What Vildagliptin Krka is and what it is used for
The active substance for Vildagliptin Krka, vildagliptin, belongs to a group of medicines called “oral diabetes medicines”.
Vildagliptin Krka 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 that Vildagliptin Krka 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 Krka works
Vildagliptin Krka 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.
Vildagliptin contained in Vildagliptin Krka 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 Krka
Do not use Vildagliptin Krka
- 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 Krka, do not take this medicine and talk to your doctor.
Warnings and precautions
- 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 Krka to avoid low blood sugar [hypoglycemia]).
- if you have moderate or severe kidney disease (you will need to take a lower dose of Vildagliptin Krka).
- 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 Krka. If this occurs, contact your doctor immediately.
Liver function tests will be done before you start treatment with Vildagliptin Krka 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 Krka in children and adolescents up to the age of 18 is not recommended.
Other medicines and Vildagliptin Krka
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 Krka 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 use Vildagliptin Krka during pregnancy. It is unknown whether Vildagliptin Krka passes into breast milk. You should not use Vildagliptin Krka if you are breastfeeding or planning to breastfeed.
Driving ability and use of machinery
If you feel dizzy while taking Vildagliptin Krka, 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 Krka contains excipients
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. it is almost “sodium-free”.
How to use Vildagliptin Krka
Always take this medicine as directed by your doctor or pharmacist. Ask your doctor or pharmacist if you are unsure.
How much to take and when
Dose en Vildagliptin Krka varies between different people depending on their medical condition. The doctor will tell you exactly how many tablets of Vildagliptin Krka you should take. The maximum daily dose is 100 mg.
The usual dose of Vildagliptin Krka is either:
- 50 mg daily, taken as a dose in the morning if you are taking Vildagliptin Krka 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 Krka 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 Krka
- Swallow the tablets whole with a little water.
How long to take Vildagliptin Krka
- Take Vildagliptin Krkavarje daily 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 Krka
If you have ingested too much medicine or if, for example, a child has ingested the medicine by mistake, 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 Krka
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 Krka
Do not stop taking Vildagliptin Krka unless your doctor tells you to. Talk to your doctor if you have any questions about how long to take this medicine.
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 Krka and see a doctor immediately if you experience any of the following side effects:
- Angioedema (rare: affects up to 1 in 1,000 patients): symptoms include swelling of the face, tongue, or throat, difficulty swallowing, difficulty breathing, and 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 ) (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 Krka together with metformin:
- Common (affects up to 1 in 10 patients): Tremors, 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 Krka 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 Krka 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 Krka 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 Krka, metformin, and sulphonylurea:
- Common: Dizziness, tremors, weakness, low blood sugar, excessive sweating
Some patients have experienced the following side effects when taking Vildagliptin Krka 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:
- Not known (frequency cannot be estimated from the available data): Itchy skin rash, inflammation of the pancreas, localized peeling of skin or blisters, muscle pain.
How to store Vildagliptin Krka
Keep this medicine out of the sight and reach of children.
Use before the expiry date which is stated on the carton after EXP. The expiration date is the last day of the specified month.
No special temperature instructions.
Store in the original packaging. Moisture sensitive.
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 (excipients) are mannitol (E421), hydroxypropyl cellulose (type EF, 300-600 mPas), low-substituted hydroxypropyl cellulose, microcrystalline cellulose (type 112), sodium starch glycolate (type A), colloidal anhydrous silica and sodium stearyl fumarate. See section 2 “Vildagliptin Krka contains sodium”.
Appearance and package sizes of the medicine
The tablets are white or almost white, round with beveled edges, 8 mm in diameter, and thickness of 3.2 – 5.0 mm.
Vildagliptin Krka is available in cartons containing:
- 14, 28, 30, 56, 60, 90, 100, 112, and 180 tablets in blister.
Not all pack sizes may be marketed.
KRKA, dd, Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
KRKA, dd, Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
TAD Pharma GmbH, Heinz-Lohmann-Strasse 5, 27472 Cuxhaven, Germany