ACTOS 30 mg TABLETS

Introduction

Prospectus:Information for the patient

Actos 15mg tablets

Actos 30mg tablets

Actos 45mg tablets

pioglitazone

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

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

Contents of the prospectus:

1. What is Actos and what is it used for
2. What you need to know before taking Actos
3. How to take Actos
4. Possible adverse effects
5. Storage of Actos
6. Package contents and additional information

1. What is Actos and what is it used for

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

Actos is used to control blood sugar levels when you have type 2 diabetes. It helps your body use the insulin it produces 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 enough to control blood sugar levels, or they can be added to other treatments (such as metformin, sulfonylurea, or insulin) if they have not provided sufficient control of blood sugar levels.

2. What you need to know before taking Actos

Do not take Actos:

• if you are allergic to pioglitazone or any of the other components of this medication (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 controlled by your doctor.

Warnings and precautions

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

• if you have fluid retention or heart problems, particularly if you are over 75 years old. If you are taking 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 cysts on the ovaries (polycystic ovary syndrome). You may be more likely to become pregnant, as taking Actos can cause you to ovulate again. If this is the case, 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 periodically. Some patients with long-standing type 2 diabetes mellitus and previous heart disease or 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, 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 observed in patients, particularly in 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 old.

Other medications and Actos

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

You can usually continue to take other medications while taking Actos tablets. However, certain medications are more likely to affect your blood sugar levels:

• gemfibrozil (used to lower 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 levels 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 using machines

This medication does not affect your ability to drive or use machines, but you should be cautious if you experience vision changes.

Actos contains lactose monohydrate

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

3. How to take Actos

Follow the instructions for taking this medication exactly as indicated by your doctor or pharmacist. If you are unsure, consult 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 indicate the dose you should take.

If you think Actos is not working effectively, consult your doctor.

When taking Actos in combination with other diabetes medications (such as insulin, chlorpropamide, glibenclamida, gliclazide, tolbutamide), your doctor will indicate if you need to take a lower dose 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 monitor that your liver is working normally.

If you follow a special diet for diabetics, maintain it while taking Actos.

You should regularly check your weight. 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 (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 sugary fruit juice with you.

If you forget to take Actos

Take Actos every day, as prescribed. 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 daily for the treatment to have the proper effect. If you stop taking Actos, your blood sugar level may increase. Consult your doctor before stopping treatment.

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

4. Possible adverse effects

Like all medications, this medication can have adverse effects, although not everyone experiences them.

In particular, patients have reported the following serious adverse 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, consult your doctor immediately.

Bladder cancer has been reported rarely (may affect up to 1 in 100 people) in patients taking Actos. The signs and symptoms include blood in the urine, pain when urinating, or urgent need to urinate. If you experience any of these symptoms, consult your doctor immediately.

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

Bone fractures: these have been reported frequently (may affect up to 1 in 10 people) in both women and men taking Actos (the frequency cannot be estimated from the available data). Consult your doctor as soon as possible if you experience this adverse 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 worsens, consult 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 medication and consult your doctor as soon as possible.

Other adverse effects that some patients have experienced while taking Actos are:

common (may affect up to 1 in 10 people)

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

uncommon (may affect up to 1 in 100 people)

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

unknown frequency (cannot be estimated from the available data)

• increased liver enzymes
• allergic reactions

Other adverse effects that some patients have experienced while taking Actos with other antidiabetic medications 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
• flatulence (gas)

uncommon (may affect up to 1 in 100 people)

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

Reporting adverse effects

If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospectus. You can also report them directly through the national reporting system included in Appendix V. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Actos

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

Do not use this medication after the expiration date stated 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 wastewater or household waste. Ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Package contents and additional information

Composition of Actos

• The active ingredient of Actos is pioglitazone.

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

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

Each 45 mg Actos 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 package contents

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

The tablets are supplied in packs with 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

Date of last revision of this prospectus: August 2023

Other sources of information

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

AnnexIV

SCIENTIFIC CONCLUSIONS AND GROUNDS FOR AMENDMENT OF THE MARKETING AUTHORIZATION(S)

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 TAC provided updated information related to identified important risks and important potential risks, as listed in the summary of safety concerns. The data presented 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 presented, 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 TAC's proposal to remove the additional risk minimization measures. As a consequence, the conditions or restrictions related to the safe and effective use of the medication should be updated to remove the additional risk minimization measures. The RMP has been updated accordingly.

The CHMP agrees with the PRAC's scientific conclusions.

Grounds for amendment of the marketing authorization(s)

In accordance with the scientific conclusions for glimepiride / pioglitazone hydrochloride, metformin / pioglitazone, pioglitazone, the CHMP considers that the benefit-risk balance of the medication or medications 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 authorization(s) be amended.