25 mg, 12.5 mg, and 6.25 mg film-coated tablets
alogliptin
What Vipidia is and what it is used for
Vipidia contains the active substance alogliptin which belongs to a group of medicines called DPP-4 inhibitors (dipeptidyl peptidase-4 inhibitors) which are ‘oral diabetes medicines. It is used to lower blood sugar levels in adults with type 2 diabetes. Type 2 diabetes is also called non-insulin-dependent diabetes.
Vipidia works by increasing the levels of insulin in the body after a meal and reducing the amount of sugar in the body. It must be taken with other diabetes medicines prescribed by doctors, such as a sulphonylurea (eg glipizide, tolbutamide, glibenclamide), metformin, and/or a thiazolidinedione (eg pioglitazone) and metformin and/or insulin.
Vipidia is taken when diet, exercise, and one or more of these other diabetes medicines do not provide adequate blood sugar control. You must continue to take your other diabetes medicines and continue to follow the diet and exercise advice given to you by your nurse or doctor.
What you need to know before you take Vipidia
Do not take Vipdia:
- if you are allergic to alogliptin or any of the other ingredients of this medicine (listed in section 6).
- if you have had a serious allergic reaction to any similar medicine that 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 in breathing or swallowing. Additional symptoms may include general itching and a feeling of warmth, particularly affecting the scalp, mouth, throat, palms of the hands, and soles of the feet (Stevens-Johnson syndrome).
Warnings and precautions
Talk to your doctor or pharmacist before taking Vipidia:
- if you have type l diabetes (your body does not produce insulin )
- if you have diabetic ketoacidosis (a complication of diabetes that occurs when the body cannot break down glucose because there is not enough insulin ). Symptoms include severe thirst, frequent urination, loss of appetite, nausea or vomiting, and rapid weight loss.
- if you use a diabetes medicine that is a so-called sulphonylurea (eg glipizide, tolbutamide, glibenclamide) or insulin. Your doctor may want to lower the dose of sulphonylurea or insulin when you take either of them together with Vipidia to avoid low blood sugar (hypoglycemia).
- if you have kidney disease, you can still take this medicine but the doctor may need to lower the dose
- if you have the liver disease
- if you suffer from heart failure
- if you take insulin or other antidiabetic medicine, your doctor may choose to reduce the dose of your antidiabetic medicine or insulin when you take them with Vipidia to avoid low blood sugar.
- if you have or have had the pancreatic disease.
Children and young people
Vipidia is not recommended for children and adolescents under 18 years of age as there is a lack of data from these patients.
Other medicines and Vipidia
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
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 using this medicine.
There is no experience with the use of Vipidia in pregnant or lactating women. Vipidia should not be used during pregnancy or breastfeeding. Your doctor will help you decide whether to continue breastfeeding or continue using Vipidia.
Driving ability and use of machinery
Vipidia has no known influence on the ability to drive and use machines. Taking Vipidia together with other diabetes medicines called sulphonylureas, insulin, or in combination with thiazolidinedione and metformin can cause low blood sugar levels (hypoglycemia), which can affect your ability to drive and use machines.
How to take Vipidia
Always take this medicine as directed by your doctor or pharmacist. Ask your doctor or pharmacist if you are unsure.
The doctor will prescribe Vipidia together with one or more other medicines to control blood sugar levels. Your doctor will tell you if you need to change the dose of one of the other medicines you are taking.
The recommended dose is 25 mg of Vipidia once daily.
Patients with kidney disease
If you have kidney disease, the doctor may prescribe a lower dose. It may be 12.5 mg or 6.25 mg once a day, depending on how severe your kidney disease is.
Patients with liver disease
If you have mild or moderate liver dysfunction, the recommended dose is one of Vipidia 25 mg once daily. This medicine is not recommended for patients with severe hepatic impairment as there is a lack of data from these patients.
Swallow the tablets whole with water. You can take the medicine with or without food.
If you have taken too much Vipidia
If you have ingested too much medicine, or if e.g. a child has ingested the medicine, you must immediately contact or visit the nearest emergency department. Bring this information and some tablets so the doctor knows exactly what you have taken.
If you forget to take Vipidia
If you have forgotten to take a dose, take it as soon as you notice that you have missed a dose. Do not take a double dose to make up for a missed dose.
If you stop taking Vipidia
Do not stop taking Vipidia without consulting a doctor. Blood sugar levels may rise when you stop taking Vipidia.
If you have any further questions about this medicine, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
STOP taking Vipidia and contact your doctor immediately if you experience any of the following serious side effects:
Frequency not known (cannot be estimated from available data):
- Allergic reaction. Symptoms can be rash, hives, swallowing or breathing problems, swelling of the lips, face, throat, or tongue, and feeling weak.
- Severe allergic reaction: skin lesions or spots on the skin that may turn into sores surrounded by pale or red rings, blisters, and/or peeling of the skin, possibly with symptoms such as itching, fever, general malaise, aching joints, vision problems, feeling hot, painful or itchy eyes and mouth ulcers. ( Stevens-Johnson syndrome and erythema multiforme).
- Severe and persistent pain in the stomach that may radiate to the back, also nausea and vomiting, as may be a sign of inflammation of the pancreas ( pancreatitis ).
You should also discuss with a doctor if you suffer from the following side effects:
Common (may affect up to 1 in 10 users):
- Symptoms of low blood sugar (hypoglycemia) may occur when Vipidia is taken together with insulin or sulphonylurea (eg glipizide, tolbutamide, glibenclamide). Symptoms may include tremors, sweating, anxiety, blurred vision, tingling of the lips, paleness, mood changes, or confusion. Blood sugar can drop below normal levels, but can be made to rise again by eating a little sugar. It is recommended that you carry some sugar cubes, candies, crackers, or sugary fruit juice with you.
- cold-like symptoms, such as sore throat, nasal congestion
- rash
- skin itching
- headache
- stomach ache
- diarrhea
- digestive problems, heartburn
No known frequency :
- liver problems such as nausea or vomiting, stomach ache, unusual or unexplained tiredness, decreased appetite, dark urine or yellow skin or whites of the eyes
How to store Vipidia
Keep this medicine out of the sight and reach of children.
Use before the expiry date stated on the carton and blister after EXP. The expiration date is the last day of the specified month.
No special storage instructions.
Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
- The active substance is alogliptin.
Each 25 mg tablet contains alogliptin benzoate equivalent to 25 mg alogliptin.
- Other ingredients are mannitol, microcrystalline cellulose, hydroxypropyl cellulose, croscarmellose sodium, magnesium stearate, hypromellose, titanium dioxide (E 171), red iron oxide (E 172), macrogol 8000, shellac and black iron oxide (E 172).
Each 12.5 mg tablet contains alogliptin benzoate equivalent to 12.5 mg alogliptin.
- Other ingredients are mannitol, microcrystalline cellulose, hydroxypropyl cellulose, croscarmellose sodium, magnesium stearate, hypromellose, titanium dioxide (E171), yellow iron oxide (E 172), macrogol 8000, shellac and black iron oxide (E 172).
Each 6.25 mg tablet contains alogliptin benzoate equivalent to 6.25 mg alogliptin.
- Other ingredients are mannitol, microcrystalline cellulose, hydroxypropyl cellulose, croscarmellose sodium, magnesium stearate, hypromellose, titanium dioxide (E 171), red iron oxide (E 172), macrogol 8000, shellac and black iron oxide (E 172).
Appearance and package sizes of the medicine
- Vipidia 25 mg film-coated tablets (tablets) are light red, oval (approximately 9.1 mm long and 5.1 mm wide), biconvex, film-coated tablets marked with “TAK” and “ALG‑25” in gray ink on one side.
- Vipidia 12.5 mg film-coated tablets (tablets) are yellow, oval (approximately 9.1 mm long and 5.1 mm wide), biconvex, film-coated tablets marked with “TAK” and “ALG‑12.5” in gray ink on one side page.
- Vipidia 6.25 mg film-coated tablets (tablets) are light pink, oval (approximately 9.1 mm long and 5.1 mm wide), biconvex, film-coated tablets marked with “TAK” and “ALG‑6.25” in gray ink on one page.
Vipidia is available in blister packs of 10, 14, 28, 30, 56, 60, 84, 90, 98, or 100 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Takeda Pharma A/S
Dybendal Alle 10
2630 Taastrup
Denmark
Manufacturer
Takeda Ireland Limited
Bray Business Park
Keel Rudder
Co. Wicklow
Ireland
Contact the representative of the Marketing Authorization Holder if you would like to know more about this medicine:
| België/Belgique/Belgien/Luxembourg/LuxemburgTakeda BelgiumTél/Tel: +32 2 464 06 11takeda-belgium@takeda.com | Lithuania“Takeda” UABPhone: +370 521 09 070lt-info@takeda.com |
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