Patient leaflet - Incresync
B. PACKAGE LEAFLET
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 all of this leaflet carefully before you start taking this medicine because it contains important information for you.
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– Keep this leaflet. You may need to read it again.
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– If you have any further questions, ask your doctor or pharmacist.
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– This medicine has been prescribed for you only. Do not pass it on to others. It may harm them,
even if their signs of illness are the same as yours.
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– If you get any side effects, talk to your doctor or pharmacist. This includes any possible side
effects not listed in this leaflet. See section 4.
What is in this leaflet
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1. What Incresync is and what it is used for
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2. What you need to know before you take Incresync
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3. How to take Incresync
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4. Possible side effects
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5. How to store Incresync
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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 one tablet:
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– 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.
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– 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.
2. What you need to know before you take Incresync
Do not take Incresync
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– if you are allergic to alogliptin, pioglitazone or any of the other ingredients of this medicine
(listed in section 6).
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– 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).
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– if you have heart failure or have had heart failure in the past.
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– if you have liver disease.
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– 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.
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– if you have or have ever had bladder cancer.
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– 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:
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– if you have type 1 diabetes (your body does not produce insulin).
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– if you are taking an anti-diabetic medicine known as sulphonylurea (e.g. glipizide, tolbutamide,
glibenclamide) or insulin.
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– 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.
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– if you are elderly and are taking insulin, because you may have an increased risk of heart
problems.
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– 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.
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– if you have a special type of diabetic eye disease called macular oedema (swelling of the back
of the eye).
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– 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.
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– 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:
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– gemfibrozil (used to lower cholesterol)
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– 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’.
3. How to take Incresync
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.
4. Possible side effects
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):
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- Sudden and severe bone pain or immobility (particularly in women).
Uncommon (may affect up to 1 in 100 people):
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- 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):
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- 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.
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- 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).
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- 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 :
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- 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.
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– Cold or flu-like symptoms such as sore throat, stuffy or blocked nose
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– Inflammation of the sinuses (sinusitis)
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– Itchy skin
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– Headache
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– Stomach ache
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– Diarrhoea
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– Indigestion, heartburn
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– Feeling sick
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– Muscle pain
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– Feeling numb in any part of your body
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– Blurred or distorted vision
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– Weight gain
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– Swollen or puffy hands or feet
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– Rash
Uncommon :
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– Difficulty sleeping
Not known :
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– Visual disturbances (caused by a condition called macular oedema).
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– 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.
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– Inflammation of the connective tissue within the kidneys (interstitial nephritis).
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– 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.
5. How to store 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 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.
6. Contents of the pack and other information
What Incresync contains
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– 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.
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– 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.
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– 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.
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– 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
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– 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.
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– 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.
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– Incresync 12.5 mg/30 mg film-coated tablets (tablets) are pale peach, round (approximately