Pioglitazone Normon 15 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Pioglitazone NORMON 15 mg tablets EFG

Pioglitazone

Read all of this leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet. 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, even if they have the same symptoms as you, because it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if the side effects are not listed in this leaflet.

Contents of the leaflet:

1. What Pioglitazone NORMON is and what it is used for
2. What you need to know before taking Pioglitazone NORMON
3. How to take Pioglitazone NORMON
4. Possible side effects
5. How to store Pioglitazone NORMON
6. Contents of the pack and other information

1. What Pioglitazone NORMON is and what it is 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 helps control blood sugar levels in people with type 2 diabetes. It allows your body to use the insulin it produces more effectively.

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

Pioglitazone may also be used in combination with insulin.

Your doctor will monitor the effect of pioglitazone treatment between 3 and 6 months after starting therapy.

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

Do not take Pioglitazone NORMON

• If you are allergic to pioglitazone or to 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 causing 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 evaluated by your doctor.

Warnings and precautions

Talk to your doctor before taking this medicine:

• If you have fluid retention or heart problems, particularly if you are over 75 years old.
• If you have a specific type of diabetic eye disease called macular edema (swelling at the back of the eye).
• If you have ovarian cysts (polycystic ovary syndrome). Pioglitazone may increase your chances of becoming pregnant, as it may restore ovulation. If this applies to you, use appropriate contraceptive methods to avoid 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 performed periodically. Some patients with long-standing type 2 diabetes mellitus and heart disease or previous stroke who received pioglitazone 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 pioglitazone together with other diabetes medicines, your blood sugar level is more likely to drop below normal (hypoglycemia).

You may also experience a decrease in blood cell counts (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 managing your diabetes.

Children and adolescents

Not recommended for children under 18 years of age.

Other medicines and Pioglitazone NORMON

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Generally, you can continue taking other medicines while using 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).

Inform your doctor or pharmacist if you are taking any of these medicines. They will monitor your blood sugar levels and you may need to adjust your dose of pioglitazone.

Pioglitazone NORMON with food and drink

You may take the tablets with or without food. Swallow them with a glass of water.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using 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 operate machinery, but you should exercise caution if you experience visual disturbances.

Pioglitazone NORMON contains lactose

This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult with him or her before taking this medicine.

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

3. How to take Pioglitazone NORMON

Follow exactly the instructions for use of this medicine as given by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

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

If you think this medicine is not working well enough, consult your doctor.

This medicine may be taken with or without food.

When taking pioglitazone in combination with other medicines used to treat diabetes (such as insulin, chlorpropamide, glibenclamide, glipizide, gliclazide, tolbutamide), your doctor will tell you whether you need to take a lower dose of those medicines.

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

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

You should monitor 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 at telephone number 91 562 04 20, indicating the medicine and the amount ingested.

Your blood sugar level may drop below normal, but it can be raised by taking sugar. It is advisable to carry some sugar lumps, sweets, biscuits, or a sugared fruit juice.

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 missed doses.

If you stop taking Pioglitazone NORMON

This medicine 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 further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, Pioglitazone NORMON can produce adverse effects, although not everyone will experience them.

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

Frequent (may affect up to 1 in 10 people)

• weight gain
• respiratory infection
• numbness
• vision abnormalities
• bone fractures: frequently reported in women taking pioglitazone; also reported in men (frequency cannot be estimated from available data). If you experience this adverse effect, consult your doctor as soon as possible.

Uncommon (may affect up to 1 in 100 people)

• inflammation of the sinuses (sinusitis)
• 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 together with other antidiabetic medicines have experienced the following adverse effects:

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

• low blood sugar (hypoglycaemia)
• localized swelling (oedema)

Frequent (may affect up to 1 in 10 people)

• headache
• dizziness
• gas (flatulence)
• joint pain
• impotence
• blood in the urine
• slight reduction in the number of red blood cells
• 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

Bladder cancer has infrequently developed (may affect up to 1 in 100 people) in patients taking pioglitazone. Signs and symptoms include blood in the urine, pain when urinating, or a strong need to urinate. If you experience any of these symptoms, consult your doctor immediately.

If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse 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 stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point located at your pharmacy. If you are in doubt, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Pioglitazone NORMON

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

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

Appearance of Pioglitazone NORMON and contents of the pack

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 film-coated tablets EFG.

The last revision of this leaflet was in June 2016

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es