Pioglitazone 45mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Pioglitazone hydrochloride

Available from:

Actavis UK Ltd

ATC code:

A10BG03

INN (International Name):

Pioglitazone hydrochloride

Dosage:

45mg

Pharmaceutical form:

Tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 06010203

Patient Information leaflet

Pioglitazone 45mg PIL Central Procedure - UK & Eire
item no:
print proof no:
origination date:
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dimensions: 380 x 190
pharmacode:
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approved for print/date
Non Printing Colours
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date sent: 27.01.12
supplier:
technically app. date: 03.02.12
min pt size: 9pt, 10 Leading
_TECHNICAL APPROVAL_
Black
AAAD2169
6
26.01.12
R.Paul
13.02.12
R.Paul
Malta
PACKAGE LEAFLET:
INFORMATION FOR THE USER
PIOGLITAZONE ACTAVIS 45 MG TABLETS
Pioglitazone
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START
TAKING THIS MEDICINE.
•
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.
Do not pass it on to others. It may harm them,
even if their symptoms are the same as yours.
•
If any of the side effects gets serious, or if you
notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.
IN THIS LEAFLET:
1.
What Pioglitazone Actavis is and what it is used for
2.
Before you take Pioglitazone Actavis
3.
How to take Pioglitazone Actavis
4.
Possible side effects
5.
How to store Pioglitazone Actavis
6.
Further information
1. WHAT PIOGLITAZONE ACTAVIS IS AND WHAT IT
IS USED FOR
Pioglitazone Actavis contains pioglitazone. It is
an anti‑diabetic medicine used to treat type 2
(non‑insulin dependent) diabetes mellitus, when
metformin is not suitable or has failed to work
adequately. This is the diabetes that usually develops
in adulthood.
Pioglitazone Actavis helps control the level of sugar
in your blood when you have type 2 diabetes by
helping your body make better use of the insulin
it produces. Your doctor will check whether
Pioglitazone Actavis is working 3
to
6 months after
you start taking
it.
Pioglitazone Actavis may be used on its own in
patients who are unable to take metformin, and
where treatment with diet and exercise has failed
to control blood sugar or may be added to other
therapies (such as insulin) which

Summary of Product characteristics

OBJECT 1
PIOGLITAZONE 45 MG TABLETS
Summary of Product Characteristics Updated 04-Apr-2012 | Accord-UK Ltd
1. Name of the medicinal product
Pioglitazone Actavis 45 mg tablets
2. Qualitative and quantitative composition
Each tablet contains 45 mg of pioglitazone (as hydrochloride).
Excipients:
Each tablet contains 113.31 mg of lactose monohydrate (see section
4.4).
For a full list of excipients, see section 6.1.
3. Pharmaceutical form
Tablet.
The tablets are white, round, flat, bevelled, 8 mm in diameter and
engraved with 'TZ45' on one side.
4. Clinical particulars
4.1 Therapeutic indications
Pioglitazone is indicated as second or third line treatment of type 2
diabetes mellitus described below:
as MONOTHERAPY
- in adult patients (particularly overweight patients) inadequately
controlled by diet and exercise for
whom metformin is inappropriate because of contraindications or
intolerance.
- Pioglitazone is also indicated for combination with insulin in type
2 diabetes mellitus adult patients with
insufficient glycaemic control on insulin for whom metformin is
inappropriate because of
contraindications or intolerance (see section 4.4).
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 HbA1c). 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
Pioglitazone treatment may be initiated at 15 mg or 30 mg once daily.
The dose may be increased in
increments up to 45 mg once daily.
In combination with insulin, the current insulin dose can be continued
upon initiation of pioglitazone
therapy. If patients report hypoglycaemia, the dose of insulin should
be decreased.
Special population
_Elderly_
No dose adjustment is necessary for elderly patients (see section
5