Actos 30 mg tablets
Spain
Table of Contents
Patient Information Leaflet
Introduction
Package Leaflet: Information for the patient
Actos 15 mg tablets
Actos 30 mg tablets
Actos 45 mg tablets
pioglitazone
Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.
- Keep this leaflet as you may need to read it again.
- If you have any questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.
Leaflet contents:
- What Actos is and what it is used for
- What you need to know before taking Actos
- How to take Actos
- Possible side effects
- How to store Actos
- 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 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 helps control blood sugar levels in people with type 2 diabetes. It allows your body to use insulin more effectively. Your doctor will monitor the effect of Actos within 3 to 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 they can be added to other treatments (such as metformin, sulfonylureas, or insulin) if these have not achieved adequate control of blood sugar levels.
2. What you need to know before starting 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 had it in the past.
- if you have any liver disease.
- if you have had diabetic ketoacidosis (a complication of diabetes causing rapid weight loss, nausea, or vomiting).
- if you have or have had bladder cancer.
- if you have unexplained blood in your urine that has not been evaluated and cleared by your doctor.
Warnings and precautions
Consult your doctor or pharmacist before starting to take Actos (see also section 4)
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if you have fluid retention or heart problems, particularly if you are over 75 years of age. If you are taking anti-inflammatory medicines, which can also cause fluid retention and swelling, you should also discuss this with your doctor.
- if you have a specific type of diabetic eye disease called macular edema (swelling at the back of the eye).
- if you have ovarian cysts (polycystic ovary syndrome). The likelihood of becoming pregnant may increase, as ovulation may resume while taking Actos. If this applies to you, use appropriate contraceptive methods to avoid the possibility of an unplanned pregnancy.
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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 carried out periodically. Some patients with long-standing type 2 diabetes 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 breathlessness, rapid weight gain, or localized swelling (edema).
If you take Actos together with other medicines for diabetes, your blood sugar level is more likely to drop below normal levels (hypoglycemia).
You may also experience a reduction in blood cell count (anemia).
Bone fractures
An increased 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
Not recommended for children and adolescents under 18 years of age.
Other medicines and Actos
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription.
You can generally continue taking 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)
Inform your doctor or pharmacist if you are taking any of these medicines. Your blood sugar level will be monitored and you may need to adjust the dose of Actos.
Taking Actos with food and drink
You may take the tablets with or without food. Take them with a glass of water.
Pregnancy and breastfeeding
Inform your doctor if:
- you are pregnant or think you might be pregnant, or are planning to become pregnant
- you are breastfeeding or planning to breastfeed your baby
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 exercise caution if you experience visual disturbances.
Actos contains lactose monohydrate
If your doctor has diagnosed you with an intolerance to certain sugars, consult him before taking Actos.
3. How to take Actos
Follow exactly the instructions for administering this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.
The recommended starting dose is one tablet containing 15 mg or 30 mg of pioglitazone daily. Your doctor may increase the dose up to a maximum of 45 mg once daily. Your doctor will tell you which dose to take.
If you think that Actos is having too little effect, consult your doctor.
When taking Actos in combination with other medicines used to treat diabetes (such as insulin, chlorpropamide, glibenclamide, glipizide, tolbutamide), your doctor will advise you whether you need to take a lower amount of these medicines.
Your doctor will request periodic blood tests while you are being treated with Actos. These tests are necessary to monitor that your liver is functioning normally.
If you are on a special diabetic diet, continue to follow it while taking Actos.
You should monitor your weight regularly. 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 medicine, inform your doctor or pharmacist immediately. Your blood sugar level may drop below normal, but this can be corrected by taking sugar. It is advisable to carry some sugar lumps, sweets, biscuits, or a sugared fruit juice.
If you forget to take Actos
Take Actos every day as prescribed. If you miss a dose, continue your treatment as usual. Do not take a double dose to make up for missed doses.
If you stop taking Actos
Actos must be taken daily for the treatment to have the desired effect. If you stop taking Actos, your blood sugar level may increase. Consult your doctor before stopping treatment.
If you have any further 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 everyone gets them.
In particular, patients have experienced the following serious side effects:
Heart failure, occurring frequently (may affect up to 1 in 10 people), 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.
Bladder cancer has occurred uncommonly (may affect up to 1 in 100 people) in patients taking Actos. Signs and symptoms include blood in the urine, pain when urinating, or a strong need to urinate. If you experience any of these symptoms, consult your doctor immediately.
Patients taking Actos in combination with insulin have also very commonly experienced localized swelling (edema) (may affect more than 1 in 10 people). Consult your doctor as soon as possible if you experience this side effect.
Bone fractures: These have been reported frequently (may affect up to 1 in 10 people) in both women and men taking Actos (frequency cannot be estimated from the available data). Consult 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 (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 unknown frequency (cannot be estimated from the available data) in patients treated with 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 and consult your doctor immediately.
Other side effects that some patients have experienced while taking Actos are:
Frequent (may affect up to 1 in 10 people)
- respiratory infection,
- vision abnormalities,
- weight gain,
- numbness
Uncommon (may affect up to 1 in 100 people)
- sinus inflammation (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 Actos together with other antidiabetic medicines are:
Very common (may affect more than 1 in 10 people)
- low blood sugar (hypoglycemia)
Frequent (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
- gas (flatulence)
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 of side effects
If you experience any type of side effect, talk to your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the national reporting system included 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 packaging after CAD and on the blister after EXP. The expiry date refers to the last day of the month indicated.
This medicine does not require any special storage conditions.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging that you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Actos
- 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 components are: lactose monohydrate, hypromellose, calcium carmellose, and magnesium stearate. See section 2, "Actos contains lactose monohydrate".
Appearance of Actos and contents of the pack
- Actos 15 mg tablets are round, convex, and white to off-white in colour, with '15' engraved on one side and 'ACTOS' on the other.
- Actos 30 mg tablets are round, flat, and white to off-white in colour, with '30' engraved on one side and 'ACTOS' on the other.
- Actos 45 mg tablets are round, flat, and white to off-white in colour, with '45' engraved on one side and 'ACTOS' on the other.
The tablets are supplied in blister packs containing 28, 56, 98, or 112 tablets. Only certain 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 the most recent revision of this 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
Annex IV
SCIENTIFIC CONCLUSIONS AND REASONS FOR THE VARIATION TO THE TERMS OF THE MARKETING AUTHORISATION(S)
Scientific conclusions
Taking into account the findings of the Periodic Safety Update Reports (PSURs) for glimepiride/pioglitazone hydrochloride, metformin/pioglitazone, and pioglitazone, as assessed by the Pharmacovigilance Risk Assessment Committee (PRAC), the scientific conclusions of the Committee for Medicinal Products for Human Use (CHMP) are as follows:
The Marketing Authorization Holder (MAH) provided updated information on important identified and important potential risks, as listed in the safety concerns summary. The data submitted during the current reporting period did not provide new information enabling further reduction, mitigation, or characterization of these risks. Based on the data presented, the risk minimisation measures included in the approved product information are considered adequate for the listed safety concerns.
Given the accumulation of data since the implementation of additional risk minimisation measures, the Pharmacovigilance Risk Assessment Committee (PRAC) accepted the MAH's proposal to remove the additional risk minimisation measures. Consequently, the terms or restrictions relating to the safe and effective use of the medicinal product should be updated to remove these additional risk minimisation measures. The Risk Management Plan (RMP) has been updated accordingly.
The CHMP agrees with the scientific conclusions of the PRAC.
Reasons for the variation to the Marketing Authorisation(s)
In line with the scientific conclusions for glimepiride/pioglitazone hydrochloride, metformin/pioglitazone, and pioglitazone, the CHMP considers that the benefit-risk balance of the medicinal product(s) containing glimepiride/pioglitazone hydrochloride, metformin/pioglitazone, or pioglitazone remains unchanged under the proposed changes to the product information.
The CHMP recommends that the terms of the Marketing Authorisation(s) be varied accordingly.