Repaglinide 1mg 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:

1mg

Pharmaceutical form:

Tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 06010203; GTIN: 5012617020239 5012617020222

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 1MG TABLETS
Summary of Product Characteristics Updated 11-Jul-2016 | Accord-UK Ltd
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1. Name of the medicinal product
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2. Qualitative and quantitative composition
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3. Pharmaceutical form
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4. Clinical particulars
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4.1 Therapeutic indications
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4.2 Posology and method of administration
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4.3 Contraindications
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4.4 Special warnings and precautions for use
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4.5 Interaction with other medicinal products and other forms of
interaction
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4.6 Fertility, pregnancy and lactation
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4.7 Effects on ability to drive and use machines
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4.8 Undesirable effects
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4.9 Overdose
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5. Pharmacological properties
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5.1 Pharmacodynamic properties
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5.2 Pharmacokinetic properties
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5.3 Preclinical safety data
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6. Pharmaceutical particulars
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6.1 List of excipients
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6.2 Incompatibilities
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6.3 Shelf life
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6.4 Special precautions for storage
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6.5 Nature and contents of container
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6.6 Special precautions for disposal and other handling
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7. Marketing authorisation holder
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8. Marketing authorisation number(s)
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9. Date of first authorisation/renewal of the authorisation
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10. Date of revision of the text
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11. Dosimetry
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12 Instructions for preparation of radiopharmaceuticals
1. Name of the medicinal product
Repaglinide 1mg Tablets
2. Qualitative and quantitative composition
Each tablet contains 1 mg of repaglinide.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Tablet
Repaglinde 1mg Tablets are mottled yellow, round, biconvex and
engraved with RE1 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