PIOGLITAZONE NORMON 15 mg TABLETS

Introduction

Package Leaflet: Information for the User

Pioglitazone NORMON 15 mg Tablets EFG

Pioglitazone

Read this 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 further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

Contents of the package leaflet:

1. What is Pioglitazone NORMON and what is it used for
2. What you need to know before you take Pioglitazone NORMON
3. How to take Pioglitazone NORMON
4. Possible side effects
5. Storage of Pioglitazone NORMON
6. Package contents and further information

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

Pioglitazone NORMON is an antidiabetic medicine used to treat type 2 diabetes mellitus (non-insulin-dependent diabetes). This type of diabetes usually occurs in adults.

Pioglitazone is used to control blood sugar levels when you have type 2 diabetes. It helps your body use insulin better.

Pioglitazone tablets can be used alone or in combination with metformin and/or a sulfonylurea. These are also oral antidiabetic medicines.

Pioglitazone can also be used in combination with insulin.

Your doctor will check the effect of pioglitazone on you between 3 and 6 months after you start treatment.

2. What you need to know before you take Pioglitazone NORMON

Do not take Pioglitazone NORMON

• 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 before taking this medicine:

• If you have fluid retention or heart problems, especially 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 make you 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 regularly. Some patients with long-standing type 2 diabetes and previous heart disease or stroke who received pioglitazone 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 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: an increased number of bone fractures has been observed in women (but not in men) taking pioglitazone. 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 medicines and Pioglitazone NORMON

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

You can usually take other medicines while taking pioglitazone 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 your pioglitazone dose.

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 are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Your doctor will advise you to stop taking this medicine.

Driving and using machines

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

Pioglitazone NORMON contains lactose

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

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

3. How to take Pioglitazone NORMON

Take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist again.

You should take one 15 mg pioglitazone tablet per day. Your doctor will tell you if you need to take a different amount.

If you think this medicine is not working as well as expected, talk to your doctor.

This medicine can be taken with or without food.

When taking pioglitazone with other diabetes medicines (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 diet for diabetics, keep to it while taking pioglitazone.

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

If you take more Pioglitazone NORMON than you should

In case of overdose or accidental ingestion, call the Toxicology Information Service, telephone 91 562 04 20, stating the medicine and the amount taken.

Your blood sugar level may fall below normal, 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.

If you forget to take Pioglitazone NORMON

Take this medicine 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 forgotten doses.

If you stop taking Pioglitazone NORMON

This medicine 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, Pioglitazone NORMON can cause side effects, although not everybody gets them.

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

Common (may affect up to 1 in 10 people)

• weight gain
• respiratory infection
• numbness
• vision disturbances
• bone fractures: these have been reported frequently in women taking pioglitazone; they have also been reported in men (the frequency cannot be estimated from the available data). Talk to 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 the 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, talk to your doctor as soon as possible
• increase in liver enzymes

Some patients taking pioglitazone with other antidiabetic medicines have experienced the following side effects:

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

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

Common (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)

• dizziness
• 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 a sudden need to urinate. If you experience any of these symptoms, talk to your doctor immediately.

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

5. Storage of Pioglitazone NORMON

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

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 the month.

This medicine does not require any special storage conditions.

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. Package contents and further information

Composition of Pioglitazone NORMON

The active substance is pioglitazone. Each tablet contains 15 mg of pioglitazone (as hydrochloride).

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

Appearance of Pioglitazone NORMON and package contents

Pioglitazone NORMON 15 mg is presented as white or almost white, round, biconvex tablets marked with P15. It is available in packs 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 30 mg tablets EFG.

This leaflet was last revised in June 2016

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