Pioglitazone Teva

Основна информация

  • Търговско наименование:
  • Pioglitazone Teva
  • Използвай за:
  • Хората
  • Вид на лекарството:
  • алопатични наркотици

Документи

Локализация

  • Предлага се в:
  • Pioglitazone Teva
    Европейски съюз
  • Език:
  • английски

Терапевтична информация

  • Терапевтична група:
  • Alimentary tract and metabolism
  • Терапевтична област:
  • Diabetes Mellitus, Type 2
  • Терапевтични показания:
  • Pioglitazone is indicated in the treatment of type 2 diabetes mellitus:as monotherapy- in adult patients (particularly overweight patients) inadequately controlled by diet and exercise for whom metformin is inappropriate because of contraindications or intoleranceas 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 sulphonylureaas triple oral therapy in combination with- metformin and a sulphonylurea, in adult patients (particularly overweight patients) with insufficient glycaemic control despite dual oral therapy.Pioglitazone is also indicated for combination with insulin in type 2 diabetes mellitus adult patients with insufficient glycaemic control on insuli
  • Каталог на резюме:
  • Revision: 9

Състояние

  • Източник:
  • EMA - European Medicines Agency
  • Статус Оторизация:
  • Authorised
  • Номер на разрешението:
  • EMEA/H/C/002297
  • Дата Оторизация:
  • 26-03-2012
  • EMEA код:
  • EMEA/H/C/002297
  • Последна актуализация:
  • 12-05-2020

Доклад обществена оценка

7 Westferry Circus

Canary Wharf

London E14 4HB

United Kingdom

Telephone

+44 (0)20 7418 8400

Facsimile

+44 (0)20 7418 8416

E-mail

info@ema.europa.eu

Website

www.ema.europa.eu

An agency of the European Union

© European Medicines Agency, 2012. Reproduction is authorised provided the source is acknowledged.

EMA/222728/2012

EMEA/H/C/002297

EPAR summary for the public

Pioglitazone Teva

pioglitazone

This is a summary of the European public assessment report (EPAR) for Pioglitazone Teva. It explains

how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its

opinion in favour of granting a marketing authorisation and its recommendations on the conditions of

use for Pioglitazone Teva.

What is Pioglitazone Teva?

Pioglitazone Teva is a medicine that contains the active substance pioglitazone. It is available as

tablets (15, 30 and 45 mg).

Pioglitazone Teva is a ‘generic medicine’. This means that Pioglitazone Teva is similar to a ‘reference

medicine’ already authorised in the European Union (EU) called Actos. For more information on generic

medicines, see the question-and-answer document here

What is Pioglitazone Teva used for?

Pioglitazone Teva is used to treat type 2 diabetes in adults (aged 18 years or over), particularly those

who are overweight. It is used in addition to diet and exercise.

Pioglitazone Teva is used on its own in patients for whom metformin (another antidiabetes medicine) is

not suitable.

Pioglitazone Teva can also be used in combination with metformin in patients who are not satisfactorily

controlled on metformin alone, or with a sulphonylurea (another type of antidiabetes medicine) when

metformin is not suitable (‘dual therapy’).

Pioglitazone Teva can also be used together with both metformin and a sulphonylurea in patients who

are not satisfactorily controlled despite dual therapy by mouth (‘triple therapy’).

Pioglitazone Teva can also be used together with insulin in patients who are not satisfactorily controlled

with insulin alone and cannot take metformin.

The medicine can only be obtained with a prescription.

How is Pioglitazone Teva used?

The recommended starting dose of Pioglitazone Teva is 15 or 30 mg once a day. This dose may need

to be increased after one or two weeks to up to 45 mg once a day if better blood glucose (sugar)

control is needed. Pioglitazone Teva should not be used in patients on dialysis (a blood clearance

technique used in people with kidney disease). The tablets should be swallowed with water.

Treatment with Pioglitazone Teva should be reviewed after three to six months, and discontinued in

patients who are not deriving sufficient benefit. At subsequent reviews prescribers should confirm that

benefits to patients are maintained.

How does Pioglitazone Teva work?

Type 2 diabetes is a disease in which the pancreas does not make enough insulin to control the level of

glucose in the blood or when the body is unable to use insulin effectively. The active substance in

Pioglitazone Teva, pioglitazone, makes cells (fat, muscle and liver) more sensitive to insulin, which

means that the body makes better use of the insulin it produces. As a consequence, the blood glucose

levels are reduced and this helps to control type 2 diabetes.

How has Pioglitazone Teva been studied?

Because Pioglitazone Teva is a generic medicine, studies in patients have been limited to tests to

determine that it is bioequivalent to the reference medicine, Actos. Two medicines are bioequivalent

when they produce the same levels of the active substance in the body.

What are the benefits and risks of Pioglitazone Teva?

Because Pioglitazone Teva is a generic medicine and is bioequivalent to the reference medicine, its

benefits and risks are taken as being the same as the reference medicine’s.

Why has Pioglitazone Teva been approved?

The CHMP concluded that, in accordance with EU requirements, Pioglitazone Teva has been shown to

have comparable quality and to be bioequivalent to Actos. Therefore, the CHMP’s view was that, as for

Actos, the benefit outweighs the identified risk. The Committee recommended that Pioglitazone Teva

be given marketing authorisation.

Other information about Pioglitazone Teva

The European Commission granted a marketing authorisation valid throughout the European Union for

Pioglitazone Teva on 26 March 2012.

The full EPAR for Pioglitazone Teva can be found on the Agency’s website: ema.europa.eu/Find

medicine/Human medicines/European Public Assessment Reports. For more information about

treatment with Pioglitazone Teva, read the package leaflet (also part of the EPAR) or contact your

doctor or pharmacist.

The full EPAR for the reference medicine can also be found on the Agency’s website.

Pioglitazone Teva

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Pioglitazone Teva

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This summary was last updated in 10-2011.

Листовка за пациента: състав, показания, Нежелани лекарствени реакции, дозиране, взаимодействия, бременност, кърмене

B. PACKAGE LEAFLET

Package leaflet: Information for the user

Pioglitazone Teva 15 mg tablets

Pioglitazone Teva 30 mg tablets

Pioglitazone Teva 45 mg tablets

Pioglitazone

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

What Pioglitazone Teva is and what it is used for

What you need to know before you take Pioglitazone Teva

How to take Pioglitazone Teva

Possible side effects

How to store Pioglitazone Teva

Contents of the pack and other information

1.

What Pioglitazone Teva is and what it is used for

Pioglitazone Teva contains pioglitazone. It is an anti-diabetic medicine used to treat type 2 (non-

insulin dependent) diabetes mellitus in adults, when metformin is not suitable or has failed to work

adequately. This is the diabetes that usually develops in adulthood.

Pioglitazone Teva 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 Teva is working 3 to 6 months after you start taking it.

Pioglitazone Teva 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 of blood

sugar.

2.

What you need to know before you take Pioglitazone Teva

Do not take Pioglitazone Teva

if you are allergic to pioglitazone 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 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 or pharmacist before taking Pioglitazone Teva (also see section 4)

if you retain water (fluid retention) or have heart failure problems, in particular if you are over

75 years old. If you take anti-inflammatory medicines which can also cause fluid retention and

swelling, you must also tell your doctor.

if you have a special type of diabetic eye disease called macular oedema (swelling of the back of

the eye).

if you have cysts on your ovaries (polycystic ovary syndrome). There may be an increased

possibility of becoming pregnant because you may ovulate again when you take Pioglitazone

Teva. If this applies to you, use appropriate contraception to avoid the possibility of an

unplanned pregnancy.

if you have a problem with your liver or heart. Before you start taking Pioglitazone Teva you

will have a blood sample taken to check your liver function. This check may be repeated at

intervals. Some patients with long-standing type 2 diabetes mellitus and heart disease or

previous stroke who were treated with Pioglitazone Teva and insulin experienced the

development of heart failure. Inform your doctor as soon as possible if you experience signs of

heart failure such as unusual shortness of breath or rapid increase in weight or localised swelling

(oedema).

If you take Pioglitazone Teva with other medicines for diabetes, it is more likely that your blood sugar

could fall below the normal level (hypoglycaemia).

You may also experience a reduction in blood count (anaemia).

Broken bones

A higher number of bone fractures was seen in patients, particularly women taking pioglitazone. Your

doctor will take this into account when treating your diabetes.

Children and adolescents

Use in children and adolescents under 18 years is not recommended.

Other medicines and Pioglitazone Teva

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other

medicines.

You can usually continue to take other medicines whilst you are being treated with Pioglitazone Teva.

However, certain medicines are especially likely to affect the amount of sugar in your blood:

gemfibrozil (used to lower cholesterol)

rifampicin (used to treat tuberculosis and other infections)

Tell your doctor or pharmacist if you are taking any of these. Your blood sugar will be checked, and

your dose of Pioglitazone Teva may need to be changed.

Pioglitazone Teva with food and drink

You may take your tablets with or without food. You should swallow the tablets with a glass of water.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask

your doctor for advice before taking this medicine.

Your doctor will advise you to discontinue this medicine.

Driving and using machines

This medicine will not affect your ability to drive or use machines but take care if you experience

abnormal vision.

3.

How to take Pioglitazone Teva

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor

or pharmacist if you are not sure.

The usual starting dose is one tablet of 15 mg or of 30 mg of pioglitazone to be taken once daily. Your

doctor may increase the dose to a maximum of 45 mg once a day. Your doctor will tell you the dose to

take.

If you have the impression that the effect of Pioglitazone Teva is too weak, talk to your doctor.

When Pioglitazone Teva is taken in combination with other medicines used to treat diabetes (such as

insulin, chlorpropamide, glibenclamide, gliclazide, tolbutamide) your doctor will tell you whether you

need to take a smaller dose of your medicines.

Your doctor will ask you to have blood tests periodically during treatment with Pioglitazone Teva.

This is to check that your liver is working normally.

If you are following a special diet for diabetes, you should continue with this while you are taking

Pioglitazone Teva.

Your weight should be checked at regular intervals; if your weight increases, inform your doctor.

If you take more Pioglitazone Teva than you should

If you accidentally take too many tablets, or if someone else or a child takes your medicine, talk to a

doctor or pharmacist immediately. Your blood sugar could fall below the normal level and can be

increased by taking sugar. It is recommended that you carry some sugar lumps, sweets, biscuits or

sugary fruit juice.

If you forget to take Pioglitazone Teva

Take Pioglitazone Teva daily as prescribed. However if you miss a dose, just carry on with the next

dose as normal. Do not take a double dose to make up for a forgotten tablet.

If you stop taking Pioglitazone Teva

Pioglitazone Teva should be used every day to work properly. If you stop using Pioglitazone Teva,

your blood sugar may go up. Talk to your doctor before stopping this treatment.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

In particular, patients have experienced the following serious side effects:

Heart failure has been experienced commonly (may affect up to 1 in 10 people) in patients taking

pioglitazone in combination with insulin. Symptoms are unusual shortness of breath or rapid increase

in weight or localised swelling (oedema). If you experience any of these, especially if you are over the

age of 65, seek medical advice straight away.

Bladder cancer has been experienced uncommonly (may affect up to 1 in 100 people) in patients

taking pioglitazone. Signs and symptoms include blood in your urine, pain when urinating or a sudden

need to urinate. If you experience any of these, talk to your doctor as soon as possible.

Localised swelling (oedema) has also been experienced very commonly (may affect more than 1 in 10

people) in patients taking pioglitazone in combination with insulin. If you experience this side effect,

talk to your doctor as soon as possible.

Broken bones have been reported commonly (may affect up to 1 in 10 people) in female patients

taking pioglitazone and have also been reported in male patients (frequency cannot be estimated from

the available data) taking pioglitazone. If you experience this side effect, talk to your doctor as soon as

possible.

Blurred vision due to swelling (or fluid) at the back of the eye (frequency cannot be estimated from the

available data) has also been reported in patients taking pioglitazone. If you experience this symptom

for the first time, talk to your doctor as soon as possible. Also, if you already have blurred vision and

the symptom gets worse, talk to your doctor as soon as possible.

Allergic reactions have been reported (frequency cannot be estimated from the available data) in

patients taking pioglitazone. If you have a serious allergic reaction, including hives and swelling of the

face, lips, tongue, or throat that may cause difficulty in breathing or swallowing stop taking this

medicine and talk to your doctor as soon as possible.

The other side effects that have been experienced by some patients taking pioglitazone are:

common (may affect up to 1 in 10 people)

respiratory infection

abnormal vision

weight gain

numbness

uncommon (may affect up to 1 in 100 people)

inflammation of the sinuses (sinusitis)

difficulty sleeping (insomnia)

not known (frequency cannot be estimated from the available data)

increase in liver enzymes

allergic reactions

The other side effects that have been experienced by some patients when pioglitazone is taken with

other antidiabetic medicines are:

very common (may affect more than 1 in 10 people)

decreased blood sugar (hypoglycaemia)

common (may affect up to 1 in 10 people)

headache

dizziness

joint pain

impotence

back pain

shortness of breath

small reduction in red blood cell count

flatulence

uncommon (may affect up to 1 in 100 people)

sugar in urine, proteins in urine

increase in enzymes

spinning sensation (vertigo)

sweating

tiredness

increased appetite

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects

not listed in this leaflet. You can also report side effects directly via the national reporting system

listed in Appendix V. By reporting side effects you can help provide more information on the safety of

this medicine.

5.

How to store Pioglitazone Teva

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and the blister after “EXP”.

The expiry date refers to the last day of that month.

This medicine does not require any special storage precautions.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to

throw away medicines you no longer use. These measures will help protect the environment.

6.

Contents of the pack and other information

What Pioglitazone Teva contains

The active substance is pioglitazone.

Each Pioglitazone Teva 15 mg tablet contains 15 mg of pioglitazone (as hydrochloride).

Each Pioglitazone Teva 30 mg tablet contains 30 mg of pioglitazone (as hydrochloride).

Each Pioglitazone Teva 45 mg tablet contains 45 mg of pioglitazone (as hydrochloride).

The other ingredients are mannitol, carmellose calcium, hydroxypropylcellulose and magnesium

stearate.

What Pioglitazone Teva looks like and contents of the pack

Pioglitazone Teva 15 mg tablets are white to off white, round, convex with the number ‘15’ on

one side and ‘TEVA’ on the other side.

Pioglitazone Teva 30 mg tablets are white to off white, round, convex with the number ‘30’ on

one side and ‘TEVA’ on the other side.

Pioglitazone Teva 45 mg tablets are white to off white, round, convex with the number ‘45’ on

one side and ‘TEVA’ on the other side.

The tablets are supplied in blisters in packs of 14, 28, 30, 50, 56, 84, 90, 98, 112 or 196 tablets.

Not all the pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Teva B.V.

Swensweg 5

2031GA Haarlem

Netherlands

Manufacturer:

Teva Pharmaceutical Works Private Limited Company

Pallagi út 13,

4042 Debrecen

Hungary

Teva UK Ltd

Brampton Road, Hampden Park, Eastbourne,

East Sussex, BN22 9AG

United Kingdom

Pharmachemie B.V.

Swensweg 5,

2031 GA Haarlem

The Netherlands

Teva Operations Poland Sp z.o.o.

ul. Mogilska 80. 31-546, Krakow

Poland

Merckle GmbH

Ludwig-Merckle Strasse 3

89143 Blaubeuren

Germany

Balkanpharma Dupnitsa AD

3 Samokovsko Shosse Str.,

Dupnitsa 2600,

Bulgaria

For any information about this medicine, please contact the local representative of the Marketing

Authorisation Holder:

België/Belgique/Belgien

Teva Pharma Belgium N.V./S.A./AG

Tél/Tel: +32 3 820 73 73

Lietuva

UAB “Sicor Biotech”

Tel: +370 5 266 0203

България

Тева Фармасютикълс България ЕООД

Teл.: +359 2 489 95 82

Luxembourg/Luxemburg

ratiopharm GmbH

Tél/Tel: +49 731 402 02

Česká republika

Teva Pharmaceuticals CR, s.r.o.

Tel: +420 251 007 111

Magyarország

Teva Gyógyszergyár Zrt.

Tel.: +36 1 288 64 00

Danmark

Teva Denmark A/S

Tlf: +45 44 98 55 11

Malta

Teva Pharmaceuticals Ireland,

L-Irlanda

Tel: +353 51 321740

Deutschland

TEVA GmbH

Tel: +49 731 402 08

Nederland

Teva Nederland B.V.

Tel: +31 800 0228 400

Eesti

UAB “Sicor Biotech” Eesti filiaal

Tel: +372 661 0801

Norge

Teva Norway AS

Tlf: +47 66 77 55 90

Ελλάδα

Teva Ελλάς Α.Ε.

Τηλ: +30 210 72 79 099

Österreich

ratiopharm Arzneimittel Vertriebs-GmbH

Tel: +43 1 97 0070

España

Teva Pharma, S.L.U.

Polska

Teva Pharmaceuticals Polska Sp. z o.o

Tel: +34 91 387 32 80

Tel.: +48 22 345 93 00

France

Teva Santé

Tél: +33 1 55 91 78 00

Portugal

Teva Pharma - Produtos Farmacêuticos, Lda

Tel: +351 21 476 75 50

Hrvatska

Pliva Hrvatska d.o.o.

Tel: +385 1 37 20 000

România

Teva Pharmaceuticals S.R.L

Tel: +40 21 230 65 24

Ireland

Teva Pharmaceuticals Ireland

Tel: +353 51 321740

Slovenija

Pliva Ljubljana d.o.o.

Tel: +386 1 58 90 390

Ísland

ratiopharm Oy, Finnland

Sími: +358 20 180 5900

Slovenská republika

TEVA Pharmaceuticals Slovakia s.r.o.

Tel: +421 2 57 26 79 11

Italia

Teva Italia S.r.l.

Tel: +39 02 89 17 98 1

Suomi/Finland

ratiopharm Oy

Puh/Tel: +358 20 180 5900

Κύπρος

Teva Ελλάς Α.Ε., Ελλάδα

Τηλ: +30 210 72 79 099

Sverige

Teva Sweden AB

Tel: +46 42 12 11 00

Latvija

UAB ”Sicor Biotech” filiāle Latvijā

Tel: +371 673 23 666

United Kingdom

Teva UK Limited

Tel: +44 1977 628500

This leaflet was last revised in

{MM/YYYY}.

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site:

http://www.ema.europa.eu