Onglyza 2.5mg tablets

País: Reino Unido

Língua: inglês

Origem: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingredientes ativos:

Saxagliptin hydrochloride

Disponível em:

AstraZeneca UK Ltd

Código ATC:

A10BH03

DCI (Denominação Comum Internacional):

Saxagliptin hydrochloride

Dosagem:

2.5mg

Forma farmacêutica:

Tablet

Via de administração:

Oral

Classe:

No Controlled Drug Status

Tipo de prescrição:

Valid as a prescribable product

Resumo do produto:

BNF: ; GTIN: 5012712004011

Folheto informativo - Bula

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ONGLYZA 2.5 MG FILM-COATED TABLETS
ONGLYZA 5 MG FILM-COATED TABLETS
Saxagliptin
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, pharmacist or
nurse.
•
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, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Onglyza is and what it is used for
2.
What you need to know before you take Onglyza
3.
How to take Onglyza
4.
Possible side effects
5.
How to store Onglyza
6.
Contents of the pack and other information
1.
WHAT ONGLYZA IS AND WHAT IT IS USED FOR
Onglyza contains the active substance saxagliptin, which belongs to a
group of medicines called ‘oral
anti-diabetics’. They work by helping to control the level of sugar
in your blood.
Onglyza is used for adult patients aged 18 years and older with
‘type 2 diabetes’, if the disease cannot
be adequately controlled with one oral anti-diabetic medicine, diet
and exercise. Onglyza is used alone
or together with insulin or other oral anti-diabetic medicines.
It is important to keep following the advice about diet and exercise
that you have been given by your
doctor or nurse.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE ONGLYZA
DO NOT TAKE ONGLYZA
•
if you are allergic to saxagliptin or any of the other ingredients of
this medicine (listed in
section 6).
•
if you have had a serious allergic reaction to any other similar
medicines that you take to control
your blood sugar. See section 4.
WARNINGS AND PRECAUTIONS:
Talk to your doctor or pharmacist before taking Onglyza:
•
if you are taking insulin. Onglyza should not be used in place of
insulin;
•
if you have

Características técnicas

OBJECT 1
ONGLYZA 2.5MG & 5MG FILM-COATED TABLETS
Summary of Product Characteristics Updated 17-Oct-2017 | AstraZeneca
UK Limited
1. Name of the medicinal product
Onglyza 2.5 mg film-coated tablets
Onglyza 5 mg film-coated tablets
2. Qualitative and quantitative composition
Each tablet contains 2.5 mg saxagliptin (as hydrochloride).
Each tablet contains 5 mg saxagliptin (as hydrochloride).
Excipient(s) with known effect:
Each tablet contains 99 mg lactose (as monohydrate).
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Film-coated tablet (tablet).
Onglyza 2.5 mg tablets are pale yellow to light yellow, biconvex,
round, film-coated tablets, with “2.5”
printed on one side and “4214” printed on the other side, in blue
ink.
Onglyza 5 mg tablets are pink, biconvex, round, film-coated tablet,
with “5” printed on one side and
“4215” printed on the other side, in blue ink.
4. Clinical particulars
4.1 Therapeutic indications
Onglyza is indicated in adult patients with type 2 diabetes mellitus
as an adjunct to diet and exercise to
improve glycaemic control:
• as monotherapy when metformin is inappropriate due to intolerance
or contraindications
• in combination with other medicinal products for the treatment of
diabetes, including insulin, when
these do not provide adequate glycaemic control (see sections 4.4, 4.5
and 5.1 for available data on
different combinations).
4.2 Posology and method of administration
Posology
The recommended dose of Onglyza is 5 mg once daily. When Onglyza is
used in combination with
insulin or a sulphonylurea, a lower dose of the insulin or
sulphonylurea may be required to reduce the risk
of hypoglycaemia (see section 4.4).
The safety and efficacy of saxagliptin as triple oral therapy in
combination with metformin and a
thiazolidinedione have not been established.
Special populations
Elderly (≥ 65 years)
No dose adjustment is recommended based solely on age (see also
sections 5.1 and 5.2).
Renal impairment
No dose adjustment is recommended for patien