Package Insert: Information for the User

Xiliarx 50 mg Tablets

vildagliptina

Read this package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medication has been prescribed only for you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this package insert. See section 4.

1.What Xiliarx is and for what it is used

2.What you need to know before starting to take Xiliarx

3.How to take Xiliarx

4.Possible adverse effects

5.Storage of Xiliarx

6.Contents of the package and additional information

The active ingredient of Xiliarx, vildagliptin, belongs to a group of medications called «oral antidiabetics».

Xiliarx is used to treat adult patients with type 2 diabetes when the diabetes cannot be controlled solely by diet and exercise. It helps to control blood sugar levels. Your doctor will prescribe Xiliarx alone or in combination with other oral antidiabetic medications you are already taking if these are not sufficient to control the diabetes.

Type 2 diabetes appears if the body does not produce enough insulin or if the insulin produced does not function properly. It can also appear if the body produces too much glucagon.

Insulin is a substance that helps to reduce blood sugar levels, especially after meals. Glucagon is a substance that promotes the production of sugar by the liver and causes blood sugar levels to increase. Both substances are produced in the pancreas.

How Xiliarx works

Xiliarx stimulates the pancreas to produce more insulin and less glucagon. This helps to control blood sugar levels.This medication has been shown to reduce blood sugar levels, which will help to prevent complications of your diabetes.

Although you start taking this medication for your diabetes, it is essential that you continue with the diet and/or exercise that have been recommended to you.

Do not take Xiliarx

• If you are allergic to vildagliptin or any of the other components of this medication (listed in section 6). If you think you may be allergic to vildagliptin or any other component of Xiliarx, do not take this medication and consult your doctor.

Warnings and precautions

Consult your doctor, pharmacist or nursebefore starting to take Xiliarx

• If you have type 1 diabetes (i.e., your body does not produce insulin) or if you have a condition called diabetic ketoacidosis.
• If you are taking a diabetes medication known as a sulfonylurea (your doctor may want to reduce your sulfonylurea dose when taken with Xiliarx to avoid low blood sugar [hypoglycemia]).
• If you have moderate or severe kidney disease (you will need to take a lower dose of Xiliarx).
• If you are undergoing dialysis.
• If you have liver disease.
• If you have heart failure.
• If you have or have had pancreatitis.

If you have previously taken vildagliptin but had to stop taking it due to liver disease, do not take this medication.

Skin lesions are common complications of diabetes. Follow the recommendations of your doctor or nurse for skin and foot care, paying special attention to the appearance of blisters or ulcers while taking Xiliarx. If this occurs, you should consult your doctor as soon as possible.

Liver function tests should be performed before starting treatment with Xiliarx, at three-month intervals during the first year, and periodically thereafter. This is done to detect as soon as possible any signs indicating an increase in liver enzymes (transaminases).

Children and adolescents

The administration of Xiliarx is not recommended in children and adolescents under 18 years of age.

Use of Xiliarx with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

Your doctor may change your Xiliarx dose if you are taking other medications such as:

• Thiazides or other diuretics (also known as urine medications)
• Corticosteroids (usually used to treat inflammation)
• Thyroid medications
• Certain medications that affect the nervous system.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or if you think you may be pregnant or plan to become pregnant, consult your doctor or pharmacist before using this medication.

You should not use Xiliarx during pregnancy. It is unknown whether Xiliarx passes into breast milk. Do not take Xiliarx if you are breastfeeding or plan to breastfeed.

Driving and operating machinery

If you feel dizzy while taking Xiliarx, do not drive or operate tools or machinery.

Xiliarx contains lactose

Xiliarx contains lactose (milk sugar). If your doctor has told you that you have a certain sugar intolerance, consult with him before taking this medication.

Xiliarx contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per tablet; it is essentially "sodium-free".

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

What amount to take and when

The dose of Xiliarx that each person should take varies depending on their condition. Your doctor will indicate exactly the number of Xiliarx tablets you should take. The maximum daily dose is 100 mg.

The recommended dose of Xiliarx is:

• 50 mg once a day in the morning, if you are taking Xiliarx along with another medication known as a sulfonylurea.
• 100 mg per day in two doses of 50 mg in the morning and evening if you are taking Xiliarx alone, with another medication known as metformin or a glitazone, with a combination of metformin and a sulfonylurea, or with insulin.
• 50 mg per day in the morning if you have moderate or severe kidney disease or if you are undergoing dialysis.

How to take Xiliarx

• Swallow the tablet whole with a little water.

Duration of treatment with Xiliarx

• Take Xiliarx every day as your doctor indicates. You may need to follow this treatment for a long period of time.
• Your doctor will perform regular checks to ensure that the treatment is having the desired effect.

If you take more Xiliarx than you should

If you have taken too many Xiliarx tablets, or if someone else has taken your medication, consult your doctor immediately. You may need medical attention. If you need to visit a doctor or go to the nearest hospital, bring the packaging with you.

If you forget to take Xiliarx

If you forget to take a dose of this medication, 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 the missed doses.

If you interrupt treatment with Xiliarx

Do not stop taking Xiliarx unless your doctor tells you to. If you have doubts about the duration of treatment with Xiliarx, consult your doctor.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Some symptoms require immediate medical attention

You should stop taking Xiliarx and see your doctor immediately if you experience any of the following side effects:

• Angioedema (rare: may affect up to 1 in 10,000 people): symptoms that include swollen face, tongue, or throat, difficulty swallowing, difficulty breathing, sudden appearance of hives or urticaria, which may be indicative of a reaction called “angioedema”.
• Liver disease (hepatitis) (unknown frequency): symptoms that include yellowing of the skin and eyes, nausea, loss of appetite, or dark-colored urine, which may be indicative of liver disease (hepatitis).
• Pancreatitis (inflammation of the pancreas) (rare: may affect up to 1 in 10,000 people): symptoms that include intense and persistent abdominal pain (stomach area), which may radiate to your back, as well as nausea and vomiting.

Other side effects

Some patients experienced the following side effects while taking Xiliarx:

• Very common (may affect more than 1 in 10 people): sore throat, nasal congestion, fever.
• Common (may affect up to 1 in 10 people): rash with itching, tremor, headache, dizziness, muscle pain, joint pain, constipation, swollen hands, ankles, or feet (edema), excessive sweating, vomiting, stomach pain and abdominal pain, diarrhea, heartburn, nausea (discomfort), blurred vision.
• Uncommon (may affect up to 1 in 100 people): weight gain, chills, weakness, sexual dysfunction, low blood glucose levels, flatulence.
• Rare (may affect up to 1 in 10,000 people): pancreatitis (inflammation of the pancreas).

Since the marketing of this product, the following side effects have also been reported:

• Unknown frequency (cannot be estimated from available data): localized skin peeling or blisters, inflammation of blood vessels (vasculitis) that may cause skin eruptions or pinpoint, flat, red, and rounded spots under the skin's surface or hematomas.

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this leaflet.You can also report them directly through the national notification system included in theAppendix V.By reporting side effects, you can contribute to providing more information about the safety of this medicine.

• Keep this medication out of the sight and reach of children.
• Do not use this medication after the expiration date that appears on theblisterand on the packaging after “EXP”/”CAD”. The expiration date is the last day of the month indicated.
• Store in the original packaging to protect it from moisture.
• Do not use Xiliarx if you observe that the packaging is damaged or shows signs of deterioration.
• Medications should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and medications that you no longer need. In this way, you will help protect the environment.

Composition of Xiliarx

• The active ingredient is vildagliptin.

Each tablet contains 50mg of vildagliptin.

• The other components are anhydrous lactose, microcrystalline cellulose, sodium starch glycolate (type A) and magnesium stearate.

Appearance of the product and contents of the pack

Xiliarx 50mg tablets are round, white to slightly yellowish, flat tablets with«NVR»on one side and«FB»on the other.

Xiliarx 50mg tablets are available in packs containing7, 14, 28, 30, 56, 60, 90, 112, 180 or 336tablets and in multiple packsformed by 3packs, each containing 112tablets.

Only some pack sizes may be marketed.

Marketing Authorisation Holder

Novartis Europharm Limited

Vista Building

Elm Park, Merrion Road

Dublin 4

Ireland

Responsible for manufacturing

Lek d.d.

Verovskova ulica 57

Ljubljana 1526

Slovenia

Novartis Farmacéutica S.A.

Gran Via de les Corts Catalanes, 764

08013 Barcelona

Spain

Novartis Pharma GmbH

Roonstrasse 25

D-90429 Nuremberg

Germany

Novartis Pharmaceutical Manufacturing LLC

Verovskova ulica 57

Ljubljana 1000

Slovenia

Novartis Pharma GmbH

Sophie-Germain-Strasse 10

90443 Nürnberg

Germany

For further information about this medicinal product, please consult the representative of the marketing authorisation holder in your country:

Last update of the summary of product characteristics:

Other sources of information

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