Vildagliptin Sandoz

Package leaflet: Information for the patient

Vildagliptin Sandoz 50 mg tablets

Generic medicine
Please read this leaflet carefully before 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 diabetes specialist nurse.
• 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, inform your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

The active substance in Vildagliptin Sandoz, vildagliptin, belongs to a group of medicines called
"oral antidiabetics".
Vildagliptin Sandoz 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 Sandoz 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, thereby increasing blood sugar levels. Both substances are produced by the pancreas.
How Vildagliptin Sandoz works
Vildagliptin Sandoz 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 levels. 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 Sandoz

Do not take Vildagliptin Sandoz:

• 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 other ingredients of Vildagliptin Sandoz, do not take this medicine and consult your doctor.

Warnings and precautions
Talk to your doctor, pharmacist, or diabetes nurse before taking
Vildagliptin Sandoz

• if you have type 1 diabetes (that is, 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 Sandoz, your doctor may wish to reduce your dose of sulfonylurea to avoid low blood glucose, hypoglycaemia).
• if you have moderate or severe kidney disease (a lower dose of Vildagliptin Sandoz will be required).
• 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 Sandoz. If this occurs, you should consult your doctor promptly.
Before starting treatment with Vildagliptin Sandoz, 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.
Children and adolescents
The use of Vildagliptin Sandoz is not recommended in children and adolescents under 18 years of age.
Other medicines and Vildagliptin Sandoz
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Your doctor may wish to adjust the dose of Vildagliptin Sandoz 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 may 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 Sandoz during pregnancy. It is not known whether Vildagliptin Sandoz passes into breast milk. You must not use Vildagliptin Sandoz if you are breastfeeding or plan to breastfeed.
Driving and using machines
If you feel dizzy when taking Vildagliptin Sandoz, do not drive or operate machinery.
Vildagliptin Sandoz contains lactose
Vildagliptin Sandoz contains lactose (milk sugar). If your doctor has diagnosed you with an intolerance to certain sugars, contact him or her before taking this medicine.

3. How to take Vildagliptin Sandoz

Take this medicine exactly as instructed by your doctor. If you have any doubts, consult your
doctor or pharmacist.
How much to take and when
The amount of Vildagliptin Sandoz you need to take depends on your individual condition.
Your doctor will tell you exactly how many Vildagliptin Sandoz tablets to take. The maximum
daily dose is 100 mg.
The usual dose of Vildagliptin Sandoz is:

• 50 mg once daily in the morning if you are taking Vildagliptin Sandoz with another medicine called a sulfonylurea.
• 100 mg daily taken as 50 mg in the morning and 50 mg in the evening if you are taking Vildagliptin Sandoz alone, with another medicine called metformin or a glitazone, with a combination of metformin and a sulfonylurea, or with insulin.
• 50 mg once daily in the morning if you have moderate or severe renal impairment or are on dialysis.

How to take Vildagliptin Sandoz

• Take the tablets with some water.

How long to take Vildagliptin Sandoz

• Take Vildagliptin Sandoz 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 monitor your condition to ensure the treatment is achieving the desired effect.

If you take more Vildagliptin Sandoz than you should
If you take too many Vildagliptin Sandoz tablets, or if someone else has taken your medicine,
contact your doctor immediately. Medical treatment may be necessary. If you need to see
a doctor or go to hospital, take the pack with you.
If you forget to take Vildagliptin Sandoz
If you forget to take a dose of this medicine, take it as soon as you remember. Then take
the next dose at your 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 a forgotten tablet.
If you stop taking Vildagliptin Sandoz
Do not stop taking Vildagliptin Sandoz unless your doctor tells you to. If you have any doubts about
how long you should continue treatment with this medicine, consult your doctor.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Some symptoms require immediate medical treatment:
You must stop taking Vildagliptin Sandoz 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) (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 pain in the abdomen (stomach 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:

• Common (may affect up to 1 in 10 people): tremor, headache, dizziness, nausea, low blood glucose levels.
• Uncommon (may affect up to 1 in 100 people): fatigue.

Some patients experienced the following side effects while taking vildagliptin and a sulfonamide:

• Common: tremor, headache, dizziness, weakness, low blood glucose levels.
• Uncommon: constipation.
• Very rare (may affect up to 1 in 10,000 people): sore throat, runny nose.

Some patients experienced the following side effects while taking vildagliptin and a glitazone:

• Common: weight gain, swelling of hands, ankles or feet (oedema).
• Uncommon: headache, weakness, low blood glucose levels.

Some patients experienced the following side effects while taking vildagliptin alone:

• Common: dizziness.
• Uncommon: headache, constipation, swelling of hands, ankles or feet (oedema), joint pain, low blood glucose levels.
• Very rare: sore throat, runny nose, fever.

Some patients experienced the following side effects while taking vildagliptin, metformin and a sulfonamide:

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

Some patients experienced the following side effects while taking vildagliptin and insulin (with or without metformin):

• Common: headache, chills, nausea (feeling unwell), low blood glucose levels, heartburn.
• 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, pharmacist or diabetes specialist nurse.
You can also report side effects directly via 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 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 on the carton
after “Exp.”. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
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 Sandoz 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 Sandoz and contents of the pack
Vildagliptin Sandoz 50 mg tablets are round, flat, white to slightly yellowish, with "NVR" engraved on one side and "FB" on the other.
Aluminium/Aluminium (PA/Al/PVC//Al) blisters.
Vildagliptin Sandoz 50 mg tablets are available in packs containing 7, 14, 28, 30, 56, 60, 90, 112, 180 or 336 tablets, and in multiple packs containing 3 boxes, each box containing 112 tablets.
Not all pack sizes may be marketed.

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

Manufacturer
Novartis Pharma GmbH
Roonstrasse 25
90429 Nuremberg
Germany
Lek Pharmaceuticals d.d.
Verovškova 57
1526 Ljubljana
Slovenia
Salutas Pharma GmbH
Otto-von-Guericke-Allee 1
Sachsen-Anhalt, 39179 Barleben
Germany

Austria Vildagliptin Sandoz 50 mg - Tablets
Belgium Vildagliptin Sandoz 50 mg tablets
Germany Vildagliptin HEXAL 50 mg Tablets
Greece Vildagliptin/Sandoz
France Vildagliptine Sandoz 50 mg, comprimé
Italy Vildagliptin Sandoz
Netherlands Vildagliptine Sandoz 50 mg, tabletten
Portugal Vildagliptina Sandoz
Czech Republic Vildagliptin Sandoz
Slovakia Vildagliptin Sandoz 50 mg
Spain Vildagliptina Sandoz 50 mg comprimidos EFG