What Vildagliptin STADA is and what it is used for
The active substance in Vildagliptin Stada, vildagliptin, belongs to a group of medicines called “oral diabetes medicines”.
Vildagliptin Stada 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 Stada 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.
How Vildagliptin Stada works
Vildagliptin Stada works by making the pancreas produce more insulin and less glucagon. This helps regulate blood sugar levels. This drug 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.
Vildagliptin contained in Vildagliptin Stada 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.
What you need to know before you use Vildagliptin STADA
Do not use Vildagliptin STADA
- if you are allergic to vildagliptin or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor, pharmacist, or nurse before taking Vildagliptin Stada if you:
- have type 1 diabetes (ie your body does not produce insulin ) or if you have a condition called diabetic ketoacidosis.
- are taking a diabetes medicine known as sulphonylurea (your doctor may want to lower your dose of sulphonylurea when you take it with this medicine to avoid low blood sugar [hypoglycemia]).
- have moderate or severe kidney disease (you will need to take a lower dose of Vildagliptin Stada).
- treated with dialysis.
- have liver disease.
- suffering from heart failure.
- 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 this medicine. If this occurs, contact your doctor immediately.
Liver function tests will be done before you start treatment with Vildagliptin Stada 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 Stada in children and adolescents up to the age of 18 is not recommended.
Other medicines and Vildagliptin STADA
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 Stada 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, breastfeeding, and fertility
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 take this medicine during pregnancy.
It is unknown whether Vildagliptin Stada passes into breast milk. You should not take Vildagliptin Stada if you are breastfeeding or planning to breastfeed.
Driving ability and use of machinery
If you feel dizzy while taking Vildagliptin Stada, 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 STADA contains lactose and sodium
Vildagliptin Stada contains lactose
If you have an intolerance to some sugars, you should consult your doctor before taking this medicine.
Vildagliptin Stada contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. is next to
How to use Vildagliptin STADA
Always take this medicine as directed by your doctor. Ask your doctor or pharmacist if you are unsure.
Dosage
The dose of Vildagliptin Stada varies between different people depending on their medical condition. The doctor will tell you exactly how many tablets of Vildagliptin Stada you should take. The maximum daily dose is 100 mg.
The usual dose of Vildagliptin Stada is either:
- 50 mg daily, taken as a dose in the morning if you take Vildagliptin Stada with another medicine called a sulphonylurea.
- 100 mg daily, taken as 50 mg in the morning and 50 mg in the evening if you take Vildagliptin Stada alone, with another medicine called metformin or a glitazone, in combination with metformin and a sulfonamide, or with insulin (with or without metformin ).
- 50 mg daily in the morning if you have moderate or severe kidney disease or if you receive dialysis.
How to take Vildagliptin Stada
Swallow the tablets whole with a little water.
How long to take Vildagliptin Stada
Take Vildagliptin Stada 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 used too much Vildagliptin STADA
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. You may need medical attention. If you need to see a doctor or go to the hospital, take the medicine package with you.
If you forget to use Vildagliptin STADA
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 using Vildagliptin STADA
Do not stop taking this medicine unless your doctor tells you to.
If you have any further questions about this medicine, ask your doctor or pharmacist.
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 Stada 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, and sudden onset of skin rash or hives.
- liver disease ( hepatitis ) (rare): symptoms include yellow-colored skin and yellow-colored whites of the eyes, nausea, decreased appetite, or dark-colored urine.
- inflammation of the pancreas ( pancreatitis ) (frequency not known): 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 together with metformin:
Common (may affect up to 1 in 10 users)
- tremors, headache, dizziness, nausea, and low blood sugar.
Uncommon (may affect up to 1 in 100 users)
- fatigue.
Some patients have experienced the following side effects when taking vildagliptin together with a sulphonylurea:
Usual
- tremors, headache, dizziness, weakness, and low blood sugar.
Less common
- constipation.
Very rare (may affect up to 1 in 10,000 users)
- sore throat, and runny nose.
Some patients have experienced the following side effects when taking vildagliptin together with glitazone:
Usual
- weight gain, swollen hands, ankles, or feet ( edema ).
Less common
- headache, weakness, and low blood sugar.
Some patients have experienced the following side effects when taking vildagliptin as a single medicine:
Usual
- dizziness.
Less common
- headache, constipation, swollen hands, ankles, or feet ( edema ), joint pain, and low blood sugar.
Very rare
- sore throat, runny nose, fever.
Some patients have experienced the following side effects when taking vildagliptin, metformin, and sulphonylurea:
Usual
- dizziness, tremors, weakness, low blood sugar, and excessive sweating.
Some patients have experienced the following side effects when taking vildagliptin with insulin (with or without metformin ):
Usual
- headache, chills, nausea, low blood sugar, and heartburn.
Less common
- diarrhea, flatulence.
After medicines containing vildagliptin as the sole substance were approved for sale, the following side effects have also been reported:
Has been reported (occurring in an unknown number of users)
- itchy rash, inflammation of the pancreas, localized peeling of skin or blisters, muscle pain
- liver disease ( hepatitis ) – usually disappears when treatment is stopped. Symptoms include yellow-colored skin and yellow-colored whites of the eyes, nausea, decreased appetite, or dark-colored urine
- abnormal liver function tests – which usually return when treatment is stopped.
Contents of the packaging and other information
Keep this medicine out of the sight and reach of children.
Use before the expiry date which is stated on the blister and carton after EXP. The expiration date is the last day of the specified month.
Store in the blister. Moisture sensitive.
No special temperature instructions.
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 declaration
- The active substance is vildagliptin. Each tablet contains 50 mg of vildagliptin.
- Other ingredients are lactose monohydrate, microcrystalline cellulose (E460), sodium starch glycolate, and magnesium stearate (E470b).
Appearance and package sizes of the medicine
Vildagliptin Stada 50 mg tablets are white to pale yellowish, round, flat tablets with a beveled edge, 8.0 ± 0.2 mm in diameter.
Vildagliptin Stada 50 mg tablets are available in standard blisters and single-dose blisters in boxes of 14, 28, 30, 56, 60, 90, 105, 112, and 180 tablets.
Not all pack sizes may be marketed.
STADA Arzneimittel AG
Stadastrasse 2-18
61118 Bad Vilbel
Germany
Local representative
STADA Nordic ApS
Marielundvej 46A
2730 Herlev
Denmark