VILDAGLIPTIN 50 mg/850 mg Film-Coated Tablets

Содержание инструкции

1. Vildagliptin and Metformin Sandoz 50 mg/850 mg film-coated tablets, mg/1000 mg film-coated tablets
   1. What Vildagliptin and Metformin Sandoz is and what it is used for
   2. What you need to know before taking Vildagliptin and Metformin Sandoz
   3. How to take Vildagliptin and Metformin Sandoz
   4. Possible side effects
   5. How to store Vildagliptin and Metformina Sandoz
   6. Package Contents and Other Information

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

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

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

The active substances of 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.
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.
Both insulin and glucagon are produced in the pancreas. Insulin helps to 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 to control blood
sugar levels. The substance vildagliptin works by inducing the pancreas to produce more insulin and less glucagon.
The substance metformin works by helping the body to make better use of insulin. This medicine has been
shown to reduce blood sugar. This can help to prevent
complications resulting 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, to metformin or to any of the other ingredients of this medicine (listed in section 6). If you think you may be allergic to any of these substances, ask your doctor before taking Vildagliptin and Metformin Sandoz.
• if you have uncontrolled diabetes associated with, for example, severe high blood sugar (high levels of glucose in the blood), 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 can lead to diabetic pre-coma. Symptoms include stomach pain, rapid and deep breathing, drowsiness and breath with an unusually fruity odour.
• if you have recently had a heart attack or if you have heart failure or severe circulatory problems or difficulty breathing which may be a sign 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 going to have an X-ray examination with a contrast agent (a particular type of X-ray that involves the use of a dye injected into the bloodstream). See also the information in the “Warnings and precautions” section.
• if you have liver problems.
• if you drink excessive amounts of alcohol (whether you do it daily or only occasionally).
• if you are breastfeeding (see also “Pregnancy and breastfeeding”).

Warnings and precautions
Risk of lactic acidosis
Vildagliptin and Metformin Sandoz can cause a very rare but very serious side effect
called lactic acidosis, particularly if your kidneys do not function 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 more information), liver problems and any other
medical condition characterised by a reduced supply of oxygen to a part
of the body (such as in the case of severe heart disease).
If you have any of the medical conditions described above, ask your doctor for further instructions.

Stop taking Vildagliptin and Metformin Sandoz for a short period of time 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 drink less fluids than usual. Ask your
doctor for further instructions.

If you experience any of the symptoms of lactic acidosis, stop taking Vildagliptin and
Metformin Sandoz and contact your doctor or the nearest hospital immediately, because lactic acidosis
can lead to coma.
The symptoms of lactic acidosis include:

• vomiting
• stomach pain (abdominal pain)
• muscle cramps
• a general feeling of unwellness with severe tiredness
• difficulty breathing
• decreased body temperature and slower heartbeat

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.
Ask your doctor, pharmacist or diabetes specialist nurse before taking
Vildagliptin and Metformin Sandoz if you have or have had a disease of the pancreas.
Ask your doctor, pharmacist or diabetes specialist nurse before taking Vildagliptin
and Metformin Sandoz if you are taking a medicine for diabetes known as a sulphonylurea. If you
take it together with Vildagliptin and Metformin Sandoz, your doctor may want to reduce your dose
of sulphonylurea, to avoid low blood sugar (hypoglycaemia).
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. 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 formation of new blisters or ulcers when
taking Vildagliptin and Metformin Sandoz. If this happens, you should contact your doctor immediately.
If you are going to have major surgery, you should stop taking Vildagliptin
and Metformin Sandoz during the surgery and for a certain period of time afterwards. Your
doctor will decide when you should stop and when you should resume treatment with Vildagliptin and
Metformin Sandoz.
Before starting treatment with Vildagliptin and Metformin Sandoz, a test will be performed
to assess liver function, which will be repeated every three months during the first year of treatment
and subsequently periodically. This is to detect signs of increased liver enzymes as early as possible.
During treatment with Vildagliptin and Metformin Sandoz, your doctor will check 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 also regularly check your blood sugar and urine.

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 going to have an iodine-containing contrast agent injected into your bloodstream, for example
to perform an X-ray, you should stop taking Vildagliptin and Metformin Sandoz
before or during the injection. Your doctor will decide when you should stop and when you should resume
treatment with Vildagliptin and Metformin Sandoz.
Tell your doctor if you are taking, have recently taken or might take any other
medicines. You may need to have your blood sugar and kidney function checked more often, or your doctor may decide to adjust the dose of Vildagliptin and Metformin
Sandoz. 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)
• some medicines for the treatment of high blood pressure (ACE inhibitors and angiotensin II receptor antagonists)
• certain medicines that affect the thyroid or
• certain medicines that affect the nervous system

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 “Warnings and precautions” section).

Pregnancy and breastfeeding

• If you are pregnant, suspect you are pregnant or are planning to become pregnant, ask your doctor for advice 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 feel dizzy while taking Vildagliptin and Metformin Sandoz, do not drive or use machines.

3. How to take Vildagliptin and Metformin Sandoz

The amount of Vildagliptin and Metformin Sandoz that you need to take varies depending on individual
conditions. Your doctor will tell you exactly the dose to take.
Take this medicine following always exactly the instructions of the doctor. If you have doubts consult your
doctor or pharmacist.
The recommended dose is one film-coated tablet with 50 mg/850 mg or 50 mg/1000 mg taken
twice a day.
If you have reduced kidney function, your doctor may prescribe you a lower dose. Your doctor may
prescribe you a lower dose also if you are taking an antidiabetic known as a sulfonylurea.
The doctor may prescribe you this medicine alone or with some medicines that lower the level of
sugar in the blood.

When and how to take Vildagliptin and Metformin Sandoz

• Take 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 discomfort.

Continue to follow any dietary advice that your doctor has given you, in particular if you are following a
diet for weight control in case of diabetes, you must continue it during the therapy 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, seek immediate medical advice from your doctor or pharmacist. Medical treatment may be
needed. If you need to go to a doctor or to the hospital, take with you the package and this leaflet.

If you forget to take Vildagliptin and Metformin Sandoz
If you forget to take a tablet, take it with the next meal, unless you still have to
take one. Do not take a double dose (two tablets together) to make up for the
forgotten tablet.

If you stop taking Vildagliptin and Metformin Sandoz
Continue to take this medicine as long as your doctor prescribes it so that you can
continue to control your blood sugar. Do not stop the treatment with Vildagliptin and
Metformin Sandoz unless your doctor tells you to do so. If you have any doubt about how long to take
this medicine, ask your doctor.
If you have any doubt about the use of this medicine, ask your doctor, pharmacist or
the 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 immediatelyif any of the following side effects occur:

Lactic acidosis(very rare: may affect up to 1 in 10,000 people)
Vildagliptin and Metformin Sandoz can cause a very rare but very serious side effect called lactic acidosis (see section “Warnings and precautions”). If this happens, you must stop taking Vildagliptin and Metformin Sandoz and immediately contact your doctor or the nearest hospital, because lactic acidosis can lead to coma.

• Angioedema (rare: may affect up to 1 in 1,000): 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) (rare): 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) (frequency not known). 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 and Metformin
Sandoz:

• Very common (may affect more than 1 in 10 people): nausea, vomiting, diarrhoea, stomach pain or discomfort (abdominal pain), loss of appetite.
• Common (may affect up to 1 in 10 people): dizziness, headache, inability to control urges, 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 (edema).
• Very rare (may affect up to 1 in 10,000): sore throat, runny nose, fever; signs of high lactic acid levels 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 (paleness, fatigue, mental symptoms such as confusion or memory problems).

While taking Vildagliptin and Metformin Sandoz and a sulfonylurea, some patients have experienced the following side effects:

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

While taking Vildagliptin and Metformin Sandoz and insulin, some patients have experienced the following side effects:

• Common: headache, chills, nausea (feeling sick), low blood glucose levels, heartburn.
• Uncommon: diarrhoea, flatulence.

The following side effects have also been reported during the post-marketing of this medicine.

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

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or diabetes specialist nurse.
You can also report side effects directly through the national reporting system at www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-
avversa . By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Vildagliptin and Metformina Sandoz

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 package after
“Exp”. The expiry date refers to the last day of that month.
Do not store at a temperature above 30°C.
Store in the original package to protect the medicine from moisture.
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. Package Contents and Other Information

What Vildagliptin and Metformin Sandoz contains

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

Description of the appearance of Vildagliptin and Metformin Sandoz and package contents
Vildagliptin and Metformin Sandoz 50 mg/850 mg film-coated tablets
Film-coated tablets of yellow color, oval with beveled edges, with “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
Film-coated tablets of dark yellow color, oval with beveled edges, with “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 Aluminum/Aluminum (PA/Alu/PVC//Alu) blisters,
in polychlorotrifluoroethylene (PCTFE)/PVC//Alu blisters or in
Polyvinyl chloride/Polyethylene/Polyvinylidene chloride/Aluminum (PVC/PE/PVDC//Alu) blisters.
Available in packs containing 10, 30, 60, 120 or 180 film-coated tablets and in multiple packs
containing 120 (2x60) or 180 (3x60) film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Sandoz S.p.A.
L.go U. Boccioni 1
21040 Origgio (VA)
Italy

Manufacturers
Novartis Pharma GmbH, Roonstrasse 25, 90429 Nürnberg, Germany
Lek Pharmaceuticals d.d., Verovškova ulica 57, 1526 Ljubljana, Slovenia
Salutas Pharma GmbH, Otto-von-Guericke-Allee 1, 39179 Sachsen-Anhalt, Barleben, Germany
Lek d.d., Trimlini 2D, 9220 Lendava, Slovenia
Austria Vildagliptin/Metformin 1A Pharma 50 mg/850 mg – Filmtabletten
Vildagliptin/Metformin 1A Pharma 50 mg/1000 mg – Filmtabletten
Germany Vildagliptin/Metformin-HCl – 1 A Pharma® 50 mg/850 mg Filmtabletten
Vildagliptin/Metformin-HCl – 1 A Pharma® 50 mg/1000 mg Filmtabletten
Italy Vildagliptin e Metformina Sandoz