Pioglitazone Krka
pioglitazone
Pioglitazone
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 Pioglitazone Krka is and what it is used for
What you need to know before you take Pioglitazone Krka
How to take Pioglitazone Krka
Possible side effects
How to store Pioglitazone Krka
Contents of the pack and other information
Medicinal product no longer authorised
Pioglitazone Krka 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 Krka 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 Krka is working 3 to 6 months after you start taking it.
Pioglitazone Krka 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 sulphonylurea or insulin) which have failed to provide sufficient control of blood sugar.
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 ever had bladder cancer.
if you have blood in your urine that your doctor has not checked.
Talk to your doctor before taking Pioglitazone Krka:
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 your becoming pregnant because you may ovulate again when you take Pioglitazone Krka. 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 Krka 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 Krka 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 Krka 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.
Use in children under 18 years is not recommended.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
Medicinal product no longer authorised
You can usually continue to take other medicines whilst you are being treated with Pioglitazone Krka. 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 Krka may need to be changed.
You may take your tablets with or without food. You should swallow the tablets with a glass of water.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Your doctor will advise you to discontinue this medicine.
Pioglitazone will not affect your ability to drive or use machines but take care if you experience
abnormal vision.
If you have been told by your doctor that you have intolerance to some sugars, contact your doctor
before taking Pioglitazone Krka.
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
One tablet 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 Pioglitazone Krka is too weak, talk to your doctor.
When Pioglitazone Krka 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 Krka. 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 Pioglitazone Krka. Your weight should be checked at regular intervals; if your weight increases, inform your doctor.
Use in children under 18 years is not recommended.
If you accidentally take too many Pioglitazone Krka 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.
Take Pioglitazone Krka tablets 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.
Medicinal product no longer authorised
Pioglitazone Krka tablets should be used every day to work properly. If you stop using Pioglitazone
Krka tablets, 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.
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 Krka 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 Krka. 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 Krka 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 women patients taking Pioglitazone Krka. 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 Krka. 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 not known) in patients taking Pioglitazone Krka. 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 Krka 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
Medicinal product no longer authorised
The other side effects that have been experienced by some patients when Pioglitazone Krka 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
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 nationalreportingsystem listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
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 packaging after EXP. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
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.
The active substance is pioglitazone. Each tablet contains 15 mg of pioglitazone (as hydrochloride).
The other ingredients are lactose monohydrate, hydroxypropylcellulose (E463), croscarmellose sodium, magnesium stearate (E572).
White to almost white round tablets with bevelled edges and with engraved "15" on one side of tablet (diameter 7.0 mm).
Medicinal product no longer authorised
The tablets are available in boxes of 14, 28, 30, 56, 60, 90 and 98 tablets in blisters. Not all pack sizes may be marketed.
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia TADPharmaGmbH, Heinz-Lohmann-Straße5,27472Cuxhaven,Germany
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
UAB KRKA Lietuva Tel: + 370 5 236 27 40
Представителство на KRKA в България
Teл.: + 359 (02) 962 34 50
KRKA ČR, s.r.o.
Tel: + 420 (0) 221 115 150
KRKA Magyarország Kereskedelmi Kft.
Tel.: + 361 (0) 355 8490
KRKA Sverige AB
Tlf: + 46 (0)8 643 67 66 (SE)
KRKA Pharma Dublin, Ltd.
Tel: + 353 1 293 91 80
TAD Pharma GmbH
Focus Care Pharmaceuticals B.V.
Tel: + 49 (0) 4721 606-0 Tel: +31 (0)75 61 20 511
KRKA, d.d., Novo mesto Eesti filiaal
Tel: + 372 (0) 6 671 658
KRKA Sverige AB
Tlf: + 46 (0)8 643 67 66 (SE)
QUALIA PHARMA S.A.
Τηλ: +30 (0)210 2832941
KRKA Pharma GmbH, Wien
Tel: + 43 (0)1 66 24 300
KRKA Farmacéutica, S.L.
Tel: + 34 911 61 03 81
KRKA-POLSKA Sp. z o.o.
Tel.: + 48 (0)22 573 7500
KRKA France Eurl
Tél: + 33 (0)1 57 40 82 25
KRKA Farmacêutica, Sociedade Unipessoal Lda.
Tel: + 351 (0)21 46 43 650
Krka – farma d.o.o. Tel: + 385 1 6312 100
KRKA Romania S.R.L., Bucharest Tel: + 4 021 310 66 05
KRKA Pharma Dublin, Ltd.
Tel: + 353 1 293 91 80
KRKA, d.d., Novo mesto
Tel: + 386 (0) 1 47 51 100
Medicinal product no longer authorised
KRKA Sverige AB
Sími: + 46 (0)8 643 67 66 (SE)
KRKA Farmaceutici Milano S.r.l.
Tel: + 39 02 3300 8841
KRKA Sverige AB
Puh/Tel: + 46 (0)8 643 67 66 (SE)
Kipa Pharmacal Ltd.
Τηλ: + 357 24 651 882
KRKA Sverige AB
Tel: + 46 (0)8 643 67 66 (SE)
KRKA Latvija SIA Tel: + 371 6 733 86 10
Consilient Health (UK) Ltd. Tel: + 44 (0)2089562310