Vildagliptin Mylan

Package leaflet: Information for the user

Vildagliptin Mylan 50 mg tablets

Generic medicine
Please read all of this leaflet carefully before you take this medicine because it contains important information for you.
‐ Keep this leaflet. You may need to read it again.
‐ If you have any questions, ask your doctor, pharmacist or nurse.
‐ This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, because it may be harmful.
‐ If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet

1. What Vildagliptin Mylan is and what it is used for
2. What you need to know before taking Vildagliptin Mylan
3. How to take Vildagliptin Mylan
4. Possible side effects
5. How to store Vildagliptin Mylan
6. Contents of the pack and other information

1. What Vildagliptin Mylan is and what it is used for

The active substance in Vildagliptin Mylan, vildagliptin, belongs to a group of medicines called
"oral antidiabetics".
Vildagliptin Mylan 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 control blood sugar levels. Your doctor will prescribe
Vildagliptin Mylan alone or together with other antidiabetic medicines you are already taking, if these have
not been sufficiently effective in controlling diabetes.
Type 2 diabetes develops when the body does not produce enough insulin, or when the insulin produced by
the body does not work properly. It may also develop when 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 the liver to produce sugar, causing blood sugar levels to rise. The pancreas produces both of
these substances.
How Vildagliptin Mylan works
Vildagliptin Mylan works by stimulating the pancreas to produce more insulin and less glucagon. This
helps control blood sugar levels. This medicine has been shown to reduce blood sugar levels, which may
help prevent complications arising from your diabetes. Even though you are now starting to take medicine
for your diabetes, it remains important that you continue to follow the diet and/or exercise regimen that has
been recommended to you.

2. What you need to know before taking Vildagliptin Mylan

Do not take Vildagliptin Mylan:

• if you are allergic to vildagliptin or to any of the other ingredients of this medicine (listed in section 6). If you think you may be allergic to vildagliptin or to any of the excipients of Vildagliptin Mylan, do not take this medicine and consult your doctor.

Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Vildagliptin Mylan

• if you have type 1 diabetes (that is, your body does not produce insulin) or if you have a condition called diabetic ketoacidosis.
• if you are taking an antidiabetic medicine known as a sulphonylurea (if taken together with Vildagliptin Mylan, your doctor may wish to reduce your dose of sulphonylurea to avoid low blood glucose [hypoglycaemia]).
• if you have moderate or severe kidney disease (you will need to take a lower dose of Vildagliptin Mylan).
• if you are on dialysis.
• if you have liver disease.
• if you have heart failure.
• if you have or have had a disease of the pancreas.

If you previously took vildagliptin but had to stop due to liver disease, you must not take this medicine.
Skin lesions are a common complication of diabetes. It is advisable to follow the skin and foot care recommendations provided by your doctor or nurse. You should also pay particular attention to the development of blisters or ulcers while taking Vildagliptin Mylan.
If this occurs, you should consult your doctor promptly.
Before starting treatment with Vildagliptin Mylan, a test will be performed to assess liver function. This test will be repeated every three months during the first year of treatment and periodically thereafter.
This is to detect, as early as possible, signs of increased liver enzymes.
Children and adolescents
The use of Vildagliptin Mylan is not recommended in children and adolescents under 18 years of age.
Other medicines and Vildagliptin Mylan
Inform your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Your doctor may need to adjust the dose of Vildagliptin Mylan if you are taking other medicines, such as:

• thiazides or other diuretics (also known as water tablets)
• corticosteroids (generally used to treat inflammation)
• thyroid medicines
• certain medicines acting on the nervous system.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
You must not use Vildagliptin Mylan during pregnancy. It is not known whether this medicine passes into breast milk. You must not use Vildagliptin Mylan if you are breastfeeding or planning to breastfeed.
Driving and using machines
If you feel dizzy when taking Vildagliptin Mylan, do not drive or operate machinery.
Vildagliptin Mylan contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this medicine.

3. How to take Vildagliptin Mylan

Take this medicine exactly as your doctor or pharmacist has told you. If you are unsure, consult your doctor or pharmacist.

How much to take and when

The amount of Vildagliptin Mylan you should take depends on your individual condition. Your doctor will tell you exactly how many tablets of this medicine you should take. The maximum daily dose is 100 mg.

The usual dose of Vildagliptin Mylan is:

• 50 mg once daily in the morning, if you are taking this medicine together with another medicine called a sulphonylurea.
• 100 mg daily, taken as 50 mg in the morning and 50 mg in the evening, if you are taking Vildagliptin Mylan alone, with another medicine called metformin or a glitazone, with a combination of metformin and a sulphonylurea, or with insulin.
• 50 mg once daily in the morning, if you have moderate or severe kidney disease or are on dialysis.

How to take Vildagliptin Mylan

• Swallow the tablets whole with a glass of water.

How long to take Vildagliptin Mylan

• Take this medicine every day as long as your doctor recommends. You may need to continue this treatment for a long period of time.
• Your doctor will regularly monitor your condition to ensure the treatment is having the desired effect.

If you take more Vildagliptin Mylan than you should

If you take too many tablets or if someone else has taken your medicine, contact your doctor immediately. Medical treatment may be necessary. If you need to see a doctor or go to hospital, take the pack with you.

If you forget to take Vildagliptin Mylan

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 missed dose. Do not take a double dose to make up for a forgotten tablet.

If you stop taking Vildagliptin Mylan

Do not stop taking this medicine unless your doctor tells you to. If you have any doubts about how to use this medicine, speak to your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Some symptoms require immediate medical attention:
You must stop taking Vildagliptin Mylan and contact your doctor immediately if any of the following side effects occur:

• 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 appearance of skin rashes or hives, which may indicate a reaction called "angioedema".
• Liver disease (hepatitis) (frequency not known): Symptoms include yellowing of the skin or eyes, nausea, loss of appetite, or dark-coloured urine, which may indicate liver disease (hepatitis).
• Inflammation of the pancreas (pancreatitis) (rare: may occur in up to 1 in 1,000 people). Symptoms include severe and persistent pain in the abdomen (stomach area), which may extend to the back, as well as nausea and vomiting.

Other side effects
Some patients experienced the following side effects while taking vildagliptin:

• Very common (may affect more than 1 in 10 people): sore throat, runny nose, fever
• Common (may affect up to 1 in 10 people): itchy rash, tremor, headache, dizziness, muscle pain, joint pain, constipation, swelling of hands, ankles or feet (oedema), excessive sweating, vomiting, stomach and abdominal pain (abdominal pain), diarrhoea, heartburn, nausea (feeling sick), blurred vision.
• Uncommon (may affect up to 1 in 100 people): weight gain, chills, weakness, sexual dysfunction, low blood glucose levels, flatulence.
• Rare (may affect up to 1 in 1,000 people): inflammation of the pancreas

During the marketing of this medicine, the following additional side effects have also been reported:

• Frequency not known (cannot be estimated from the available data): localized skin peeling or blisters, inflammation of blood vessels (vasculitis), which may cause skin rash or round, red, flat, raised spots under the skin surface or bruising.

Reporting of side effects
If you get any side effect, including ones not listed in this leaflet, talk to your doctor, pharmacist or nurse. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
Reporting side effects can help provide more information on the safety of this medicine.

5. How to store Vildagliptin Mylan

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and the outer carton after "Exp.".
The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not use this medicine if you notice that the packaging is damaged or shows signs of tampering.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Vildagliptin Mylan contains
- The active substance is vildagliptin. Each tablet contains 50 mg of vildagliptin.
- The other components are lactose (see section 2, “Vildagliptin Mylan contains lactose”), microcrystalline cellulose, pregelatinized maize starch, and magnesium stearate.

Description of the appearance of Vildagliptin Mylan and contents of the pack
Vildagliptin Mylan 50 mg tablets are round, flat, white to off-white, with “VLD” imprinted on one side and smooth on the other.

Vildagliptin Mylan 50 mg tablets are available in packs containing 7, 14, 28, 30, 56, 60, 90, 112, 180 or 336 tablets, and in multiple packs comprising 3 boxes, each containing 112 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Mylan S.p.A.
Via Vittor Pisani 20
20124 Milan, Italy

Manufacturer
Adipharm EAD, 130 ‘Simeonovsko shosse’ Blvd., 1700 Sofia, Bulgaria.
Combino Pharm (Malta) Ltd., HF60, Hal Far Industrial Estate, BBG3000, Malta.
Genepharm S.A., 18th km Marathonos Avenue, 15351 Pallini Attiki, Greece.

This medicinal product is authorised in the European Economic Area countries under the following names:
Denmark Vildagliptin Mylan
Finland Vildagliptin Mylan
France Vildagliptine Viatris 50 mg, comprimé
Italy Vildagliptin Mylan
Norway Vildagliptin Mylan
Portugal Vildagliptina Mylan
Spain Vildagliptina Viatris 50 mg comprimidos EFG