Repaglinide 500microgram tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Repaglinide

Available from:

Actavis UK Ltd

ATC code:

A10BX02

INN (International Name):

Repaglinide

Dosage:

500microgram

Pharmaceutical form:

Tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 06010203; GTIN: 5012617020253 5012617020246

Patient Information leaflet

AAAI6580
Repaglinide 0.5mg 1mg and 2mg tablet leaflet - UK
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TECHNICAL APPROVAL
AAAI6580
1
12.01.16
jh
Malta Zejtun
190 x 380
9
N/A
N/A
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START
TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or
pharmacist.
• This medicine has been prescribed for you only. Do
not pass it on to others. It may harm them, even if
their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects not
listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1
WHAT REPAGLINIDE TABLETS ARE AND WHAT THEY
ARE USED FOR
2 WHAT YOU NEED TO KNOW BEFORE YOU TAKE
3 HOW TO TAKE
4 POSSIBLE SIDE EFFECTS
5 HOW TO STORE
6 CONTENTS OF THE PACK AND OTHER INFORMATION
1 WHAT REPAGLINIDE TABLETS ARE AND WHAT THEY
ARE USED FOR
Repaglinide tablets are an oral antidiabetic medicine
containing repaglinide_ _which helps your pancreas produce
more insulin and thereby lower your blood sugar (glucose).
Type 2 diabetes is a disease in which your pancreas does
not make enough insulin to control the sugar in your blood
or where your body does not respond normally to the
insulin it produces.
Repaglinide is used to control type 2 diabetes in adults as
an add-on to diet and exercise: treatment is usually started
if diet, exercise and weight reduction alone have not been
able to control (or lower) your blood sugar. Repaglinide
can also be given with metformin, another medicine for
diabetes.
Repaglinide has been shown to lower the blood sugar,
which helps to prevent complications from your diabetes.
2 WHAT YOU NEED TO KNOW BEFORE YOU TAKE
DO NOT TAK

Summary of Product characteristics

OBJECT 1
REPAGLINIDE 0.5 MG TABLETS
Summary of Product Characteristics Updated 11-Jul-2016 | Accord-UK Ltd
1. Name of the medicinal product
Repaglinide 0.5 mg Tablets
2. Qualitative and quantitative composition
Each tablet contains 0.5 mg of repaglinide.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Tablet
Repaglinde 0.5 mg Tablets are white, round, biconvex and engraved with
RE on one side.
4. Clinical particulars
4.1 Therapeutic indications
Repaglinide is indicated in adults with type 2 diabetes mellitus whose
hyperglycaemia can no longer be
controlled satisfactorily by diet, weight reduction and exercise.
Repaglinide is also indicated in
combination with metformin in adults with type 2 diabetes mellitus who
are not satisfactorily controlled
on metformin alone.
Treatment should be initiated as an adjunct to diet and exercise to
lower the blood glucose in relation to
meals.
4.2 Posology and method of administration
Posology
Repaglinide is given preprandially and is titrated individually to
optimise glycaemic control. In addition
to the usual self-monitoring by the patient of blood and/or urinary
glucose, the patient's blood glucose
must be monitored periodically by the physician to determine the
minimum effective dose for the patient.
Glycosylated haemoglobin levels are also of value in monitoring the
patient's response to therapy.
Periodic monitoring is necessary to detect inadequate lowering of
blood glucose at the recommended
maximum dose level (i.e. primary failure) and to detect loss of
adequate blood glucose lowering response
after an initial period of effectiveness (i.e. secondary failure).
Short-term administration of repaglinide may be sufficient during
periods of transient loss of control in
type 2 diabetic patients usually controlled well on diet.
_Initial dose_
The dosage should be determined by the physician, according to the
patient's requirements.
The recommended starting dose is 0.5 mg. One to two weeks should
elapse between titration steps (as
determined by blood gluco