部份中文阿格列汀/二甲双胍处方资料（仅供参考）
英文名：alogliptin/metformin Tablets
商品名：Vipdomet Filmtabletten
中文名：阿格列汀/二甲双胍复方薄膜片
生产商：武田制药
药品介绍
商品名称：Vipdomet
通用名称；alogliptin/metformin
规格：12.5mg/850mg  12.5mg/1000mg
厂家：Takeda Pharma A/S
上市时间：原研：武田，欧盟/美国2013年批准
阿格列汀与二甲双胍联用优于格列吡嗪
二酰基肽酶 -4（DPP-4）抑制剂作为一种降糖药，与磺脲类药物相比，不仅可以有效降低血糖，还具有不影响患者体重、无明显胃肠道副作用的独特优势。因此，在 T2DM 患者治疗过程中备受亲睐。常用的DPP-4抑制剂有阿格列汀、西格列汀、沙格列汀、维格列汀等。
Vipdomet (alogliptin, metformin)
Vipdomet 12.5 mg/850 mg film-coated tablets
Vipdomet 12.5 mg/1000 mg film-coated tablets
Alogliptin/Metformin hydrochloride
1. What Vipdomet is and what it is used for
What Vipdomet is
Vipdomet contains two different medicines called alogliptin and metformin in one tablet:
•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.
•metformin belongs to a group of medicines called biguanides which also help to lower blood sugar by lowering the amount of sugar made in the liver and helping insulin to work more effectively.
Both of these groups of medicines are “oral anti-diabetics”.
What Vipdomet is used for
Vipdomet 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.
Vipdomet is taken when your blood sugar cannot be adequately controlled by diet, exercise and other anti-diabetic medicines such as metformin alone; insulin alone; or metformin and pioglitazone taken together.
If you are already taking both alogliptin and metformin as single tablets, Vipdomet 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 Vipdomet
Do NOT take Vipdomet:
•if you are allergic to alogliptin, metformin 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 medications 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
•if you recently had a heart attack or have severe circulatory problems including shock
•if you have severe breathing difficulties
•if you have liver disease
•if you have moderate or severe kidney disease
•if you drink alcohol excessively (either every day or in large quantities only from time to time)
•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
•if you have a severe infection or are seriously dehydrated (have lost a lot of water from your body)
Warnings and precautions
Talk to your doctor or pharmacist before taking Vipdomet :
•if you have type 1 diabetes (your body does not produce insulin).
•if you are taking Vipdomet with insulin or a thiazolidinedione. Your doctor may want to reduce your dose of insulin or a thiazolidinedione when you take it together with Vipdomet in order to avoid too low blood sugar (hypoglycaemia).
•if you are taking another medicine for diabetes that contains a “sulphonylurea”, you should not start taking Vipdomet.
•if you are going to have an operation under general, spinal or epidural anaesthetic. You may be advised to stop taking this medicine for some time before and after the procedure.
•if you have had allergic reactions to any other medications that you take to control your blood sugar. 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)
•if you have or have had a disease of the pancreas
During treatment with Vipdomet, your doctor will check your kidney function at least once a year and more frequently if you are elderly or if your kidney function is borderline or at risk of worsening.
Children and adolescents
Vipdomet is not recommended for children and adolescents under 18 years due to the lack of data in these patients.
Other medicines and Vipdomet
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:
•hydrocortisone and prednisolone (corticosteroids) used to treat diseases that involve inflammation like asthma and arthritis
•cimetidine, used to treat stomach problems
•bronchodilators (beta-2 agonists) which are used to treat asthma
•ramipril, lisinopril and enalapril (ACE inhibitors) used to treat high blood pressure
•water tablets (diuretics) which increase urine production
•iodinated contrast agents used in taking X-rays
•medicines containing alcohol
Vipdomet with alcohol
Do not take this medicine with excessive amounts of alcohol as you could be at greater risk of developing lactic acidosis, a serious complication which must be treated in a hospital (see section 4 ‘Possible side effects’).
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. You should not use Vipdomet if you are pregnant.
Vipdomet is not recommended during breast-feeding since metformin passes into breast milk.
Driving and using machines
Vipdomet is not known to affect your ability to drive and use machines. Taking Vipdomet in combination with medicines called pioglitazone or insulin can cause too low blood sugar levels (hypoglycaemia), which may affect your ability to drive and use machines.
3. How to take Vipdomet
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 exactly how much Vipdomet you need to take. The amount of Vipdomet will vary depending on your condition and the doses you currently take of metformin alone, metformin in combination with pioglitazone, insulin and/or individual tablets of alogliptin and metformin.
The recommended dose is one tablet twice a day.
Swallow your tablet(s) whole with water. You should take this medicine with food to reduce your chance of an upset stomach.
If you take more Vipdomet 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 Vipdomet
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 Vipdomet
Do not stop taking Vipdomet without consulting your doctor first. Your blood sugar levels may increase when you stop taking Vipdomet.
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 Vipdomet and contact a doctor immediately if you notice any of the following serious side effects:
Very rare (may affect less than 1 in 10,000 people):
•Lactic acidosis (a build-up of lactic acid in the blood). Lactic acidosis is a medical emergency and must be treated in a hospital. It can particularly affect patients whose kidneys are not working properly. Symptoms include some or all of the following: feeling cold or uncomfortable, severe nausea with or without vomiting, unexplained weight loss, or rapid breathing.
Not known (frequency cannot be estimated from the available data):
•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.
•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).
•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:
Very common (may affect more than 1 in 10 people):
•Stomach ache
•Diarrhoea
•Loss of appetite
•Feeling sick
•Being sick.
Common (may affect up to 1 in 10 people):
•Symptoms of low blood sugar (hypoglycaemia) may occur when Vipdomet 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 symptoms such as sore throat, stuffy or blocked nose, feeling tired, fever, chills, dry cough
•Rash
•Itchy skin with or without hives
•Headache
•Indigestion, heartburn
•Vomiting and/or diarrhoea
Very rare:
•Decreased vitamin B12 levels or anaemia; symptoms include tiredness, lethargy, feeling faint, becoming breathless
•Liver problems (hepatitis).
Not known:
•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.
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: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Vipdomet
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 Vipdomet contains
•The active substances are alogliptin and metformin hydrochloride.
Each 12.5 mg/850 mg film-coated tablet contains alogliptin benzoate equivalent to 12.5 mg alogliptin and 850 mg metformin hydrochloride.
Each 12.5 mg/1000 mg film-coated tablet contains alogliptin benzoate equivalent to 12.5 mg alogliptin and 1000 mg metformin hydrochloride.
•The other ingredients are mannitol, microcrystalline cellulose, povidone, crospovidone, magnesium stearate, hypromellose, talc, titanium dioxide (E171) and yellow iron oxide (E172).
What Vipdomet looks like and contents of the pack
•Vipdomet 12.5 mg/850 mg film-coated tablets (tablets) are light yellow, oblong (approximately 21.0 mm long by 10.1 mm wide), biconvex, film-coated tablets with “12.5/850” debossed on one side and “322M” debossed on the other side.
•Vipdomet 12.5 mg/1000 mg film-coated tablets (tablets) are pale yellow, oblong (approximately 22.3 mm long by 10.7 mm wide), biconvex, film-coated tablets with “12.5/1000” debossed on one side and “322M” debossed on the other side.
Vipdomet is available in blister packs containing 10, 14, 20, 28, 56, 60, 98, 112, 120, 180, 196, 196 (2x98 multipack) or 200 tablets.
https://www.medicines.org.uk/emc/product/5234/smpc