Vipidia
alogliptin benzoate
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or pharmacist.
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.
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 Vipidia is and what it is used for
What you need to know before you take Vipidia
How to take Vipidia
Possible side effects
How to store Vipidia
Contents of the pack and other information
Vipidia contains the active substance alogliptin which belongs to a group of medicines called DPP-4 inhibitors (dipeptidyl peptidase-4 inhibitors) which are “oral anti-diabetics”. It 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.
Vipidia works to increase the levels of insulin in the body after a meal and decrease the amount of sugar in the body. It must be taken together with other anti-diabetic medicines, which your doctor will have prescribed for you, such as sulphonylureas (e.g. glipizide, tolbutamide, glibenclamide), metformin and/or thiazolidinediones (e.g. pioglitazone) and metformin and/or insulin.
Vipidia is taken when your blood sugar cannot be adequately controlled by diet, exercise and one or more of these other oral anti-diabetic medicines. It is important that you continue to take your other anti-diabetic medicine, and continue to follow the advice on diet and exercise that your nurse or doctor has given you.
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 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).
Talk to your doctor or pharmacist before taking Vipidia:
if you have type 1 diabetes (your body does not produce insulin)
if you have diabetic ketoacidosis (a complication of diabetes that occurs when the body is unable to breakdown glucose because there is not enough insulin). Symptoms include excessive thirst, frequent urination, loss of appetite, nausea or vomiting and rapid weight loss
if you are taking an anti-diabetic medicine known as sulphonylurea (e.g. glipizide, tolbutamide,
glibenclamide) or insulin. Your doctor may want to reduce your dose of sulphonylurea or insulin when you take any of them together with Vipidia in order to avoid too low blood sugar (hypoglycaemia)
if you have kidney disease, you can still take this medicine but your doctor may reduce the dose
if you have liver disease
if you suffer from heart failure
if you are taking insulin or an anti-diabetic medicine, your doctor may want to reduce your dose of the other anti-diabetic medicine or insulin when you take either of them together with Vipidia in order to avoid low blood sugar
if you have or have had a disease of the pancreas
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.
Vipidia is not recommended for children and adolescents under 18 years due to the lack of data in these patients.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
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 Vipidia in pregnant women or during breast-feeding. Vipidia should not be used during pregnancy or breast-feeding. Your doctor will help you to decide whether to continue breast-feeding or to continue using Vipidia.
Vipidia is not known to affect your ability to drive and use machines. Taking Vipidia in combination with other anti-diabetic medicines called sulphonylureas, insulin or combination therapy with thiazolidinedione plus metformin can cause too low blood sugar levels (hypoglycaemia), which may affect your ability to drive and use machines.
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 prescribe Vipidia together with one or more other medicines to control your blood sugar levels. Your doctor will tell you if you need to change the amount of other medicines you take.
The recommended dose of Vipidia is 25 mg once a day.
Patients with kidney disease
If you have kidney disease your doctor may prescribe you a reduced dose. This may be 12.5 mg or
6.25 mg once a day, depending on the severity of your kidney disease.
Patients with liver disease
If you have mildly or moderately reduced liver function, the recommended dose of Vipidia is 25 mg once a day. This medicine is not recommended for patients with severely reduced liver function due to the lack of data in these patients.
Swallow your tablet(s) whole with water. You can take this medicine with or without food.
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 a dose, take it as soon as you remember it. Do not take a double dose to make up for a forgotten dose.
Do not stop taking Vipidia without consulting your doctor first. Your blood sugar levels may increase when you stop taking Vipidia.
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.
You should also discuss with your doctor if you experience the following side effects:
Symptoms of low blood sugar (hypoglycaemia) may occur when Vipidia 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 like symptoms such as sore throat, stuffy or blocked nose.
Rash
Itchy skin
Headache
Stomach ache
Diarrhoea
Indigestion, heartburn.
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).
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 thenationalreportingsystem listedinAppendixV. 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 storage conditions.
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.
The active substance is alogliptin.
Each 25 mg tablet contains alogliptin benzoate equivalent to 25 mg alogliptin,
The other ingredients are: mannitol, microcrystalline cellulose, hydroxypropylcellulose, croscarmellose sodium, magnesium stearate, hypromellose, titanium dioxide (E171), red iron oxide (E172), macrogol 8000, shellac and black iron oxide (E172).
Each 12.5 mg tablet contains alogliptin benzoate equivalent to 12.5 mg alogliptin
The other ingredients are: mannitol, microcrystalline cellulose, hydroxypropylcellulose, croscarmellose sodium, magnesium stearate, hypromellose, titanium dioxide (E171), yellow iron oxide (E172), macrogol 8000, shellac and black iron oxide (E172).
Each 6.25 mg tablet contains alogliptin benzoate equivalent to 6.25 mg alogliptin
The other ingredients are: mannitol, microcrystalline cellulose, hydroxypropylcellulose, croscarmellose sodium, magnesium stearate, hypromellose, titanium dioxide (E171), red iron oxide (E172), macrogol 8000, shellac and black iron oxide (E172).
Vipidia 25 mg film-coated tablets (tablets) are light red, oval (approximately 9.1 mm long by
5.1 mm wide), biconvex, film-coated tablets, with “TAK” and “ALG-25” printed in grey ink on one side.
Vipidia 12.5 mg film-coated tablets (tablets) are yellow, oval (approximately 9.1 mm long by
5.1 mm wide), biconvex, film-coated tablets, with “TAK” and “ALG-12.5” printed in grey ink on one side.
Vipidia 6.25 mg film-coated tablets (tablets) are light pink, oval (approximately 9.1 mm long by
5.1 mm wide), biconvex, film-coated tablets, with “TAK” and “ALG-6.25” on printed in grey ink on one side.
Vipidia is available in blister packs containing 10, 14, 28, 30, 56, 60, 84, 90, 98 or 100 tablets. Not all pack sizes may be marketed.
Takeda Pharma A/S
Delta Park 45
2665 Vallensbaek Strand
Denmark
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:
Takeda Belgium
Tél/Tel: +32 2 464 06 11
Takeda UAB
Tel: +370 521 09 070
Такеда България
Тел.: +359 2 958 27 36; +359 2 958 15 29
Takeda Belgium
Tél/Tel: +32 2 464 06 11
Takeda Pharmaceuticals Czech Republic s.r.o. Tel: +420 234 722 722
Takeda Pharma A/S Tlf/Tel: +45 46 77 11 11
TAKEDA HELLAS S.A. Tel: +30 210 6387800
Takeda GmbH
Tel: +49 (0) 800 825 3325
Takeda Nederland B.V.
Tel: +31 20 203 5492
Takeda Pharma AS Tel: +372 617 7669
Takeda AS
Tlf: +47 6676 3030
TAKEDA ΕΛΛΑΣ Α.Ε Τηλ: +30 210 6387800
Takeda Pharma Ges. m.b.H. Tel: +43 (0) 800-20 80 50
Laboratorios Menarini, S.A. Tel: +34 934 628 800
Takeda Pharma sp. z o.o. Tel. +48 22 608 13 00
Takeda France SAS Tél: + 33 1 40 67 33 00
Takeda Farmacêuticos Portugal, Lda. Tel: +351 21 120 1457
Takeda Pharmaceuticals Croatia d.o.o Tel: +385 1 377 88 96
Takeda Pharmaceuticals SRL Tel: +40 21 335 03 91
Takeda Products Ireland Limited Tel: 1800 937 970
Takeda Pharmaceuticals farmacevtska družba d.o.o. Tel: +386 (0) 59 082 480
Vistor hf.
Sími: +354 535 7000
Takeda Pharmaceuticals Slovakia s.r.o. Tel: +421 (2) 20 602 600
Takeda Italia S.p.A. Tel: +39 06 502601
Takeda Oy
Tel. +358 20 746 5000
TAKEDA ΕΛΛΑΣ Α.Ε. Τηλ: +30 210 6387800
Takeda Pharma AB Tel: +46 8 731 28 00
Takeda Latvia SIA Tel: +371 67840082
Takeda UK Ltd
Tel: +44 (0) 2830 640 902