase
/day
(corresponds to 50 to 100 mg
acarbose/day).
The dose can be gradually
Prandase tablets are taken orally and are effective only if swallowed whole with a little
liquid directly before the meal or be chewed with the first few mouthfuls of the meal, with
each one of the three main daily meals containing carbohydrates. Owing to the great
individual variation of glucosidase activity in the intestinal mucosa, there is no fixed
dosage regimen, and patients should be treated and titrated according to clinical response
and tolerance of intestinal side-effects.
Adults: The Recommended initial dose is 50 mg three times a day to be taken gradually as Dosage and
specified in the table below. If after four to eight weeks treatment patients show inadequate
clinical response, the dosage may be increased to 100 mg three times a day. administration
Acarbose Dosing Schedule*
________________Meal__________________
Week
1
2
Breakfast
½ 50 mg
Lunch
Dinner
-
½ 50 mg
-
½ 50
mg
increased, depending on the blood
glucose level, and also as treatment
progresses if it is not therapeutically
effective enough, up to:
3x 1 tablet 100 mg Prandase /day
(corresponds to 300 mg
acarbose/day).
The average dose is 150 to 300 mg
acarbose/day, depending on the
requirements of the individual
patient.
A further increase in dosage to:
3x 2 tablets 100 mg Prandase /day
(corresponds to 600 mg
acarbose/day).
may occasionally be necessary (see
also Section 4.8 "Undesirable
effects").
If distressing complaints develop in
spite of strict adherence to the diet,
the dose should not be increased
further, and if necessary should be
somewhat reduced.
Type and duration of administration
Prandase tablets are effective only
if swallowed whole with a little
liquid directly before the meal or if
chewed with the first few mouthfuls
3-4
½ 50 mg
½ 50 mg
½ 50 mg
5
½ 50 mg
½ 50 mg
50 mg
6
50 mg
½ 50 mg
50 mg
50 mg
50 mg
7-8
50 mg
See your patient evaluation
9 (if necessary)
10-11 (if necessary)
12 (if necessary)
50 mg
50 mg
100 mg
100 mg
50 mg
100 mg
100 mg
100 mg
100 mg
*Drug should be taken with the first bite of food of each meal.
A further increase in dosage to a maximum of 3 x 200mg. Prandase/day may occasionally
be necessary. If distressing complaints develop in spite of strict adherence to the diet, the
dose should not be increased further, and if necessary should be somewhat reduced. The
average dose is 300 mg Prandase/day (corresponding to 3 X 2 tablets of Prandase 50
mg/day, or 3 X 1 tablet of Prandase tablets 100 mg/day).Elderly (above 65 years): No
alteration of dosage or dosing frequency is recommended with regard to the age of the
patients.
of the meal.
It is not envisaged that there will be
any time restriction on the use of
Prandase.
In addition events reported as liver
disorder, hepatic function abnormal,
and liver injury have been received
especially from Japan.
Adverse
events