Sepioglin - patient leaflet, side effects, dosage

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

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

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.

s who are unable to take metformin, and where treatment ol blood sugar or may be added to other therapies (such as which have failed to provide sufficient control in blood sugar.

KESEPIOGLIN

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 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 ch

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.

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.

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

d 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.

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 1,00 – 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

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

European Medicines Agency web site: