Vildagliptin Accord

Package leaflet: Information for the user

Vildagliptin Accord 50 mg tablets

vildagliptin
Equivalent medicine
Please read all of this leaflet carefully before you start taking 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 they have the same symptoms as yours, as it may be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, talk to 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 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

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

The active substance in 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 diabetes cannot be controlled by diet and exercise alone. It helps control blood sugar levels. Your doctor will prescribe Vildagliptin Accord either alone or in combination 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. Both of these substances are produced by the pancreas.
How Vildagliptin Accord works
Vildagliptin Accord 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. This may help prevent complications arising from your diabetes. Even though you are now starting to take a medicine for 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 Accord

Do not take Vildagliptin Accord

• 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 in 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 have a condition called diabetic ketoacidosis.
• if you are taking an antidiabetic medicine known as a sulfonylurea (if taken together with Vildagliptin Accord, your doctor may wish to reduce your dose of sulfonylurea to avoid low blood sugar [hypoglycaemia]).
• 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 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 Accord. If this occurs, you should consult your doctor promptly.
Before starting treatment with Vildagliptin Accord, a liver function test will be performed, which will be repeated every three months during the first year of treatment and periodically thereafter. This is to detect as early as possible any signs of increased liver enzymes.
Children and adolescents
Vildagliptin Accord is not recommended for use in children and adolescents under 18 years of age.
Other medicines and Vildagliptin Accord
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 Accord 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 that act on the nervous system.

Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, are planning to become pregnant, or 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 operate machinery.
Vildagliptin Accord contains lactose
Vildagliptin Accord contains lactose (milk sugar). If your doctor has diagnosed you with an intolerance to certain sugars, contact him/her 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 exactly as instructed by your doctor. If you have any doubts, consult your doctor.

How much to take and when

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

The usual dose of Vildagliptin Accord is:

• 50 mg once daily in the morning if you are taking Vildagliptin Accord 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 Accord 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 Accord

• Take the tablets with some water.

How long to take Vildagliptin Accord

• Take Vildagliptin Accord every day for as long as your doctor recommends. You may need to continue this treatment for a long period of time.
• Your doctor will regularly check your condition to ensure 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 attention may be required. If you need to see a doctor or go to hospital, bring the pack 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 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 the forgotten tablet.

If you stop taking Vildagliptin Accord

Do not stop taking Vildagliptin Accord unless your doctor tells you to. If you have any doubts about how long you should take this medicine, speak to your doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Some symptoms require immediate medical treatment:
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 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 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 rash, tremor, headache, dizziness, muscle pain, joint pain, constipation, swelling of hands, ankles or feet (oedema), excessive sweating, vomiting, stomach and around-the-stomach 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 sugar 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 experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via 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 carton after “Exp.”. The expiry date refers to the last day of that month.
• Do not use any pack of Vildagliptin Accord if it 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 Accord contains
The active substance is vildagliptin.
Each tablet contains 50 mg of vildagliptin.
The other components are anhydrous lactose, microcrystalline cellulose, sodium starch glycolate (type A) and magnesium stearate.

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

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 European Economic Area countries under the following names: