What Vildagliptin Accord is and what it is used for
The active substance in Vildagliptin Accord, vildagliptin, belongs to a group of medicines called “oral diabetes medicines”.
Vildagliptin Accord is used in the treatment of adult patients with type 2 diabetes.
It is used when the disease cannot be controlled with diet and exercise alone. It helps regulate blood sugar levels. The doctor will prescribe Vildagliptin Accord to be taken either alone or at the same time as certain other diabetes medicines that you are already taking if these are not effective enough to control diabetes.
Type 2 diabetes develops if the body does not produce enough insulin or if the insulin the body produces does not work satisfactorily. Diabetes can also develop if the body produces too much glucagon.
Insulin is a substance that helps lower blood sugar levels, especially after meals. Glucagon is a substance that triggers sugar production in the liver, which causes the blood sugar level to rise. Both of these substances are produced in the pancreas.
Vildagliptin contained in Vildagliptin Accord may also be approved to treat other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
How Vildagliptin Accord works
Vildagliptin Accord works by making the pancreas produce more insulin and less glucagon. This helps regulate blood sugar levels. This medication has been shown to lower blood sugar, which can help prevent complications of your diabetes. Even if you now start medication for your diabetes, you must continue to follow the diet and/or exercise guidelines that have been recommended.
What you need to know before you take Vildagliptin Accord
Do not take Vildagliptin Accord
- if you are allergic to vildagliptin or any of the other ingredients of this medicine (listed in section 6). If you think you may be allergic to vildagliptin or any of the other ingredients in Vildagliptin Accord, do not take this medicine and talk to your doctor.
Warnings and precautions
Talk to your doctor, pharmacist, or nurse before taking Vildagliptin Accord.
- if you have type 1 diabetes (ie your body does not produce insulin ) or if you have a condition called diabetic ketoacidosis.
- if you are taking a diabetes medicine known as sulphonylurea (your doctor may want to lower your dose of sulphonylurea when you take it with Vildagliptin Accord to avoid low blood sugar [hypoglycemia]).
- if you have moderate or severe kidney disease (you will need to take a lower dose of Vildagliptin Accord).
- if you are being treated with dialysis.
- if you have liver disease.
- if you suffer from heart failure.
- if you have or have had a disease of the pancreas.
If you have taken vildagliptin before but had to stop taking it because of liver disease, you should not take this medicine.
Skin conditions are a common complication in diabetics. Follow the recommendations you receive from your doctor or nurse for skin and foot care. Be especially alert for new blisters or sores while taking Vildagliptin Accord. If this occurs, contact your doctor immediately.
Liver function tests will be done before you start treatment with Vildagliptin Accord at three-month intervals during the first year and periodically thereafter. This is to detect elevated liver enzyme values as early as possible.
Children and young people
Use of Vildagliptin Accord in children and adolescents up to the age of 18 is not recommended.
Other medicines and Vildagliptin Accord
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
The doctor may want to change your dose of Vildagliptin Accord if you are taking other medicines such as:
- thiazides or other diuretics (also called diuretics)
- corticosteroids (usually used to treat inflammation )
- medicines for thyroid diseases
- certain drugs that affect the nervous system.
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.
You should not use Vildagliptin Accord during pregnancy. It is unknown whether Vildagliptin Accord passes into breast milk. You should not use Vildagliptin Accord if you are breastfeeding or planning to breastfeed.
Driving ability and use of machinery
If you feel dizzy while taking Vildagliptin Accord, do not drive or use machines. You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. A description of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. Discuss with your doctor or pharmacist if you are unsure.
Vildagliptin Accord contains lactose
Vildagliptin Accord contains lactose (milk sugar). If you have an intolerance to some sugars, you should consult your doctor before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. it is almost ‘sodium-free’.
How to use Vildagliptin Accord
Always take this medicine as directed by your doctor. Ask your doctor or pharmacist if you are unsure.
How much to take and when
The dose of Vildagliptin Accord varies between different people depending on their medical condition. The doctor will tell you exactly how many tablets of Vildagliptin Accord you should take. The maximum daily dose is 100 mg.
The usual dose of Vildagliptin Accord is either:
- 50 mg daily, taken as a dose in the morning if you are taking Vildagliptin Accord with another medicine called sulphonylurea.
- 100 mg daily, taken as 50 mg in the morning and 50 mg in the evening if you take Vildagliptin Accord alone, with another medicine called metformin or a glitazone, in combination with metformin and a sulphonylurea, or with insulin.
- 50 mg daily in the morning if you have moderate or severe kidney disease or if you receive dialysis.
How to take Vildagliptin Accord
- Swallow the tablets whole with a little water.
How long to take Vildagliptin Accord
- Take Vildagliptin Accord every day and for as long as the doctor tells you. You may need to be treated for a longer period.
- The doctor will check on you regularly, to see that the treatment is having the desired effect.
If you have taken too much Vildagliptin Accord
If you have ingested too much medicine or if, for example, If a child has ingested the medicine by mistake, immediately contact a doctor or hospital for an assessment of the risk and advice.
If you forget to take Vildagliptin Accord
If you forget to take a dose, take it as soon as you remember. Then take your next dose at the usual time. However, if it is almost time to take the next dose, skip the dose you missed. Do not take a double dose to make up for a missed tablet.
If you stop taking Vildagliptin Accord
Do not stop taking Vildagliptin Accord unless your doctor tells you to. Talk to your doctor if you have any questions about how long to take this medicine.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Some symptoms require immediate medical attention:
You should stop taking Vildagliptin Accord and see a doctor immediately if you experience any of the following side effects:
- Angioedema (rare: may affect up to 1 in 1,000 people): symptoms include swelling of the face, tongue, or throat, difficulty swallowing, difficulty breathing, sudden onset of a rash or hives, which may be signs of a reaction called “angioedema”.
- Liver disease ( hepatitis ) (rare): symptoms include yellowing of the skin and whites of the eyes, nausea, decreased appetite, or dark-colored urine, which may be signs of liver disease ( hepatitis ).
- Inflammation of the pancreas ( pancreatitis ) (has been reported): Symptoms include severe and persistent pain in the abdomen, which may reach back to your back, as well as nausea and vomiting.
Other side effects ar
Some patients have experienced the following side effects when taking Vildagliptin Accord together with metformin:
- Common (may affect up to 1 in 10 people): Trembling, headache, dizziness, nausea, low blood sugar
- Uncommon (may affect up to 1 in 100 patients): Fatigue
Some patients have experienced the following side effects when taking Vildagliptin Accord together with a sulphonylurea:
- Common: Tremors, headache, dizziness, weakness, low blood sugar
- Uncommon: Constipation
- Very rare (may affect up to 1 in 10,000 patients): Sore throat, runny nose
Some patients have experienced the following side effects when taking Vildagliptin Accord together with a glitazone:
- Common: Weight gain, swollen hands, ankles, and feet (edema)
- Uncommon: Headache, weakness, low blood sugar
Some patients have experienced the following side effects when taking Vildagliptin Accord as a single medicine:
- Common: Dizziness
- Uncommon: Headache, constipation, swollen hands, ankles, and feet (edema), joint pain, low blood sugar
- Very rare: Sore throat, runny nose, fever
Some patients have experienced the following side effects when taking Vildagliptin Accord, metformin, and sulphonylurea:
- Common: Dizziness, tremors, weakness, low blood sugar, excessive sweating
Some patients have experienced the following side effects when taking Vildagliptin Accord with insulin (with or without metformin ):
- Common: Headache, chills, nausea, low blood sugar, heartburn
- Uncommon: Diarrhoea, flatulence
After the medicine was approved for sale, the following side effects have also been reported:
- Has been reported (occurring in an unknown number of patients): Itchy skin rash, inflammation of the pancreas, localized peeling of skin or blisters, and muscle pain.
How to store Vildagliptin Accord
- Keep this medicine out of the sight and reach of children.
- Use before the expiry date which is stated on the printed packaging and carton after EXP. The expiration date is the last day of the specified month.
- Do not use Vildagliptin Accord if the package is damaged or if it shows signs of alteration.
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 vildagliptin. Each tablet contains 50 mg of vildagliptin.
- Other ingredients are anhydrous lactose, microcrystalline cellulose, sodium starch glycolate, and magnesium stearate.
Appearance and package sizes of the medicine
Vildagliptin Accord 50 mg tablets are white to off-white, round, flat, uncoated tablets with a beveled edge, debossed with “GF1” on one side and plain on the other side.
Vildagliptin Accord 50 mg tablets are available in packs of 14, 28, 30, 56, 60, 90, and 112 tablets.
Not all pack sizes may be marketed.
Accord Healthcare BV
Winthontlaan 200
3526 VK Utrecht
Netherlands
Manufacturer
Laboratory Fundacio Dau
C/c 12-14 Poligon Industrial Zona Franca
Barcelona, 08040, Spain
Paradox Healthcare Ltd.
KW20A Kordin Industrial Park, Paola, PLA 3000
Malta
Accord Healthcare Polska Sp.z oo,
ul. Lutomirska 50, Pabianice 95-200, Poland