Vildagliptin and metformin hydrochloride Accord: detailed information

Package leaflet: Information for the user
Vildagliptin/Metformin hydrochloride Accord 50 mg/850 mg film-coated tablets
Vildagliptin/Metformin hydrochloride Accord 50 mg/1000 mg film-coated tablets
vildagliptin/metformin hydrochloride

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 further 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, because it may be harmful.
If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

What Vildagliptin/Metformin hydrochloride Accord is and what it is used for
What you need to know before you take Vildagliptin/Metformin hydrochloride Accord
How to take Vildagliptin/Metformin hydrochloride Accord
Possible side effects
How to store Vildagliptin/Metformin hydrochloride Accord
Contents of the pack and other information

1. What Vildagliptin/Metformin hydrochloride Accord is and what it is used for

The active substances in Vildagliptin/Metformin hydrochloride Accord, vildagliptin and metformin hydrochloride, belong to a group of medicines called "oral antidiabetics".
Vildagliptin/Metformin hydrochloride Accord is used to treat adult patients with type 2 diabetes.
This type of diabetes is also known as non-insulin-dependent diabetes mellitus.
Vildagliptin/Metformin hydrochloride Accord is used when diabetes cannot be controlled by diet and exercise alone and/or in combination with other antidiabetic medicines (insulin or sulfonylureas).
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.
Both insulin and glucagon are produced in the pancreas. Insulin helps lower blood sugar levels, especially after meals. Glucagon stimulates the liver to produce sugar, leading to an increase in blood sugar levels.

How Vildagliptin/Metformin hydrochloride Accord works
Both active substances, vildagliptin and metformin, help control blood sugar levels. The substance vildagliptin works by stimulating the pancreas to produce more insulin and less glucagon. The substance metformin works by helping the body make better use of insulin.
This medicine has been shown to reduce blood sugar levels. This may help prevent complications associated with your diabetes.

2. What you need to know before taking Vildagliptin/Metformin Hydrochloride Accord

Do not take Vildagliptin/Metformin Hydrochloride Accord

if you are allergic to vildagliptin, metformin, or any of the other ingredients of this medicine (listed in section 6). If you think you may be allergic to any of
these substances, consult your doctor before taking Vildagliptin/Metformin Hydrochloride
Accord.
if you have uncontrolled diabetes, for example with severe hyperglycaemia (high blood glucose levels), nausea, vomiting, diarrhoea, rapid weight loss, lactic acidosis (see below “Risk of lactic acidosis”) or ketoacidosis. Ketoacidosis is a condition in which substances called “ketone bodies” accumulate in the blood and may lead to diabetic pre-coma. Symptoms include stomach pain, rapid and deep breathing, drowsiness, or breath with an unusual fruity odour.
if you have recently had a heart attack or if you have heart failure or severe circulatory problems or breathing difficulties, which may be signs of heart problems.
if you have severely reduced kidney function.
if you have a severe infection or are severely dehydrated (your body has lost a lot of water).
if you are due to undergo an X-ray examination with a contrast agent (a special type of X-ray involving an injectable dye). For further information, see also the section “Warnings and precautions”.
if you have liver problems.
if you drink alcohol excessively (either on a daily basis or occasionally).
if you are breastfeeding (see also “Pregnancy and breastfeeding”).

Warnings and precautions
Risk of lactic acidosis
Vildagliptin/Metformin Hydrochloride Accord may cause a very rare but serious side effect called lactic acidosis, particularly if the kidneys are not functioning properly. The risk of developing lactic acidosis is higher in the presence of uncontrolled diabetes, severe infections, prolonged fasting or alcohol consumption, dehydration (for further information, see below), liver problems, or any other medical condition characterised by reduced oxygen supply to part of the body (such as severe heart disease).
If you have any of the medical conditions listed above, consult your doctor for further instructions.
Temporarily stop taking Vildagliptin/Metformin Hydrochloride Accord if you have a medical condition that may be associated with dehydration (significant loss of body fluids), such as severe vomiting, diarrhoea, fever, heat exposure, or if you are drinking less fluid than usual. Consult your doctor for further instructions.
If you experience any of the symptoms of lactic acidosis, stop taking Vildagliptin/Metformin Hydrochloride Accord and contact your doctor or go to the nearest hospital immediately, as lactic acidosis may lead to coma.
Symptoms of lactic acidosis include:

vomiting
stomach ache (abdominal pain)
muscle cramps
a general feeling of being unwell associated with severe tiredness
difficulty breathing
lowered body temperature and slower heart rate

Lactic acidosis is a medical emergency and must be treated in hospital.
Contact your doctor immediately for further instructions if:

you know you have a hereditary genetic disease affecting mitochondria (the components that produce energy within cells), such as MELAS (Mitochondrial Encephalopathy, myopathy, Lactic Acidosis and Stroke-like episodes) or Maternal Inherited Diabetes and Deafness (MIDD);
you develop any of the following symptoms after starting metformin: seizures, reduced cognitive function, difficulty with body movements, symptoms indicating nerve damage (e.g. pain or numbness), headache, or deafness.

Vildagliptin/Metformin Hydrochloride Accord is not a substitute for insulin. Therefore, Vildagliptin/Metformin Hydrochloride Accord must not be prescribed for the treatment of type 1 diabetes.
Consult your doctor, pharmacist, or nurse before taking Vildagliptin/Metformin Hydrochloride Accord if you have or have had a pancreatic disease.
Consult your doctor, pharmacist, or nurse before taking Vildagliptin/Metformin Hydrochloride Accord if you are taking an antidiabetic medicine known as a sulphonylurea. If taken together with Vildagliptin/Metformin Hydrochloride Accord, your doctor may reduce your sulphonylurea dose to avoid low blood glucose levels (hypoglycaemia).
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. You are advised to follow the skin and foot care recommendations provided by your doctor or nurse.
When taking Vildagliptin/Metformin Hydrochloride Accord, you are also advised to pay particular attention to the development of new blisters or ulcers. If this occurs, you must contact your doctor immediately.
If you are undergoing major surgery, you must stop taking Vildagliptin/Metformin Hydrochloride Accord during the procedure and for a certain period afterwards. Your doctor will decide when you should stop and when you should resume treatment with Vildagliptin/Metformin Hydrochloride Accord.
Before starting treatment with Vildagliptin/Metformin Hydrochloride Accord, a test will be performed to assess liver function, 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.
During treatment with Vildagliptin/Metformin Hydrochloride Accord, your doctor will monitor your kidney function at least once a year, or more frequently if you are elderly and/or if your kidney function worsens.
Your doctor will regularly monitor your blood and urine sugar levels.
Children and adolescents
In children and adolescents under 18 years of age, the use of Vildagliptin/Metformin Hydrochloride Accord is not recommended.
Other medicines and Vildagliptin/Metformin Hydrochloride Accord
If you are due to receive an injection of iodinated contrast medium into the bloodstream, for example, for an X-ray or scan, you must stop taking Vildagliptin/Metformin Hydrochloride Accord before or at the time of the injection. Your doctor will decide when you should stop and when you should resume treatment with Vildagliptin/Metformin Hydrochloride Accord.
Inform your doctor if you are taking, have recently taken, or might take any other medicine. You may need to have blood glucose and kidney function tests more frequently, or your doctor may decide to adjust the dose of Vildagliptin/Metformin Hydrochloride Accord. It is particularly important to mention the following:

glucocorticoids, generally used to treat inflammation
beta-2 agonists, generally used to treat respiratory diseases
other medicines used to treat diabetes
medicines that increase urine production (diuretics)
medicines used for pain and inflammation (NSAIDs and COX-2 inhibitors, such as ibuprofen and celecoxib)
some medicines used to treat high blood pressure (ACE inhibitors and angiotensin II receptor antagonists)
some medicines that affect the thyroid
some medicines that affect the nervous system
some medicines used to treat angina (e.g., ranolazine)
some medicines used to treat HIV infection (e.g., dolutegravir)
some medicines used to treat a specific type of thyroid cancer (medullary thyroid cancer) (e.g., vandetanib)
some medicines used to treat heartburn and peptic ulcers (e.g., cimetidine)

Vildagliptin/Metformin Hydrochloride Accord and alcohol
Avoid excessive alcohol consumption while being treated with Vildagliptin/Metformin Hydrochloride Accord, as this may increase the risk of lactic acidosis (see section “Warnings and precautions”).
Pregnancy and breastfeeding

If you are pregnant, think you may be pregnant, or are planning to become pregnant, consult your doctor before taking this medicine. Your doctor will discuss with you the potential risks of taking Vildagliptin/Metformin Hydrochloride Accord during pregnancy.
Do not use Vildagliptin/Metformin Hydrochloride Accord if you are pregnant or breastfeeding (see also “Do not take Vildagliptin/Metformin Hydrochloride Accord”).

Consult your doctor or pharmacist before taking any medicine.
Driving and using machines
If you experience dizziness while taking Vildagliptin/Metformin Hydrochloride Accord, do not drive or operate machinery.

3. How to take Vildagliptin/Metformin Hydrochloride Accord

The amount of Vildagliptin/Metformin Hydrochloride Accord you should take varies depending on your individual condition. Your doctor will tell you the exact dose to take. Always take this medicine exactly as your doctor has instructed you. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is one 50 mg/850 mg or 50 mg/1000 mg film-coated tablet taken twice daily.
If you have reduced kidney function, your doctor may prescribe a lower dose. Your doctor may also prescribe a lower dose if you are taking an antidiabetic medicine such as a sulfonamide.
Your doctor may prescribe this medicine alone or together with other medicines that lower blood sugar levels.

When and how to take Vildagliptin/Metformin Hydrochloride Accord

Swallow the tablets whole with a glass of water.
Take one tablet in the morning and one in the evening, with food or immediately after a meal. Taking the tablet immediately after eating may reduce the risk of stomach upset.

Continue to follow any dietary advice your doctor has given you. In particular, if you have diabetes or are following a diet for weight control, continue this during treatment with Vildagliptin/Metformin Hydrochloride Accord.

If you take more Vildagliptin/Metformin Hydrochloride Accord than you should
If you take too many tablets of Vildagliptin/Metformin Hydrochloride Accord, or if someone else takes your tablets, contact your doctor or pharmacist immediately. Medical treatment may be necessary. If you need to see a doctor or go to hospital, take the pack and this leaflet with you.

If you forget to take Vildagliptin/Metformin Hydrochloride Accord
If you forget to take a tablet, take it with your next meal, unless you are due to take another tablet anyway. Do not take a double dose (two tablets together) to make up for a forgotten tablet.

If you stop taking Vildagliptin/Metformin Hydrochloride Accord
Continue taking this medicine for as long as your doctor prescribes it, so that you can keep controlling your blood sugar. Do not stop treatment with Vildagliptin/Metformin Hydrochloride Accord unless your doctor tells you to. If you have any doubts about how long you should take this medicine, consult your doctor.

If you have any questions about the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
You must stop taking Vildagliptin/Hydrochloride Metformin Accord and contact your doctor immediately if any of the following side effects occur:

Lactic acidosis (very rare: may occur in up to 1 person in 10,000): Vildagliptin/Hydrochloride Metformin Accord may cause a very rare but serious side effect called lactic acidosis (see section “Warnings and precautions”). If this occurs, you must stop taking Vildagliptin/Hydrochloride Metformin Accord and seek immediate medical attention at the nearest doctor’s office or hospital, as lactic acidosis can lead to coma.
Angioedema (rare: may occur in up to 1 person in 1,000): symptoms include swelling of the face, tongue or throat, difficulty swallowing, breathing difficulties, sudden appearance of skin rashes or hives, which may indicate a reaction called “angioedema”.
Liver disease (hepatitis) (may affect up to 1 person in 100): 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) (may affect up to 1 person in 100): symptoms include severe and persistent abdominal (stomach area) pain, 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/Hydrochloride Metformin Accord:

Common (may affect up to 1 in 10 people): sore throat, runny nose, fever, itchy rash, excessive sweating, joint pain, dizziness, headache, uncontrollable tremor, constipation, nausea (feeling unwell), vomiting, diarrhoea, flatulence, heartburn, pain inside and around the stomach (abdominal pain).
Uncommon (may affect up to 1 in 100 people): weakness, metallic taste, hypoglycaemia, loss of appetite, swelling of hands, ankles or feet (oedema), chills, inflammation of the pancreas, muscle pain, fatigue.
Very rare (may affect up to 1 in 10,000 people): signs of high levels of lactic acid in the blood (known as lactic acidosis), such as drowsiness or dizziness, severe nausea or vomiting, abdominal pain, irregular heartbeat or rapid and deep breathing; skin redness, itching; reduced levels of vitamin B12 (pallor, fatigue, mental symptoms such as confusion or memory disturbances).

During treatment with Vildagliptin/Hydrochloride Metformin Accord and a sulfonylurea, some patients experienced the following side effects:

Common: dizziness, tremor, weakness, low blood glucose levels, excessive sweating.

During treatment with Vildagliptin/Hydrochloride Metformin Accord and insulin, some patients experienced the following side effects:
The following side effects have also been reported during post-marketing experience with this medicine.

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

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. You can also report side effects directly through the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Vildagliptin/Metformin hydrochloride 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”/”Scad”.
The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
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/Metformin Hydrochloride Accord contains

The active substances are vildagliptin and metformin hydrochloride.
Each film-coated tablet of Vildagliptin/Metformin Hydrochloride Accord 50 mg/850 mg contains 50 mg of vildagliptin and 850 mg of metformin hydrochloride (equivalent to 660 mg of metformin).
Each film-coated tablet of Vildagliptin/Metformin Hydrochloride Accord 50 mg/1000 mg contains 50 mg of vildagliptin and 1000 mg of metformin hydrochloride (equivalent to 780 mg of metformin).
The other components are:
Tablet core: hydroxypropylcellulose, low-substituted hydroxypropylcellulose, microcrystalline cellulose, magnesium stearate.
Film coating: hypromellose, titanium dioxide (E171), yellow iron oxide (E172), macrogol, talc.

Description of the appearance of Vildagliptin/Metformin Hydrochloride Accord and contents of the
pack
Vildagliptin/Metformin Hydrochloride Accord 50 mg/850 mg film-coated tablets
Yellow, oval, biconvex, film-coated tablet, with the letters “GG2” engraved on one side and smooth on the other. Approximate tablet dimensions are 20.15 x 8.00 mm.
Vildagliptin/Metformin Hydrochloride Accord 50 mg/1000 mg film-coated tablets
Dark yellow, oval, biconvex, film-coated tablet, with the letters “GG3” engraved on one side and smooth on the other. Approximate tablet dimensions are 21.11 x 8.38 mm.
Vildagliptin/Metformin Hydrochloride Accord is available in aluminium/aluminium blisters containing 30, 60 or 180 film-coated tablets.
Not all pack sizes may be marketed in your country.

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

Manufacturer
LABORATORI FUNDACIÓ DAU
C/ C, 12-14 Pol. Ind. 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,
95-200 Pabianice, Poland
Accord Healthcare B.V.
Winthontlaan 200, Utrecht, 3526 KV,
The Netherlands
Accord Healthcare single member S.A.
64th Km National Road Athens, Lamia,
Schimatari, 32009, Greece

Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu