Vildagliptin and metformin Krka

Patient Information Leaflet

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

vildagliptin/metformin hydrochloride
Generic medicine
Please read this entire 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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What Vildagliptin and metformin Krka is and what it is used for

The active substances in Vildagliptin and metformin Krka, vildagliptin and metformin, belong to a group of medicines called "oral antidiabetics".
Vildagliptin and metformin Krka 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 Krka is used when diabetes cannot be controlled by diet and exercise alone and/or in combination with other antidiabetic medicines (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 blood sugar levels to rise.
How Vildagliptin and metformin Krka works
Both active substances, vildagliptin and metformin, help control blood sugar levels. The substance vildagliptin works by prompting 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 Krka

Do not take Vildagliptin and metformin Krka

• if you are allergic to vildagliptin or metformin hydrochloride 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 Krka.
• 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 deep breathing, drowsiness and breath with an unusual fruity odour.
• if you have recently had a heart attack or have heart failure or severe circulatory problems or breathing difficulties that may be signs of heart problems.
• if you have severely reduced kidney function.
• if you have a serious infection or are severely dehydrated (your body has lost a lot of water).
• if you are due to have 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 Krka may cause a very rare but very 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, serious infections, prolonged fasting or alcohol consumption, dehydration (see below for further information), liver problems and any other medical condition characterized by reduced oxygen supply to part of the body (such as in the case of severe acute heart disease).
If you have any of the medical conditions described above, consult your doctor for further instructions.
Stop taking Vildagliptin and metformin Krka temporarily if you have a medical condition that may be associated with dehydration (significant loss of body fluids), such as severe vomiting, diarrhoea, fever, exposure to heat, or if you are drinking less fluid than normal. Consult your doctor for further instructions.
Stop taking Vildagliptin and metformin Krka and contact your doctor or the nearest hospital immediately if you experience any of the symptoms of lactic acidosis, because lactic acidosis can lead to coma.
Symptoms of lactic acidosis include:

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

Lactic acidosis is a medical emergency and must be treated in hospital.
Vildagliptin and metformin Krka is not a substitute for insulin. Therefore, Vildagliptin and metformin Krka must not be prescribed for the treatment of type 1 diabetes.
Consult your doctor, pharmacist or nurse before taking Vildagliptin and metformin Krka if you have or have had a disease of the pancreas.
Consult your doctor, pharmacist or nurse before taking Vildagliptin and metformin Krka if you are taking an antidiabetic medicine known as a sulphonylurea. If you take it together with Vildagliptin and metformin Krka, your doctor may wish to reduce your dose of sulphonylurea 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 recommendations for skin and foot care 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 Krka. If this occurs, you should contact your doctor immediately.
If you are undergoing major surgery, you must stop taking Vildagliptin and metformin Krka 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 Krka.
Before starting treatment with Vildagliptin and metformin Krka, 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 and metformin Krka, 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 Krka is not recommended in children and adolescents under 18 years of age.
Other medicines and Vildagliptin and metformin Krka
If you are due to receive an injection of iodinated contrast medium into the bloodstream, for example for an X-ray or radiological examination, you must stop taking Vildagliptin and metformin Krka before or during the injection. Your doctor will decide when to stop and when to restart treatment with Vildagliptin and metformin Krka.
Inform your doctor if you are taking, have recently taken or might take any other medicines. You may need to have more frequent blood glucose and kidney function tests, or your doctor may decide to adjust the dose of Vildagliptin and metformin Krka. It is particularly important to mention the following:

• glucocorticoids, 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 to treat 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 Krka with alcohol
Avoid excessive alcohol consumption during treatment with Vildagliptin and metformin Krka, 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, ask your doctor or pharmacist for advice before taking this medicine. Your doctor will discuss with you the potential risks of taking Vildagliptin and metformin Krka during pregnancy.
• Do not use Vildagliptin and metformin Krka if you are pregnant or breastfeeding (see also “Do not take Vildagliptin and metformin Krka”).

Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
If you feel dizzy when taking Vildagliptin and metformin Krka, do not drive or operate tools or machinery.
Vildagliptin and metformin Krka contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially ‘sodium-free’.

3. How to take Vildagliptin and metformin Krka

The amount of Vildagliptin and metformin Krka you should take varies depending on individual
conditions. Your doctor will tell you exactly the dose of Vildagliptin and metformin Krka to take.
Always take this medicine exactly as instructed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
The recommended dose is one film-coated tablet of 50 mg/850 mg or 50 mg/1000 mg 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 sulfonilurea.
Your doctor may prescribe this medicine alone or together with certain medicines that lower blood sugar levels.
When and how to take Vildagliptin and metformin Krka

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

Continue to follow any dietary advice your doctor has given you. In particular, if you are following a diet for weight control in diabetes, you must continue it during treatment with Vildagliptin and metformin Krka.
If you take more Vildagliptin and metformin Krka than you should
If you take too many tablets of Vildagliptin and metformin Krka, 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, take the pack and this

Patient Information Leaflet

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

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

If you have any questions about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
You must stop taking Vildagliptin and Metformin Krka and contact your doctor immediately if you experience any of the following side effects:

• Lactic acidosis (very rare: may affect up to 1 person in 10,000): Vildagliptin and Metformin Krka 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 Krka and seek immediate medical attention at the nearest doctor or hospital, as lactic acidosis can lead to coma.
• Angioedema (rare: may affect 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) (rare): 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) (frequency not known): symptoms include severe and persistent stomach pain (abdominal area), which may spread to the back, as well as nausea and vomiting.

Other side effects
Some patients experienced the following side effects while taking Vildagliptin and Metformin Krka:

• Very common (may affect more than 1 in 10 people): nausea, vomiting, diarrhoea, stomach or surrounding area pain (abdominal pain), loss of appetite.
• Common (may affect up to 1 in 10 people): dizziness, headache, uncontrollable tremor, metallic taste, low blood glucose levels.
• Uncommon (may affect up to 1 in 100 people): joint pain, fatigue, constipation, swelling of hands, ankles or feet (oedema).
• Very rare (may affect up to 1 in 10,000 people): sore throat, runny nose, fever;

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 sensation; reduced vitamin B12 levels (pallor, fatigue, mental symptoms such as confusion or memory disturbances).
While taking Vildagliptin and Metformin Krka together with a sulfonylurea, some patients experienced the following side effects:

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

While taking Vildagliptin and Metformin Krka together with other diabetes medicines, some patients experienced the following side effects:

• Common: headache, chills, nausea (feeling unwell), low blood glucose levels, stomach burning.

• Uncommon: diarrhoea, flatulence.
  During the marketing of this medicine, the following side effects have also been reported:

• Frequency not known (cannot be estimated based on available data): itchy skin rash, inflammation of the pancreas, localized skin peeling or blisters, muscle pain.

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 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 and metformin Krka

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after "EXP"/"Scad". 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 no longer required. This will help protect the environment.

6. Pack contents and other information

What Vildagliptin and metformin Krka contains

• The active substances are vildagliptin and metformin hydrochloride.
  Vildagliptin and metformin Krka 50 mg/850 mg film-coated tablets: Each film-coated tablet contains 50 mg of vildagliptin and 850 mg of metformin hydrochloride.
  Vildagliptin and metformin Krka 50 mg/1000 mg film-coated tablets: Each film-coated tablet contains 50 mg of vildagliptin and 1000 mg of metformin hydrochloride.
• The other components (excipients) are hydroxypropylcellulose (E463), mannitol (E421), sodium stearate fumarate (E470a) and magnesium stearate (E470b) in the tablet core, and hypromellose (E464), titanium dioxide (E171), talc (E553b), propylene glycol (E1520) and yellow iron oxide (E172) in the tablet coating. See section 2 “Vildagliptin and metformin Krka contains sodium”.

Description of the appearance of Vildagliptin and metformin Krka and pack contents
Vildagliptin and metformin Krka 50 mg/850 mg: brownish-yellow, oval, biconvex film-coated tablets, marked with "V1" on one side. Tablet dimensions: approximately 20 x 11 mm.
Vildagliptin and metformin Krka 50 mg/1000 mg: brownish-yellow, oval, biconvex film-coated tablets, marked with "V2" on one side. Tablet dimensions: approximately 21 x 11 mm.
Vildagliptin and metformin Krka is available in packs containing 10, 30, 60, 120 and 180 film-coated tablets, and in multipacks containing 120 (2 x 60) and 180 (3 x 60) film-coated tablets in blisters.
Not all pack sizes may be marketed.

Marketing Authorization Holder
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Manufacturer
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany

Local representative for Italy
KRKA Farmaceutici Milano S.r.l. - Italy

This medicinal product is authorized in the European Economic Area countries under the following names: