GLUCO-RITE

País: Israel

Idioma: anglès

Font: Ministry of Health

ingredients actius:

GLIPIZIDE

Disponible des:

PADAGIS ISRAEL PHARMACEUTICALS LTD, ISRAEL

Codi ATC:

A10BB07

formulario farmacéutico:

TABLETS

Composición:

GLIPIZIDE 5 MG

Vía de administración:

PER OS

tipo de receta:

Required

Fabricat per:

PADAGIS ISRAEL PHARMACEUTICALS LTD, ISRAEL

Grupo terapéutico:

GLIPIZIDE

Área terapéutica:

GLIPIZIDE

indicaciones terapéuticas:

Is indicated as an adjunct to diet for the control of hyperglycemia and its associated symptomatology in patients with diabetes mellitus type II

Data d'autorització:

2015-01-31

Informació per a l'usuari

PATIENT LEAFLET IN ACCORDANCE WITH THE
PHARMACISTS‘ REGULATIONS
)PREPARATIONS( - 1986
This medicine is dispensed with a doctor’s
prescription only
GLUCO-RITE
5 MG TABLETS
EACH TABLET CONTAINS 5 MG GLIPIZIDE
Inactive
ingredients
and
allergens
in
the
medicine: see section 2 ‘IMPORTANT INFORMATION
ABOUT SOME OF THE INGREDIENTS OF GLUCO-RITE’
and section 6 in the leaflet.
READ THE ENTIRE LEAFLET CAREFULLY BEFORE USING
THE
MEDICINE.
This
leaflet
contains
concise
information about the medicine. If you have any
further questions, refer to the doctor or pharmacist.
Keep this leaflet, you may want to read it again. This
medicine has been prescribed for the treatment
of your illness. Do not pass it on to others. It may
harm them, even if it seems to you that their illness
is similar.
1. WHAT IS THE MEDICINE INTENDED
FOR?
Gluco-Rite is used for control of hyperglycemia
)high blood sugar levels( and the accompanying
symptoms in patients with type 2 diabetes in
addition to a change in diet.
THERAPEUTIC GROUP: Medicine to lower blood
sugar level from the sulphonylurea group.
2. BEFORE USING THE MEDICINE DO NOT USE GLUCO-RITE IF:
• You are hypersensitive )allergic( to the active
ingredient glipizide, to another similar antidiabetic
drug or to any of the other ingredients this
medicine contains )see section 6(.
• You have juvenile diabetes )type 1 diabetes
which probably began in your childhood and is
an insulin-dependent diabetes(.
• Ketone bodies or sugar have appeared in your
urine )you may suffer from diabetic ketoacidosis(.
• You suffer from episodes of unconsciousness
)you may suffer from diabetic coma(.
• You suffer from problems with the kidneys or
liver.
• You are pregnant, planning to become pregnant
or breastfeeding.
• You are currently taking miconazole to treat
fungal infections.
! SPECIAL WARNINGS REGARDING THE USE OF
THE MEDICINE
BEFORE STARTING TREATMENT WITH GLUCO-RITE, TELL
THE DOCTOR IF:
• You have been told that you have a problem with
the adrenal gland or the pituitary gland.
• You

Fitxa tècnica

SUMMARY OF PRODUCT
CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Gluco-Rite 5mg Tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Glipizide 5 mg
Excipient with known effect:
Each tablet contains 153 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Tablet.
White tablets, convex, scored with a break line on one side and with
'A' on the
other side.
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
Gluco-Rite is indicated as an adjunct to diet for the control of
hyperglycemia and its
associated symptomatology in patients with diabetes mellitus type II.
4.2 Posology and method of administration
PosologyAs for any hypoglycaemic agent, dosage must be adapted for
each
individual case.
Short term administration of glipizide may be sufficient during
periods of transient
loss of control in patients usually controlled well on diet.
In general, glipizide should be given shortly before a meal to achieve
the greatest
reduction in post-prandial hyperglycaemia.
Initial Dose
The recommended starting dose is 5 mg, given before breakfast or the
midday
meal. Mild diabetics, geriatric patients or those with liver disease
may be started
on 2.5 mg.
2
Titration
Dosage adjustments should ordinarily be in increments of 2.5 to 5 mg,
as
determined by blood glucose response. At least several days should
elapse
between titration steps. The maximum recommended single dose is 15 mg.
If this
is not sufficient, splitting the daily dosage may prove effective.
Doses above 15 mg
should ordinarily be divided.
Maintenance
Some patients may be effectively controlled on a once-a-day regimen.
Total daily
dosage above 15 mg should ordinarily be divided.
The maximum recommended daily dosage is 20 mg_._
Paediatric population
Safety and effectiveness in children have not been established.
Use in Elderly and High Risk Patients
In elderly, debilitated and malnourished patients or patients with an
impaired renal
or hepatic function, the initial and maintenance dosing should be
conservative to
avoid hypoglyca