PIOGLITAZONE NORMON 30 mg TABLETS

2. What you need to know before taking Pioglitazone NORMON

Do not take Pioglitazone NORMON

• If you are allergic to pioglitazone or any of the other ingredients 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 blood in your urine that has not been controlled by your doctor.

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 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 birth control 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 who have taken pioglitazone and insulin have 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 with other diabetes medications, you are more likely to experience low blood sugar (hypoglycemia).

You may also experience a reduction in blood cell count (anemia).

Bone fractures: an increased number of bone fractures has been observed in women (but not in men) taking Pioglitazone NORMON. Your doctor will take this into account when treating your diabetes.

Children and Adolescents

It is not recommended for children under 18 years old.

Other Medications and Pioglitazone NORMON

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

Generally, you can continue taking other medications while taking pioglitazone tablets.

However, certain medications 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 medications. They will monitor your blood sugar levels and may need to adjust the dose of pioglitazone.

Pioglitazone 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, 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 Using Machines

Pioglitazone does not affect your ability to drive or use machines, but you should be cautious if you experience vision changes.

Pioglitazone NORMON contains Lactose

This medication contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult with them before taking this medication.

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

3. How to take Pioglitazone NORMON

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

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

If you think this medication is not working, consult your doctor.

This medication can be taken with or without food.

When taking pioglitazone in combination with other medications used to treat diabetes (such as insulin, chlorpropamide, glibenclamide, gliclazide, tolbutamide), your doctor will indicate 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 check that your liver is functioning normally.

If you follow a diabetic diet, maintain it while taking Pioglitazone NORMON.

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

If you take more Pioglitazone 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.

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

If you forget to take Pioglitazone 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 doses.

If you stop taking Pioglitazone NORMON

This medication should be taken daily for the treatment to have the proper effect. If you stop taking pioglitazone, your blood sugar level may increase. Consult your doctor before stopping treatment.

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

4. Possible Side Effects

Like all medications, Pioglitazone NORMON can cause side effects, although not everyone will experience them.

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

Frequent (may affect up to 1 in 10 people)

• weight gain
• respiratory infection
• numbness
• vision disturbances
• bone fractures: have been reported frequently in women taking Pioglitazone NORMON; 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.

Uncommon (may affect up to 1 in 100 people)

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

Frequency not known (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 pioglitazone with other antidiabetic 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 red blood cell count
• back pain
• shortness of breath
• heart failure (when taken with insulin)

Uncommon (may affect up to 1 in 100 people)

• vertigo
• sweating
• fatigue
• sugar in the urine, protein in the urine
• increased appetite
• increase in enzymes

Rarely (may affect up to 1 in 100 people), bladder cancer has been 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, consult your doctor immediately.

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

5. Storage of Pioglitazone NORMON

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

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

This medication does not require special storage conditions.

Medications should not be disposed of via wastewater or household waste. Deposit the packaging and any unused medications at the pharmacy's SIGRE point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medications. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Pioglitazone NORMON

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

The other ingredients are: lactose monohydrate, sodium croscarmellose, hydroxypropyl cellulose, anhydrous colloidal silica, and magnesium stearate.

Appearance of Pioglitazone NORMON and Package Contents

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

Marketing Authorization Holder and Manufacturer

LABORATORIOS NORMON, S.A.

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

OTHER PRESENTATIONS

Pioglitazone NORMON 15 mg tablets EFG.

This package leaflet was last revised in June 2016

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