PIOGLITAZONE CINFA 30 mg TABLETS

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 well. This type of diabetes usually occurs in adults.

Pioglitazone helps control blood sugar levels when you have type 2 diabetes. It allows your body to use the insulin it produces more effectively. Your doctor will check the effect that pioglitazone is having on you between 3 and 6 months after you start treatment.

Pioglitazone 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 it 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 you 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 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

Talk to your doctor or pharmacist before you start taking pioglitazone cinfa.

• 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 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 pioglitazone 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 pioglitazone, you will have a blood test to check your liver function. These tests should be done periodically. Some patients with type 2 diabetes mellitus of long duration and previous heart disease or stroke who received pioglitazone cinfa and insulin 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 pioglitazone cinfa 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 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 of age.

Taking pioglitazone cinfa with other medicines

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

Generally, you can 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)

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 the dose of pioglitazone cinfa.

Taking pioglitazone cinfa with food and drinks

You can 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 have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Tell your doctor if:

• you are or think you may be pregnant or are planning to have a baby.
• you are breastfeeding or plan to breastfeed your child.

Your doctor will advise you to stop taking this medicine.

Driving and using machines

Treatment of diabetes with pioglitazone as the only medicine (monotherapy) does not produce hypoglycemia (low blood sugar) and therefore does not affect the ability to drive or use machinery. However, if you take pioglitazone with other diabetes medicines, you may experience hypoglycemia (symptoms of low blood sugar such as fainting, confusion, increased sweating, vision changes, or difficulty concentrating) and therefore should be extremely cautious when driving or using hazardous machinery.

pioglitazone cinfa contains lactose.

If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

3. How to take pioglitazone cinfa

Take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask 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 what dose to take.

If you think pioglitazone is not working effectively, talk to your doctor.

When you take pioglitazone in combination with other medicines used to treat diabetes (such as insulin, chlorpropamide, glibenclamide, 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 pioglitazone. 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 pioglitazone.

You should check your weight regularly. If you gain weight, tell 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 medicine, talk to your doctor or pharmacist immediately. Your blood sugar level may become too low, but it can be increased by taking sugar. It is recommended that you carry some sugar lumps, sweets, biscuits, or some sugary fruit juice with you.

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

If you forget to take pioglitazone cinfa

Take pioglitazone 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 pioglitazone cinfa

Pioglitazone should be taken daily for the treatment to have the right effect. If you stop taking pioglitazone, your blood sugar level may increase. Talk to your doctor before stopping treatment.

If you have any further questions on the use of this medicine, 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, common (may affect up to 1 in 10 people) in patients taking pioglitazone 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.

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

Patient taking pioglitazone 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: frequently (may affect up to 1 in 10 people) reported in both women and men taking pioglitazone (frequency not known: 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 pioglitazone (frequency not known: 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, 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 pioglitazone. 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 pioglitazone 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)

• inflammation of the nasal passages (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 pioglitazone 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
• vertigo
• sweating
• fatigue
• increased appetite

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible that they are not listed in this leaflet. You can also report side effects directly to the Spanish Medicines and Healthcare Products Agency (AEMPS) via their website: https://www.notificaram.es. By reporting side 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 any special storage precautions.

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.

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

Composition of pioglitazone cinfa

• The active substance is pioglitazone. Each tablet contains 30 mg of pioglitazone (as hydrochloride).
• The other ingredients are: calcium carmellose, hydroxypropyl cellulose (E-465), lactose monohydrate, and magnesium stearate (E-572).

Appearance of the product and pack contents

Pioglitazone cinfa is presented as cylindrical, flat tablets with beveled edges, white or almost white in color, with the mark 'PIO' on one face and '30' on the other.

Each OPA-Aluminum/PVC-Aluminum pack contains 14, 28, 56, and 196 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) - Spain

Date of last revision of this leaflet:August 2020

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS) http://www.aemps.gob.es/

You can access detailed and updated information about this medicine by scanning the QR code included in the leaflet and packaging with your smartphone. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/76485/P_76485.html

QR code to: https://cima.aemps.es/cima/dochtml/p/76485/P_76485.html