Sepioglin

Informazzjoni prinċipali

  • Isem kummerċjali:
  • Sepioglin
  • Dominju tal-mediċina:
  • Bnedmin
  • Tip ta 'mediċina:
  • Droga allopatika

Dokumenti

Lokalizzazzjoni

  • Disponibbli fi:
  • Sepioglin
    Unjoni Ewropea
  • Lingwa:
  • Ingliż

Informazzjoni terapewtika

  • Grupp terapewtiku:
  • Drugs used in diabetes,
  • Żona terapewtika:
  • Diabetes Mellitus, Type 2
  • Indikazzjonijiet terapewtiċi:
  • 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. Pioglitazone is also indicated for combination with insulin in type-2-diabetes-mellitus adult patients with insu
  • Sommarju tal-prodott:
  • Revision: 1

Status

  • Sors:
  • EMA - European Medicines Agency
  • L-istatus ta 'awtorizzazzjoni:
  • Withdrawn
  • Numru ta 'awtorizzazzjoni:
  • EMEA/H/C/002021
  • Data ta 'l-awtorizzazzjoni:
  • 08-03-2012
  • Kodiċi EMEA:
  • EMEA/H/C/002021
  • L-aħħar aġġornament:
  • 31-03-2019

Rapport ta 'Valutazzjoni Pubblika

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.

EMEA/H/C/002021

EPAR summary for the public

Sepioglin

pioglitazone

This is a summary of the European public assessment report (EPAR) for Sepioglin. 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

Sepioglin.

What is Sepioglin?

Sepioglin is a medicine that contains the active substance pioglitazone. It is available as tablets (15, 30

and 45 mg).

Sepioglin is a ‘generic medicine’. This means that Sepioglin 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 Sepioglin used for?

Sepioglin 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.

Sepioglin is used on its own in patients for whom metformin (another antidiabetes medicine) is not

suitable.

Sepioglin 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’).

Sepioglin 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’).

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

insulin alone and cannot take metformin.

Medicinal product no longer authorised

Sepioglin

Page 2/2

The medicine can only be obtained with a prescription.

How is Sepioglin used?

The recommended starting dose of Sepioglin 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. Sepioglin 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 Sepioglin 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 Sepioglin 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

Sepioglin, 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 Sepioglin been studied?

Because Sepioglin 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 Sepioglin?

Because Sepioglin 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 Sepioglin been approved?

The CHMP concluded that, in accordance with EU requirements, Sepioglin 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 Sepioglin be given

marketing authorisation.

Other information about Sepioglin

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

Sepioglin on 9 March 2012.

The full EPAR for Sepioglin 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 Sepioglin, 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.

This summary was last updated in 10-2011.

Medicinal product no longer authorised

Fuljett ta 'Informazzjoni għall-Pazjent: prodott - kompożizzjoni, indikazzjonijiet, effetti sekondarji, dożaġġ, interazzjonijiet, reazzjonijiet avversi, tqala, treddigħ

B. PACKAGE LEAFLET

Medicinal product no longer authorised

PACKAGE LEAFLET: INFORMATION FOR THE USER

Sepioglin 15 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

What Sepioglin is and what it is used for

Before you take Sepioglin

How to take Sepioglin

Possible side effects

How to store Sepioglin

Further information

1.

WHAT SEPIOGLIN IS AND WHAT IT IS USED FOR

Sepioglin 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.

Sepioglin 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 Sepioglin is

working 3 to 6 months after you start taking it.

Sepioglin 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.

BEFORE YOU TAKESEPIOGLIN

Do not take Sepioglin

if you are hypersensitive (allergic) to pioglitazone or any of the other ingredients of Sepioglin.

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.

Take special care with Sepioglin

Tell your doctor before you start to take this medicine

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

75 years old.

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 Sepioglin. If

Medicinal product no longer authorised

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 Sepioglinyou 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 Sepioglin 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 Sepioglin 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 women (but not in men) taking pioglitazone. Your

doctor will take this into account when treating your diabetes.

Children

Use in children under 18 years is not recommended.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines,

including medicines obtained without a prescription.

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

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 Sepioglin may need to be changed.

Taking Sepioglinwith food and drink

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

Pregnancy and breastfeeding

Tell your doctor if

you are, you think you might be or are planning to become pregnant.

you are breast-feeding or if you are planning to breast-feed your baby.

Your doctor will advise you to discontinue this medicine.

Driving and using machines

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

abnormal vision.

Important information about some of the ingredients of Sepioglin

This medicine contains lactose monohydrate. If you have been told by your doctor that you have

intolerance to some sugars, contact your doctor before taking Sepioglin.

3.

HOW TO TAKE SEPIOGLIN

One tablet of 15 mg of pioglitazone should be taken once daily. If necessary your doctor may tell you

to take a different dose.

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

Medicinal product no longer authorised

When Sepioglinis 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 Sepioglin. This is to

check that your liver is working normally.

If you are following a diabetic diet, you should continue with this while you are taking Sepioglin.

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

If you take more Sepioglin 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 Sepioglin

Take Sepioglin 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 Sepioglin

Sepioglinshould be used every day to work properly. If you stop using Sepioglin, 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, Sepioglin 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 (1 to 10 users in 100) 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 (1 to 10 users in 1000) 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 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 (1 to 10 users in 100) in women patients 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 not known) 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.

Medicinal product no longer authorised

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

common (affects 1 to 10 users in 100)

respiratory infection

abnormal vision

weight gain

numbness

uncommon (affects 1 to 10 users in 1,000)

inflammation of the sinuses (sinusitis)

difficulty sleeping (insomnia)

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

increase in liver enzymes

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

other antidiabetic medicines are:

very common (affects more than 1 user in 10)

decreased blood sugar (hypoglycaemia)

common (affects 1 to 10 users in 100)

headache

dizziness

joint pain

impotence

back pain

shortness of breath

small reduction in red blood cell count

flatulence

uncommon (affects 1 to 10 users in 1,000)

sugar in urine, proteins in urine

increase in enzymes

spinning sensation (vertigo)

sweating

tiredness

increased appetite

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.

5.

HOW TO STORE SEPIOGLIN

Keep out of the reach and sight of children.

Do not use Sepioglin after the expiry date which is stated on the carton and the blister pack after the

word “EXP”. The expiry date refers to the last day of that month.

This medicine does not require any special storage precautions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to

dispose of medicines no longer required. These measures will help to protect the environment.

Medicinal product no longer authorised

6.

FURTHER INFORMATION

What Sepioglin contains

The active substance is pioglitazone. Each tablet contains 15 mg of pioglitazone (as

hydrochloride).

The other ingredients are lactose monohydrate, hydroxypropylcellulose, carmellose calcium and

magnesium stearate.

What Sepioglin looks like and contents of the pack

Sepioglin 15 mg tablets are white, round, flat tablets, with “15” embossed on one side and a diameter

of approximately 5.5 mm. The tablets are supplied in PA/Aluminium/PVC/Aluminium blister packs of

14, 28, 30, 50, 56, 90 or 98 tablets.

Not all the pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing authorisation holder

Vaia S.A.

1, 28 Octovriou str., Ag. Varvara

123 51 Athens, Greece.

Manufacturer

Specifar S.A.

1, 28 Octovriou str., Ag. Varvara

123 51 Athens, Greece

This leaflet was last approved in

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

http://www.ema.europa.eu

Medicinal product no longer authorised

PACKAGE LEAFLET: INFORMATION FOR THE USER

Sepioglin 30 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

What Sepioglin is and what it is used for

Before you take Sepioglin

How to take Sepioglin

Possible side effects

How to store Sepioglin

Further information

1.

WHAT SEPIOGLIN IS AND WHAT IT IS USED FOR

Sepioglin 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.

Sepioglin 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 Sepioglin is

working 3 to 6 months after you start taking it.

Sepioglin 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.

BEFORE YOU TAKE SEPIOGLIN

Do not take Sepioglin

if you are hypersensitive (allergic) to pioglitazone or any of the other ingredients Sepioglin.

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.

Take special care with Sepioglin

Tell your doctor before you start to take this medicine

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

75 years old.

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 Sepioglin. If

Medicinal product no longer authorised

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 Sepioglin 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 Sepioglin 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 Sepioglin 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 women (but not in men) taking pioglitazone. Your

doctor will take this into account when treating your diabetes.

Children

Use in children under 18 years is not recommended.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines,

including medicines obtained without a prescription.

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

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 Sepioglin may need to be changed.

Taking Sepioglin 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 breastfeeding

Tell your doctor if

you are, you think you might be or are planning to become pregnant.

you are breast-feeding or if you are planning to breast-feed your baby.

Your doctor will advise you to discontinue this medicine.

Driving and using machines

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

abnormal vision.

Important information about some of the ingredients of Sepioglin

This medicine contains lSepiogline monohydrate. If you have been told by your doctor that you have

intolerance to some sugars, contact your doctor before taking Sepioglin.

3.

HOW TO TAKE SEPIOGLIN

One tablet of 30 mg of pioglitazone should be taken once daily. If necessary your doctor may tell you

to take a different dose.

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

Medicinal product no longer authorised

When Sepioglin 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 Sepioglin. This is to

check that your liver is working normally.

If you are following a diabetic diet, you should continue with this while you are taking Sepioglin.

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

If you take more Sepioglin 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 Sepioglin

Take Sepioglin 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 a forgotten tablet.

If you stop taking Sepioglin

Sepioglin should be used every day to work properly. If you stop using Sepioglin, 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, Sepioglin 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 (1 to 10 users in 100) 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 (1 to 10 users in 1000) 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 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 (1 to 10 users in 100) in women patients 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 not known) 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.

Medicinal product no longer authorised

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

common (affects 1 to 10 users in 100)

respiratory infection

abnormal vision

weight gain

numbness

uncommon (affects 1 to 10 users in 1,000)

inflammation of the sinuses (sinusitis)

difficulty sleeping (insomnia)

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

increase in liver enzymes

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

other antidiabetic medicines are:

very common (affects more than 1 user in 10)

decreased blood sugar (hypoglycaemia)

common (affects 1 to 10 users in 100)

headache

dizziness

joint pain

impotence

back pain

shortness of breath

small reduction in red blood cell count

flatulence

uncommon (affects 1 to 10 users in 1,000)

sugar in urine, proteins in urine

increase in enzymes

spinning sensation (vertigo)

sweating

tiredness

increased appetite

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.

5.

HOW TO STORE SEPIOGLIN

Keep out of the reach and sight of children.

Do not use Sepioglin after the expiry date which is stated on the carton and the blister pack after the

word “EXP”. The expiry date refers to the last day of that month.

This medicine does not require any special storage precautions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to

dispose of medicines no longer required. These measures will help to protect the environment.

Medicinal product no longer authorised

6.

FURTHER INFORMATION

What Sepioglin contains

The active substance is pioglitazone. Each tablet contains 30 mg of pioglitazone (as

hydrochloride).

The other ingredients are lactose monohydrate, hydroxypropylcellulose, carmellose calcium and

magnesium stearate.

What Sepioglin looks like and contents of the pack

Sepioglin 30 mg tablets are white, round, flat tablets, with a break line on one side, “30” embossed on

the other side and a diameter of approximately 7.0 mm. The tablets are supplied in

PA/Aluminium/PVC/Aluminium blister packs of 14, 28, 30, 50, 56, 90 or 98tablets. Not all the pack

sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing authorisation holder

Vaia S.A.

1, 28 Octovriou str., Ag. Varvara

123 51 Athens, Greece.

Manufacturer

Specifar S.A.

1, 28 Octovriou str., Ag. Varvara

123 51 Athens, Greece

This leaflet was last approved in

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

http://www.ema.europa.eu

Medicinal product no longer authorised

PACKAGE LEAFLET: INFORMATION FOR THE USER

Sepioglin 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

What Sepioglin is and what it is used for

Before you take Sepioglin

How to take Sepioglin

Possible side effects

How to store Sepioglin

Further information

1.

WHAT SEPIOGLIN IS AND WHAT IT IS USED FOR

Sepioglin 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.

Sepioglin 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 Sepioglin is

working 3 to 6 months after you start taking it.

Sepioglin 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.

BEFORE YOU TAKE SEPIOGLIN

Do not take Sepioglin

if you are hypersensitive (allergic) to pioglitazone or any of the other ingredients of Sepioglin.

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.

Take special care with Sepioglin

Tell your doctor before you start to take this medicine

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

75 years old.

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

the eye).

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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 Sepioglin. 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 Sepioglin 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 Sepioglin 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 Sepioglin 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 women (but not in men) taking pioglitazone. Your

doctor will take this into account when treating your diabetes.

Children

Use in children under 18 years is not recommended.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines,

including medicines obtained without a prescription.

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

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 Sepioglin may need to be changed.

Taking Sepioglin 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 breastfeeding

Tell your doctor if

you are, you think you might be or are planning to become pregnant.

you are breast-feeding or if you are planning to breast-feed your baby.

Your doctor will advise you to discontinue this medicine.

Driving and using machines

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

abnormal vision.

Important information about some of the ingredients of Sepioglin

This medicine contains lSepiogline monohydrate. If you have been told by your doctor that you have

intolerance to some sugars, contact your doctor before taking Sepioglin.

3.

HOW TO TAKE SEPIOGLIN

One tablet of 45 mg of pioglitazone should be taken once daily. If necessary your doctor may tell you

to take a different dose.

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

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When Sepioglin 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 Sepioglin. This is to

check that your liver is working normally.

If you are following a diabetic diet, you should continue with this while you are taking Sepioglin.

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

If you take more Sepioglin 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 Sepioglin

Take Sepioglin 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 Sepioglin

Sepioglin should be used every day to work properly. If you stop using Sepioglin, 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, Sepioglin 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 (1 to 10 users in 100) 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 (1 to 10 users in 1000) 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 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 (1 to 10 users in 100) in women patients 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 not known) 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.

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

common (affects 1 to 10 users in 100)

respiratory infection

abnormal vision

weight gain

numbness

uncommon (affects 1 to 10 users in 1,000)

inflammation of the sinuses (sinusitis)

difficulty sleeping (insomnia)

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

increase in liver enzymes

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

other antidiabetic medicines are:

very common (affects more than 1 user in 10)

decreased blood sugar (hypoglycaemia)

common (affects 1 to 10 users in 100)

headache

dizziness

joint pain

impotence

back pain

shortness of breath

small reduction in red blood cell count

flatulence

uncommon (affects 1 to 10 users in 1,000)

sugar in urine, proteins in urine

increase in enzymes

spinning sensation (vertigo)

sweating

tiredness

increased appetite

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.

5.

HOW TO STORE SEPIOGLIN

Keep out of the reach and sight of children.

Do not use Sepioglin after the expiry date which is stated on the carton and the blister pack after the

word “EXP”. The expiry date refers to the last day of that month.

This medicine does not require any special storage precautions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to

dispose of medicines no longer required. These measures will help to protect the environment.

6.

FURTHER INFORMATION

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What Sepioglin contains

The active substance is pioglitazone. Each tablet contains 45 mg of pioglitazone (as

hydrochloride).

The other ingredients are lactose monohydrate, hydroxypropylcellulose, carmellose calcium and

magnesium stearate.

What Sepioglin looks like and contents of the pack

Sepioglin 45 mg tablets are white, round, flat tablets, with “45” embossed on one side and a diameter

of approximately 8.0 mm. The tablets are supplied in PA/Aluminium/PVC/Aluminium blister packs of

14, 28, 30, 50, 56, 90 or 98 tablets. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing authorisation holder

Vaia S.A.

1, 28 Octovriou str., Ag. Varvara

123 51 Athens, Greece.

Manufacturer

Specifar S.A.

1, 28 Octovriou str., Ag. Varvara

123 51 Athens, Greece

This leaflet was last approved in

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

http://www.ema.europa.eu

Medicinal product no longer authorised