Incresync 25 mg/30 mg film-coated tablets

2. What you need to know before you take Incresync

Do not take Incresync

• if you are allergic to alogliptin, pioglitazone, or any of the other ingredients of this medicine (listed in section 6).

• if you have had a severe allergic reaction to any other medicine used to control blood sugar levels. Symptoms of a severe allergic reaction can include rash, red raised patches on the skin (hives), swelling of the face, lips, tongue, and throat, which can cause difficulty breathing or swallowing. Other symptoms can include itching (pruritus) and a feeling of heat, which particularly affects the scalp, mouth, throat, and palms of the hands and feet (Stevens-Johnson syndrome).

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

• if you have liver disease.

• if you have diabetic ketoacidosis (a serious 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 blood in your urine that has not been checked by your doctor. Do not take Incresync and see your doctor as soon as possible to have your urine checked.

Warnings and precautions

Talk to your doctor or pharmacist before taking Incresync:

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

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

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

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

• if you have any liver or kidney problems. Before starting this medicine, your doctor will take a blood sample to check your liver and kidney function. This test 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 cysts on the ovaries (polycystic ovary syndrome). You may have an increased chance of becoming pregnant, as you may ovulate again when taking Incresync. If this applies to you, use a suitable contraceptive method to avoid the possibility of an unplanned pregnancy.

• if you have or have had pancreatitis.

There may be slight changes in blood cell counts.

Your doctor may discuss the results with you.

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

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

Children and adolescents

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

Taking Incresync with other medicines

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

In particular, tell 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 checked, and the dose of Incresync may need to be changed.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

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

Incresync should not be used during pregnancy or breastfeeding.

Driving and using machines

You may experience changes in vision when taking this medicine. If this happens, do not drive or use machines or tools. Taking Incresync with other diabetes medicines may cause low blood sugar levels (hypoglycemia), which could affect your ability to drive and use machines.

Incresync contains lactose

If your doctor has told you that you have an intolerance to some sugars, consult them before taking Incresync.

Incresync contains sodium

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

3. How to take Incresync

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, check with your doctor or pharmacist.

Your doctor will tell you how much Incresync to take and if you need to change the amount of other medicines you are taking.

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 medicine with or without food.

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

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

You should check your weight at regular intervals; if you gain weight, tell 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 medicine, contact your doctor or go to the nearest emergency department immediately. Take this leaflet or some tablets with you to show the doctor 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 forgotten dose.

If you stop taking Incresync

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

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Incresync can cause side effects, although not everybody gets them.

STOP taking Incresync and contact a doctor immediatelyif you notice any of the following serious side effects:

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

• Sudden and severe bone painor limited mobility (especially in women).

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

• Bladder cancer symptoms, including blood in the urine, pain when urinating, or a sudden need to urinate.

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

• Allergic reaction. Symptoms can include: skin rash, hives, difficulty swallowing or breathing, swelling of the lips, face, throat, or tongue, and a feeling of fainting.

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

• Severe and persistent abdominal painthat may radiate to the back, as well as nausea and vomiting, which could be a sign of pancreatitis (inflammation of the pancreas).

You should also talk to your doctorif you experience any of the following side effects:

Common:

• Low blood sugar symptoms(hypoglycemia), which can occur when taking Incresync with insulin or sulfonylureas (e.g., glipizide, tolbutamide, glibenclamide). These symptoms can include:shaking, sweating, anxiety, blurred vision, tingling of the lips, paleness, change in mood, or feeling confused. Your blood sugar level may fall below normal, but you can raise it again by taking sugar. It is recommended that you carry some sugar lumps, sweets, biscuits, or sugary fruit juice with you.

• Symptoms similar to flu or a cold, such as sore throat, stuffy or runny nose

• Sinusitis (inflammation of the sinuses)

• Itching of the 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:

• Changes in vision (caused by a condition called macular edema)

• Liver problems, such as nausea and vomiting, stomach pain, unusual or unexplained tiredness, loss of appetite, dark urine, or yellowing of the skin or the whites of the eyes

• Kidney problems, such as interstitial nephritis (inflammation of the kidney tissue).

• Blisters on the skin (bullous pemphigoid).

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines Monitoring System for Human Use: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Incresync

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 and blister after EXP. The expiry date refers to the last day of that month.

This medicine does not require any special temperature storage conditions. Store in the original package to protect the medicine from moisture.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Package Contents and Additional Information

Incresync Contents

• The active ingredientsare alogliptin and pioglitazone.

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

• The other ingredientsare mannitol, microcrystalline cellulose, hydroxypropylcellulose, 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 section "Incresync contains lactose".

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

• The other ingredientsare mannitol, microcrystalline cellulose, hydroxypropylcellulose, sodium croscarmellose, magnesium stearate, lactose monohydrate, hypromellose, talc, titanium dioxide (E171), red iron oxide (E172), macrogol 8000, shellac, and black iron oxide (E172). See section "Incresync contains lactose".

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

• The other ingredientsare mannitol, microcrystalline cellulose, hydroxypropylcellulose, 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 glycerol monooleate. See section "Incresync contains lactose".

Product Appearance and Package Contents

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

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

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

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

Only some pack sizes may be marketed.

Marketing Authorization Holder

Takeda Pharma A/S

Delta Park 45

2665 Vallensbaek Strand

Denmark

Manufacturer

Takeda Ireland Limited

Bray Business Park

Kilruddery

Co. Wicklow

Ireland

You can request more information about this medicinal product by contacting the local representative of the marketing authorization holder:

België/Belgique/Belgien/Lietuva

Luxembourg/LuxemburgTakeda UAB

Takeda Belgium Tel: +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 29 Tel: +361 2707030

Ceská republikaMalta

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

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

DanmarkNederland

Takeda Pharma A/S Takeda Nederland bv

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

[email protected]

DeutschlandNorge

Takeda GmbH Takeda AS

Tel: 0800 825 3325 Tlf: +47 6676 3030

[email protected] [email protected]

EestiÖsterreich

Takeda Pharma AS Takeda Pharma Ges m.b.H

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

Ελλ?δαPolska

TAKEDA ΕΛΛΑΣ Α.Ε Takeda Pharma sp. z o.o.

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

[email protected]

EspañaPortugal

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

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

[email protected]

FranceRomânia

Takeda France S.A.S Takeda Pharmaceuticals SRL

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

HrvatskaSlovenija

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

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

IrelandSlovenská republika

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

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

ÍslandSuomi/Finland

Vistor hf. Takeda Oy

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

[email protected]

ItaliaSverige

Takeda Italia S.p.A. Takeda Pharma AB

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

[email protected]

Κ?προςUnited Kingdom

Takeda Pharma A/S Takeda UK Ltd

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

Latvija

Takeda Latvia SIA

Tel: +371 67840082

Date of Last Revision of this Leaflet: 03/2021

Other Sources of Information

Detailed information on this medicinal product is available on the European Medicines Agency website: http://www.ema.europa.eu.