Pioglitazone Teva Pharma
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 Teva Pharma is and what it is used for
What you need to know before you take Pioglitazone Teva Pharma
How to take Pioglitazone Teva Pharma
Possible side effects
How to store Pioglitazone Teva Pharma
Contents of the pack and other information
Pioglitazone Teva Pharma 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 Pharma 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 Pharma is working 3 to 6 months after you start taking it.
Pioglitazone Teva Pharma may also be used 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 insulin therapy when it fails 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 have ever had bladder cancer.
if you have blood in your urine that your doctor has not checked.
Talk to your doctor or pharmacist before taking Pioglitazone Teva Pharma (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 Pharma. 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
Pharma 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 Pharma 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 Pharma 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.
Use in children and adolescents under 18 years is not recommended.
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 Pharma. 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 Pharma 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 for advice before taking this medicine.
Your doctor will advise you to discontinue this medicine.
This medicine will not affect your ability to drive or use machines but take care if you experience abnormal vision.
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 Pharma is too weak, talk to your doctor.
When Pioglitazone Teva Pharma 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 Pharma. 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 Pharma.
Your weight should be checked at regular intervals; if your weight increases, inform your doctor.
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.
Take Pioglitazone Teva Pharma 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.
Pioglitazone Teva Pharma should be used every day to work properly. If you stop using Pioglitazone Teva Pharma, 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 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
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.
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.
The active substance is pioglitazone.
Each Pioglitazone Teva Pharma 15 mg tablet contains 15 mg of pioglitazone (as hydrochloride). Each Pioglitazone Teva Pharma 30 mg tablet contains 30 mg of pioglitazone (as hydrochloride). Each Pioglitazone Teva Pharma 45 mg tablet contains 45 mg of pioglitazone (as hydrochloride).
The other ingredients are mannitol, carmellose calcium, hydroxypropylcellulose and magnesium stearate.
Pioglitazone Teva Pharma 15 mg tablets are white to off white, round, convex with the number ‘15’ on one side and ‘TEVA’ on the other side.
The tablets are supplied in Aluminium/aluminium blisters in packs of 14, 28, 30, 50, 56, 84, 90,
98, 112 or 196 tablets.
Pioglitazone Teva Pharma 30 mg tablets are white to off white, round, convex with the number ‘30’ on one side and ‘TEVA’ on the other side.
The tablets are supplied in Aluminium/aluminium blisters in packs of 14, 28, 30, 50, 56, 84, 90,
98, 112 or 196 tablets or 50 x 1 tablets in Aluminium/aluminium perforated unit dose blisters.
Pioglitazone Teva Pharma 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 Aluminium/aluminium blisters in packs of 14, 28, 30, 50, 56, 84, 90,
98, 112 or 196 tablets or 50 x 1 tablets in Aluminium/aluminium perforated unit dose blisters. Not all the pack sizes may be marketed.
Marketing Authorisation Holder: Teva B.V.
Swensweg 5
2031GA Haarlem Netherlands
Manufacturer:
Teva Pharmaceutical Works Private Limited Company
Pallagi út 13,
4042 Debrecen Hungary
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:
Teva Pharma Belgium N.V./S.A./AG Tél/Tel: +32 38207373
UAB Teva Baltics Tel: +370 52660203
Тева Фарма ЕАД
Teл: +359 24899585
Teva Pharmaceuticals CR, s.r.o. Tel: +420 251007111
Teva Gyógyszergyár Zrt. Tel: +36 12886400
Teva Denmark A/S Tlf: +45 44985511
Teva Pharmaceuticals Ireland L-Irlanda
Tel: +353 19127700
TEVA GmbH
Tel: +49 73140208
Teva Nederland B.V. Tel: +31 8000228400
UAB Teva Baltics Eesti filiaal Tel: +372 6610801
Teva Norway AS Tlf: +47 66775590
Specifar A.B.E.E.
Τηλ: +30 2118805000
ratiopharm Arzneimittel Vertriebs-GmbH Tel: +43 1970070
Teva Pharma, S.L.U. Tel: +34 913873280
Teva Pharmaceuticals Polska Sp. z o.o. Tel: +48 223459300
Teva Santé
Tél: +33 155917800
Teva Pharma - Produtos Farmacêuticos, Lda. Tel: +351 214767550
Pliva Hrvatska d.o.o. Tel: +385 13720000
Teva Pharmaceuticals S.R.L. Tel: +40 212306524
Teva Pharmaceuticals Ireland Tel: +353 19127700
Pliva Ljubljana d.o.o. Tel: +386 15890390
Alvogen ehf.
Sími: +354 5222900
TEVA Pharmaceuticals Slovakia s.r.o. Tel: +421 257267911
Teva Italia S.r.l. Tel: +39 028917981
Teva Finland Oy
Puh/Tel: +358 201805900
Specifar A.B.E.E.
Ελλάδα
Τηλ: +30 2118805000
Tel: +370 70001320
UAB Teva Baltics filiāle Latvijā
Tel: +371 67323666