PIOGLITAZONE AUROVITAS 15 mg TABLETS

Introduction

Package Leaflet: Information for the User

Pioglitazone Aurovitas 15 mg Tablets EFG

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. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

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

Pioglitazone Aurovitas contains pioglitazone. It is an antidiabetic medicine used to treat type 2 diabetes mellitus (non-insulin-dependent) in adults, when metformin is not suitable or has not worked well. This type of diabetes usually occurs in adults.

Pioglitazone helps control blood sugar levels when you have type 2 diabetes. It allows your body to use insulin better. Your doctor will check the effect this medicine is having on you between 3 and 6 months after you start treatment.

Pioglitazone can be used alone in patients who cannot take metformin, and when diet and exercise have not been enough to control blood sugar levels, or it can be added to other treatments (such as metformin, sulfonylurea, or insulin) if they have not provided sufficient control of blood sugar levels.

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

Do not take Pioglitazone Aurovitas

• 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

Consult your doctor or pharmacist before starting to take Pioglitazone Aurovitas (see also section 4):

• if you have fluid retention or heart problems, particularly if you are over 75 years old. If you are taking anti-inflammatory medicines 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 cysts on the ovaries (polycystic ovary syndrome). You may be more likely to become pregnant, as taking Pioglitazone Aurovitas may cause you to 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 Aurovitas, you will have a blood test to check your liver function. These tests should be done periodically. Some patients with long-standing type 2 diabetes mellitus and pre-existing heart disease or stroke who received Pioglitazone Aurovitas 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 Aurovitas 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

A higher number of bone fractures has been observed in patients, particularly in women taking pioglitazone. 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 of age.

Taking Pioglitazone Aurovitas with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription.

Generally, you can continue taking other medicines while taking Pioglitazone Aurovitas 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 the dose of Pioglitazone Aurovitas.

Taking Pioglitazone Aurovitas with food and drinks

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

Pregnancy and breastfeeding

Tell your doctor if:

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

Your doctor will advise you to stop taking this medicine.

Driving and using machines

Treatment of diabetes with pioglitazone as the only medicine (monotherapy) does not produce hypoglycemia (low blood sugar) and therefore does not affect the ability to drive or use machinery. However, if you take pioglitazone with other diabetes medicines, hypoglycemia (symptoms of low blood sugar such as fainting, confusion, increased sweating, vision changes, or difficulty concentrating) may occur, and you should be extremely cautious when driving or using hazardous machinery.

Pioglitazone Aurovitas contains lactose

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

3. How to take Pioglitazone Aurovitas

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. If you are in doubt, consult your doctor or pharmacist again.

The recommended starting dose is one 15 mg or 30 mg pioglitazone tablet 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 Aurovitas is not working effectively, consult your doctor.

When taking Pioglitazone Aurovitas in combination with other medicines used to treat diabetes (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 being treated with Pioglitazone Aurovitas. These tests are necessary to check that your liver is working normally.

If you follow a special diet for diabetics, keep to it while taking Pioglitazone Aurovitas.

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

If you take more Pioglitazone Aurovitas than you should

If you accidentally take too many tablets, or if someone else (e.g., a child) takes your medicine, tell your doctor or pharmacist immediately. Your blood sugar level may become too low, 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.

In case of overdose or accidental ingestion, consult your doctor immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Pioglitazone Aurovitas

Take Pioglitazone Aurovitas every day, as prescribed by your doctor. 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 Aurovitas

Pioglitazone Aurovitas should be taken daily for the treatment to have the right effect. If you stop taking Pioglitazone Aurovitas, your blood sugar levels may increase. Consult 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, this medicine can cause side effects, although not everybody gets them.

In particular, patients have experienced the following serious side effects:

Heart failure, which is a common side effect (may 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.

Uncommonly (may 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 when urinating, or urgent need to urinate. If you experience any of these symptoms, consult your doctor immediately.

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

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

Blurred vision due to swelling (or fluid) in the back of the eye (the frequency cannot be estimated from the available data) has also been reported in patients taking pioglitazone. If you experience this symptom for the first time or if you already have it and it worsens, consult your doctor as soon as possible.

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

Other side effects that some patients have experienced while taking pioglitazone are:

Common(may affect up to 1 in 10 people)

• respiratory infection
• vision disturbances
• weight gain
• numbness

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)

• increased liver enzymes
• allergic reactions

Other side effects that have been experienced by some patients when pioglitazone is taken with other antidiabetic medicines are:

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

• low blood sugar (hypoglycemia)

Common(may affect up to 1 in 10 people)

• headache
• dizziness
• joint pain
• impotence
• back pain
• shortness of breath
• mild reduction in red blood cell count
• gas (flatulence)

Uncommon(may affect up to 1 in 100 people)

• sugar in urine, protein in urine
• increased enzymes
• feeling of spinning (vertigo)
• sweating
• fatigue
• increased appetite

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible that they are not listed in this leaflet. You can also report side effects directly to the Spanish Medicines and Healthcare Products Agency (AEMPS) via their website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Pioglitazone Aurovitas

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, blister, and label of the bottle after EXP. The expiry date is the last day of the month stated.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Return the containers and any unused medicines to the pharmacy for proper disposal. This will help protect the environment.

6. Contents of the pack and other information

Composition of Pioglitazone Aurovitas

• The active substance is pioglitazone. Each tablet contains 15 mg of pioglitazone (as hydrochloride).
• The other ingredients (excipients) are: lactose monohydrate (see section 2 Pioglitazone Aurovitas contains lactose), carmellose calcium, hydroxypropylcellulose, magnesium stearate.

Appearance of the product and pack contents

The Pioglitazone Aurovitas 15 mg tablets are white to off-white, biconvex, round, and marked with “31” on one side and “H” on the other side of the tablet.

They are available in transparent PVC/PVDC/Aluminum blisters.

The pack sizes are 28 and 56 tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Manufacturer

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far,

Birzebbugia, BBG 3000

Malta

Milpharm Limited

Ares Block, Odyssey Business Park, West End Road,

Ruslip HA4 6QD

United Kingdom

Date of last revision of this leaflet:May 2024

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