Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - incresync

Document Subject

Generated Narrative: MedicinalProductDefinition mp9cd7665100fd3b81b318cbcb65d45fef

identifier: http://ema.europa.eu/identifier/EU/1/13/842/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Incresync 12.5 mg/30 mg film-coated tablets

type: Full name

part

part: nan

type: Invented name part

part

part: nan

type: Scientific name part

part

part: nan

type: Strength part

part

part: nan

type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-9cd7665100fd3b81b318cbcb65d45fef

identifier: http://ema.europa.eu/identifier/EU/1/13/842/001

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - incresync

Attesters

What is in this leaflet

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

What Incresync is Incresync contains two different medicines called alogliptin and pioglitazone in one tablet:

alogliptin belongs to a group of medicines called DPP-4 inhibitors (dipeptidyl peptidase-4 inhibitors). Alogliptin works to increase the levels of insulin in the body after a meal and decrease the amount of sugar in the body.

pioglitazone belongs to a group of medicines called thiazolidinediones. It helps your body make better use of the insulin it produces. Both of these groups of medicines are oral anti-diabetics . 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 your blood sugar cannot be adequately controlled by diet, exercise and other oral anti-diabetic medicines such as pioglitazone; or pioglitazone and metformin taken together. Your doctor will check whether Incresync is working 3 to 6 months after you start taking it. If you are already taking both alogliptin and pioglitazone as single tablets, Incresync can replace them in one tablet. It is important that you continue to follow the advice on diet and exercise that your nurse or doctor has given you.

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 serious allergic reaction to any other similar medicines that you take to control your blood sugar. Symptoms of a serious allergic reaction may include; rash, raised red patches on your skin (hives), swelling of the face, lips, tongue, and throat that may cause difficulty in breathing or swallowing. Additional symptoms may include general itching and feeling of heat especially affecting the scalp, mouth, throat, palms of hands and soles of feet (Stevens-Johnson syndrome).

if you have heart failure or have had heart failure in the past.

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 ever had bladder cancer.

if you have blood in your urine that your doctor has not checked. Do not take Incresync and get your doctor to check your urine 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 an anti-diabetic medicine known as sulphonylurea (e.g. glipizide, tolbutamide, glibenclamide) or insulin.

if you suffer from heart disease or fluid retention. If you take anti-inflammatory medicines which can also cause fluid retention and swelling, you must also tell your doctor.

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

if you have a problem with your liver or kidneys. Before you start taking this medicine you will have a blood sample taken to check your liver and kidney function. This check may be repeated at intervals. In case of kidney disease, your doctor may reduce the dose of Incresync.

if you have a special type of diabetic eye disease called macular oedema (swelling of the back of the eye).

if you have cysts on your ovaries (polycystic ovarian syndrome). There may be an increased possibility of becoming pregnant because you may ovulate again when you take Incresync. If this applies to you, use appropriate contraception to avoid the possibility of an unplanned pregnancy.

if you have or have had a disease of the pancreas. Slight changes in cell counts may show up in blood tests. Your doctor may discuss the results with you. A higher number of bone fractures was seen in patients, particularly women taking pioglitazone. Your doctor will take this into account when treating your diabetes. Contact your doctor if you encounter blistering of the skin, as it may be a sign for a condition called bullous pemphigoid. Your doctor may ask you to stop alogliptin. Children and adolescents Incresync is not recommended for children and adolescents under 18 years due to the lack of data in these patients. Other medicines and Incresync 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 will be checked and your dose of Incresync may need to be changed. Pregnancy and breast-feeding If you are pregnant or breast-feeding, 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 of using Incresync in pregnant women or during breast-feeding. Incresync should not be used during pregnancy or breast-feeding. Driving and using machines You may experience visual disturbances while taking this medicine. If this happens, do not drive or use any tools or machines. Taking Incresync in combination with other anti-diabetic medicines can cause low blood sugar levels (hypoglycaemia), which may affect your ability to drive and use machines. Incresync contains lactose If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking Incresync. Incresync contains sodium This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially sodium-free .

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. Your doctor will tell you how much Incresync you need to take and if you need to change the amount of other medicines you take. The maximum recommended daily dose is one 25 mg/45 mg tablet. Incresync should be taken once daily. Swallow your tablet(s) whole with water. You can 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 with this while you are taking Incresync. Your weight should be checked at regular intervals; if your weight increases, 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 or go to your nearest emergency centre straight away. Take this leaflet or some tablets with you so that 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 it. Do not take a double dose to make up for a forgotten dose. If you stop taking Incresync Do not stop taking Incresync without consulting your doctor first. Your blood sugar levels may increase when you stop taking Incresync. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everybody gets them. STOP taking Incresync and contact a doctor immediately if you notice any of the following serious side effects: Common (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 your urine, pain when urinating or a sudden need to urinate. Not known (frequency cannot be estimated from the available data):

An allergic reaction. The symptoms may include: a rash, hives, swallowing or breathing problems, swelling of your lips, face, throat or tongue and feeling faint.

A severe allergic reaction: skin lesions or spots on your skin that can progress to a sore surrounded by pale or red rings, blistering and/or peeling of the skin possibly with symptoms such as itching, fever, overall ill feeling, achy joints, vision problems, burning, painful or itchy eyes and mouth sores (Stevens-Johnson syndrome and Erythema multiforme).

Severe and persistent pain in the abdomen (stomach area) which might reach through to your back, as well as nausea and vomiting, as it could be a sign of an inflamed pancreas (pancreatitis). You should also discuss with your doctor if you experience the following side effects: Common:

Symptoms of low blood sugar (hypoglycaemia) may occur when Incresync is taken in combination with insulin or sulphonylureas (e.g. glipizide, tolbutamide, glibenclamide). Symptoms may include: trembling, sweating, anxiety, blurred vision, tingling lips, paleness, mood change or feeling confused. Your blood sugar could fall below the normal level, but can be increased again by taking sugar. It is recommended that you carry some sugar lumps, sweets, biscuits or sugary fruit juice.

Cold or flu-like symptoms such as sore throat, stuffy or blocked nose

Inflammation of the sinuses (sinusitis)

Itchy skin

Headache

Stomach ache

Diarrhoea

Indigestion, heartburn

Feeling sick

Muscle pain

Feeling numb in any part of your body

Blurred or distorted vision

Weight gain

Swollen or puffy hands or feet

Rash Uncommon:

Difficulty sleeping Not known:

Visual disturbances (caused by a condition called macular oedema).

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

Inflammation of the connective tissue within the kidneys (interstitial nephritis).

Blistering of the skin (bullous pemphigoid). Reporting of side effects If you get 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 via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

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 medicinal product does not require any special temperature storage conditions. Store in the original package in order to protect from moisture. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

What Incresync contains

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 alogliptin and 30 mg pioglitazone.

The other ingredients are mannitol, microcrystalline cellulose, hydroxypropylcellulose, croscarmellose sodium, 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 2 Incresync contains lactose . Each 25 mg/45 mg film-coated tablet contains alogliptin benzoate and pioglitazone hydrochloride equivalent to 25 mg alogliptin and 45 mg pioglitazone.

The other ingredients are mannitol, microcrystalline cellulose, hydroxypropylcellulose, croscarmellose sodium, magnesium stearate, lactose monohydrate, hypromellose, talc, titanium dioxide (E171), red iron oxide (E172), macrogol 8000, shellac and black iron oxide (E172). See section 2 Incresync contains lactose . Each12.5 mg/30 mg film-coated tablet contains alogliptin benzoate and pioglitazone hydrochloride equivalent to 12.5 mg alogliptin and 30 mg pioglitazone.

The other ingredients are mannitol, microcrystalline cellulose, hydroxypropylcellulose, croscarmellose sodium, 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 2 Incresync contains lactose . What Incresync looks like and contents of the pack

Incresync 25 mg/30 mg film-coated tablets (tablets) are peach, round (approximately 8.7 mm in diameter), biconvex, film-coated tablets, with both A/P and 25/30 printed in grey ink on one side.

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

Incresync 12.5 mg/30 mg film-coated tablets (tablets) are pale peach, round (approximately 8.7 mm in diameter), biconvex, film-coated tablets, with both A/P and 12.5/30 printed in red ink on one side. Incresync is available in blister packs containing 10, 14, 28, 30, 56, 60, 90, 98 or 100 tablets. Not all pack sizes may be marketed. Marketing Authorisation Holder Takeda Pharma A/S Delta Park 2665 Vallensbaek Strand Denmark Manufacturer Takeda Ireland Limited Bray Business Park Kilruddery Co. Wicklow Ireland For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder: Belgi /Belgique/Belgien Takeda Belgium NV Tel/T l: +32 2 464 06 medinfoEMEA@takeda.com Lietuva Takeda, UAB Tel: +370 521 09 medinfoEMEA@takeda.com

.: +359 2 958 27 medinfoEMEA@takeda.com Luxembourg/Luxemburg Takeda Belgium NV Tel/T l: +32 2 464 06 medinfoEMEA@takeda.com esk republika Takeda Pharmaceuticals Czech Republic s.r.o. Tel: +420 234 722 medinfoEMEA@takeda.com Magyarorsz g Takeda Pharma Kft. Tel: +36 1 270 7medinfoEMEA@takeda.com Danmark Takeda Pharma A/S Tlf: +45 46 77 10 medinfoEMEA@takeda.com Malta Takeda HELLAS S.A. Tel: +30 210 6387medinfoEMEA@takeda.com Deutschland Takeda GmbH Tel: +49 (0)800 825 3medinfoEMEA@takeda.com Nederland Takeda Nederland B.V. Tel: +31 20 203 5medinfoEMEA@takeda.com Eesti Takeda Pharma AS Tel: +372 6177 medinfoEMEA@takeda.com Norge Takeda AS Tlf: +47 800 800 medinfoEMEA@takeda.com

Takeda . . : +30 210 6387medinfoEMEA@takeda.com sterreich Takeda Pharma Ges. m.b.H. Tel: +43 (0) 800-20 80 medinfoEMEA@takeda.com Espa a Laboratorios Menarini, S.A Tel: +34 934 628 info@menarini.es Polska Takeda Pharma Sp. z o.o. tel: +48223062medinfoEMEA@takeda.com France Takeda France SAS Tel: + 33 1 40 67 33 medinfoEMEA@takeda.com Portugal Tecnimede - Sociedade T cnico-Medicinal, S.A Tel: +351 21 041 41 dmed.fv@tecnimede.pt Hrvatska Takeda Pharmaceuticals Croatia d.o.o Tel: +385 1 377 88 medinfoEMEA@takeda.com Rom nia Takeda Pharmaceuticals SRL Tel: +40 21 335 03 medinfoEMEA@takeda.com Ireland Takeda Products Ireland Ltd Tel: 1800 937 medinfoEMEA@takeda.com Slovenija Takeda Pharmaceuticals farmacevtska dru ba d.o.o.. Tel: +386 (0) 59 082 medinfoEMEA@takeda.com sland Vistor hf. S mi: +354 535 7medinfoEMEA@takeda.com Slovensk republika Takeda Pharmaceuticals Slovakia s.r.o. Tel: +421 (2) 20 602 medinfoEMEA@takeda.com Italia Takeda Italia S.p.A. Tel: +39 06 502medinfoEMEA@takeda.com Suomi/Finland Takeda Oy Puh/Tel: 0800 774 medinfoEMEA@takeda.com

Takeda . . : +30 210 6387medinfoEMEA@takeda.com Sverige Takeda Pharma AB Tel: 020 795 medinfoEMEA@takeda.com Latvija Takeda Latvia SIA Tel: +371 67840medinfoEMEA@takeda.com United Kingdom (Northern Ireland) Takeda UK Ltd Tel: +44 (0) 2830 640 medinfoEMEA@takeda.com This leaflet was last revised in Other sources of information Detailed information on this medicine is available on the European Medicines Agency web site: