Package Leaflet: Information for the User

Pioglitazone Cinfa 15 mg Tablets EFG

Read this leaflet carefully before you start taking this medicine because 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. Do not pass it on to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

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

2. What you need to know before you start taking pioglitazone cinfa

3. How to take pioglitazone cinfa

4. Possible side effects

5. Storage of pioglitazone cinfa

6. Contents of the pack and additional information

pioglitazona cinfa 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 typically presents in adults.

Pioglitazona helps control blood sugar levels when you have type 2 diabetes.It allows your body to use insulin more effectively. Your doctor will monitor the effect of pioglitazona between 3 and 6 months since treatment began.

pioglitazona 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 can be added to other treatments (such as metformin, sulfonylurea, or insulin) if they have not provided sufficient control of blood sugar levels.

Do not take pioglitazona cinfa

• if you are allergic to pioglitazona 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 uncontrolled blood in your urine.

Warnings and precautions

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

• if you have fluid retention or heart problems, particularly if you are over 75 years old. If you take 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 ovarian cysts (polycystic ovary syndrome). This may increase the chances of becoming pregnant, as taking pioglitazona may cause you to ovulate again. If this is your case, use suitable contraceptive methods to avoid the possibility of unplanned pregnancy.

-if you have liver or heart problems. Before starting treatment with pioglitazona, you will have a blood test to check your liver function. These tests should be done periodically. Some patients with type 2 diabetes of long duration and heart disease or previous stroke who received pioglitazona 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 pioglitazona cinfa with other diabetes medications, it is more likely that your blood sugar level will drop below the normal limit (hypoglycemia).

You may also show a reduction in the count of blood cells (anemia).

Bone fractures

A higher number of bone fractures has been observed in patients, particularly in women who took pioglitazona. 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.

Taking pioglitazona cinfa with other medications

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

You can usually continue taking other medications while taking pioglitazona cinfa tablets.

However, certain medications have a higher probability of affecting blood sugar content:

• gemfibrozilo (used to reduce cholesterol)
• rifampicina (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 level and may need to change the dose of pioglitazona cinfa.

Taking pioglitazona 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, or think you may be pregnant or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Inform your doctor if:

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

Your doctor will advise you to stop taking this medication.

Driving and operating machinery

The treatment of diabetes with pioglitazona as the only medication (monotherapy) does not produce hypoglycemia (low blood sugar levels) and therefore does not affect the ability to drive or operate machinery. However, if you take pioglitazona with other medications to treat your diabetes, hypoglycemia (symptoms of low blood sugar levels such as dizziness, confusion, increased sweating, visual disturbances, or difficulty concentrating) may occur, and you should exercise extreme caution when driving and operating hazardous machinery.

pioglitazona cinfa contains lactose.If your doctor has told you that you have an intolerance to certain sugars, consult with him before taking this medication.

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The recommended starting dose is one 15 mg or 30 mg tablet of pioglitazone 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 having enough effect, consult your doctor.

When taking pioglitazone in combination with other medications used to treat diabetes (such as insulin, chlorpropamide, glibenclamide, glimepiride, tolbutamide), your doctor will tell you if you need to take a lower amount of those medications.

Your doctor will ask you to have periodic blood tests while you are being treated with pioglitazone. These tests are necessary to control that your liver is functioning normally.

Follow any special diet for diabetics while taking pioglitazone.

You must control your weight regularly. If you gain weight, inform your doctor.

If you take more pioglitazone cinfa than you should

If, by accident, you 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 fruit juice with sugar.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 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 forget to take a dose, continue your treatment as usual. Do not take a double dose to make up for the missed doses.

If you interrupt treatment with pioglitazone cinfa

Pioglitazone should 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 interrupting treatment.

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

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

Particularly, patients have presented the following serious side effects:

Heart failure, a frequent occurrence (can 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, consult your doctor immediately.

Infrequently (can 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 while urinating, or a sudden urgent need to urinate. If you experience any of these symptoms, consult your doctor immediately.

Patients taking pioglitazone in combination with insulin also experienced localized swelling (edema) very frequently (can affect more than 1 in 10 people). Consult your doctor as soon as possible if you experience this side effect.

Bone fractures: Frequent occurrences (can affect up to 1 in 10 people) have been reported in both men and women taking pioglitazone (frequency unknown: cannot be estimated from available data). Consult your doctor as soon as possible if you experience this side effect.

Also, blurred vision due to swelling (or fluid) in the back of the eye has 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, consult your doctor as soon as possible.

Unknown frequency (cannot be estimated from available data) allergic reactions have been reported in patients treated with pioglitazone. If you experience a severe allergic reaction, including hives, facial, lip, tongue, or throat swelling that can cause breathing or swallowing difficulties, stop taking this medicine and consult your doctor as soon as possible.

Other side effects experienced by some patients taking pioglitazone are:

Frequent (can affect up to 1 in 10 people)

• Respiratory infection,
• Vision abnormalities,
• Weight gain,
• Numbness

Infrequent (can affect up to 1 in 100 people)

• Nasal sinus inflammation (sinusitis)
• Difficulty sleeping (insomnia)

Unknown frequency (cannot be estimated from available data)

• Increased liver enzymes
• Allergic reactions

Other side effects experienced by some patients taking pioglitazone with other diabetes medications are:

Frequent (can affect up to 1 in 10 people)

• Low blood sugar (hypoglycemia)

Frequent (can affect up to 1 in 10 people)

• Headache
• Dizziness
• Joint pain
• Impotence
• Back pain
• Shortness of breath
• Mild reduction in the number of red blood cells
• Gas (flatulence)

Infrequent (can affect up to 1 in 100 people)

• Sugar in the urine, proteins in the urine
• Increased enzymes
• Dizziness
• Sweating
• Fatigue
• Increased appetite

Reporting side effects

If you experience any type of side effect, consult 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 Spanish System for Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

This medication does not require special storage precautions.

Do not use this medication after the expiration date that appears on the packaging after CAD.The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and themedications that you no longer need at the SIGREpoint at the pharmacy. If in doubt, ask yourpharmacist how to dispose of the packaging and the medications that you no longer need. By doing so,you will help protect the environment.

Composition of pioglitazone cinfa

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

Appearance of the product and content of the packaging

pioglitazone cinfa is presented in the form of cylindrical, biconvex tablets, white or almost white in color, with the mark 'P' on one face and '15' on the other.

Each OPA-Aluminio/PVC-Aluminio container contains 14, 28, 56 and 196 tablets.

Only some packaging sizes may be commercially marketed.

Holder of the marketing authorization and responsible for manufacturing

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Industrial Park Areta

31620 Huarte (Navarra) - Spain

Last review date of this leaflet: August 2020

The detailed information of this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/

You can access detailed and updated information about this medicine by scanning with your smartphone the QR code included in the leaflet and packaging. You can also access this information at the following internet 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