Pioglitazone Hydrochloride 45mg Tablets

Pays: Irlande

Langue: anglais

Source: HPRA (Health Products Regulatory Authority)

Ingrédients actifs:

Pioglitazone hydrochloride

Disponible depuis:

Wockhardt UK Limited

Code ATC:

A10BG; A10BG03

DCI (Dénomination commune internationale):

Pioglitazone hydrochloride

Dosage:

45 milligram(s)

forme pharmaceutique:

Tablet

Type d'ordonnance:

Product subject to prescription which may be renewed (B)

Domaine thérapeutique:

Thiazolidinediones; pioglitazone

Statut de autorisation:

Not marketed

Date de l'autorisation:

2018-07-20

Notice patient

CHANGE CONTROL : Version changes due to change in:
Size/Layout Regulatory Non-Regulatory
Changes in detail:
• Regulatory text amends
• Pharmacode re-positioned at 8mm from the cutting edge
WHAT IS IN THIS LEAFLET:
1. What Pioglitazone Tablets are and what they are used for
2.
What you need to know before you take Pioglitazone Tablets
3. How to take Pioglitazone Tablets
4. Possible side effects
5. How to store Pioglitazone Tablets
6. Contents of the pack and other information
1. WHAT PIOGLITAZONE TABLETS ARE AND WHAT THEY ARE USED FOR
Pioglitazone Tablets 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 Tablets 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
Tablets
is working 3 to 6 months after you start taking it.
Pioglitazone Tablets 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 metformin, sulphonylurea or insulin) which have failed to provide
sufficient control in blood sugar.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE PIOGLITAZONE TABLETS
DO NOT TAKE PIOGLITAZONE TABLETS
•
if you are allergic to pioglitazone or any of the other ingredients of
Pioglitazone Tablets (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 had diabetic ketoacidosis (a complication of diabetes
causing rapid weight loss, nausea or vomiting).
• if you have or have ever had bladder cancer.
• if you have blood in your urine that your doctor has not checked.
WARNINGS AND PRECAUTIONS
Talk to your doctor, pharmacist or nurse before taking Pioglitazone
Tablets if any of

Résumé des caractéristiques du produit

Health Products Regulatory Authority
19 October 2018
CRN008L6M
Page 1 of 16
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Pioglitazone Hydrochloride 45mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 49.59mg pioglitazone hydrochloride, equivalent to
45mg
pioglitazone
Excipients with known effect:
Each 45 mg tablet contains 115.21mg of lactose monohydrate (see
section 4.4).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet.
Pioglitazone Tablets 45 mg tablets are white to off-white, round, flat
beveled tablet
debossed with
on one side and plain on other side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Pioglitazone is indicated as second or third line treatment of type 2
diabetes mellitus
as 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
as DUAL ORAL THERAPY in combination with
- metformin, in adult patients (particularly overweight patients) with
insufficient
glycaemic control despite maximal tolerated dose of monotherapy with
metformin
- a sulphonylurea, only in adult patients who show intolerance to
metformin or for
whom metformin is contraindicated, with insufficient glycaemic control
despite
maximal tolerated dose of monotherapy with a sulphonylurea.
as TRIPLE ORAL THERAPY in combination with
- metformin and a sulphonylurea, in adult patients (particularly
overweight patients)
with insufficient glycaemic control despite dual oral therapy.
Health Products Regulatory Authority
19 October 2018
CRN008L6M
Page 2 of 16
- 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 adeq