Pioglitazone Actavis

Patient Information Leaflet: Information for the User

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

pioglitazone
Please read all of 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 give it to other people, even if they have the same symptoms as you, because it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, talk to 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 taking 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 Pioglitazone Actavis is and what it is used for

Pioglitazone Actavis contains pioglitazone. It is an antidiabetic medicine used to treat
type 2 diabetes mellitus (non-insulin-dependent diabetes), when metformin is not suitable or has
not worked adequately. This type of diabetes usually occurs in adults.
Pioglitazone Actavis helps control blood sugar levels in patients with
type 2 diabetes by helping the body make better use of the insulin it produces. Your doctor
will check whether Pioglitazone Actavis is working 3–6 months after starting treatment.
Pioglitazone Actavis can be used alone in patients who are unable to take
metformin, and when diet and exercise have failed to control blood glucose levels, or it can
be added to other therapies (such as metformin, a sulphonylurea, or insulin) that have not
provided adequate blood glucose control.

2. What you need to know before taking Pioglitazone Actavis

Do not take Pioglitazone Actavis

• if you are hypersensitive (allergic) to pioglitazone or to any of the excipients of Pioglitazone Actavis (see section 6 for the list of excipients).
• if you have heart failure or have previously had heart failure.
• if you have liver disorders.
• if you have experienced diabetic ketoacidosis (a diabetes complication causing rapid weight loss, nausea or vomiting).
• if you have or have previously had bladder cancer.
• if you have blood in your urine for which your doctor has not yet carried out investigations.

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

• if you retain fluid (fluid retention) or have heart failure problems, especially if you are over 75 years old. You should also inform your doctor if you are taking anti-inflammatory medicines, which can also cause fluid retention and swelling,
• if you have a specific type of diabetic eye disease called macular edema (swelling at the back of the eye).
• if you have ovarian cysts (polycystic ovary syndrome). The likelihood of becoming pregnant may increase, as ovulation may resume when you take Pioglitazone Actavis. If this applies to you, use an appropriate contraceptive method to avoid the risk of unplanned pregnancy.
• if you have liver or heart problems. Before starting Pioglitazone Actavis, you will have a blood test to check your liver function. This test may be repeated periodically. Some patients with long-standing type 2 diabetes and heart disease or previous stroke who were treated with pioglitazone and insulin have developed heart failure. Inform your doctor as soon as possible if you experience signs of heart failure such as unusual shortness of breath, rapid weight gain, or localized swelling (edema).

If you take Pioglitazone Actavis together with other diabetes medicines, your blood sugar level is more likely to drop below normal levels (hypoglycaemia).
You may also experience a reduction in the number of blood cells (anaemia).
Bone fractures
A higher number of bone fractures has been observed in patients, particularly in women taking pioglitazone. Your doctor will take this into account when managing your diabetes.
Children and adolescents
Use in children under 18 years of age is not recommended.
Other medicines and Pioglitazone Actavis
Inform your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Generally, you can continue taking other medicines while being treated with Pioglitazone Actavis.
However, certain medicines in particular may affect your blood sugar levels:

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

Pioglitazone Actavis with food and drink
You may take the tablets with or without food. Swallow the tablets with a glass of water.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or are breastfeeding, 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 effect on the ability to drive or operate machinery, but be cautious if you experience vision disturbances.
Pioglitazone Actavis contains lactose monohydrate
If your doctor has informed you that you have an intolerance to certain sugars, contact your doctor before taking Pioglitazone Actavis.

3. How to take Pioglitazone Actavis

Take this medicine exactly as directed by your doctor or pharmacist. If
you have any doubts, consult your doctor or pharmacist.
The usual starting dose is one tablet containing 15 mg or 30 mg of pioglitazone taken once
daily. Your doctor may increase your dose up to a maximum of 45 mg taken once
daily. Your doctor will tell you which dose to take.
If you feel that the effect of Pioglitazone Actavis is too weak, speak to your doctor.
Pioglitazone Actavis may be taken with or without food.
When Pioglitazone Actavis 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 lower dose of these other medicines.
Your doctor will ask you to have periodic blood tests during treatment with
Pioglitazone Actavis. These tests are to monitor normal liver function.
If you are following a diabetic diet, you should continue it while taking Pioglitazone Actavis.
Your weight should be monitored at regular intervals; if you gain weight, inform your doctor.
If you take more Pioglitazone Actavis tablets than you should
If you accidentally take too many tablets, or if someone else or a child takes your
tablets, contact your doctor or pharmacist immediately. Your blood sugar level
might drop below normal levels, which can be treated by taking sugar. It is advisable to carry sugar lumps, sweets, biscuits, or sugared 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 containing 14, 28, 56, 84 and 98 tablets, you can check the day on which you took the last Pioglitazone Actavis tablet by referring to the calendar printed on the blister.
If you stop taking Pioglitazone Actavis
Pioglitazone Actavis must be taken every day to work properly. If you stop taking
Pioglitazone Actavis, your blood sugar level may increase. Talk to your doctor
before stopping treatment.
If you have any questions about how to use this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
In particular, the following serious side effects have been reported in some patients:

Common cases (up to 1 in 10 people) of heart failure have occurred in patients taking pioglitazone in combination with insulin. Symptoms include unusual shortness of breath, rapid weight gain, or localized swelling (edema). If you experience any of these symptoms, especially if you are over 65 years old, seek immediate medical advice.

Uncommon cases (up to 1 in 100 people) of bladder cancer have been reported 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, speak 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 estimation of 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 (frequency not known) has also been reported 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 experience a severe allergic reaction, including hives and swelling of the face, lips, tongue, or throat, which may cause difficulty breathing or swallowing, stop taking this medicine immediately and consult your doctor as soon as possible.

Other side effects observed 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)

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

• increase in liver enzymes
• allergic reactions

Other side effects observed in some patients taking pioglitazone in combination with other antidiabetic medicines are:
Very common (may affect more than 1 in 10 people)

• decrease in blood sugar (hypoglycaemia)

Common (may affect up to 1 in 10 people)

• headache
• dizziness
• joint pain
• impotence
• back pain
• shortness of breath
• slight reduction 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
• increase in enzymes
• sensation of dizziness (vertigo)
• sweating
• fatigue
• increased appetite

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system listed 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 the sight and reach of children.
Do not use Pioglitazone Actavis after the expiry date stated on the cardboard carton and blister
after the word “Exp.”. The expiry date refers to the last day of the month.
This medicinal product requires no special storage precautions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. 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, or 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 monohydrate lactose, hydroxypropylcellulose, calcium carmellose, and magnesium stearate.

Description of the appearance of Pioglitazone Actavis and pack sizes
The 15 mg tablets of Pioglitazone Actavis are white, round, flat, bevelled, 5.5 mm in diameter, with 'TZ15' engraved on one side.
The tablets are white, round, flat, bevelled, 7 mm in diameter, with 'TZ30' engraved on one side.
The tablets are white, round, flat, bevelled, 8 mm in diameter, with 'TZ45' engraved on one side.
The tablets are supplied in blisters, in pack sizes of 14, 28, 30, 50, 56, 84, 90, 98, and 100 tablets.
The pack sizes of 14, 28, 56, 84, and 98 tablets contain blisters with 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, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien Lietuva
Actavis Group PTC ehf. UAB Teva Baltics
IJsland/Islande/Island Tel: +370 52660203
Tél/Tel: +354 5503300

България Luxembourg/Luxemburg
Тева Фарма ЕАД Actavis Group PTC ehf.
Тел: +359 24899585 Islande/Island
Tél/Tel: +354 5503300

Česká republika Magyarország
Teva Pharmaceuticals CR, s.r.o. Teva Gyógyszergyár Zrt.
Tel: +420 251007111 Tel: +36 12886400

Danmark Malta
Teva Denmark A/S Teva Pharmaceuticals Ireland
Tlf: +45 44985511 L-Irlanda
Tel: +44 2075407117

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

Eesti Norge
UAB Teva Baltics Eesti filiaal Teva Norway AS
Tel: +372 6610801 Tlf: +47 66775590

Ελλάδα Österreich
Specifar A.B.E.E. ratiopharm Arzneimittel Vertriebs-GmbH
Τηλ: +30 2118805000 Tel: +43 1970070

España Polska
Actavis Group PTC ehf. Teva Pharmaceuticals Polska Sp. z o.o.
Islandia Tel: +48 223459300
Tel: +354 5503300

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

Hrvatska România
Pliva Hrvatska d.o.o. Teva Pharmaceuticals S.R.L.
Tel: +385 13720000 Tel: +40 212306524

Ireland Slovenija
Teva Pharmaceuticals Ireland Pliva Ljubljana d.o.o.
Tel: +44 2075407117 Tel: +386 15890390

Ísland Slovenská republika
Actavis Group PTC ehf. TEVA Pharmaceuticals Slovakia s.r.o.
Sími: +354 5503300 Tel: +421 257267911

Italia Suomi/Finland
Actavis Group PTC ehf. Teva Finland Oy
Islanda Puh/Tel: +358 201805900
Tel: +354 5503300

Κύπρος Sverige
Specifar A.B.E.E. Teva Sweden AB
Ελλάδα Tel: +46 42121100
Τηλ: +30 2118805000

Latvija United Kingdom (Northern Ireland)
UAB Teva Baltics filiāle Latvijā Teva Pharmaceuticals Ireland
Tel: +371 67323666 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/.