Pioglitazone CINFA 15 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

pioglitazone cinfa 15 mg tablets EFG

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 you should not give it to others, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

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

1. What pioglitazone cinfa is and what it is used for

Pioglitazone cinfa 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.

Pioglitazone helps control blood sugar levels in people with type 2 diabetes. It enables your body to use insulin more effectively, improving the way your body responds to the insulin it produces. Your doctor will monitor the effect of pioglitazone within 3 to 6 months after starting treatment.

Pioglitazone may be used alone in patients who cannot take metformin, when diet and exercise alone have not been sufficient to control blood sugar levels, or it may be added to other treatments (such as metformin, sulfonylureas, or insulin) if those treatments have not provided adequate blood sugar control.

2. What you need to know before starting to take pioglitazone cinfa

Do not take pioglitazone cinfa

• 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 heart failure 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 blood in your urine that has not been evaluated and managed by your doctor.

Warnings and precautions

Consult your doctor or pharmacist before starting to take pioglitazone cinfa.

• 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 possibility of becoming pregnant may increase, as ovulation may resume when taking pioglitazone. If this applies to you, use appropriate contraceptive methods to avoid an unplanned pregnancy.

• if you have liver or heart problems. Before starting treatment with pioglitazone, you will have a blood test to check liver function. These tests should be performed periodically. Some patients with long-standing type 2 diabetes and heart disease or a history of stroke who received pioglitazone cinfa 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 pioglitazone cinfa together with other medicines for diabetes, your blood sugar level is more likely to drop below normal (hypoglycemia).

You may also experience a reduction in blood cell counts (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.

Taking Pioglitazone Cinfa with other medicines

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 pioglitazone cinfa 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. They will monitor your blood sugar levels and you may need to adjust the dose of pioglitazone cinfa.

Taking pioglitazone cinfa with food and drinks

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Inform your doctor if:

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

Your doctor will advise you to stop taking this medicine.

Driving and operating machinery

Treatment of diabetes with pioglitazone as monotherapy does not cause hypoglycemia (low blood sugar levels) and therefore does not affect the ability to drive or operate machinery. However, if you take pioglitazone together with other medications for the treatment of your diabetes, hypoglycemia may occur (symptoms of low blood sugar such as fainting, confusion, increased sweating, vision disturbances, or difficulty concentrating); therefore, you should exercise extreme caution when driving or operating dangerous machinery.

pioglitazone cinfa contains lactose. If your doctor has informed you of an intolerance to certain sugars, consult with him before taking this medicine.

3. How to take pioglitazone cinfa

Follow exactly the instructions given by your doctor or pharmacist for taking this medicine. If in doubt, 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 up to a maximum of 45 mg once daily. Your doctor will tell you the dose you should take.

If you think that pioglitazone is having too little effect, consult your doctor.

When taking pioglitazone 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 receiving treatment with pioglitazone. 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 pioglitazone.

You should monitor your weight regularly. If you gain weight, inform your doctor.

If you take more pioglitazone cinfa 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 it can be raised by consuming sugar. It is advisable to carry some sugar lumps, sweets, biscuits, or a sugared fruit juice.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately, or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take pioglitazone cinfa

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

If you interrupt treatment with pioglitazone cinfa

Pioglitazone must be taken daily for the treatment to have the desired effect. If you interrupt taking pioglitazone, your blood sugar level may increase. Consult your doctor before stopping treatment.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

In particular, patients have experienced the following serious adverse effects:

Heart failure, occurring frequently (may affect up to 1 in 10 people), in patients taking pioglitazone in combination with insulin. Symptoms include unusual breathlessness, rapid weight gain, or localized swelling (edema). If you experience any of these symptoms, especially if you are over 65 years of age, consult your doctor immediately.

Bladder cancer has occurred uncommonly (may affect up to 1 in 100 people) in patients taking pioglitazone. Signs and symptoms include blood in the urine, pain during urination, or a strong urge to urinate. If you experience any of these symptoms, consult your doctor immediately.

Patients taking pioglitazone in combination with insulin have also very frequently experienced localized swelling (edema) (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 pioglitazone (frequency not known: cannot be estimated from available data). Consult your doctor as soon as possible if you experience this adverse effect.

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

Allergic reactions have been reported with unknown frequency (cannot be estimated from available data) in patients treated with pioglitazone. 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 consult your doctor as soon as possible.

Other adverse effects experienced by some patients taking pioglitazone 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)

• inflammation of the sinuses (sinusitis)
• difficulty sleeping (insomnia)

Frequency not known (cannot be estimated from available data)

• increased liver enzymes
• allergic reactions

Other adverse effects experienced by some patients taking pioglitazone in combination with other antidiabetic medicines are:

Very frequent (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 adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of pioglitazone cinfa

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

This medicine does not require special storage conditions.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of pioglitazone cinfa

• The active substance is pioglitazone. Each tablet contains 15 mg of pioglitazone (as hydrochloride).
• The other components are: calcium carmellose, hydroxypropyl cellulose (E-465), lactose monohydrate, and magnesium stearate (E-572).

Appearance of the medicinal product and contents of the container

pioglitazone cinfa is presented as cylindrical, biconvex tablets, white or almost white, with the imprint 'P' on one side and '15' on the other.

Each Alu-Alu (Aluminum/PVC-Aluminum) pack contains 14, 28, 56, and 196 tablets.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturing Responsibility

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) - Spain

Date of the most recent review of this leaflet: August 2020

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/

You can access detailed and up-to-date information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the package leaflet and outer packaging. You can also access this information at the following web address: https://cima.aemps.es/cima/dochtml/p/76481/P_76481.html

QR code to: https://cima.aemps.es/cima/dochtml/p/76481/P_76481.html