PIOGLITAZONE ACTAVIS 15 mg TABLETS (56 TABLETS) - Generic

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

Do not take Actavis Pioglitazone

• if you are allergic (hypersensitive) to pioglitazone or any of the other ingredients of Actavis Pioglitazone (see section 6).
• if you have heart failure or have had it in the past.
• if you have liver disease.
• if you have had diabetic ketoacidosis (a complication of diabetes that causes rapid weight loss, nausea or vomiting).
• if you have or have had bladder cancer.
• if you have blood in your urine that has not been checked by your doctor.

Warnings and precautions

Tell your doctor before taking this medicine:

• if you have fluid retention or heart problems, particularly if you are over 75 years old. If you are taking anti-inflammatory medicines, which can also cause fluid retention and swelling, you should 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 the ovaries (polycystic ovary syndrome). You may be more likely to become pregnant, as taking Actavis Pioglitazone can make you ovulate again. If this applies to you, use appropriate contraceptive methods to avoid the possibility of unplanned pregnancy.
• if you have liver or heart problems. Before starting treatment with Actavis Pioglitazone, you will have a blood test to check your liver function. These tests should be done regularly. Some patients with long-standing type 2 diabetes and pre-existing heart disease or stroke who received pioglitazone and insulin developed heart failure. Tell your doctor as soon as possible if you experience signs of heart failure such as unusual shortness of breath, rapid weight gain or localised swelling (oedema).

If you take Actavis Pioglitazone with other diabetes medicines, you are more likely to get low blood sugar (hypoglycaemia).

You may also have a reduced red blood cell count (anaemia).

Bone fractures

A higher number of bone fractures has been seen in patients, especially women, taking pioglitazone. Your doctor will take this into account when treating your diabetes.

Children and adolescents

Actavis Pioglitazone is not recommended for children under 18 years old.

Taking Actavis Pioglitazone with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

You can usually take other medicines while being treated with Actavis Pioglitazone. However, certain medicines have a higher chance of affecting your blood sugar levels:

• 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 medicines. They will check your blood sugar levels and may need to change your dose of Actavis Pioglitazone.

Taking Actavis Pioglitazone with food and drink

You can take the tablets with or without food. Take them with a glass of water.

Pregnancy and breast-feeding

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 stop taking this medicine.

Driving and using machines

Pioglitazone does not affect your ability to drive or use machines, but you should be careful if you experience vision problems.

Actavis Pioglitazone contains lactose

If your doctor has told you that you have an intolerance to some sugars, contact them before taking Actavis Pioglitazone.

3. How to take Actavis Pioglitazone

Take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.

The recommended starting dose is one 15 mg or 30 mg pioglitazone tablet per day. Your doctor may increase the dose to a maximum of 45 mg once a day. Your doctor will tell you which dose to take.

If you think that Actavis Pioglitazone is not working as well as expected, talk to your doctor.

Actavis Pioglitazone can be taken with or without food.

When taking Actavis Pioglitazone in combination with other diabetes medicines (such as insulin, chlorpropamide, glibenclamide, gliclazide, tolbutamide), your doctor will tell you whether you need to take less of these medicines.

Your doctor will ask you to have regular blood tests while you are taking Actavis Pioglitazone. These tests are necessary to check that your liver is working normally.

If you follow a diabetic diet, keep to it while you are taking Actavis Pioglitazone.

You should check your weight regularly. If you gain weight, tell your doctor.

If you take more Actavis Pioglitazone than you should

If you accidentally take too many tablets, or if someone else takes your medicine, talk to your doctor or pharmacist immediately.

Your blood sugar levels may become too low, but this can be treated by taking sugar. It is recommended that you carry some sugar lumps, sweets, biscuits or some sugary fruit juice with you.

If you forget to take Actavis Pioglitazone

Take Actavis Pioglitazone every day as prescribed by your doctor. If you forget to take a dose, just take the next dose at the usual time. Do not take a double dose to make up for forgotten doses. In packs of 14, 28, 56, 84 and 98 tablets, you can check the day you last took a tablet of Actavis Pioglitazone by looking at the calendar printed on the blister pack.

If you stop taking Actavis Pioglitazone

Actavis Pioglitazone should be taken daily to have the right effect. If you stop taking Actavis Pioglitazone, your blood sugar levels may increase. Talk to your doctor before stopping treatment.

If you have any further questions on the use of this product, 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, patients have experienced the following serious side effects:

Heart failure, common (up to 1 in 10 people) in patients taking pioglitazone in combination with insulin. The symptoms are unusual shortness of breath, rapid weight gain or localised swelling (oedema). If you experience any of these symptoms, especially if you are over 65 years old, talk to your doctor immediately.

Uncommonly (up to 1 in 100 people), bladder cancer has developed in patients taking pioglitazone. The signs and symptoms include blood in the urine, pain when urinating or an urgent need to urinate. If you experience any of these symptoms, talk to your doctor immediately.

Patients taking pioglitazone in combination with insulin also commonly developed localised swelling (oedema). Talk to your doctor as soon as possible if you experience this side effect.

Bone fractures: these have been reported commonly (up to 1 in 10 people) in both women and men taking pioglitazone (the frequency cannot be estimated from the available data). Talk to your doctor as soon as possible if you experience this side effect.

Blurred vision due to swelling (or fluid) in the back of the eye (frequency not known) has been reported in patients taking pioglitazone. If you experience this symptom for the first time or if you already have it and it gets worse, talk to your doctor as soon as possible.

Allergic reactions (frequency not known) have been reported in patients treated with Actavis Pioglitazone. If you have a severe allergic reaction, including hives and swelling of the face, lips, tongue or throat that may cause difficulty breathing or swallowing, stop taking this medicine and talk to your doctor as soon as possible.

Other side effects that some patients have experienced while taking pioglitazone:

Common (up to 1 in 10 people)

• respiratory infection
• vision problems
• weight gain
• numbness

Uncommon (up to 1 in 100 people)

• inflammation of the nasal passages (sinusitis)
• difficulty sleeping (insomnia)

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

• increased liver enzymes
• allergic reactions

Other side effects that some patients have experienced while taking pioglitazone with other diabetes medicines are:

Very common (more than 1 in 10 people)

• low blood sugar (hypoglycaemia)

Common (up to 1 in 10 people)

• headache
• dizziness
• joint pain
• impotence
• back pain
• shortness of breath
• mild reduction in red blood cell count
• flatulence (gas)

Uncommon (up to 1 in 100 people)

• sugar in the urine, protein in the urine
• increased enzymes
• vertigo
• sweating
• fatigue
• increased appetite

Reporting of side effects

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.

5. Storage of Actavis Pioglitazone

Keep out of the sight and reach of children.

Do not use Actavis Pioglitazone after the expiry date which is stated on the carton and on the blister after EXP. The expiry date refers to the last day of that month.

This medicine does not require any special storage conditions.

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. Contents of the pack and other information

What Actavis Pioglitazone 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 other ingredients are lactose monohydrate, hydroxypropylcellulose, calcium carmellose and magnesium stearate.

What Actavis Pioglitazone looks like and contents of the pack

The Actavis Pioglitazone 15 mg tablets are white, round, flat, bevelled, 5.5 mm in diameter and engraved with “TZ15” on one side.

The Actavis Pioglitazone 30 mg tablets are white, round, flat, bevelled, 7 mm in diameter and engraved with “TZ30” on one side.

The Actavis Pioglitazone 45 mg tablets are white, round, flat, bevelled, 8 mm in diameter and engraved with “TZ45” on one side.

The tablets are packaged in aluminium blister 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 them (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.

Reykjavikurvegi 76-78

220 Hafnarfjördur

Iceland

Manufacturer

Actavis Ltd.

BLB 015-016 Bulebel Industrial Estate

Zejtun ZTN 3000

Malta

You can get more information on this medicine by contacting the local representative of the Marketing Authorisation Holder:

Date of last revision of this leaflet:{MM/YYYY}.

Detailed information on this medicine is available on the European Medicines Agency web site http://www.ema.europa.eu.