Active ingredient
- alogliptin benzoate
Legal Category
POM: Prescription only medicine
POM: Prescription only medicine
The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.
Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.
The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet are: EU/1/13/844/006, EU/1/13/844/008, EU/1/13/844/003, EU/1/13/844/007, EU/1/13/844/009, EU/1/13/844/005, EU/1/13/844/001, EU/1/13/844/002, EU/1/13/844/004.
Vipidia 6.25mg, 12.5mg, 25mg film-coated tablets
Package leaflet: Information for the patient
Vipidia 25 mg film-coated tablets
Vipidia 12.5 mg film-coated tablets
Vipidia 6.25 mg film-coated tablets
alogliptin
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
What is in this leaflet
1. What Vipidia is and what it is used for
2. What you need to know before you take Vipidia
3. How to take Vipidia
4. Possible side effects
5. How to store Vipidia
6. Contents of the pack and other information
1. 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 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.
2. What you need to know before you take Vipidia
Do not take Vipidia:
Warnings and precautions
Talk to your doctor or pharmacist before taking Vipidia:
Children and adolescents
Vipidia is not recommended for children and adolescents under 18 years due to the lack of data in 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 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 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.
Driving and using machines
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.
3. How to take Vipidia
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 Vipidia 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 Vipidia
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 Vipidia
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.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
STOP taking Vipidia and contact a doctor immediately if you notice any of the following serious side effects:
Not known (frequency cannot be estimated from the available data):
You should also discuss with your doctor if you experience the following side effects:
Common (may affect up to 1 in 10 people):
Not known:
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 Yellow Card Scheme at Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the GooglePlay or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Vipidia
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.
6. Contents of the pack and other information
What Vipidia contains
Each 25 mg tablet contains alogliptin benzoate equivalent to 25 mg alogliptin,
Each 12.5 mg tablet contains alogliptin benzoate equivalent to 12.5 mg alogliptin
Each 6.25 mg tablet contains alogliptin benzoate equivalent to 6.25 mg alogliptin
What Vipidia looks like and contents of the pack
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.
Marketing Authorisation Holder
Manufacturer
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
This leaflet was last revised in 05/2018.
Other sources of information.
Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
1 Kingdom Street, London, W2 6BD, UK
+44 3333 000 181