Incresync 25/30 mg tablet, 12.5 mg / 30 mg, 12.5 mg / 45 mg, 25 mg / 45 mg film-coated tablets
alogliptin/pioglitazone
1. What Incresync Is And What It Is Used For
What Incresync is
Incresync contains two different medicines in one tablet. The two substances are alogliptin and pioglitazone.
- Alogliptin belongs to a group of medicines called 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 called thiazolidinediones. It helps the body to use the insulin that is produced in a better way.
Both of these drug groups are diabetes drugs that are taken orally.
What Incresync is used for
Incresync lowers blood sugar levels in adults with type 2 diabetes. Type 2 diabetes is also called non-insulin-dependent diabetes.
Incresync is used when blood sugar cannot be adequately controlled on a diet, exercise, and other oral diabetes medicines, such as pioglitazone, pioglitazone, and metformin. Your doctor will check if Incresync works for you 3 to 6 months after you start treatment.
If you are already taking alogliptin and pioglitazone as separate tablets, the Incresync tablet may replace them with one tablet.
You must continue to follow the diet and exercise advice given to you by your nurse or doctor.
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 of the medicines, you take to control your blood sugar. Symptoms of a severe allergic reaction may include rash, red raised spots on the skin (hives), and swelling of the face, lips, tongue, and throat, which may cause difficulty breathing or swallowing. Additional symptoms can include general itching and a feeling of warmth that affects the scalp, mouth, neck, palms, and soles of the feet (Stevens-Johnson syndrome).
- If you have or have had heart failure in the past.
- If you have any liver disease.
- Suppose you have diabetic ketoacidosis (a serious complication of poorly controlled diabetes ). Symptoms include
- Severe thirst
- Frequent urination
- Loss of appetite
- Nausea or vomiting
- Rapid weight loss
- If you have or have ever had bladder cancer.
- If you have blood in your urine, your doctor has not examined it further. Do not take Incresync and see a doctor so your urine can be checked as soon as possible.
Warnings And Cautions
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 sulphonylurea (e.g., glipizide, tolbutamide, glibenclamide) or insulin.
- Suppose you have heart disease or fluid retention in your body. If you take anti-inflammatory painkillers that can cause fluid retention and swelling, you must also tell your doctor.
- If you are older and taking insulin, you may be at increased risk for heart problems.
- If you have liver or kidney problems. Before you start taking this medicine, you must submit a blood sample that is used to test your liver and kidney function. This check can be repeated at regular intervals. If you have kidney disease, your doctor may need to lower your Incresync dose.
- If you have a specific type of diabetes-related eye disease called macular edema (swelling of the back of the eye).
- If you have ovarian cysts ( polycystic ovary syndrome ). The risk of getting pregnant may increase as ovulation may start again when you take Incresync. If this applies to you, use an appropriate method of contraception to avoid an unplanned pregnancy.
- If you have or have had pancreatic disease.
Small changes in the number of blood cells can be seen through tests of blood samples. Doctors can tell you about the results.
A greater number of bone fractures than normal have been observed in patients, especially women, using pioglitazone. Your doctor will consider this when deciding on the treatment of your diabetes.
Children And Young People
Incresync is not recommended for use in children and adolescents below 18 years due to a lack of data from 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 medicines:
- Gemfibrozil (used to lower cholesterol)
- Rifampicin (for tuberculosis and other infections ).
Your blood sugar level will be checked, and the Incresync dose 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 using Incresync in pregnant or lactating women. Incresync should not be used during pregnancy or breastfeeding.
Driving And Using Machines
You may experience visual disturbances while using this medicine. If this happens, do not drive or use any power tools or machines. Taking Incresync, along with other medicines for diabetes, can cause low blood sugar levels ( hypoglycemia ), which can 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, contact your doctor before taking this medicine.
3. How To Take Incresync
Incresync 25 mg/30 mg uses
- Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
- Your doctor will tell you how much Incresync you need to take and if you need to change the dose of any of the other medicines you are taking.
- The highest recommended daily dose is 25 mg / 45 mg Incresync tablet.
- Incresync should be taken once daily. Swallow the Incresync tablet whole with water. You can take medicine with or without food.
- If you have kidney problems, your doctor may prescribe a lower dose.
- If you are on a diabetic diet, continue with it while you are taking Incresync.
- Your weight should be checked at regular intervals. Tell your doctor if you gain weight.
If You Take More Incresync Than You Should
If you have ingested too much medicine, or if, e.g., a child has ingested the medicine, you should contact or contact the nearest emergency department immediately. Bring this information and some tablets, 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 find out you have missed 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. Your blood sugar levels may rise when you stop taking Incresync.
If you have any further questions about the use of this product, ask your doctor or pharmacist.
4. Possible Incresync Side Effects
This medicine can cause side effects like all medicines, although not everybody gets them.
STOP taking Incresync and contact your doctor immediately if you experience any of the following serious side effects:
Common Incresync side effects (may affect up to 1 in 10 users):
- Sudden and severe skeletal pain or immobility (especially in women).
Uncommon (may affect up to 1 in 100 people):
- Symptoms of bladder cancer include
- Blood in the urine
- Pain when urinating or urination (sudden need to urinate).
No known frequency (cannot be calculated from the available data):
- Allergic reaction. Symptoms may include
- Rash
- Hives
- Difficulty swallowing or breathing
- Lips, face, throat, or tongue swelling
- Feeling weak
- Severe allergic reaction: skin damage or blemishes on the skin that can turn into sores surrounded by pale or red rings, blisters, or flaking of the skin, possibly with symptoms such as
- Itching
- Fever
- General malaise
- Joint pain
- Vision problems
- Feeling hot
- Painful or itchy eyes and cold sores ( Stevens-Johnson syndrome and erythema multiforme).
- Severe and persistent pain in the abdomen that may radiate to the back, even nausea and vomiting, as it may be a sign of inflammation of the pancreas ( pancreatitis ).
You should also discuss with your doctor if you experience the following side effects:
Usual:
- Symptoms of low blood sugar (hypoglycemia) may occur when Incresync is taken with insulin or a sulphonylurea (e.g., glipizide, tolbutamide, glibenclamide). Symptoms may include
- Tremors
- Sweating
- Anxiety
- Blurred vision
- Tingling in the lips
- Paleness
- Mood swings
- Confusion
- Blood sugar may drop below normal levels. Still, it may rise again by eating some sugar. You should carry some sugar cubes, caramels, biscuits, or sugar-containing fruit juices with you.
- Cold or flu-like symptoms, such as
- Sore throat
- Nasal congestion
- Sinusitis
- Skin itching
- Headache
- Stomach ache
- Diarrhea
- Digestive problems, heartburn
- Nausea
- Muscle pain
- Numbness in any part of the body
- Blurred vision or visual distortions
- Weight gain
- Swollen hands or feet
- Rash
Uncommon:
- Difficulty sleeping
No known frequency:
- Visual disturbances (caused by a condition called macular edema).
- Liver problems include nausea or vomiting, abdominal pain, unusual or unexplained tiredness, decreased appetite, dark urine or yellow skin, or whites of the eyes.
Reporting of side effects
Talk to your doctor, pharmacist, or nurse if you get any side effects. This also applies to any side effects not mentioned in this information. You can also report side effects directly to the Medical Products Agency. By reporting side effects, you can help increase drug safety information.
5. How To Store Incresync
- Keep this medicine out of sight and reach of children.
- Do not use this medicine after the expiry date stated on the carton and blister after EXP. The expiration date is the last day of the specified month.
- No special temperature instructions. Store in the original package. Moisture sensitive.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer required. These measures will help to protect the environment.
6. Contents Of The Packaging And Other Information
Content Declaration
- 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, hydroxypropyl cellulose, croscarmellose sodium, magnesium stearate, lactose monohydrate, hypromellose, talc, titanium dioxide (E 171), yellow iron oxide (E 172), red iron oxide (E 172), macrogol 8000, shellac and black iron ). 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, hydroxypropyl cellulose, croscarmellose sodium, magnesium stearate, lactose monohydrate, hypromellose, talc, titanium dioxide (E 171), red iron oxide (E 172), macrogol 8000, shellac and black iron oxide (E 172). See section 2, “Incresync contains lactose.”
Each 12.5 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, hydroxypropyl cellulose, croscarmellose sodium, magnesium stearate, lactose monohydrate, hypromellose, talc, titanium dioxide (E 171), yellow iron oxide (E 172), red iron oxide (E 172), macrogol 8000, shellac; glycol See section 2 “Incresync contains lactose.”
Each 12.5 mg / 45 mg film-coated tablet contains alogliptin benzoate and pioglitazone hydrochloride equivalent to 12.5 mg alogliptin and 45 mg pioglitazone.
- The other ingredients are mannitol, microcrystalline cellulose, hydroxypropyl cellulose, croscarmellose sodium, magnesium stearate, lactose monohydrate, hypromellose, talc, titanium dioxide (E 171), red iron oxide (E 172), macrogol 8000, shellac, carnauba wax, and glycerol monooleate. See section 2, “Incresync contains lactose.”
What The Medicine Looks Like And Contents Of The Pack
- Incresync 25 mg / 30 mg film-coated tablets (tablets) are apricot, round (approximately 8.7 mm in diameter), biconvex, film-coated tablets marked with “A / P” and “25/30” in gray 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 marked with “A / P” and “25/45” in gray ink on one side.
- Incresync 12.5 mg / 30 mg film-coated tablets (tablets) are light apricot, round (approximately 8.7 mm in diameter), biconvex, film-coated tablets marked with “A / P” and “12.5 / 30” in red ink on one side.
- Incresync 12.5 mg / 45 mg film-coated tablets (tablets) are light red, round (approximately 8.7 mm in diameter), biconvex, film-coated tablet marked with “A / P” and “12.5 / 45” in red ink on one side.
- Incresync is available in blister packs of 10, 14, 28, 30, 56, 60, 90, 98, or 100 tablets.
- Not all pack sizes may be marketed.
Marketing Authorization Holder And Manufacturer
Marketing Authorisation Holder
Takeda Pharma A / S
Dybendal Alle 10
2630 Taastrup
Denmark
Manufacturer
Takeda Ireland Limited
Bray Business Park
Kilruddery
Co. Wicklow
Ireland
Contact the representative of the marketing authorization holder to find out more about this medicine:
| Belgium / Belgium / Belgium / Luxembourg / LuxembourgTakeda BelgiumTel: +32 2 464 06 11takeda-belgium@takeda.com | Lithuania“Takeda” UABTel: +370 521 09 070lt-info@takeda.com |
| BulgariaTakade BulgariaTel .: +359 2 958 27 36; +359 2 958 15 29 | HungaryTakeda Pharma Kft.Tel: +361 2707030 |
| Czech RepublicTakeda Pharmaceuticals Czech Republic sroTel: +420 234722722 | MaltaTakeda Italia SpATel: +39 06 502601 |
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| FranceTakeda France SASTel: +33 1 46 25 16 16 | RomaniaTakeda Pharmaceuticals SRLTel: +40 21 335 03 91 |
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| IrelandTakeda Products Ireland LimitedTel: +353 (0) 1 6420021 | Slovak RepublicTakeda Pharmaceuticals Slovakia sroTel: +421 (2) 20 602 600 |
| IcelandVistor hf.Phone: +354 535 7000vistor@vistor.is | Finland / FinlandTakeda OyTel. +358 20 746 5000 |
| ItalyTakeda Italia SpATel: +39 06 502601 | SwedenTakeda Pharma ABTel: +46 8 731 28 00infosweden@takeda.com |
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| LatviaTakeda Latvia SIATel: +371 67840082 |