Bilxona 60mg modified-release tablets

Country: Ingilterra

Lingwa: Ingliż

Sors: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingredjent attiv:

Gliclazide

Disponibbli minn:

Actavis UK Ltd

Kodiċi ATC:

A10BB09

INN (Isem Internazzjonali):

Gliclazide

Dożaġġ:

60mg

Għamla farmaċewtika:

Modified-release tablet

Rotta amministrattiva:

Oral

Klassi:

No Controlled Drug Status

Tip ta 'preskrizzjoni:

Valid as a prescribable product

Sommarju tal-prodott:

BNF: 06010201; GTIN: 5012617025555 5012617025562

Fuljett ta 'informazzjoni

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AAAJ1992
BILXONA 30MG AND 60MG
MODIFIED-RELEASE TABLETS
Gliclazide
_Continued over page_
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 BILXONA IS AND WHAT IT IS USED FOR
2 WHAT YOU NEED TO KNOW BEFORE YOU TAKE BILXONA
3 HOW TO TAKE BILXONA
4 POSSIBLE SIDE EFFECTS
5 HOW TO STORE BILXONA
6 CONTENTS OF THE PACK AND OTHER INFORMATION
1 WHAT BILXONA IS AND WHAT IT IS USED FOR
Bilxona is a medicine that reduces blood sugar levels (oral anti-
diabetic medicine belonging to the sulphonylurea group).
Bilxona is used in a certain form of diabetes (type 2 diabetes
mellitus) in adults, when diet, exercise and weight loss alone do
not have an adequate effect on keeping blood sugar at the correct
level.
2 WHAT YOU NEED TO KNOW BEFORE YOU TAKE BILXONA
DO NOT TAKE BILXONA:
• if you are allergic to gliclazide or any of the other ingredients
of this medicine (listed in section 6), or to other medicines of
the same group (sulphonylureas), or to other related medicines
(hypoglycaemic sulphonamides)
• if you have insulin-dependent diabetes (type 1)
• if you have ketone bodies and sugar in your urine (this may mean
you have diabetic keto-acidosis), a diabetic pre-coma or coma
• if you have severe kidney or liver disease
• if you are taking medicines to treat fungal infections
(miconazole,
see section ‘Other medicines and Bilxona’)
• if you are breastfeeding (see Section ‘Pregnancy and
breastfeeding’).
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacis

Karatteristiċi tal-prodott

OBJECT 1
BILXONA 60MG MODIFIED-RELEASE TABLETS
Summary of Product Characteristics Updated 30-Aug-2016 | Accord-UK Ltd
•
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
Bilxona 60mg Modified-release Tablets
2. Qualitative and quantitative composition
Each modified-release tablet contains 60 mg gliclazide.
Excipient with known effect:
Each modified-release tablet contains 108 mg lactose (as the
monohydrate) (see section 4.4)
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Modified-release tablet.
Bilxona 60 mg modified-release tablets are white, oval, biconvex 7 x
15 mm tablets scored on both sides,
marked with “G“ on one side of the score and “60“ on the other
side of the score. The tablet can be
divided into equal doses.
4. Clinical particulars
4.1 Therapeutic indications
Non insulin-dependent diabetes (type 2) in adults when dietary
measures, physical exercise and weight
loss alone are not sufficient to control blood glucose.
4.2 Posology and