ACTOS 15 mg TABLETS

2. What you need to know before you take Actos

Do not take Actos:

• if you are allergic to pioglitazone or any of the other ingredients of this medicine (listed in section 6).
• 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 blood in your urine that has not been checked by your doctor.

Warnings and precautions

Talk to your doctor or pharmacist before starting Actos (see also section 4)

• if you have fluid retention or heart problems, especially if you are over 75 years old. If you are taking anti-inflammatory medicines that can also cause fluid retention and swelling, you should also talk to 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 cysts on the ovaries (polycystic ovary syndrome). You may be more likely to become pregnant, as taking Actos can make you ovulate again. If this applies to you, use appropriate contraceptive methods to avoid the possibility of an unplanned pregnancy.

• if you have liver or heart problems. Before starting treatment with Actos, you will have a blood test to check your liver function. These tests should be done regularly. Some patients with type 2 diabetes who have taken Actos 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, rapid weight gain, or localized swelling (edema).

If you take Actos with other diabetes medicines, you are more likely to experience low blood sugar (hypoglycemia).

You may also experience a reduction in blood cell count (anemia)

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

It is not recommended for children and adolescents under 18 years of age.

Other medicines and Actos

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription.

You can usually continue to take other medicines while taking Actos tablets. However, certain medicines are more likely to affect 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 Actos.

Taking Actos with food and drink

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

Pregnancy and breastfeeding

Tell 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 medicine.

Driving and using machines

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

Actos contains lactose monohydrate

If your doctor has told you that you have an intolerance to some sugars, talk to them before taking Actos.

3. How to take Actos

Follow exactly the instructions given to you by your doctor or pharmacist. If you are not sure, talk to your doctor or pharmacist again.

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 Actos is not working as well as expected, talk to your doctor.

When you take Actos with other medicines used to treat diabetes (such as insulin, chlorpropamide, glibenclamida, gliclazide, tolbutamide), your doctor will tell you if you need to take a lower dose of those medicines.

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

If you follow a special diet for diabetics, keep to it while you are taking Actos.

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

If you take more Actos than you should

If you accidentally take too many tablets, or if someone else (e.g., a child) takes your medicine, talk to your doctor or pharmacist immediately. Your blood sugar levels may become too low, but you can increase them 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 Actos

Take Actos every day, as prescribed by your doctor. If you forget to take a dose, continue with your treatment as usual. Do not take a double dose to make up for forgotten doses.

If you stop taking Actos

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

If you have any other questions about 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 reported the following serious side effects:

Heart failure, which is common (may affect up to 1 in 10 people) in patients taking Actos in combination with insulin. The symptoms are 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, talk to your doctor immediately.

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

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

Bone fractures: have been reported commonly (may affect up to 1 in 10 people) in both women and men taking Actos (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 has also been reported in patients taking Actos (the frequency cannot be estimated from the available data). 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 have been reported with an unknown frequency (cannot be estimated from the available data) in patients treated with Actos. 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 Actos are:

common (may affect up to 1 in 10 people)

• respiratory infection,
• vision problems,
• weight gain,
• numbness

uncommon (may affect up to 1 in 100 people)

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

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 Actos 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
• mild reduction in red blood cell count
• gas (flatulence)

uncommon (may affect up to 1 in 100 people)

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

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package 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 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 carton after EXP and on the blister after EXP. The expiry date refers to the last day of the month shown.

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 protect the environment.

6. Contents of the pack and other information

What Actos contains

• The active substance of 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: lactose monohydrate, hypromellose, calcium carmellose, and magnesium stearate. See section 2 "Actos contains lactose monohydrate".

Appearance of Actos and pack contents

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

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

Marketing authorisation 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

Date of last revision of this package leaflet: August 2023

Other sources of information

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

AnnexIV

SCIENTIFIC CONCLUSIONS AND GROUNDS FOR AMENDMENT OF THE MARKETING AUTHORISATIONS

Scientific conclusions

Taking into account the provisions of the Pharmacovigilance Risk Assessment Committee (PRAC) report on the periodic safety update reports (PSURs) for glimepiride / pioglitazone hydrochloride, metformin / pioglitazone, pioglitazone, the scientific conclusions of the Committee for Medicinal Products for Human Use (CHMP) are as follows:

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

Given the accumulation of data since the implementation of the additional risk minimization measures, the PRAC accepted the proposal of the Pharmacovigilance Risk Assessment Committee to remove 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 remove the additional risk minimization measures. The RMP has been updated accordingly.

The CHMP agrees with the scientific conclusions of the PRAC.

Grounds for amendment of the marketing authorisations

In accordance with 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 affected subject to the proposed changes in the product information.

The CHMP recommends that the marketing authorisations be amended.