Package Leaflet: Information for the User

Pioglitazona NORMON 30 mg tablets EFG

Pioglitazona

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 similar symptoms to those you have, 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.

1. What Pioglitazona NORMON is and what it is used for

2. What you need to know before taking Pioglitazona NORMON

3. How to take Pioglitazona NORMON

4. Possible side effects

5. Storage of Pioglitazona NORMON

6. Contents of the pack and additional information

Pioglitazona NORMON is an antidiabetic medication used to treat type 2 diabetes (non-insulin dependent). This type of diabetes typically occurs in adults.

Pioglitazona helps control blood sugar levels in people with type 2 diabetes. It allows your body to use insulin more effectively.

Pioglitazona tablets can be used alone or in combination with metformin and/or some sulfonylureas. These medications are also oral antidiabetic agents.

Pioglitazona NORMON may also be used in combination with insulin.

Your doctor will monitor the effect of pioglitazona on you between 3 and 6 months after starting treatment.

Do not take Pioglitazona NORMON

• 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 before taking this medication:

• If you have fluid retention or heart problems, particularly if you are over 75 years old.
• If you have a special type of diabetic eye disease called macular edema (inflammation of the back of the eye).
• If you have polycystic ovary syndrome (PCOS). You may be more likely to become pregnant, as taking pioglitazona may cause you to ovulate again. If this is your case, use appropriate contraceptive methods to avoid the possibility of unplanned pregnancy.
• If you have liver or heart problems. Before starting treatment with pioglitazona, a blood test will be performed to check liver function. These tests should be performed periodically. Some patients with type 2 diabetes of long duration and previous heart disease or stroke who received pioglitazona 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 with other diabetes medications, it is more likely that your blood sugar level may 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 have been observed in women (but not in men) taking pioglitazona. Your doctor will take this into account when treating your diabetes.

Children and adolescents

Not recommended for children under 18 years old.

Other medications and Pioglitazona NORMON

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

Generally, you can continue taking other medications while taking pioglitazona 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.

Pioglitazona NORMON with food and drinks

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

Pregnancy, breastfeeding, and fertility

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.

Your doctor will advise you to stop taking this medication.

Driving and operating machinery

Pioglitazona does not affect your ability to drive or operate machinery, but you should be cautious if you experience visual disturbances.

Pioglitazona NORMON contains lactose

This medication contains lactose. If your doctor has informed you that you have a certain sugar intolerance, consult with him before taking this medication.

This medication contains less than 23 mg of sodium (1mmol) per tablet; it is essentially "sodium-free".

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

You should take one 30 mg pioglitazona tablet per day. Your doctor will tell you if you need to take a different amount.

If you think this medication is not having the desired effect, consult your doctor.

This medication can be taken with or without food.

When taking pioglitazona 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 pioglitazona. These tests are necessary to ensure that your liver is functioning normally.

If you are following a diabetic diet, continue to follow it while taking Pioglitazona NORMON.

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

If you take more Pioglitazona NORMON than you should

In case of overdose or accidental ingestion, call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

The blood sugar level may decrease below normal, but it can be increased by taking sugar. It is recommended that you carry some sugar cubes, candies, cookies, or some fruit juice with sugar.

If you forget to take Pioglitazona NORMON

Take this medication 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 the missed dose.

If you interrupt treatment with pioglitazona NORMON

This medication should be taken daily for the treatment to have the desired effect. If you interrupt taking pioglitazona, 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 medications, Pioglitazona NORMON may cause side effects, although not everyone will experience them.

Some patients have experienced the following side effects when taking pioglitazona:

Frequent (may affect up to 1 in 10 people)

• weight gain
• respiratory infection
• numbness
• vision abnormalities
• bone fractures: frequent reports have been made in women taking Pioglitazona NORMON; they have also been reported in men (frequency cannot be estimated from available data). Consult your doctor as soon as possible if you experience this side effect.

Rare (may affect up to 1 in 100 people)

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

Unknown frequency (cannot be estimated from available data)

• blurred vision due to swelling (or fluid) in the back of the eye. If you experience these symptoms for the first time or if they worsen, consult your doctor as soon as possible
• increase in liver enzymes

Some patients taking pioglitazona with other diabetes medications have experienced the following side effects:

Very frequent (may affect more than 1 in 10 people)

• low blood sugar (hypoglycemia)
• localized swelling (edema)

Frequent (may affect up to 1 in 10 people)

• headache
• dizziness
• gas (flatulence)
• joint pain
• impotence
• blood in the urine
• mild reduction in the number of red blood cells
• back pain
• shortness of breath
• heart failure (when taken with insulin)

Rare (may affect up to 1 in 100 people)

• dizziness
• sweating
• fatigue
• sugar in the urine, proteins in the urine
• increased appetite
• increase in enzymes

With rare frequency (may affect up to 1 in 100 people), bladder cancer has developed in patients taking pioglitazona. Symptoms include blood in the urine, pain while urinating, or a sudden need to urinate. If you experience any of these symptoms, consult your doctor immediately.

If you experience side effects, consult your doctor or pharmacist, even if they are side effects not listed in this prospectus.

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

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.

This medication does not require special conditions for conservation.

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

Composition of Pioglitazona NORMON

The active ingredient is pioglitazone. Each tablet contains 30 mg of pioglitazone (as hydrochloride).

The other components are: lactose monohydrate, croscarmellose sodium, hydroxypropylcellulose, anhydrous colloidal silica, and magnesium stearate.

Appearance of pioglitazona NORMON and content of the packaging

Pioglitazona NORMON 30 mg is presented in the form of white or almost white, round, biconvex tablets marked with P30.It is presented in packaging of 28 or 56 tablets.

Holder of the marketing authorization and responsible for manufacturing

Laboratorios Normon, S.A.

Ronda de Valdecarrizo, 6 - 28760 Tres Cantos – Madrid (SPAIN)

OTHER PRESENTATIONS

Pioglitazona NORMON 15 mg tablets EFG.

LAST REVIEW OF THIS PROSPECTUS WAS IN JUNE 2016

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