VILDAGLIPTIN 50 mg Coated Tablet

Зміст інструкції

1. Vildagliptin Accord 50 mg tablets
   1. What Vildagliptin Accord is and what it is used for
   2. What you need to know before taking Vildagliptin Accord
   3. How to take Vildagliptin Accord
   4. Possible side effects
   5. How to store Vildagliptin Accord
   6. Contents of the pack and other information

Vildagliptin Accord 50 mg tablets

vildagliptin

Generic medicine

Read this leaflet carefully before you start 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 you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

The active substance of Vildagliptin Accord, vildagliptin, belongs to a group of medicines called
“oral antidiabetics”.
Vildagliptin Accord 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 Accord alone or together with other antidiabetic
medicines that you are already taking, if these have not proven sufficiently effective for
controlling 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 Vildagliptin Accord works
Vildagliptin Accord works by inducing the pancreas to produce more insulin and less glucagon. This helps to
control the level of blood sugar. It has been shown that this medicine reduces blood
sugar. This can help prevent complications resulting from your diabetes. Even if you are now
starting to take a medicine for 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 Accord

Do not take Vildagliptin Accord

• 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 Accord, do not take this medicine and consult your doctor.

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

• 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 Accord, 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 Accord).
• 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 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 Accord. If this occurs, you should consult your doctor quickly.
Before starting treatment with Vildagliptin Accord, a test will be performed to assess the
functioning of the liver, which will be repeated every three months during the first year of treatment and
then periodically. This is to detect as early as possible signs of increased liver enzymes.

Children and adolescents
The use of Vildagliptin Accord is not recommended in children and adolescents up to 18 years of age.

Other medicines and Vildagliptin Accord
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 Accord 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)
• thyroid medicines
• 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 Accord during pregnancy. It is not known whether Vildagliptin Accord passes into
breast milk. You must not use Vildagliptin Accord if you are breastfeeding or planning to breastfeed.

Driving and using machines
If you feel dizzy when taking Vildagliptin Accord, do not drive or use machines.

Vildagliptin Accord contains lactose
Vildagliptin Accord contains lactose (milk sugar). If your doctor has told you that you have
an intolerance to some sugars, contact your doctor before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially
“sodium-free”..

3. How to take Vildagliptin Accord

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

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

• 50 mg per day taken as a single dose in the morning if you take Vildagliptin Accord 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 Accord 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 Accord

• Take the tablets with a little water.

For how long to take Vildagliptin Accord

• Take Vildagliptin Accord 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 Accord than you should
If you take too many Vildagliptin Accord 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 Accord
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 have
forgotten. Do not take a double dose to make up for a missed tablet.

If you stop taking Vildagliptin Accord
Do not stop taking Vildagliptin Accord unless your doctor tells you to do so. If you have doubts about
the duration of treatment with this medicine, ask your doctor.

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 must stop taking Vildagliptin Accord and contact your 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, 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 Accord:

• 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 skin rash, tremor, headache, dizziness, muscle pain, joint pain, constipation, swelling of the 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 blisters, inflammation of blood vessels (vasculitis), which may cause skin rash or flat, round, red, raised spots under the skin surface or bruising.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, please tell your doctor or pharmacist. You can also report side effects directly through the Italian Medicines Agency website: 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 Accord

• 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 carton after “Exp.”. The expiry date refers to the last day of that month.
• Do not use any pack of Vildagliptin Accord which is damaged or shows signs of tampering.

Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Vildagliptin Accord contains
The active ingredient is vildagliptin
Each tablet contains 50 mg of Vildagliptin
The other ingredients are anhydrous lactose, microcrystalline cellulose, sodium starch glycolate (type A) and
magnesium stearate

Description of the appearance of Vildagliptin Accord and contents of the pack
Vildagliptin Accord tablets are uncoated tablets, white to off-white, round,
flat, with a bevelled edge imprinted with “GF1” on one side and smooth on the other
Vildagliptin Accord tablets are available in packs containing 14, 28, 30, 56, 60, 90 and
112 tablets.
Not all pack sizes may be marketed

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Accord Healthcare S.L.U.
World Trade Center, Moll de Barcelona,
s/n, Edifici Est 6ª planta,
08039 Barcelona,
Spain

Manufacturer
Laboratori Fundacio Dau
C/c 12-14 Poligon Industrial Zona Franca
Barcelona, 08040, Spain
Pharmadox Healthcare Ltd.
KW20A Kordin Industrial Park, Paola, PLA 3000
Malta
Accord Healthcare Polska Sp.z o.o.,
ul. Lutomierska 50, Pabianice 95-200, Poland

This medicinal product is authorised in the Member States of the European Economic Area with the
following denominations: