Vildagliptin and metformin Sandoz: detailed information

Package leaflet: Information for the user

Vildagliptin and Metformin Sandoz 50 mg/850 mg film-coated tablets, mg/1000 mg film-coated tablets

Generic medicine
Please read all of 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 diabetes specialist nurse.
This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as you, because it may be harmful.
If you experience any side effect, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet

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

1. What Vildagliptin and Metformin Sandoz is and what it is used for

The active substances in Vildagliptin and Metformin Sandoz, vildagliptin and metformin, belong to a
group of medicines called "oral antidiabetics".
Vildagliptin and Metformin Sandoz is used to treat adult patients with type 2 diabetes. This type of
diabetes is also known as non-insulin-dependent diabetes mellitus. Vildagliptin and Metformin Sandoz 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, causing an increase in blood
sugar levels.
How Vildagliptin and Metformin Sandoz 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 arising from your diabetes.

2. What you need to know before taking Vildagliptin and Metformin Sandoz

Do not take Vildagliptin and Metformin Sandoz

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 and Metformin Sandoz.
if you have uncontrolled diabetes associated, 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, and 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 that may indicate 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). See also the information provided in the section “Warnings and precautions”.
if you have liver problems.
if you drink alcohol in excess (either daily or occasionally).
if you are breastfeeding (see also “Pregnancy and breastfeeding”).

Warnings and precautions
Risk of lactic acidosis
Vildagliptin and Metformin Sandoz 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 (see below for further information), 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. Contact your doctor immediately for further advice if:

You know you have a hereditary genetic disease affecting the mitochondria (the components that produce energy within cells), such as MELAS (Mitochondrial Encephalopathy, myopathy, Lactic Acidosis and Stroke-like episodes) or maternally inherited diabetes and deafness (MIDD).
You experience any of the following symptoms after starting metformin: seizures, reduced cognitive ability, difficulty with body movements, symptoms indicating nerve damage (e.g. pain or numbness), headache, or hearing loss.

Temporarily stop taking Vildagliptin and Metformin Sandoz 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 fluids than usual. Consult your doctor for further instructions.
If you experience any of the symptoms of lactic acidosis, stop taking Vildagliptin and Metformin Sandoz and seek immediate medical advice from your doctor or the nearest hospital, as lactic acidosis can lead to coma.
Symptoms of lactic acidosis include:

vomiting
stomach pain (abdominal pain)
muscle cramps
a general feeling of malaise associated with severe fatigue
difficulty breathing
reduced body temperature and slower heart rate

Lactic acidosis is a medical emergency and must be treated in hospital.
Vildagliptin and Metformin Sandoz is not a substitute for insulin. Therefore, Vildagliptin and Metformin Sandoz should not be prescribed for the treatment of type 1 diabetes.
Consult your doctor, pharmacist, or diabetes-experienced nurse before taking Vildagliptin and Metformin Sandoz if you have or have had a pancreatic disease.
Consult your doctor, pharmacist, or diabetes specialist nurse before taking Vildagliptin and Metformin Sandoz if you are taking an antidiabetic medicine known as a sulphonylurea. If taken together with Vildagliptin and Metformin Sandoz, your doctor may wish to reduce your sulphonylurea dose to avoid low blood glucose (hypoglycaemia).
If you previously took vildagliptin but had to stop due to liver disease, do 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. You are also advised to pay particular attention to the development of new blisters or ulcers while taking Vildagliptin and Metformin Sandoz. If this occurs, contact your doctor immediately.
If you are undergoing major surgery, you must stop taking Vildagliptin and Metformin Sandoz during the procedure and for a certain period afterwards. Your doctor will decide when to stop and when to restart treatment with Vildagliptin and Metformin Sandoz.
Before starting treatment with Vildagliptin and Metformin Sandoz, a liver function test will be performed, 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 and Metformin Sandoz, your doctor will monitor your kidney function at least once a year, or more frequently if you are elderly and/or if kidney function worsens. Your doctor will regularly check your blood and urine sugar levels.
Children and adolescents
The use of Vildagliptin and Metformin Sandoz is not recommended in children and adolescents under 18 years of age.
Other medicines and Vildagliptin and Metformin Sandoz
If you are due to receive an injection of iodinated contrast medium into the bloodstream, for example for an X-ray, you must stop taking Vildagliptin and Metformin Sandoz before or during the injection. Your doctor will decide when to stop and when to restart treatment with Vildagliptin and Metformin Sandoz.
Inform your doctor if you are taking, have recently taken, or might take any other medicines. You may need to monitor your blood glucose and kidney function more frequently, or your doctor may decide to adjust the dose of Vildagliptin and Metformin Sandoz. It is particularly important to mention the following:

corticosteroids, generally used to treat inflammation
beta-2 agonists, generally used to treat respiratory disorders
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)
certain medicines used to treat high blood pressure (ACE inhibitors and angiotensin II receptor antagonists)
certain medicines affecting the thyroid gland
certain medicines affecting the nervous system
certain medicines used to treat angina (e.g., ranolazine)
certain medicines used to treat HIV infection (e.g., dolutegravir)
certain medicines used to treat a specific type of thyroid cancer (medullary thyroid cancer) (e.g., vandetanib)
certain medicines used to treat heartburn and peptic ulcers (e.g., cimetidine)

Vildagliptin and Metformin Sandoz with alcohol
Avoid excessive alcohol consumption during treatment with Vildagliptin and Metformin Sandoz, 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 a pregnancy, consult your doctor before taking this medicine. Your doctor will discuss with you the potential risks of taking Vildagliptin and Metformin Sandoz during pregnancy.
Do not use Vildagliptin and Metformin Sandoz if you are pregnant or breastfeeding (see also “Do not take Vildagliptin and Metformin Sandoz”).

Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
If you experience dizziness while taking Vildagliptin and Metformin Sandoz, do not drive or operate machinery.

3. How to take Vildagliptin and Metformin Sandoz

The amount of Vildagliptin and Metformin Sandoz you should take varies depending on your individual condition. Your doctor will tell you exactly what dose to take.
Always take this medicine exactly as your doctor has instructed. 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 known as a sulphonylurea.
Your doctor may prescribe this medicine alone or together with certain other medicines that lower blood sugar levels.

When and how to take Vildagliptin and Metformin Sandoz

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 disturbances.

Continue to follow all dietary advice given by your doctor, especially if you are on a diet for weight control in diabetes. You should continue this diet during treatment with Vildagliptin and Metformin Sandoz.

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

If you forget to take Vildagliptin and Metformin Sandoz
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 and Metformin Sandoz
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 and Metformin Sandoz unless your doctor tells you to. If you have any doubts about how long to take this medicine, consult your doctor.

If you have any questions about how to use this medicine, ask your doctor, pharmacist, or diabetes specialist nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
You must stop taking Vildagliptin and Metformin Sandoz and contact your doctor immediately if you experience any of the following side effects:
Lactic acidosis (very rare: may affect up to 1 in 10,000 people)
Vildagliptin and Metformin Sandoz 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 and Metformin Sandoz and seek immediate medical attention at the nearest hospital, as lactic acidosis can lead to coma.

Angioedema (rare: may affect up to 1 in 1,000 people): 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) (uncommon: may affect up to 1 in 100 people). 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) (uncommon: may affect up to 1 in 100 people). Symptoms include severe and persistent stomach (abdominal) pain, 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 and Metformin Sandoz:

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 sick), vomiting, diarrhoea, flatulence, heartburn, stomach pain and pain around the stomach (abdominal pain).
Uncommon (may affect up to 1 in 100 people): tiredness, weakness, metallic taste, low blood glucose levels, loss of appetite, swelling in hands, ankles or feet (oedema), chills, inflammation of the pancreas, muscle pain.
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 deep breathing; skin redness, itching; reduced levels of vitamin B12 (pallor, tiredness, mental symptoms such as confusion or memory disturbances).

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, 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, pharmacist, or diabetes specialist nurse.
You can also report side effects directly via the national reporting system at 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 and Metformin Sandoz

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 packaging following "Exp". The expiry date refers to the last day of that month.
Do not store above 30°C.
Store in the original packaging to protect the medicine from moisture.
Do not dispose of any medicine 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 and Metformin Sandoz contains

The active substances are vildagliptin and metformin hydrochloride.
Vildagliptin and Metformin Sandoz 50 mg/850 mg film-coated tablets
Each film-coated tablet contains 50 mg of vildagliptin and 850 mg of metformin hydrochloride (equivalent to 660 mg of metformin).
Vildagliptin and Metformin Sandoz 50 mg/1000 mg film-coated tablets
Each film-coated tablet contains 50 mg of vildagliptin and 1000 mg of metformin hydrochloride (equivalent to 780 mg of metformin).
The other components are: hydroxypropylcellulose, magnesium stearate, hypromellose 2910 3 cP, titanium dioxide (E 171), yellow iron oxide (E 172), macrogol 4000 and talc.

Description of the appearance of Vildagliptin and Metformin Sandoz and the contents of the pack
Vildagliptin and Metformin Sandoz 50 mg/850 mg film-coated tablets
Yellow, oval-shaped, film-coated tablets with bevelled edges, marked “NVR” on one side and “SEH” on the other.
Length: approximately 20.1 mm
Width: approximately 8.0 mm
Vildagliptin and Metformin Sandoz 50 mg/1000 mg film-coated tablets
Dark yellow, oval-shaped, film-coated tablets with bevelled edges, marked “NVR” on one side and “FLO” on the other.
Length: approximately 21.1 mm
Width: approximately 8.4 mm
Vildagliptin and Metformin Sandoz is packaged in aluminium/aluminium blisters (PA/Alu/PVC//Alu) or in polyvinyl chloride/polyethylene/polyvinylidene chloride/aluminium blisters (PVC/PE/PVDC//Alu).
Available in packs containing 10, 30, 60, 120 or 180 film-coated tablets, and in multipacks containing 120 (2 x 60) or 180 (3 x 60) film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Sandoz S.p.A.
Viale Luigi Sturzo 43
20154 Milan
Italy

Manufacturer
Lek Pharmaceuticals d.d., Verovškova ulica 57, 1526 Ljubljana, Slovenia
Salutas Pharma GmbH, Otto-von-Guericke-Allee 1, 39179 Saxony-Anhalt, Barleben, Germany
Lek d.d., Trimlini 2D, 9220 Lendava, Slovenia
Novartis Pharmaceutical Manufacturing LLC, Verovškova ulica 57, 1000 Ljubljana, Slovenia
Novartis Farmacéutica, S.A., Gran Via de les Corts Catalanes, 764, 08013 Barcelona, Spain

This medicinal product is authorized in the European Economic Area countries under the following names:
Austria Vildagliptin/Metformin 1A Pharma 50 mg/850 mg – Film tablets
Vildagliptin/Metformin 1A Pharma 50 mg/1000 mg – Film tablets
Germany Vildagliptin/Metformin-HCl – 1 A Pharma® 50 mg/850 mg Film tablets
Vildagliptin/Metformin-HCl – 1 A Pharma® 50 mg/1000 mg Film tablets
Italy Vildagliptin e Metformina Sandoz