Pioglitazone Aurovitas 30 mg tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Pioglitazone Aurovitas 30 mg tablets EFG

Read the 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only; do not pass it on to other people, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if the effects are not listed in this leaflet. See section 4.

Leaflet Contents

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

1. What Pioglitazone Aurovitas is and what it is 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 properly. This type of diabetes usually occurs in adults.

Pioglitazone helps control blood sugar levels in patients with type 2 diabetes. It allows your body to use the insulin it produces more effectively. Your doctor will monitor the effect of this medicine between 3 and 6 months after starting treatment.

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

2. What you need to know before taking Pioglitazone Aurovitas

Do not take Pioglitazone Aurovitas

• 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 diabetes complication 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 or pharmacist before starting to take Pioglitazone Aurovitas (see also section 4):

• if you have fluid retention or heart problems, especially if you are over 75 years old. If you are taking anti-inflammatory medicines, which can also cause fluid retention and swelling, you should also discuss this with your doctor.
• 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 Aurovitas may increase your chance 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 Aurovitas, you will have a blood test to check your liver function. These tests should be repeated periodically. Some patients with long-standing type 2 diabetes and heart disease or previous 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 together with other diabetes medicines, your blood sugar level is more likely to drop below normal (hypoglycaemia).

You may also experience a reduced blood cell count (anaemia).

Bone fractures

An increased number of bone fractures has been observed in patients, particularly in women, taking pioglitazone. Your doctor will take this into account when managing your diabetes.

Children and adolescents

Not recommended for children and adolescents under 18 years of age.

Taking Pioglitazone Aurovitas with other medicines

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

You can generally 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).

Inform your doctor or pharmacist if you are taking any of these medicines. Your blood sugar level will be monitored and you may need to adjust the dose of Pioglitazone Aurovitas.

Taking Pioglitazone Aurovitas with food and drink

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

Pregnancy and breastfeeding

Inform your doctor if:

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

Your doctor will advise you to stop taking this medicine.

Driving and using machines

Diabetes treatment with pioglitazone as monotherapy does not cause hypoglycaemia (low blood sugar) and therefore does not affect your ability to drive or operate machinery. However, if you take pioglitazone together with other diabetes medicines, hypoglycaemia may occur (symptoms of low blood sugar such as fainting, confusion, increased sweating, vision disturbances or difficulty concentrating), and therefore you should exercise extreme caution when driving or operating dangerous machinery.

Pioglitazone Aurovitas contains lactose

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

3. How to take Pioglitazone Aurovitas

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

The recommended starting dose is one 15 mg or 30 mg pioglitazone tablet daily. Your doctor may increase your dose up to a maximum of 45 mg once daily. Your doctor will tell you the dose you should take.

If you think that Pioglitazone Aurovitas is not working well enough, speak to 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 advise 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 Aurovitas. These tests are necessary to monitor that your liver is functioning normally.

If you follow a special diabetic diet, continue to follow it while taking Pioglitazone Aurovitas.

You should monitor 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, inform your doctor or pharmacist immediately. Your blood sugar level may drop below normal, but this can be corrected by taking sugar. It is advisable to carry some sugar lumps, sweets, biscuits, or a sugared fruit juice.

In case of overdose or accidental ingestion, contact your doctor immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Pioglitazone Aurovitas

Take Pioglitazone Aurovitas 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 Aurovitas

Pioglitazone Aurovitas must be taken daily for the treatment to have the desired effect. If you stop taking Pioglitazone Aurovitas, 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, this medicine can cause adverse effects, although not everyone experiences them.

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

Heart failure, which occurs frequently (may affect up to 1 in 10 people), in patients taking pioglitazone in combination with insulin. Symptoms include unusual shortness of breath, rapid weight gain, or localized swelling (edema). If you experience any of these symptoms, especially if you are over 65 years of age, consult your doctor immediately.

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

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

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

Blurred vision due to swelling (or fluid) in the back of the eye has also been reported (frequency cannot be estimated from the available data) 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 (frequency cannot be estimated from the available data) have been reported in patients treated with pioglitazone. If you experience a severe allergic reaction, including hives and swelling of the face, lips, tongue, or throat, which may cause difficulty breathing or swallowing, stop taking this medicine and consult your doctor immediately.

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

Frequent (may affect up to 1 in 10 people)

• Respiratory infection
• Vision abnormalities
• Weight gain
• Numbness

Uncommon (may affect up to 1 in 100 people)

• Inflammation of the sinuses (sinusitis)
• Difficulty sleeping (insomnia)

Frequency not known (cannot be estimated from the available data)

• Increase in liver enzymes
• Allergic reactions

Other adverse effects reported in some patients when pioglitazone is taken together with other antidiabetic medicines are:

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

• Decrease in blood sugar (hypoglycaemia)

Common (may affect up to 1 in 10 people)

• Headache
• Dizziness
• Joint pain
• Impotence
• Back pain
• Shortness of breath
• Slight reduction in the number of red blood cells
• Gas (flatulence)

Uncommon (may affect up to 1 in 100 people)

• Sugar in urine, protein in urine
• Increase in enzymes
• Sensation of spinning (vertigo)
• Sweating
• Fatigue
• Increased appetite

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse 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 stated on the carton, blister pack, and label of the bottle 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 containers and medicines at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of containers and medicines you no longer need. 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 30 mg of pioglitazone (as hydrochloride).
• The other components (excipients) are: monohydrate lactose (see section 2 Pioglitazone Aurovitas contains lactose), calcium carmellose, hydroxypropylcellulose, magnesium stearate.

Appearance of the product and contents of the pack

Pioglitazone Aurovitas 30 mg tablets are white to off-white, flat-faced, bevelled-edged, round tablets, marked with "32" on one side and "H" on the other side.

It is available in transparent PVC/PVDC/Aluminum blisters.

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,

Ruislip HA46QD

United Kingdom

Date of the most recent review of this leaflet: May 2024

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