Label:Patient Information

Actos 15mg tablets

Actos 30mg tablets

Actos 45mg tablets

pioglitazone

Read this label carefully before starting to take this medication, as it contains important information for you.

• Keep this label, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you and should not be given to others who may have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this label. See section 4.

1.What is Actos and how is it used

2.What you need to know before starting to take Actos

3.How to take Actos

4.Possible adverse effects

5.Storage of Actos

6.Contents of the package and additional information

Actos contains pioglitazone. It is an antidiabetic medication used to treat type 2 (non-insulin-dependent) diabetes in adults, when metformin is not suitable or has not worked properly. This type of diabetes typically occurs in adults.

Actos helps control blood sugar levels when you have type 2 diabetes. It allows your body to use insulin more effectively. Your doctor will monitor the effect of Actos on you between 3 and 6 months after starting treatment.

Actos tablets can be used alone in patients who cannot take metformin and when diet and exercise have not been sufficient to control blood sugar levels or can be added to other treatments (such as metformin, sulfonylurea, or insulin) if they have not provided sufficient control of blood sugar levels.

Do not take Actos:

-if you are allergic to pioglitazone or any of the other ingredients in this medication (listed in section6).

-if you have heart failure or have had it in the past.

-if you have any 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 uncontrolled blood in your urine.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Actos (also see section4)

-if you have fluid retention or heart problems, particularly if you are over 75 years old.If you take anti-inflammatory medications that can also cause fluid retention and swelling, you should also consult your doctor.

• if you have a special type of diabetic eye disease called macular edema (swelling of the back of the eye).
• if you have ovarian cysts (polycystic ovary syndrome). This may increase the chances of becoming pregnant, as taking Actos may cause you to ovulate again. If this is your case, use suitable contraceptive methods to avoid the possibility of unplanned pregnancy.

• if you have liver or heart problems. Before starting treatment with Actos, a blood test will be performed to check liver function. These tests must be performed periodically. Some patients with type2 diabetes of long duration and heart disease or previous stroke who received 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 with other diabetes medications, it is more likely that your blood sugar level may drop below the normal limit (hypoglycemia).

You may also show a reduction in the count 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 treating your diabetes.

Children and adolescents

Not recommended for children and adolescents under 18 years old.

Other medications and Actos

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication, including those purchased without a prescription.

Generally, you can continue to take other medications while taking Actos tablets. However, certain medications have a higher probability of affecting blood sugar content:

• gemfibrozil (used to reduce cholesterol)
• rifampicin (used to treat tuberculosis and other infections)

Inform your doctor or pharmacist if you are taking any of these medications. They will monitor your blood sugar level and may need to adjust the dose of Actos.

Taking Actos with food and drinks

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

Pregnancy and breastfeeding

Inform your doctor if:

• you are or think you may be pregnant or are planning to become pregnant
• you are breastfeeding or plan to breastfeed your child

Your doctor will advise you to stop taking this medication.

Driving and operating machinery

This medication does not affect your ability to drive or operate machinery, but you should be cautious if you experience visual disturbances.

Actos contains lactose monohydrate

If your doctor has indicated that you have an intolerance to certain sugars, consult with them before taking Actos.

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

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

If you think Actos is not having the desired effect, consult your doctor.

When taking Actos in combination with other medications used to treat diabetes (such as insulin, chlorpropamide, glibenclamide, glimepiride, tolbutamide), your doctor will tell you if you need to take a lower amount of those medications.

Your doctor will ask you to have periodic blood tests while you are being treated with Actos. These tests are necessary to control that your liver is functioning normally.

Follow any special diet for diabetics while taking Actos.

You must control your weight regularly. If you gain weight, inform your doctor.

If you take more Actos than you should

If, by accident, you take too many tablets, or if someone else (e.g. a child) takes your medication, inform your doctor or pharmacist immediately. Your blood sugar level may drop below normal, but you can increase it by taking sugar. It is recommended that you carry some sugar cubes, candies, cookies, or some fruit juice with sugar.

If you forget to take Actos

Take Actos every day as prescribed. If you forget to take a dose, continue your treatment as usual. Do not take a double dose to make up for the missed dose.

If you interrupt treatment with Actos

Actos should be taken daily for the treatment to have the desired effect. If you interrupt taking Actos, your blood sugar level may increase. Consult your doctor before interrupting treatment.

If you have any other questions about the use of this product, ask your doctor or pharmacist.

Like all medicines, this medicine may haveside effects, although not everyone will experience them.

Particularly, patients have reported the following serious side effects:

Heart failure, a frequent occurrence (may affect up to 1in 10people)in patients taking Actos in combination with insulin. Symptoms include unusual shortness of breath or rapid weight gain or localized swelling (edema). If you experience any of these symptoms, especially if you are over 65 years old, consult your doctor immediately.

Infrequently (may affect up to 1in 100people), bladder cancer has developed in patients taking Actos. Signs and symptoms include blood in the urine, pain while urinating or urgent need to urinate. If you experience any of these symptoms, consult your doctor immediately.

Patients taking Actos in combination with insulin also experienced localized swelling (edema) very frequently (may affect more than 1in 10people). Consult your doctor as soon as possible if you experience this side effect.

Bone fractures: frequent occurrences (may affect up to 1in 10people)in both men and women taking Actos (frequency cannot be estimated from available data). Consult your doctor as soon as possible if you experience this side effect.

Also, blurred vision due to swelling (or fluid) in the back of the eye has been reported in patients taking Actos (frequency cannot be estimated from available data). If you experience this symptom for the first time or if it worsens, consult your doctor as soon as possible.

Frequent allergic reactions have been reported in patients treated with Actos (frequency cannot be estimated from available data). If you have a severe allergic reaction, including hives, facial swelling, lip, tongue, or throat swelling that may cause difficulty breathing or swallowing, stop taking this medicine and consult your doctor as soon as possible.

Other side effects experienced by some patients taking Actos are:

Frequent (may affect up to 1in10 people)

• Respiratory infection,
• Vision abnormalities,
• Weight gain,
• Numbness

Infrequent (may affect up to 1in100 people)

• Nasal sinus inflammation (sinusitis)
• Difficulty sleeping (insomnia)

Frequency unknown (cannot be estimated from available data)

• Increased liver enzymes
• Allergic reactions

Other side effects experienced by some patients taking Actos in combination with other diabetes medications are:

Very frequent (may affect more than 1in10 people)

• Low blood sugar (hypoglycemia)

Frequent (may affect up to 1in10 people)

• Headache
• Dizziness
• Joint pain
• Impotence
• Back pain
• Shortness of breath
• Mild reduction in red blood cell count
• Gas (flatulence)

Infrequent (may affect up to 1in100 people)

• Sugar in the urine, proteins in the urine
• Increased enzymes
• Dizziness
• Sweating
• Fatigue
• Increased appetite

Reporting side effects

If you experienceany type of side effect, consult your doctor or pharmacist, even if it is apossibleside effect not listed in this leaflet.You can also report them directly through thenational notification system included in theAppendix V. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging after CAD and on the blister pack after EXP.The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Actos

-The active ingredient of Actos is pioglitazone.

Cada tablet of Actos 15mg contains 15mg of pioglitazone (as hydrochloride).

Cada tablet of Actos 30mg contains 30mg of pioglitazone (as hydrochloride).

Cada tablet of Actos 45mg contains 45mg of pioglitazone (as hydrochloride).

-The other components are: lactose monohydrate, hypromellose, calcium carmelose and magnesium stearate. See section2 “Actos contains lactose monohydrate”.

Appearance of Actos and contents of the package

-The tablets of Actos 15mg are round, convex and white to off-white, andhave a ‘15’ engraved on one face and ‘ACTOS’ on the other.

-The tablets of Actos 30mg are round, flat and white to off-white, and have a ‘30’ engraved on one face and ‘ACTOS’ on the other.

-The tablets of Actos 45mg are round, flat and white to off-white, and have a ‘45’ engraved on one face and ‘ACTOS’ on the other.

The tablets are supplied in packs of 28, 56, 98, or 112 tablets. Some pack sizes may only be marketed.

Marketing Authorization Holder

CHEPLAPHARM Arzneimittel GmbH

Ziegelhof 24

17489 Greifswald

Germany

Responsible Person

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

Last review date of this leaflet: August 2023

Other sources of information

The detailed information on this medicine is available on the website of the European Medicines Agencyhttp://www.ema.europa.eu

AnnexIV

SCIENTIFIC CONCLUSIONS AND REASONS FOR THE MODIFICATION OF THE CONDITIONS OF THE MARKETING AUTHORISATION(S)

Scientific Conclusions

Considering the provisions of the PRAC Report on the Periodic Safety Update Reports (PSURs) for glimepiride/pioglitazone hydrochloride, metformin/pioglitazone, pioglitazone, the scientific conclusions of the CHMP are as follows:

The TAC provided updated information related to the identified and potential important risks, as listed in the summary of safety problems. The data presented during the current reporting period did not provide new information that would allow the reduction, mitigation, or characterization of these risks. According to the data presented, the risk minimization measures approved in the product information are considered adequate for the safety problems listed.

Given the accumulation of data since the implementation of additional risk minimization measures, the PRAC accepted the TAC's proposal to eliminate the additional risk minimization measures. As a consequence, the conditions or restrictions related to the safe and effective use of the medicine should be updated to eliminate the additional risk minimization measures. The PSUR has been updated accordingly.

The CHMP agrees with the scientific conclusions of the PRAC.

Reasons for the modification of the conditions of the Marketing Authorisation(s)

According to the scientific conclusions for glimepiride/pioglitazone hydrochloride, metformin/pioglitazone, pioglitazone, the CHMP considers that the benefit-risk balance of the medicine or medicines containing glimepiride/pioglitazone hydrochloride, metformin/pioglitazone, pioglitazone is not modified subject to the proposed changes in the product information.

The CHMP recommends that the conditions of the Marketing Authorisation(s) be modified.