Patient Information Leaflet

Incresync 12.5 mg/30 mg Film-Coated Tablets Incresync 25 mg/30 mg Film-Coated Tablets Incresync 25 mg/45 mg Film-Coated Tabletsalogliptina/pioglitazona

Read this leaflet carefully before you start taking this medicine because 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 give it to others even if they have similar symptoms to you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1. How to take Incresync
2. Possible side effects
3. Storage of Incresync

1. Contents of the pack and additional information

What is Incresync

Incresync contains two different medications, called alogliptin and pioglitazone, in a single tablet:

• alogliptin belongs to a group of medications called DPP-4 inhibitors (dipeptidyl peptidase-4 inhibitors). Alogliptin acts to increase insulin levels in the body after a meal and decrease the amount of sugar in the body.
• pioglitazone belongs to a group of medications called thiazolidinediones. It helps your body use insulin more effectively.

Both groups of medications are "oral antidiabetics".

What is Incresync used for

Incresync is used to lower blood sugar levels in adults with type 2 diabetes. Type 2 diabetes is also known as non-insulin-dependent diabetes mellitus, or DMNID.

Incresync is taken when it is not possible to control blood sugar levels through diet, exercise, and other oral antidiabetic medications such as pioglitazone, or pioglitazone and metformin taken together. Your doctor will monitor if Incresync is effective 3 to 6 months after you have started taking it.

If you are already taking alogliptin and pioglitazone in individual tablets, Incresync may replace them in a single tablet.

It is essential that you do not stop following the diet and exercise advice given by your doctor or nurse.

Do not take Incresync

• if you are allergic to alogliptina, pioglitazona, or any of the other components of this medication (listed in section 6).

• if you have had a severe allergic reaction to another medication similar to Incresync that you take to control your blood sugar levels. Symptoms of a severe allergic reaction may include rash, red, raised patches on the skin (urticaria), swelling of the face, lips, tongue, and throat, which may cause difficulty breathing or swallowing. Other symptoms may include general itching (pruritus) and a sensation of heat, especially affecting the scalp, mouth, throat, and palms of the hands and feet (Stevens-Johnson syndrome).

• if you have heart failure or have had heart failure previously.

• if you have liver disease.

• if you have diabetic ketoacidosis (a severe complication of poorly controlled diabetes). Symptoms include excessive thirst, frequent urination, loss of appetite, nausea or vomiting, and rapid weight loss.
• if you have or have had bladder cancer.

• if you have uncontrolled blood in your urine. Do not take Incresync and consult your doctor as soon as possible.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Incresync:

• if you have type 1 diabetes (your body does not produce insulin).

• if you are taking a diabetes medication called a sulfonylurea (e.g., glipizide, tolbutamide, glibenclamide) or insulin.

• if you have heart disease or fluid retention. If you are taking anti-inflammatory medications that may cause fluid retention and swelling, you should also inform your doctor.

• if you are elderly and taking insulin, as you may be at a higher risk of heart problems.

• if you have any liver or kidney problems. Before starting this medication, a blood sample will be taken to evaluate your liver and kidney function. This analysis may be repeated at intervals. If you have kidney disease, your doctor may reduce the dose of Incresync.

• if you have a special type of diabetic eye disease called macular edema (inflammation of the back of the eye).

• if you have polycystic ovary syndrome (PCOS). There may be an increased risk of becoming pregnant, as you may ovulate again while taking Incresync. If this applies to your situation, use an appropriate contraceptive method to avoid the possibility of unplanned pregnancy.

• if you have or have had pancreatitis.

Mild changes in blood cell counts may appear in blood tests.

Your doctor may discuss the results with you.

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

Contact your doctor if you develop blisters on your skin, as it could be one of the signs of a condition called bullous pemphigoid. Your doctor will ask you to stop treatment with alogliptina.

Children and adolescents

Incresync is not recommended for use in children and adolescents under 18 years of age, due to a lack of data in these patients.

Taking Incresync with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

Particularly, inform your doctor or pharmacist if you are taking any of the following:

• gemfibrozil (used to lower cholesterol)

• rifampicin (used to treat tuberculosis and other infections)

Your blood sugar levels will be monitored, and you may need to adjust the dose of Incresync.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

There is no experience with the use of Incresync in pregnant women or during breastfeeding.

Incresync should not be used during pregnancy or breastfeeding.

Driving and operating machinery

You may experience vision changes while taking this medication. If this happens, do not drive or use machines. Taking Incresync in combination with other diabetes medications may cause a drop in blood sugar levels (hypoglycemia), which may affect your ability to drive and use machines.

Incresync contains lactose

If your doctor has told you that you are intolerant to some sugars, consult them before taking Incresync.

Incresync contains sodium

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

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.

Your doctor will tell you what amount of Incresync to take, and if you need to modify the amount of other medications you take.

The maximum recommended daily dose is one 25 mg/45 mg tablet.

Incresync should be taken once a day. Swallow the tablets whole with water. You can take this medication with or without food.

If you have kidney problems, your doctor may prescribe a reduced dose.

If you are following a diabetic diet, you should continue with it while taking Incresync.

You should monitor your weight at regular intervals; if you gain weight, inform your doctor.

If you take more Incresync than you should

If you take more tablets than you should, or if someone else or a child takes your medication, contact or go immediately to the nearest emergency center. Bring this leaflet or some tablets with you, so your doctor knows exactly what you have taken.

If you forget to take Incresync

If you forget to take a dose, take it as soon as you remember. Do not take a double dose to make up for a missed dose.

If you interrupt treatment with Incresync

Do not stop taking Incresync without first consulting your doctor. Your blood sugar levels may increase if you stop taking Incresync.

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

Like all medicines, Incresync may cause side effects, although not everyone will experience them.

STOP taking Incresync and seek medical attention immediatelyif you noticeany of the followingserious side effects:

Common(may affect up to 1 in 10 people):

• Sudden and intense bone pain or immobility(particularly in women).

Uncommon(may affect up to 1 in 100 people):

• Bladder cancer symptoms, including blood in the urine, pain while urinating ora sudden urge to urinate.

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

• Allergic reaction. Symptoms may include: skin rash, urticaria, difficulty swallowing or breathing, swelling of the lips, face, throat, or tongue, and feeling faint.

• Severe allergic reaction:skin lesions or skin patches, which may progress to aulcer surrounded by pale or erythematous rings, with blisters and/or skin peeling, possibly accompanied by symptoms such as itching, fever, general feeling of discomfort, joint pain, vision problems, burning, pain, or itching in the eyes, and mouth ulcers (Stevens-Johnson syndrome and erythema multiforme).

• Intense and persistent abdominal pain(stomach area) that may radiate to the back, as well as nausea and vomiting, which could be a sign of pancreatitis.

You should alsoconsult your doctorif you experience any of the following side effects:

Common:

• Hypoglycemia symptoms(low blood sugar), which may occur whenIncresync is taken in combination with insulin or sulfonylureas (e.g., glipizide, tolbutamide, glibenclamide).Symptoms may include:shaking, sweating, anxiety, blurred vision, tingling in the lips, paleness, change in mood, or feeling confused. Your blood sugar level may drop below the normal range, but you can raise it again by consuming sugar. It is recommended that you carry some sugar cubes, candies, biscuits, or fruit juice with sugar.

• Symptoms similar to the flu or common cold, such as sore throat, congested or runny nose

• Paranasal sinus inflammation (sinusitis)

• Itching skin

• Headache

• Stomach pain

• Diarrhea

• Indigestion, heartburn

• Nausea

• Muscle pain

• Numbness in any part of the body

• Blurred or distorted vision

• Weight gain

• Swollen or inflamed hands or feet

• Skin rash

Uncommon:

• Difficulty sleeping

Frequency not known:

• Visual disturbances (caused by a condition called macular edema)

• Hepatic problems such as nausea and vomiting, stomach pain, unusual or unexplained fatigue, loss of appetite, dark-colored urine, or yellowing of the skin or eyes

• Interstitial nephritis (inflammation of the kidney tissue).

• Pemphigoid bullous (appearance of blisters on the skin).

Reporting 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 theSpanish System for Pharmacovigilance of Medicines for Human Use: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 and on the blister pack after CAD/EXP. The expiration date is the last day of the month indicated.

This medication does not require special temperature conditions for storage. Store in the original packaging to protect the medication from moisture.

Medications should not be disposed of through drains or trash. Ask your pharmacist how to dispose of the packaging and medications that you no longer need. This will help protect the environment.

Incresync Content

• Theactive ingredientsare alogliptina and pioglitazone.

Each film-coated tablet of 25 mg/30 mg contains benzoate of alogliptin and hydrochloride of pioglitazone equivalent to 25 mg of alogliptin and 30 mg of pioglitazone.

• Theother componentsare mannitol, microcrystalline cellulose, hydroxypropyl cellulose, sodium croscarmellose, magnesium stearate, lactose monohydrate, hypromellose, talc, titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172), macrogol 8000, shellac, and black iron oxide (E172). See the section “Incresync contains lactose”.

Each film-coated tablet of 25 mg/45 mg contains benzoate of alogliptin and hydrochloride of pioglitazone equivalent to 25 mg of alogliptin and 45 mg of pioglitazone.

• Theother componentsare mannitol, microcrystalline cellulose, hydroxypropyl cellulose, sodium croscarmellose, magnesium stearate, lactose monohydrate, hypromellose, talc, titanium dioxide (E171), red iron oxide (E172), macrogol 8000, shellac, and black iron oxide (E172). See the section “Incresync contains lactose”.

Each film-coated tablet of 12.5 mg/30 mg contains benzoate of alogliptin and hydrochloride of pioglitazone equivalent to 12.5 mg of alogliptin and 30 mg of pioglitazone.

• Theother componentsare mannitol, microcrystalline cellulose, hydroxypropyl cellulose, sodium croscarmellose, magnesium stearate, lactose monohydrate, hypromellose, talc, titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172), macrogol 8000, shellac, carnauba wax, and mono-oleate of glycerol. See the section “Incresync contains lactose”.

Appearance of the product and contents of the package

• Incresync 25 mg/30 mg film-coated tablets (tablets) are film-coated tablets, round, (approximately 8.7 mm in diameter), biconvex, orange-colored, with the inscription “A/P” and “25/30” printed in gray ink on one face.

• Incresync 25 mg/45 mg film-coated tablets (tablets) are film-coated tablets, round, (approximately 8.7 mm in diameter), biconvex, red-colored, with the inscription “A/P” and “25/45” printed in gray ink on one face.

• Incresync 12.5 mg/30 mg film-coated tablets (tablets) are film-coated tablets, round, (approximately 8.7 mm in diameter), biconvex, light orange-colored, with the inscription “A/P” and “12.5/30” printed in red ink on one face.

Incresync is available in blisters with 10, 14, 28, 30, 56, 60, 90, 98, or 100 tablets.

Only some package sizes may be marketed.

Marketing Authorization Holder

Takeda Pharma A/S

Delta Park45

2665Vallensbaek Strand

Dinamarca

Responsible for manufacturing

Takeda Ireland Limited

Bray Business Park

Kilruddery

Co. Wicklow

Irlanda

For more information about this medicine, please contact the local representative of the marketing authorization holder:

België/Belgique/Belgien/Lietuva

Luxembourg/LuxemburgTakeda UAB

Takeda BelgiumTel: +370 521 09 070

Tél/Tel: +32 2 464 06 11[email protected]

[email protected]

????????Magyarország

?????? ????????Takeda Pharma Kft.

???.: +359 2 958 27 36; +359 2 958 15 29Tel: +361 2707030

Ceská republikaMalta

Takeda Pharmaceuticals Czech Republic s.r.o.Takeda Italia S.p.A.

Tel: +420 234 722 722Tel: +39 06 502601

DanmarkNederland

Takeda Pharma A/STakeda Nederland bv

Tlf./Tel: +45 46 77 11 11Tel: +31 23 56 68 777

[email protected]

DeutschlandNorge

Takeda GmbHTakeda AS

Tel: 0800 825 3325Tlf: +47 6676 3030

[email protected][email protected]

EestiÖsterreich

Takeda Pharma ASTakeda Pharma Ges m.b.H

Tel: +372 6177 669Tel: +43 (0) 800-20 80 50

Ελλ?δαPolska

TAKEDA ΕΛΛΑΣ Α.ΕTakeda Pharma sp. z o.o.

Tel: +30 210 6387800tel. +48 22 608 13 00

[email protected]

EspañaPortugal

Laboratorios Menarini, S.A.Takeda Farmacêuticos Portugal, Lda.

Tel: +34 934 628 800Tel: +351 21 120 1457

info@menarini.es

FranceRomânia

Takeda France S.A.STakeda Pharmaceuticals SRL

Tél: +33 1 46 25 16 16Tel: +40 21 335 03 91

HrvatskaSlovenija

Takeda Pharmaceuticals Croatia d.o.oTakeda GmbH, Podružnica Slovenija

Tel: +385 1 377 88 96Tel: +386 (0) 59 082 480

IrelandSlovenská republika

Takeda Products Ireland LimitedTakeda Pharmaceuticals Slovakia s.r.o.

Tel: +353 (0) 1 6420021Tel: +421 (2) 20 602 600

ÍslandSuomi/Finland

Vistor hf.Takeda Oy

Sími: +354 535 7000Tel. +358 20 746 5000

[email protected]

ItaliaSverige

Takeda Italia S.p.A.Takeda Pharma AB

Tel: +39 06 502601Tel: +46 8 731 28 00

[email protected]

Κ?προςUnited Kingdom

Takeda Pharma A/STakeda UK Ltd

Τηλ: +45 46 77 11 11Tel: +44 (0) 1628 537 900

Latvija

Takeda Latvia SIA

Tel: +371 67840082

Fecha de la última revisión de este prospecto: 03/2021

Otras fuentes de información

The detailed information about this medicine is available on the website of the European Medicines Agency:http://www.ema.europa.eu.