Actos

Patient Information Leaflet

Actos 15 mg tablets, 30 mg tablets, 45 mg tablets

pioglitazone
Please read this leaflet carefully before 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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What Actos is and what it is used for

Actos contains pioglitazone. It is an antidiabetic medicine used to treat type 2 diabetes (non-insulin-dependent) in adults when metformin is not suitable or has not worked adequately. This type of diabetes usually occurs in adults.
Actos 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 Actos is working 3–6 months after starting treatment.
Actos may be used alone in patients who are unable to take metformin and in whom diet and exercise have failed to control blood glucose levels, or it may be added to other therapies (such as metformin, a sulphonylurea, or insulin) that have not provided adequate glycaemic control.

2. What you need to know before taking Actos

Do not take Actos

• if you are allergic to pioglitazone or to any of the other ingredients of this medicine (listed in section 6).
• if you have heart failure or have previously had heart failure.
• if you have liver problems.
• 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 (bladder tumour).
• if you have blood in your urine for which your doctor has not yet carried out investigations.

Warnings and precautions
Talk to your doctor or pharmacist before taking Actos (see also section 4)

• if you retain fluid (fluid retention) or have heart failure problems, especially if you are over 75 years old. You must 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 in the back of the eye).
• if you have ovarian cysts (polycystic ovary syndrome). The chance of becoming pregnant may increase, as ovulation may resume when you take Actos. 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 Actos, 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 a history of stroke who were treated with Actos and insulin 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 Actos together with other diabetes medicines, your blood sugar level is more likely to drop below normal levels (hypoglycemia).
You may also experience a reduction in the number of blood cells (anemia).
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 and adolescents under 18 years of age is not recommended.
Other medicines and Actos
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those without a prescription.
Generally, you can continue taking other medicines while being treated with Actos.
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 your dose of Actos.

Actos with food and drink
You may take the tablets with or without food. Swallow the tablets with a glass of water.
Pregnancy and breastfeeding
Inform your doctor if

• you are pregnant, suspect you may be pregnant, or are planning a pregnancy.
• you are breastfeeding or planning to breastfeed. Your doctor will advise you to stop treatment with this medicine.

Driving and using machines
This medicine has no effect on the ability to drive or use machinery, but be cautious if you experience vision disturbances.
Actos contains lactose monohydrate
If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking Actos.

3. How to take Actos

Take this medicine exactly as your doctor or pharmacist has told you. If
you have any doubts, consult your doctor or pharmacist.
The usual starting dose is one 15 mg or 30 mg tablet 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 Actos is too weak, talk to your doctor.
When Actos tablets are 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 blood tests periodically during treatment with Actos.
This is to monitor normal liver function.
If you are following a special diet for diabetes, you must continue it while taking Actos.
Your weight should be checked at regular intervals; if you gain weight, inform your doctor.
If you take more Actos 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 could drop below normal levels and can be raised by taking sugar. It is advisable to carry sugar lumps, sweets, biscuits, or sugared fruit juices with you.
If you forget to take Actos
Try to take Actos every day as prescribed. However, if you forget to take a dose, take your next dose as usual. Do not take a double dose to make up for the forgotten tablet.
If you stop taking Actos
Actos must be taken every day to work properly. If you stop taking Actos, your blood sugar level may increase. Talk to your doctor before stopping treatment.
If you have any questions about the use of this medicine, consult 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:
Common cases (may affect up to 1 in 10 people) of heart failure have occurred in patients taking Actos 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 (may affect up to 1 in 100 people) of bladder cancer have occurred in patients treated with Actos. Signs and symptoms include blood in the urine, pain during urination, or 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) (may affect more than 1 in 10 people) have occurred in patients taking Actos in combination with insulin. If you experience this side effect, inform your doctor as soon as possible.
Common cases (may affect up to 1 in 10 people) of bone fractures have been reported in female patients and also in male patients taking Actos (available data do not allow 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 has also been reported in patients taking Actos (frequency cannot be determined from available data). Inform your doctor as soon as possible if you notice the new onset of these symptoms. Also inform your doctor as soon as possible if you already have blurred vision and the symptom worsens.
Allergic reactions have been reported with unknown frequency (frequency cannot be determined from available data) in patients taking Actos. 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 contact your doctor as soon as possible.

Other side effects observed in some patients taking Actos 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 determined from available data)

• increased liver enzymes
• allergic reactions

Other side effects observed in some patients taking Actos together 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
• increased enzymes
• feeling 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 through the national reporting system listed in Annex V. Reporting side effects can help provide more information on the safety of this medicine.

5. How to store Actos

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 cardboard box after "Exp." 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 precautions.
Do not dispose of any medicine via 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 Actos contains

• The active substance in Actos is pioglitazone. Each Actos 15 mg tablet contains 15 mg of pioglitazone (as hydrochloride). Each Actos 30 mg tablet contains 30 mg of pioglitazone (as hydrochloride). Each Actos 45 mg tablet contains 45 mg of pioglitazone (as hydrochloride).
• The other ingredients are monohydrate lactose, hypromellose, calcium carmellose, and magnesium stearate. See section 2 “Actos contains monohydrate lactose”.

Description of the appearance of Actos and the contents of the pack

• Actos 15 mg tablets are white to off-white, round, convex, with ‘15’ engraved on one side and 'ACTOS' on the other.
• Actos 30 mg tablets are white to off-white, round, flat, with ‘30’ engraved on one side and 'ACTOS' on the other.
• Actos 45 mg tablets are white to off-white, round, flat, with ‘45’ engraved on one side and 'ACTOS' on the other.

The tablets are supplied in blisters, in pack sizes of 28, 56, 98 or 112 tablets. Not all pack sizes may be marketed.

Marketing Authorization Holder
CHEPLAPHARM Arzneimittel GmbH
Ziegelhof 24
17489 Greifswald
Germany

Manufacturer
Takeda Ireland Limited, Bray Business Park, Kilruddery, County Wicklow, Ireland.
Lilly S.A., Avda. de la Industria 30, 28108 Alcobendas (Madrid), Spain.
CHEPLAPHARM Arzneimittel GmbH, Ziegelhof 23-24, 17489 Greifswald, Germany.

Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu