Prospect: information for the user

Pioglitazona Aurovitas 15 mg tablets EFG

Read this prospect carefully before starting to take this medicine, as it contains important information for you.

-Keep this prospect, as you may need to read it again.

-If you have any doubts, consult your doctor or pharmacist.

-This medicine has been prescribed only for you, and you should not give it 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 they are not listed in this prospect. See section 4.

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

2.What you need to know before starting to take Pioglitazona Aurovitas

3.How to take Pioglitazona Aurovitas

4.Possible adverse effects

5.Storage of Pioglitazona Aurovitas

6.Contents of the package and additional information

Pioglitazona Aurovitas contains pioglitazone. It is an antidiabetic medication used to treat type 2 diabetes mellitus (non-insulin dependent) in adults, when metformin is not suitable or has not worked correctly. This type of diabetes typically presents in adults.

Pioglitazone is used to control blood sugar levels when you have type 2 diabetes. It allows your body to use insulin more effectively. Your doctor will monitor the effect this medication is having on you between 3 and 6 months since starting treatment.

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

Do not take Pioglitazona Aurovitas

-if you are allergic to pioglitazona or any of the other components 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 uncontrolled blood in your urine.

Warnings and precautions

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

-if you have fluid retention or heart problems, particularly if you are over 75 years old.If you take anti-inflammatory medications 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 ovarian cysts (polycystic ovary syndrome). It may increase the chances of getting pregnant, as taking Pioglitazona Aurovitas may cause you to ovulate again. If this is your case, use suitable contraceptive methods to avoid the possibility of an unplanned pregnancy.

-if you have liver or heart problems. Before starting treatment with Pioglitazona Aurovitas, a blood test will be performed to check liver function. These tests must be performed periodically. Some patients with type 2 diabetes of long duration and heart disease or previous stroke who received Pioglitazona 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 Pioglitazona Aurovitas with other diabetes medications, it is more likely that your blood sugar level may drop below the normal limit (hypoglycemia).

You may also show a reduction in the count of blood cells (anemia).

Bone fractures

A higher number of bone fractures has been observed in patients, particularly in women who took pioglitazona. Your doctor will take this into account when treating your diabetes.

Children and adolescents

Not recommended for children and adolescents under 18 years old.

Taking Pioglitazona Aurovitas with other medications

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

You can usually continue taking other medications while taking Pioglitazona Aurovitas tablets. However, certain medications have a higher probability of affecting blood sugar content:

-gemfibrozilo (used to reduce cholesterol),

-rifampicina (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 level and may need to change the dose of Pioglitazona Aurovitas.

Taking Pioglitazona 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

Inform 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 medication.

Driving and using machines

Diabetes treatment with pioglitazona as the only medication (monotherapy) does not produce hypoglycemia (low blood sugar) and therefore does not affect the ability to drive or use machinery. However, if you take pioglitazona with other medications to treat your diabetes, hypoglycemia (symptoms of low blood sugar such as fainting, confusion, increased sweating, visual disturbances, or difficulty concentrating) may occur and you should exercise extreme caution when driving and using hazardous machinery.

Pioglitazona Aurovitas contains lactose

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

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The recommended starting dose is one 15 mg or 30 mg pioglitazona tablet per day. Your doctor may increase the dose to a maximum of 45 mg once a day. Your doctor will indicate the dose you should take.

If you think Pioglitazona Aurovitas is not having enough effect, consult with your doctor.

When taking Pioglitazona Aurovitas in combination with other medications used to treat diabetes (such as insulin, chlorpropamide, glibenclamide, glimepiride, tolbutamide), your doctor will indicate if you need to take a lower dose of those medications.

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

Follow any special diet for diabetics while taking Pioglitazona Aurovitas.

You must control your weight regularly. If you gain weight, inform your doctor.

If you take more Pioglitazona Aurovitas than you should

If you accidentally take too many tablets, or if someone else (e.g. a child) takes your medication, inform your doctor or pharmacist immediately. Your blood sugar level may decrease below normal, but you can increase it by taking sugar. It is recommended that you carry some sugar cubes, candies, cookies or some fruit juice with sugar.

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

If you forget to take Pioglitazona Aurovitas

Take Pioglitazona 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 the missed dose.

If you interrupt treatment with Pioglitazona Aurovitas

Pioglitazona Aurovitas should be taken daily for the treatment to have the desired effect. If you interrupt taking Pioglitazona Aurovitas, your blood sugar level may increase. Consult with your doctor before interrupting treatment.

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Specifically, patients have experienced the following serious side effects:

Heart failure, occurring frequently (may affect up to 1 in 10 people) in patients taking pioglitazone in combination with insulin. Symptoms include unusual feeling of suffocation 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.

Infrequently (may affect up to 1 in 100 people), bladder cancer has developed in patients taking pioglitazone. Signs and symptoms include blood in the urine, pain while 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 presented frequently (may affect more than 1 in 10 people) localized swelling (edema). Consult your doctor as soon as possible if you experience this side effect.

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

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

Severe allergic reactions (frequency cannot be estimated from 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 may 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 when taking pioglitazone are:

Frequent(may affect up to 1 in 10 people)

• Respiratory infection
• Vision abnormalities
• Weight gain
• Numbness

Rare(may affect up to 1 in 100 people)

• Nasal sinus inflammation (sinusitis)
• Difficulty sleeping (insomnia)

Unknown frequency(cannot be estimated from available data)

• Increased liver enzymes
• Allergic reactions

Other side effects that have been experienced by some patients when pioglitazone is taken with other diabetes medications are as follows:

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

• Low blood sugar (hypoglycemia)

Frequent(may affect up to 1 in 10 people)

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

Rare(may affect up to 1 in 100 people)

• Sugar in the urine, protein in the urine
• Increased enzymes
• Sensation of rotational movement (vertigo)
• Sweating
• Fatigue
• Increased appetite

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the box, blister pack, and label of the bottle after CAD. The expiration date is the last day of the month indicated.

This medication does not require special conditions for conservation.

Medications should not be disposed of through drains or in the trash. Dispose of the containers and medications you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. By doing so, you will help protect the environment.

Composition of Pioglitazona Aurovitas

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

- The other components (excipients) are: lactose monohydrate ( see section 2 Pioglitazona Aurovitas contains lactose ), calcium carbonate, hydroxypropylcellulose, magnesium stearate.

Appearance of the product and content of the container

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

It is available in a transparent PVC/PVDC/Aluminum blister.

The presentations are 28 and 56 tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Responsible for manufacturing

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

Last review date of this leaflet: May 2024

The detailed and updated information of this medicine is available on the website of the Spanish Agency of Medicaments and Health Products (AEMPS) http://www.aemps.gob.es .