Bilxona 30mg modified-release tablets

País: Reino Unido

Língua: inglês

Origem: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingredientes ativos:

Gliclazide

Disponível em:

Accord-UK Ltd

Código ATC:

A10BB09

DCI (Denominação Comum Internacional):

Gliclazide

Dosagem:

30mg

Forma farmacêutica:

Modified-release tablet

Via de administração:

Oral

Classe:

No Controlled Drug Status

Tipo de prescrição:

Valid as a prescribable product

Resumo do produto:

BNF: 06010201; GTIN: 5012617025531 5012617025548

Folheto informativo - Bula

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)
•
have insulin-dependent diabetes (type 1)
•
have ketone bodies and sugar in your urine
(this may mean you have diabetic keto-
acidosis), a diabetic pre-coma or coma
•
have severe kidney or liver disease
•
are taking medicines to treat fungal infections
(miconazole, see section ‘Other medicines and
Bilxona’)
•
are breast-feeding (see Section ‘Pregnancy
and breast-feeding’).
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking
Bilxona.
You should observe the treatment plan
prescribed

Características técnicas

OBJECT 1
BILXONA 30MG MODIFIED-RELEASE
TABLETS
Summary of Product Characteristics Updated 13-Nov-2019 | 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
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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
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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
•
6.2 Incompatibilities
•
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
•
7. Marketing authorisation holder
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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 30mg Modified-release Tablets
2. Qualitative and quantitative composition
Each modified-release tablet contains 30 mg gliclazide.
Excipient with known effect:
Each modified-release tablet contains 54 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 30mg Modified-release Tablets are white, oval, biconvex 5 x 11
mm tablets marked “G” on one side.
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 method of administration
Posology
The daily dose may vary from 1 to 4 tablets per day, _i.e_. from 30 to
120 mg taken orally i