XILIARX 50 MG TABLETS

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Xiliarx 50mg tablets

vildagliptin

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse reactions, consult your doctor, pharmacist or nurse, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents:

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

1. What Xiliarx is and what it is used for

The active substance in Xiliarx, vildagliptin, belongs to a group of medicines called "oral antidiabetics".

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

Type 2 diabetes occurs when the body does not produce enough insulin or when the insulin produced does not work properly. It may also occur when the body produces too much glucagon.

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

How Xiliarx works

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

Even if you start taking this medicine for your diabetes, it is important that you continue with the diet and/or exercise regimen recommended to you.

2. What you need to know before taking Xiliarx

Do not take Xiliarx

• 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 any other component of Xiliarx, do not take this medicine and consult your doctor.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting 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 an antidiabetic medicine known as a sulfonylurea (your doctor may want to reduce your sulfonylurea dose when taken together with Xiliarx to avoid low blood glucose levels [hypoglycaemia]).
• 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 a disease of the pancreas.

If you have previously taken vildagliptin but had to stop due to liver disease, you must not take this medicine.

Skin lesions are common complications of diabetes. Follow your doctor's or nurse's recommendations 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 early as possible any signs indicating an increase in liver enzymes (transaminases).

Children and adolescents

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

Taking Xiliarx with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Your doctor may need to adjust your dose of Xiliarx if you are taking other medicines such as:

• thiazides or other diuretics (also called water tablets)
• corticosteroids (generally used to treat inflammation)
• thyroid medications
• certain medicines that affect the nervous system.

Pregnancy and breastfeeding

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

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

Driving and using machines

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 informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.

Xiliarx contains sodium

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

3. How to take Xiliarx

Follow exactly the instructions for taking this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

How much to take and when

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

The recommended dose of Xiliarx is:

• 50 mg once daily in the morning, if you are taking Xiliarx together with another medicine known as a sulfonamide.
• 100 mg daily in two doses of 50 mg in the morning and at night if you are taking Xiliarx alone, with another medicine known as metformin or a glitazone, with a combination of metformin and a sulfonamide, or with insulin.
• 50 mg daily 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 some water.

Duration of treatment with Xiliarx

• Take Xiliarx every day as long as your doctor tells you to. You may need to continue this treatment for a long period of time.
• Your doctor will carry out periodic 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 medicine, consult your doctor immediately. You may need medical attention. If you have to visit a doctor or go to the nearest hospital, take the pack with you.

If you forget to take Xiliarx

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 the next dose, skip the missed dose. Do not take a double dose to make up for missed doses.

If you stop taking Xiliarx

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

4. Possible adverse effects

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

Some symptoms require immediate medical attention

You must stop taking Xiliarx and contact your doctor immediately if you experience any of the following adverse effects:

• Angioedema (rare: may affect up to 1 in 1,000 people): symptoms including swelling of the face, tongue or throat, difficulty swallowing, difficulty breathing, sudden appearance of rash or hives, which may indicate a reaction called “angioedema”.
• Liver disease (hepatitis) (frequency not known): symptoms including yellowing of the skin and eyes, nausea, loss of appetite, or darkening of the urine, which may indicate liver disease (hepatitis).
• Inflammation of the pancreas (pancreatitis) (rare: may affect up to 1 in 1,000 people): symptoms including severe and persistent abdominal pain (in the stomach area), which may radiate to your back, as well as nausea and vomiting.

Other adverse effects

Some patients experienced the following adverse 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): itchy rash, tremor, headache, dizziness, muscle pain, joint pain, constipation, swollen hands, ankles or feet (edema), excessive sweating, vomiting, stomach and abdominal pain (abdominal pain), diarrhea, heartburn, nausea (feeling unwell), 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 1,000 people): inflammation of the pancreas.

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

• Frequency not known (cannot be estimated from available data): localized skin peeling or blistering, inflammation of blood vessels (vasculitis) which may cause skin rashes or small, flat, red, round spots under the skin surface or bruising.

Reporting of adverse effects

If you experience any type of adverse effect, talk to your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the national reporting system included in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Xiliarx

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date stated on the blister pack and on the outer packaging following “EXP”/”CAD”. The expiry date refers to the last day of the month indicated.
• Store in the original packaging to protect from moisture.
• Do not use Xiliarx if you notice that the packaging is damaged or shows signs of deterioration.
• Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging that you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Xiliarx

• 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.

Appearance of the product and contents of the pack

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

Xiliarx 50 mg tablets are available in packs containing 7, 14, 28, 30, 56, 60, 90, 112, 180 or 336 tablets and in multiple packs consisting of 3 packs, each containing 112 tablets.

Only some pack sizes may be marketed.

Marketing Authorization Holder

Novartis Europharm Limited

Vista Building

Elm Park, Merrion Road

Dublin 4

Ireland

Manufacturer responsible

Lek d.d.

Verovskova ulica 57

Ljubljana 1526

Slovenia

Novartis Farmacéutica S.A.

Gran Via de les Corts Catalanes, 764

08013 Barcelona

Spain

Novartis Pharmaceutical Manufacturing LLC

Verovskova ulica 57

Ljubljana 1000

Slovenia

Novartis Pharma GmbH

Sophie-Germain-Strasse 10

90443 Nuremberg

Germany

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

Date of the most recent review of this leaflet:

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.euopa.eu