Patient leaflet - Vildagliptin 50 mg tablets
What Vildagliptin is and what it is used for
1
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Your doctor may wish to alter your dose of Vildagliptin if you are taking other medicines such as:
The active substance of Vildagliptin, vildagliptin, belongs to a group of medicines called “oral antidiabetics”.
- thiazides or other diuretics (also called water tablets)
Vildagliptin is used to treat adult patients with type 2 diabetes. It is used when diabetes cannot be controlled by diet and exercise alone. It helps to control the level of sugar in the blood. Your doctor will prescribe Vildagliptin either alone or together with certain other antidiabetic medicines which you will already be taking, if these have not proved sufficiently effective to control diabetes.
- corticosteroids (generally used to treat inflammation)
- thyroid medicines
- certain medicines affecting the nervous system.
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.
Type 2 diabetes develops if the body does not make enough insulin or if the insulin that the body makes does not work as well as it should. It can also develop if the body produces too much glucagon.
You should not use Vildagliptin during pregnancy. It is not known if Vildagliptin passes into breast milk. You should not use Vildagliptin if you are breast-feeding or plan to breast-feed.
Insulin is a substance which helps to lower the level of sugar in the blood, especially after meals. Glucagon is a substance which triggers the production of sugar by the liver, causing the blood sugar level to rise. The pancreas makes both of these substances.
Driving and using machines
If you feel dizzy while taking Vildagliptin, do not drive or use machines.
Vildagliptin contains lactose
Vildagliptin contains lactose (milk sugar). If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
How Vildagliptin works
Vildagliptin works by making the pancreas produce more insulin and less glucagon. This helps to control the blood sugar level. This medicine has been shown to reduce blood sugar, which may help to prevent complications from your diabetes. Even though you are now starting a medicine for your diabetes, it is important that you continue to follow the diet and/or exercise which has been recommended for you.
Vildagliptin contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say it is essentially ‘sodium-free’.
How to take Vildagliptin
3
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
What you need to know before you take Vildagliptin
2
Do not take Vildagliptin:
How much to take and when
if you are allergic to vildagliptin or any
The amount of Vildagliptin people have to take varies depending on their condition. Your doctor will tell you exactly how many tablets of Vildagliptin to take. The maximum daily dose is 100 mg.
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 of Vildagliptin, do not take this medicine and talk to your doctor.
The usual dose of Vildagliptin is either:
- 50 mg daily taken as one dose in the
Warnings and precautions
morning if you are taking Vildagliptin with another medicine called a sulphonylurea.
Talk to your doctor, pharmacist or nurse before taking Vildagliptin if you:
have type 1 diabetes (i.e. your body
does not produce insulin) or if you have a condition called diabetic ketoacidosis
- 100 mg daily taken as 50 mg in the morning and 50 mg in the evening if you are taking Vildagliptin alone, with another medicine called metformin or a glitazone, with a combination of metformin and a sulphonylurea, or with insulin.
are taking an anti-diabetic medicine
known as a sulphonylurea (your doctor may want to reduce your dose of the sulphonylurea when you take it together with Vildagliptin in order to avoid low blood glucose
- 50 mg daily in the morning if you have
[hypoglycaemia])
moderate or severe kidney disease or if you are on dialysis.
have moderate or severe kidney
disease (you will need to take a lower dose of Vildagliptin)
- are on dialysis
have liver disease
Version:1
How to take Vildagliptin
Swallow the tablets whole with some
water.
Some patients have had the following side effects while taking Vildagliptin (vildagliptin), metformin and a
sulphonylurea:
How long to take Vildagliptin
Take Vildagliptin every day for as long
- Common: Dizziness, tremor, weakness, low blood glucose, excessive sweating.
as your doctor tells you. You may have to take this treatment over a long period of time.
Your doctor will regularly monitor your
condition to check that the treatment is having the desired effect.
If you take more Vildagliptin than you should
Some patients have had the following side effects while taking Vildagliptin (vildagliptin) and insulin (with or without metformin):
Common: Headache, chills, nausea
(feeling sick), low blood glucose, heartburn.
- Uncommon: Diarrhoea, flatulence.
If you take too many Vildagliptin tablets, or if someone else has taken your medicine, talk to your doctor straight away. Medical attention may be needed. If you need to see a doctor or go to the hospital, take the pack with you.
If you forget to take Vildagliptin
If you forget to take a dose of this medicine, take it as soon as you remember. Then take your next dose at the usual time. If it is almost time for your next dose, skip the dose you missed. Do not take a double dose to make up for a forgotten tablet.
If you stop taking Vildagliptin
Do not stop taking Vildagliptin unless your doctor tells you to. If you have questions about how long to take this medicine, talk to your doctor.
Since this product has been marketed, the following side effects have also been reported:
- Frequency not known (cannot be estimated from the available data): Itchy rash, inflammation of the pancreas, localised peeling of skin or blisters, muscle pain.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
4
Possible side effects
5
How to store Vildagliptin
Like all medicines, this medicine can cause side effects, although not everybody gets them.
- Keep this medicine out of the sight and reach of children.
- Do not use this medicine after the
Some symptoms need immediate medical attention:
You should stop taking Vildagliptin and see your doctor immediately if you experience the following side effects:
Angioedema (rare: may affect up to 1
in 1,000 people): Symptoms include swollen face, tongue or throat, difficulty swallowing, difficulties breathing, sudden onset rash or hives, which may indicate a reaction called “angioedema”.
Liver disease (hepatitis) (rare):
expiry date which is stated on the carton and blister foil after ‘EXP’. The expiry date refers to the last day of that month.
- Do not store above 25°C.
- Store in the original package in order to protect from moisture.
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.
Symptoms include yellow skin and eyes, nausea, loss of appetite or dark-coloured urine, which may indicate liver disease (hepatitis).
6
Contents of the pack and other information
Inflammation of the pancreas
(pancreatitis) (frequency not known): Symptoms include severe and persistent pain in the abdomen (stomach area), which might reach through to your back, as well as nausea and vomiting.
What Vildagliptin contains
- The active substance is vildagliptin. Each tablet contains 50 mg vildagliptin.
The other ingredients are
microcrystalline cellulose, lactose, sodium starch glycolate (type A) and magnesium stearate.
Other side effects
Some patients have had the following side effects while taking Vildagliptin (vildagliptin) and metformin:
Common (may affect up to 1 in
10 people): Trembling, headache, dizziness, nausea, low blood glucose.
What Vildagliptin looks like and contents of the pack
Vildagliptin 50 mg tablets are white, round, flat, bevel edged tablets with diameter of 8.5 mm and debossed with “A013” on one side.
Uncommon (may affect up to 1 in
100 people): Tiredness.
Some patients have had the following side effects while taking Vildagliptin (vildagliptin) and a sulphonylurea:
Common: Trembling, headache,
Vildagliptin 50 mg Tablets are available in blister packs containing 10, 14, 28, 30, 50, 56, 60, 90, 100 and 180 tablets and in perforated unit dose blister packs containing 10 x 1, 30 x 1, 56 x 1 and 60 x 1 tablets.
dizziness, weakness, low blood glucose.
Not all pack sizes may be marketed.
- Uncommon: Constipation.
Very rare (may affect up to 1 in
Marketing Authorisation Holder
10,000 people): Sore throat, runny nose.
TEVA UK Limited, Eastbourne, BN22 9AG, United Kingdom
Some patients have had the following side effects while taking Vildagliptin (vildagliptin) and a glitazone:
Common: Weight increase, swollen
hands, ankle or feet (oedema).
Uncommon: Headache, weakness, low
Manufacturer
Balkanpharma-Dupnitsa AD, 3
Samokovsko Shosse Str., Dupnitsa 2600, Bulgaria
blood glucose.
This leaflet was last revised in 11/2021
Some patients have had the following side effects while taking Vildagliptin (vildagliptin) alone:
PL 00289/2176
- Common: Dizziness.
Uncommon: Headache, constipation,
swollen hands, ankle or feet (oedema), joint pain, low blood glucose.
Very rare: Sore throat, runny nose,
fever.
EAS6180a
REG0289839 0.1 Approved Page 2 of 3