Tandemact
Land: Europäische Union
Sprache: Englisch
Quelle: EMA (European Medicines Agency)
Gebrauchsinformation
(PIL)
13-09-2023
Fachinformation
(SPC)
13-09-2023
Öffentlichen Beurteilungsberichts
(PAR)
14-06-2016
Wirkstoff:
pioglitazone, glimepiride
Verfügbar ab:
CHEPLAPHARM Arzneimittel GmbH
ATC-Code:
A10BD06
INN (Internationale Bezeichnung):
pioglitazone, glimepiride
Therapiegruppe:
Drugs used in diabetes
Therapiebereich:
Diabetes Mellitus, Type 2
Anwendungsgebiete:
Tandemact is indicated for the treatment of patients with type-2 diabetes mellitus who show intolerance to metformin or for whom metformin is contraindicated and who are already treated with a combination of pioglitazone and glimepiride.
Produktbesonderheiten:
Revision: 22
Berechtigungsstatus:
Authorised
Berechtigungsdatum:
2007-01-08
Gebrauchsinformation
29
B. PACKAGE LEAFLET
30
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
TANDEMACT 30 MG/2 MG TABLETS
TANDEMACT 30 MG/4 MG TABLETS
pioglitazone/glimepiride
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 Tandemact is and what it is used for
2.
What you need to know before you take Tandemact
3.
How to take Tandemact
4.
Possible side effects
5.
How to store Tandemact
6.
Contents of the pack and other information
1.
WHAT TANDEMACT IS AND WHAT IT IS USED FOR
Tandemact contains pioglitazone and glimepiride which are
anti-diabetic medicines, used to control
blood sugar level.
It is used in adults when metformin is not suitable to treat type 2
(non-insulin dependent) diabetes
mellitus. This type 2 diabetes usually develops in adulthood where the
body either does not produce
enough insulin (a hormone that controls blood sugar levels), or cannot
effectively use the insulin it
produces.
Tandemact helps control the level of sugar in your blood when you have
type 2 diabetes by increasing
the amount of insulin available and helping your body make better use
of it. Your doctor will check
whether Tandemact is working 3 to 6 months after you start taking it.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE TANDEMACT
DO NOT TAKE TANDEMACT
-
if you are allergic to pioglitazone, glimepiride, other sulphonylureas
or sulphonamides, or any
of the other ingredients of this medicine (listed in section 6)
-
if you have heart failure or have had heart failure in the past
-
if you have liver disease
-
if you have diabetic ketoacidos
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Fachinformation
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Tandemact 30 mg/2 mg tablets
Tandemact 30 mg/4 mg tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Tandemact 30 mg/2 mg tablets
Each tablet contains 30 mg of pioglitazone (as hydrochloride) and 2 mg
of glimepiride.
_Excipient with known effect_
Each tablet contains approximately 125 mg lactose monohydrate (see
section 4.4).
Tandemact 30 mg/4 mg tablets
Each tablet contains 30 mg of pioglitazone (as hydrochloride) and 4 mg
of glimepiride.
_Excipient with known effect_
Each tablet contains approximately 177 mg lactose monohydrate (see
section 4.4).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet
Tandemact 30 mg/2 mg tablets
White to off-white, round, convex and debossed ‘4833 G’ on one
face and ‘30/2’ on the other.
Tandemact 30 mg/4 mg tablets
White to off-white, round, convex and debossed ‘4833 G’ on one
face and ‘30/4’ on the other.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Tandemact is indicated as second line treatment of adult patients with
type 2 diabetes mellitus who
show intolerance to metformin or for whom metformin is contraindicated
and who are already treated
with a combination of pioglitazone and glimepiride.
After initiation of therapy with pioglitazone, patients should be
reviewed after 3 to 6 months to assess
adequacy of response to treatment (e.g. reduction in HbA
1c
). In patients who fail to show an adequate
response, pioglitazone should be discontinued. In light of potential
risks with prolonged therapy,
prescribers should confirm at subsequent routine reviews that the
benefit of pioglitazone is maintained
(see section 4.4).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The recommended dose of Tandemact is one tablet taken once daily.
If patients report hypoglycaemia, the dose of Tandemact should be
reduced or free combination
therapy should be considered.
3
If patients are receiving pioglitazone in combination with a
sulphonylurea other than glimepiri
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