Prandin 0.5mg tablets

Țară: Regatul Unit

Limbă: engleză

Sursă: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingredient activ:

Repaglinide

Disponibil de la:

Novo Nordisk Ltd

Codul ATC:

A10BX02

INN (nume internaţional):

Repaglinide

Dozare:

500microgram

Forma farmaceutică:

Tablet

Calea de administrare:

Oral

Clasă:

No Controlled Drug Status

Tip de prescriptie medicala:

Valid as a prescribable product

Rezumat produs:

BNF: 06010203; GTIN: 5017954001477 5017954001484

Prospect

_ _
1
PACKAGE LEAFLET: INFORMATION FOR THE USER
PRANDIN
® 0.5 MG TABLETS
PRANDIN
® 1 MG TABLETS
PRANDIN
® 2 MG TABLETS
Repaglinide
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 PRANDIN
® IS AND WHAT IT IS USED FOR
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE PRANDIN
®
3.
HOW TO TAKE PRANDIN
®
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE PRANDIN
®
6.
CONTENTS OF THE PACK AND OTHER INFORMATION
1.
WHAT PRANDIN
® IS AND WHAT IT IS USED FOR
Prandin
®
is 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.
Prandin
®
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. Prandin
®
can also be given with metformin, another medicine for diabetes.
Prandin
®
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 PRANDIN
®
DO NOT TAKE PRANDIN
®
•
If you are ALLERGIC to repaglinide or any of the other ingredients in
this medicine (listed in
section 6).
•
If you have TYPE 1 DIABETES.
•
If the acid level in your blood is raised (DIABETIC KETOACIDOSIS).
•
If you have a SE

Caracteristicilor produsului

OBJECT 1
PRANDIN 0.5MG TABLETS
Summary of Product Characteristics Updated 10-Jun-2016 | Novo Nordisk
Limited
•
1. Name of the medicinal product
•
2. Qualitative and quantitative composition
•
3. Pharmaceutical form
•
4. Clinical particulars
•
4.1 Therapeutic indications
•
4.2 Posology and method of administration
•
4.3 Contraindications
•
4.4 Special warnings and precautions for use
•
4.5 Interaction with other medicinal products and other forms of
interaction
•
4.6 Fertility, pregnancy and lactation
•
4.7 Effects on ability to drive and use machines
•
4.8 Undesirable effects
•
4.9 Overdose
•
5. Pharmacological properties
•
5.1 Pharmacodynamic properties
•
5.2 Pharmacokinetic properties
•
5.3 Preclinical safety data
•
6. Pharmaceutical particulars
•
6.1 List of excipients
•
6.2 Incompatibilities
•
6.3 Shelf life
•
6.4 Special precautions for storage
•
6.5 Nature and contents of container
•
6.6 Special precautions for disposal and other handling
•
7. Marketing authorisation holder
•
8. Marketing authorisation number(s)
•
9. Date of first authorisation/renewal of the authorisation
•
10. Date of revision of the text
1. Name of the medicinal product
Prandin 0.5 mg tablets
Prandin 1 mg tablets
Prandin 2 mg tablets
2. Qualitative and quantitative composition
Each tablet contains 0.5 mg of repaglinide or 1 mg of repaglinide or 2
mg of repaglinide.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Tablet
Repaglinide tablets are white (0.5 mg), yellow (1 mg), or
peach-coloured (2 mg), round and convex and
engraved with Novo Nordisk logo (Apis bull).
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 ini