Eucreas (metformin, vildagliptin) - United Kingdom[英国药品]

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Eucreas (metformin, vildagliptin)

2014-02-23 22:40:31 来源: 作者: 【大中小】浏览:382次评论:0条

Main use	Active ingredient	Manufacturer
Type 2 diabetes	Vildagliptin, metformin hydrochloride	Novartis

How does it work?

Eucreas tablets contain two active ingredients, metformin and vildagliptin. These are both medicines used to help control blood sugar levels in people with type 2 diabetes.

People with diabetes mellitus have a deficiency or absence of a hormone produced by the pancreas called insulin. Insulin is the main hormone responsible for the control of sugar (glucose) in the blood. In type 2 diabetes the pancreas does not produce sufficient insulin, and the cells of the body are resistant to the low levels of insulin circulating in the blood. Insulin would normally make the cells remove sugar from the blood; hence in type 2 diabetes blood sugar levels can rise too high.

Metformin is a type of antidiabetic medicine known as a biguanide. It works in a number of ways to decrease the amount of sugar in the blood. Firstly, it reduces the amount of sugar produced by cells in the liver. Secondly, it increases the sensitivity of muscle cells to insulin. This enables these cells to remove sugar from the blood more effectively. Finally, it also delays absorption of sugar from the intestines into the bloodstream after eating.

Vildagliptin is a type of antidiabetic medicine known as a dipeptidyl peptidase-4 (DPP-4) inhibitor. It helps to reduce blood sugar levels by preventing the breakdown of two incretin hormones, called glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic peptide (GIP). These hormones are normally produced naturally by the body in response to food intake. They stimulate the pancreas to produce insulin in response to increasing levels of glucose in the blood, and they also reduce the production of glucagon, which is a hormone that normally increases glucose production by the liver. These actions help control blood sugar levels.

This combination of medicines helps control blood sugar levels both directly after meals and between meals.

Eucreas tablets should be taken with or after food.

What is it used for?

Type 2 (non-insulin dependent) diabetes.

Eucreas tablets are licensed for use in people with type 2 diabetes whose blood sugar is not controlled by the maximum tolerated dose of metformin alone or who are already taking metformin and vildagliptin as separate tablets.

Warning!

Hypoglycaemia (low blood glucose) has been commonly reported with this medicine. Symptoms of hypoglycaemia usually occur suddenly and may include cold sweats, cool pale skin, tremor, anxious feeling, unusual tiredness or weakness, confusion, difficulty in concentration, excessive hunger, temporary vision changes, headache, nausea and palpitations. You should talk to your doctor or diabetes specialist about this and make sure you know what to do if you experience these symptoms.
Your ability to concentrate or react may be reduced if you have low blood sugar, and this can cause problems driving or operating machinery. You should take precautions to avoid low blood sugar when driving - discuss this with your doctor. This medicine may also cause dizziness, and if affected you should take care when driving or operating machinery.
You should avoid drinking alcohol while you are taking this medicine, as it can increase the risk of low blood sugar (hypoglycaemia) and lactic acidosis (see below).
Metformin can cause a rare but serious condition called lactic acidosis, which is an excess of lactic acid in the blood. It is more likely to occur in people with decreased kidney function. Drinking excessive amounts of alcohol while taking this medicine, particularly on an empty stomach or if you have liver problems, can also increase the risk of lactic acidosis. Your doctor will monitor you for this side effect, but symptoms that might indicate its development include rapid and/or deep breathing and non-specific symptoms such as feeling weak, sick or generally unwell, vomiting, abdominal pain, or unusual muscle pains or discomfort. You should stop taking this medicine and consult your doctor if you experience any of these.
Your kidney function should be monitored regularly while you are taking this medicine. Your doctor will usually want to check your kidney function once or twice a year, or more frequently if you are elderly or have any existing kidney problems.
Rare cases of inflammation of the liver (hepatitis) have been reported in people taking vildagliptin. For this reason, your liver function should be checked before starting treatment, every three months during the first year of treatment, and regularly thereafter. You should consult your doctor if you develop any of the following symptoms while taking this medicine, so that your liver can be checked: unexplained nausea, vomiting, abdominal pain, fatigue, loss of appetite, darkened urine or yellowing of the eyes or skin (jaundice).
People with diabetes have a higher risk of developing foot ulcers and blistering of the skin. It is therefore important to have a good foot care routine. Consult your doctor if you get any new blisters or ulcers while taking this medicine.
Your doctor will ask you to stop taking this medicine temporarily if you are going to have a certain type of X-ray involving an injection of iodinated dye (contrast agent). Tell your doctor that you are taking this medicine if you are due to have this type of X-ray. You should not start taking this medicine again until 48 hours after the X-ray, and only after your kidney function has been tested and found to be normal.
Consult your doctor about your diabetes treatment if you are due to have surgery under a general anaesthetic. In these situations blood sugar is normally controlled by insulin, so your doctor may ask you to stop taking this medicine 48 hours before surgery.

Use with caution in

Elderly people.
People taking ACE inhibitor medicines, eg captopril.

Not to be used in

Type 1 diabetes.
Diabetic keto-acidosis.
Diabetic pre-coma (due to ketoacidosis in severe and inadequately treated diabetes).
Decreased kidney function or kidney failure.
Decreased liver function.
Heart failure.
People who have recently had a heart attack.
People with conditions that cause breathing to be ineffective, ie to not effectively oxygenate the blood or remove carbon dioxide from the lungs (respiratory failure).
People with reduced blood flow to vital internal organs (shock).
Severe infections or trauma.
Dehydration.
Alcohol intoxication.
Alcoholism.
Pregnancy.
Breastfeeding.
This medicine is not recommended for children and adolescents under 18 years of age because its safety and effectiveness have not been established in children.

This medicine should not be used if you are allergic to one or any of its ingredients. Please inform your doctor or pharmacist if you have previously experienced such an allergy.

If you feel you have experienced an allergic reaction, stop using this medicine and inform your doctor or pharmacist immediately.

Pregnancy and breastfeeding

Certain medicines should not be used during pregnancy or breastfeeding. However, other medicines may be safely used in pregnancy or breastfeeding providing the benefits to the mother outweigh the risks to the unborn baby. Always inform your doctor if you are pregnant or planning a pregnancy, before using any medicine.

This medicine should not be used during pregnancy because its safety has not been established. Diabetes is usually controlled using insulin during pregnancy, because this provides a more stable control of blood sugar. If you get pregnant while taking this medicine, or are planning a pregnancy, you should seek medical advice from your doctor.
It is not known if vildagliptin passes into breast milk, however metformin does. As it could have side effects on a nursing infant, this medicine should not be used by women who are breastfeeding. Seek medical advice from your doctor

Label warnings

Take this medication with or after food.

Side effects

Medicines and their possible side effects can affect individual people in different ways. The following are some of the side effects that are known to be associated with this medicine. Just because a side effect is stated here does not mean that all people using this medicine will experience that or any side effect.

Very common (affects more than 1 in 10 people)

Disturbances of the gut such as diarrhoea, nausea, vomiting or abdominal pain.
Loss of appetite.

Common (affects between 1 in 10 and 1 in 100 people)

Dizziness.
Headache.
Tremor.
Metallic taste.
Low blood sugar levels (hypoglycaemia).

Uncommon (affects between 1 in 100 and 1 in 1000 people)

Joint pain (arthralgia).
Fatigue, weakness or loss of strength (asthenia).
Constipation.
Swelling of feet or ankles (peripheral oedema).

Rare (affects between 1 in 1000 and 1 in 10,000 people)

Inflammation of the liver (hepatitis).

Very rare (affects less than 1 in 10,000 people)

Inflammation of the nose and throat, causing a blocked or runny nose and sore throat (nasopharyngitis).
Skin reactions such as redness or itching.
Upper respiratory tract infection.
Elevated levels of lactic acid in the blood (lactic acidosis).
Decreased absorption of vitamin B12 during long-term use.

The side effects listed above may not include all of the side effects reported by the medicine's manufacturer.

For more information about any other possible risks associated with this medicine, please read the information provided with the medicine or consult your doctor or pharmacist.

How can this medicine affect other medicines?

It is important to tell your doctor or pharmacist what medicines you are already taking, including those bought without a prescription and herbal medicines, before you start treatment with this medicine. Similarly, check with your doctor or pharmacist before taking any new medicines while taking this one, to ensure that the combination is safe.

Cimetidine may increase the blood level of metformin, which could increase the risk of its side effects. Your doctor may need to reduce your dose of this medicine if you take cimetidine as well.

Medicines that increase blood sugar levels as a side effect may make this medicine less effective at controlling blood sugar. Medicines that can increase blood sugar levels include the following:

beta-2-agonists, such as salbutamol
corticosteroids, such as prednisolone
levothyroxine
thiazidediuretics, such as bendroflumethiazide.

Your blood sugar should be monitored more frequently if you start or stop treatment with any of these while taking this medicine, and if necessary your doctor may alter your dose of this medicine.

Low blood sugar levels (hypoglycaemia) may occur, sometimes unpredictably, if ACE inhibitors such as captopril are taken with this medicine.

Your doctor will ask you to stop taking this medicine temporarily if you are going to have a certain type of X-ray involving an injection of iodinated dye. Tell your doctor that you are taking this medicine if you are due to have this type of X-ray. You should not start taking this medicine again until 48 hours after the X-ray, and only after your kidney function has been tested and found to be normal.