PIOGLITAZONE 15 mg Tabletki

Treść ulotki

1. Pioglitazone Actavis 15 mg, 30 mg and 45 mg tablets, 15 mg tablets, 30 mg tablets, 45 mg tablets
   1. What is Pioglitazone Actavis and what is it used for
   2. What you need to know before you take Pioglitazone Actavis
   3. How to take Pioglitazone Actavis
   4. Possible side effects
   5. How to store Pioglitazone Actavis
   6. Package contents and other information

Pioglitazone Actavis 15 mg, 30 mg and 45 mg tablets, 15 mg tablets, 30 mg tablets, 45 mg tablets

pioglitazone

Read this leaflet carefully before you start taking this medicine as it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Pioglitazone Actavis is and what it is used for
• 2. What you need to know before you take Pioglitazone Actavis
• 3. How to take Pioglitazone Actavis
• 4. Possible side effects
• 5. How to store Pioglitazone Actavis
• 6. Contents of the pack and other information

1. What is Pioglitazone Actavis and what is it used for

Pioglitazone Actavis contains pioglitazone. It is an anti-diabetic medicine used for the treatment of
type 2 diabetes mellitus (non-insulin dependent), when metformin is not suitable or has not
worked adequately. This type of diabetes usually occurs in adults.
Pioglitazone Actavis helps to control blood sugar levels in patients suffering from
type 2 diabetes by helping the body to make better use of the insulin it produces. The doctor
will check if Pioglitazone Actavis is working 3-6 months after the start of treatment.
Pioglitazone Actavis can be used alone in patients who are unable to take
metformin, and where diet and exercise have failed to control blood glucose, or it may
be added to other therapies (such as metformin, a sulfonylurea or insulin), which have not
provided sufficient blood glucose control.

2. What you need to know before you take Pioglitazone Actavis

Do not take Pioglitazone Actavis

• if you are allergic to pioglitazone or any of the other ingredients of Pioglitazone Actavis (see section 6 for the list of ingredients).
• if you have or have had heart failure.
• if you have liver problems.
• if you have had diabetic ketoacidosis (a complication of diabetes that causes rapid weight loss, nausea or vomiting).
• if you have or have ever had bladder cancer.
• if you have blood in your urine for which your doctor has not yet investigated.

Warnings and precautions
Talk to your doctor before starting to take this medicine:

• if you retain water (fluid retention) or have problems with heart failure, especially if you are over 75 years old. You should also tell your doctor if you are taking anti-inflammatory medicines, which can also cause fluid retention and swelling,
• if you have a particular type of diabetic eye disease called macular edema (swelling of the back of the eye).
• if you have cysts on the ovaries (polycystic ovary syndrome). The likelihood of becoming pregnant may increase, because ovulation may resume when you take Pioglitazone Actavis. If this is the case, use adequate contraception to avoid the risk of an unwanted pregnancy.
• if you have problems with your liver or heart. Before starting to take Pioglitazone Actavis, you will have a blood test to check your liver function. This test may be repeated periodically. Some patients with type 2 diabetes mellitus of long duration and heart disease or previous stroke who have been treated with Pioglitazone and insulin have developed heart failure. Tell your doctor as soon as possible if you experience signs of heart failure such as unusual shortness of breath or rapid weight gain or localized swelling (edema).

If you take Pioglitazone Actavis with other medicines for diabetes, it is more likely that your blood sugar level may fall below normal (hypoglycemia).
You may also experience a decrease in the number of blood cells (anemia).
Bone fractures
A higher number of bone fractures have been found in patients, especially in women who
are taking pioglitazone. Your doctor will take this into account when treating your diabetes.

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

Other medicines and Pioglitazone Actavis
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicine
Normally, you can continue to take other medicines while you are being treated with Pioglitazone Actavis.
However, some medicines in particular are likely to affect the amount of sugar in
your blood:

• gemfibrozil (used to reduce cholesterol levels)
• rifampicin (used to treat tuberculosis and other infections) Tell your doctor or pharmacist if you are taking any of these medicines. Your blood sugar level will be checked and it may be necessary to adjust the dose of Pioglitazone Actavis.

Pioglitazone Actavis with food and drink
You can take the tablets with or without food. You should take the tablets with a glass of water.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning to become pregnant, or are breastfeeding with breast
milk, ask your doctor or pharmacist for advice before taking this medicine.
Your doctor will advise you to stop treatment with this medicine.

Driving and using machines
Pioglitazone has no effects on the ability to drive or operate machinery, but be careful if
you experience vision problems.

Pioglitazone Actavis contains lactose monohydrate
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before
taking Pioglitazone Actavis.

3. How to take Pioglitazone Actavis

Take this medicine following exactly the instructions of your doctor or pharmacist. If you
have doubts, consult your doctor or pharmacist.
The normal starting dose is one 15 mg or 30 mg pioglitazone tablet to be taken once
a day. Your doctor may increase your dose to a maximum of 45 mg to be taken once a
day. Your doctor will tell you which dose to take.
If you feel that the effect of Pioglitazone Actavis is too weak, talk to your doctor.
Pioglitazone Actavis can be taken with or without food.
When Pioglitazone Actavis is taken in association with other medicines used for the treatment of
diabetes (such as insulin, chlorpropamide, glibenclamide, gliclazide, tolbutamide) your doctor will tell you if it is
necessary to take a lower dose of the other medicines.
Your doctor will ask you to undergo blood tests periodically during treatment with
Pioglitazone Actavis. This is to check the normal functioning of the liver.
If you are following a diet for diabetics, you should continue it while taking Pioglitazone Actavis.
Your weight should be checked at regular intervals; if your weight increases, inform your doctor.

If you take more Pioglitazone Actavis tablets than you should
If you accidentally take too many tablets, or if another person or a child takes your
tablets, contact your doctor or pharmacist immediately. Your blood sugar level
may decrease below normal levels and can be increased by taking
sugar. It is advisable to carry sugar lumps, sweets, biscuits or sugary fruit juices
with you.

If you forget to take Pioglitazone Actavis tablets
Try to take Pioglitazone Actavis every day as prescribed. However, if you forget to
take a dose, continue normally with the next dose. Do not take a double dose to
make up for a forgotten tablet.
For packs of 14, 28, 56, 84 and 98 tablets, you can check the day on which you took
your last Pioglitazone Actavis tablet by referring to the calendar printed on the blister.

If you stop taking Pioglitazone Actavis
Pioglitazone Actavis must be used every day to work properly. If you stop using
Pioglitazone Actavis, it is possible that your blood sugar level will increase. Talk to your doctor
before stopping treatment.
If you have any doubts about 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 everyone gets them.
In particular, the following serious side effects have occurred in some patients:
Cases of common (up to 1 in 10 people) heart failure have occurred in patients who
were taking pioglitazone in combination with insulin. Symptoms are unusual shortness of breath or a
rapid weight gain or localized swelling (edema). If you experience any of these symptoms,
especially if you are over 65 years old, seek medical advice immediately.
Cases of uncommon bladder cancer (up to 1 in 100 people) have occurred in patients
treated with pioglitazone. Signs and symptoms include blood in the urine, pain during
urination or a sudden need to urinate. If you experience any of these symptoms, talk to your
doctor as soon as possible.
Very common cases of localized swelling (edema) have occurred in patients taking
pioglitazone in combination with insulin. If you experience this side effect, inform your doctor as
soon as possible.
Common cases (up to 1 in 10 people) of bone fractures have been reported in female
patients and also in male patients taking pioglitazone (available data do not allow
an estimate of the frequency). If you experience this side effect, inform your doctor as soon as possible.
Blurred vision due to swelling (edema) of the back of the eye has also been reported
(frequency not known) in patients taking pioglitazone. Inform your doctor as soon as possible if
you notice the onset of these symptoms for the first time. Also inform your doctor as soon as possible if
you already have blurred vision and the symptom worsens.
Allergic reactions (frequency not known) have been reported in patients taking Pioglitazone
Actavis. If you have a severe allergic reaction, including hives and swelling of the face, lips,
tongue or throat that can cause difficulty breathing or swallowing, stop
taking this medicine and talk to your doctor as soon as possible.
Other side effects that have occurred in some patients taking pioglitazone
are:
common (may affect up to 1 in 10 people)

• respiratory infections
• 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 on the basis of available data)

• increased liver enzymes.
• allergic reactions

Other side effects that have occurred in some patients when they took
pioglitazone together with other antidiabetic medicines are:
very common (may affect more than 1 in 10 people)

• low blood sugar (hypoglycemia)

common (may affect up to 1 in 10 people)

• headache
• dizziness
• joint pain
• impotence
• back pain
• shortness of breath
• a slight decrease in the number of red blood cells in the blood
• flatulence

uncommon (may affect up to 1 in 100 people)

• sugar in the urine, protein in the urine
• increased enzymes
• feeling of spinning (vertigo)
• sweating
• fatigue
• increased appetite

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the
national reporting system detailed in Annex V. By reporting side effects you can help provide more
information on the safety of this medicine.

5. How to store Pioglitazone Actavis

Keep out of sight and reach of children.
Do not use Pioglitazone Actavis after the expiry date which is stated on the cardboard packaging and on the
blister after the word “Exp.”. The expiry date refers to the last day of the month.
This medicinal product does not require any special storage precautions.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Pioglitazone Actavis contains

• The active substance is pioglitazone. Each tablet contains 15 mg, 30 mg and 45 mg of pioglitazone (as hydrochloride). Each tablet contains 15 mg of pioglitazone (as hydrochloride). Each tablet contains 30 mg of pioglitazone (as hydrochloride). Each tablet contains 45 mg of pioglitazone (as hydrochloride).
• The excipients are lactose monohydrate, hydroxypropylcellulose, calcium carmellose and magnesium stearate.

Description of the appearance of Pioglitazone Actavis and package contents
The 15 mg tablets of Pioglitazone Actavis are white, round, flat, bevelled, with a diameter of 5.5 mm and with ‘TZ15’ imprinted on one side.
The tablets are white, round, flat, bevelled, with a diameter of 7 mm and with ‘TZ30’ imprinted on one side.
The tablets are white, round, flat, bevelled, with a diameter of 8 mm and with ‘TZ45’ imprinted on one side.
The tablets are supplied in blisters, in packs of 14, 28, 30, 50, 56, 84, 90, 98 and 100 tablets.
The packs of 14, 28, 56, 84 and 98 tablets contain blisters with the abbreviations of the days of the week printed on the blister (Mon., Tue., Wed., Thu., Fri., Sat., Sun.).
Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation holder
Actavis Group PTC ehf.
Dalshraun 1
220 Hafnarfjörður
Iceland

Manufacturer
Actavis Ltd.
BLB 015-016 Bulebel Industrial Estate
Zejtun ZTN 3000
Malta
For further information on this medicinal product, contact the local representative of the marketing authorisation holder:

België/Belgique/Belgien
Actavis Group PTC ehf.
IJsland/Islande/Island
Tél/Tel: +354 5503300

Lietuva
UAB Teva Baltics
Tel: +370 52660203

България
Тева Фарма ЕАД
Тел: +359 24899585

Luxembourg/Luxemburg
Actavis Group PTC ehf.
Islande/Island
Tél/Tel: +354 5503300

Česká republika
Teva Pharmaceuticals CR, s.r.o.
Tel: +420 251007111

Magyarország
Teva Gyógyszergyár Zrt.
Tel: +36 12886400

Danmark
Teva Denmark A/S
Tlf: +45 44985511

Malta
Teva Pharmaceuticals Ireland
L-Irlanda
Tel: +44 2075407117

Deutschland
Actavis Group PTC ehf.
Island
Tel: +354 5503300

Nederland
Actavis Group PTC ehf.
IJsland
Tel: +354 5503300

Eesti
UAB Teva Baltics Eesti filiaal
Tel: +372 6610801

Norge
Teva Norway AS
Tlf: +47 66775590

Ελλάδα
Specifar A.B.E.E.
Τηλ: +30 2118805000

Österreich
ratiopharm Arzneimittel Vertriebs-GmbH
Tel: +43 1970070

España
Actavis Group PTC ehf.
Islandia
Tel: +354 5503300

Polska
Teva Pharmaceuticals Polska Sp. z o.o.
Tel: +48 223459300

France
Actavis Group PTC ehf.
Islande
Tél: +354 5503300

Portugal
Actavis Group PTC ehf.
Islândia
Tel: +354 5503300

Hrvatska
Pliva Hrvatska d.o.o.
Tel: +385 13720000

România
Teva Pharmaceuticals S.R.L.
Tel: +40 212306524

Ireland
Teva Pharmaceuticals Ireland
Tel: +44 2075407117

Slovenija
Pliva Ljubljana d.o.o.
Tel: +386 15890390

Ísland
Actavis Group PTC ehf.
Sími: +354 5503300

Slovenská republika
TEVA Pharmaceuticals Slovakia s.r.o.
Tel: +421 257267911

Italia
Actavis Group PTC ehf.
Islanda
Tel: +354 5503300

Suomi/Finland
Teva Finland Oy
Puh/Tel: +358 201805900

Κύπρος
Specifar A.B.E.E.
Ελλάδα
Τηλ: +30 2118805000

Sverige
Teva Sweden AB
Tel: +46 42121100

Latvija
UAB Teva Baltics filiāle Latvijā
Tel: +371 67323666

United Kingdom (Northern Ireland)
Teva Pharmaceuticals Ireland
Ireland
Tel: +44 2075407117
More detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu/.