Incresync 12.5 mg/30 mg film-coated tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Incresync 12.5 mg/30 mg film-coated tablets Incresync 25 mg/30 mg film-coated tablets Incresync 25 mg/45 mg film-coated tablets alogliptin/pioglitazone

Read the entire 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, and you should not give it to other people, even if they have the same symptoms as you, because it could harm them.

• If you experience any adverse effects, talk to your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Incresync is and what it is used for

2. What you need to know before taking Incresync

3. How to take Incresync

4. Possible side effects

5. How to store Incresync

6. Contents of the pack and other information

1. What Incresync is and what it is used for

What Incresync is

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

• alogliptin belongs to a group of medicines known as DPP-4 inhibitors (dipeptidyl peptidase-4 inhibitors). Alogliptin works by increasing insulin levels in the body after a meal and reducing the amount of sugar in the body.
• pioglitazone belongs to a group of medicines known as thiazolidinediones. It helps your body make better use of the insulin it produces.

Both groups of medicines are "oral antidiabetic agents".

What Incresync is used for

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

Incresync is taken when blood sugar cannot be controlled by diet, exercise, and other oral antidiabetic medicines such as pioglitazone alone, or pioglitazone and metformin taken together. Your doctor will monitor whether Incresync is working 3 to 6 months after you have started taking it.

If you are already taking alogliptin and pioglitazone as separate tablets, Incresync may replace them with a single tablet.

It is important that you continue to follow the dietary and exercise advice given to you by your doctor or nurse.

2. What you need to know before taking 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 similar medicine used to control blood sugar. Symptoms of a severe allergic reaction may include rash, raised red blotchy skin rash (urticaria), swelling of the face, lips, tongue, and throat, which may cause difficulty breathing or swallowing. Other symptoms may include generalized itching (pruritus) and a feeling of warmth, especially affecting the scalp, mouth, throat, and palms of the hands and soles of the feet (Stevens-Johnson syndrome).

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

• 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 evaluated by your doctor. Do not take Incresync and see your doctor for a urine examination as soon as possible.

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 (for example, glipizide, tolbutamide, glibenclamide) or insulin.

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

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

• if you have liver or kidney problems. A blood sample will be taken before starting this medicine to assess 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 specific type of diabetic eye disease called macular edema (swelling in the back of the eye).

• if you have ovarian cysts (polycystic ovary syndrome). There may be an increased chance of becoming pregnant, as you may resume ovulation while taking Incresync. If this applies to you, use an appropriate contraceptive method to avoid the possibility of unplanned pregnancy.

• if you have or have had a disease of the pancreas.

Slight abnormalities in blood cell counts may appear in blood tests.

Your doctor may discuss the results with you.

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.

Contact your doctor if blisters appear on the skin, as this could be a sign of a condition called bullous pemphigoid. Your doctor will instruct you to stop treatment with alogliptin.

Children and adolescents

The use of Incresync is not recommended in children and adolescents under 18 years of age due to 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 need to take any other medicines.

In particular, 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 level will be monitored, and your dose of Incresync may need to be adjusted.

Pregnancy and breastfeeding

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

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

Incresync must not be used during pregnancy or breastfeeding.

Driving and using machines

You may experience changes in vision while taking this medicine. If this happens, do not drive or operate machinery or tools. Taking Incresync in combination with other antidiabetic medicines may cause a drop in 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 certain sugars, discuss this with your doctor before taking Incresync.

Incresync contains sodium

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

3. How to take Incresync

Follow exactly the administration instructions for this medicine as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Your doctor will tell you how much Incresync to take and whether you need to adjust the dosage of any other medicines you are taking.

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

Incresync should be taken once daily. Swallow the tablets whole with water. You may take this medicine with or without food.

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

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

You should monitor your weight regularly; if you gain weight, inform your doctor.

If you take more Incresync than you should

If you take more tablets than prescribed, or if someone else or a child takes your medicine, contact your nearest emergency department or go there immediately. Take 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 forgotten dose.

If you stop taking 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 further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

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

STOP taking Incresync and contact a doctor immediately if you notice any of the following serious adverse effects:

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

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

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

• Symptoms of bladder cancer, including blood in the urine, pain when urinating, or a strong urge to urinate.

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

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

• Severe allergic reaction: skin lesions or skin spots, which may progress to an ulcer surrounded by pale or erythematous rings, with blisters and/or skin peeling, possibly accompanied by symptoms such as itching, fever, general malaise, joint pain, vision problems, burning, pain or itching in the eyes, and mouth ulcers (Stevens-Johnson Syndrome and Erythema multiforme).

• Severe and persistent pain in the abdomen (stomach area) that may spread to the back, as well as nausea and vomiting, as these could be signs of inflammation of the pancreas (pancreatitis).

You should also consult your doctor if you experience any of the following adverse effects:

Frequent:

• Symptoms of low blood sugar levels (hypoglycaemia), which may occur when Incresync is taken in combination with insulin or sulfonylureas (e.g., glipizide, tolbutamide, glibenclamide). Symptoms may include: trembling, sweating, anxiety, blurred vision, tingling in the lips, paleness, change in mood or feeling confused. Your blood sugar level could drop below normal, but you can raise it again by consuming sugar. It is recommended that you carry sugar lumps, sweets, biscuits, or sweetened fruit juice with you.

• Flu- or cold-like symptoms such as sore throat, stuffy or blocked nose

• Inflammation of the sinuses (sinusitis)

• Skin irritation or stinging

• Headache

• Stomach pain

• Diarrhoea

• Indigestion, heartburn

• Nausea

• Muscle pain

• Numbness anywhere in the body

• Blurred or distorted vision

• Weight gain

• Swollen or inflamed hands or feet

• Skin rash

Uncommon:

• Difficulty sleeping

Frequency not known:

• Vision disturbances (caused by a condition called macular oedema)

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

• Inflammation of the connective tissue inside the kidneys (interstitial nephritis)

• Appearance of blisters on the skin (bullous pemphigoid)

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Incresync

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

Do not use Incresync after the expiry date which is stated on the carton and the blister after “Expiry date”. The expiry date refers to the last day of that month.

This medicinal product does not require any special storage conditions.

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.

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 on the blister after CAD/EXP. The expiry date refers to the last day of the month indicated.

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

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Contents of Incresync

• The active substances are 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 components are 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 components are 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 components are 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 mono-oleate. See section “Incresync contains lactose”.

Appearance of the product and contents of the pack

• Incresync 25 mg/30 mg film-coated tablets (tablets) are film-coated, round (approximately 8.7 mm in diameter), biconvex, peach-coloured tablets, with the imprint “A/P” and “25/30” printed in grey 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-coloured tablets, with the imprint “A/P” and “25/45” printed in grey 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-coloured tablets, with the imprint “A/P” and “12.5/30” printed in red ink on one side.

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

Only certain pack sizes may be marketed.

Marketing Authorisation Holder

Takeda Pharma A/S

Delta Park 45

2665 Vallensbaek Strand

Denmark

Manufacturer

Takeda Ireland Limited

Bray Business Park

Kilruddery

Co. Wicklow

Ireland

For further information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien/Lietuva

Luxembourg/Luxemburg Takeda 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 the latest revision of this leaflet: 03/2021

Other sources of information

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