VILDAGLIPTIN 50 mg Coated Tablet

Зміст інструкції

1. Vildagliptin Mylan 50 mg tablets
   1. What is Vildagliptin Mylan 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

Vildagliptin Mylan 50 mg tablets

Generic medicine

Read this leaflet carefully before taking this medicine as 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 pass it on to others, even if they have the same
symptoms as you, as it may be harmful.
‐ If any side effects occur, including those not listed in this leaflet, tell 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 you take 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 is Vildagliptin Mylan and what it is used for

The active substance of Vildagliptin Mylan, vildagliptin, belongs to a group of medicines called
“oral antidiabetic drugs”.
Vildagliptin Mylan is used to treat adult patients with type 2 diabetes. It is used when the
diabetes cannot be controlled only by diet and exercise. It helps to control the level of
blood sugar. Your doctor will prescribe Vildagliptin Mylan alone or together with other antidiabetic medicines
that you are already taking, if these have not proven sufficiently effective to control
diabetes.
Type 2 diabetes develops when the body does not produce enough insulin, or if the insulin produced
by the body does not work as it should. It can also develop when the body produces too much
glucagon.
Insulin is a substance that helps to lower blood sugar levels, especially after meals.
Glucagon is a substance that triggers the production of sugar by the liver, causing an
increase in blood sugar levels. The pancreas produces both of these substances.
How does Vildagliptin Mylan work
Vildagliptin Mylan works by inducing the pancreas to produce more insulin and less glucagon. This helps to
control the level of blood sugar. This medicine has been shown to reduce blood sugar, which can help to prevent complications resulting from your diabetes. Even if you are now starting to take
a medicine for your diabetes, it is important that you continue to follow the diet and/or exercise 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 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 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 (i.e. your body does not produce insulin) or if you suffer from a condition called diabetic ketoacidosis.
• if you are taking a medicine for diabetes known as a sulfonylurea (if you take it together with Vildagliptin Mylan, your doctor may want to reduce your dose of sulfonylurea, to avoid low blood glucose [hypoglycemia]).
• 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 suffer from heart failure.
• if you have or have had a disease of the pancreas.

If you have previously taken vildagliptin, but had to stop due to liver disease, you should not
take this medicine.
Skin lesions are a common complication of diabetes. It is advisable to follow the recommendations
for skin and foot care that are provided to you by your doctor or nurse. It is also advisable
to pay particular attention to the appearance of blisters or ulcers while taking Vildagliptin Mylan.
If this occurs, you should consult your doctor quickly.
Before starting treatment with Vildagliptin Mylan, a test will be performed to assess the functionality
of the liver, which will be repeated every three months during the first year of treatment and subsequently periodically.
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 up to 18 years of age.

Other medicines and Vildagliptin Mylan
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines.
Your doctor may want to adjust the dose of Vildagliptin Mylan if you are taking other medicines, such as
for example:

• thiazides or other diuretics (also called water tablets)
• corticosteroids (generally used for the treatment of inflammation)
• medicines for the thyroid
• certain medicines that act on the nervous system.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning to become pregnant, or if you are breastfeeding
ask your doctor or pharmacist for advice 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 while taking Vildagliptin Mylan, do not drive or use machines.

Vildagliptin Mylan contains lactose
If your doctor has told you that you have an intolerance to some sugars, contact him before taking this
medicine.

3. How to take Vildagliptin Mylan

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have
any doubts, ask your doctor or pharmacist.

How much to take and when
The amount of Vildagliptin Mylan that you need to take varies depending on individual conditions. Your
doctor will tell you exactly how many tablets of this medicine you need to take. The maximum
daily dose is 100 mg.
The usual dose of Vildagliptin Mylan is:

• 50 mg per day, taken as a single dose in the morning if you take this medicine with another medicine called a sulfonylurea.
• 100 mg per day, taken as 50 mg in the morning and 50 mg in the evening, if you take Vildagliptin Mylan alone, with another medicine called metformin or a glitazone, with a combination of metformin and a sulfonylurea, or with insulin.
• 50 mg per day, in the morning, if you have moderate or severe kidney disease or if you are on dialysis.

How to take Vildagliptin Mylan

• Swallow the tablets whole with a little water.

For how long to take Vildagliptin Mylan

• Take this medicine every day until your doctor tells you to stop. It is possible that you may need to continue this treatment for a long period of time.
• Your doctor will regularly check your condition to verify that 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 care may be needed. If you need to see a doctor or go
to hospital, take the packaging 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 the
next dose at the usual time. If it is almost time for your next dose, skip the dose you forgot.
Do not take a double dose to make up for a missed tablet.

If you stop taking Vildagliptin Mylan
Do not stop taking this medicine unless your doctor tells you to do so. If you have any doubts
about using this medicine, ask your doctor or pharmacist.

4. 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 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 onset of skin rashes or hives, which may indicate a reaction called “angioedema”.
• Liver disease (hepatitis) (frequency not known): Symptoms include yellowing of the skin and eyes, nausea, loss of appetite or dark urine, which may indicate liver disease (hepatitis).
• Inflammation of the pancreas (pancreatitis) (rare: may affect up to 1 in 1,000 people). Symptoms include severe and persistent abdominal pain (stomach area), which may spread to the back, as well as nausea and vomiting.

Other side effects
Some patients have 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, pain in the stomach and around the stomach (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

The following side effects have also been reported during the post-marketing of this medicine:

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

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. You can also report side effects directly through
the national reporting system at https://www.aifa.gov.it/content/segnalazioni-
reazioni-avverse .
By reporting side effects you 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 which is stated on the blister and the package after “Exp.”.
The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.
Do not use this medicine if you notice that the package is damaged or shows signs of tampering.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how
to eliminate medicines that you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Vildagliptin Mylan contains
‐ The active ingredient is vildagliptin. Each tablet contains 50 mg of vildagliptin.
‐ The other ingredients 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, from white to off-white with imprinted
“VLD” 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 Milano

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 Member States of the European Economic Area under the following
denominations:
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