Xiliarx

Package leaflet: Information for the user

Xiliarx 50 mg tablets

vildagliptin
Please read all of 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 nurse.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as you, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet

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. It is used when diabetes cannot be controlled by diet and exercise alone. It helps control blood sugar levels. Your doctor will prescribe Xiliarx either alone or in combination with other antidiabetic medicines you are already taking, if these have not been sufficiently effective in controlling your 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, causing blood sugar levels to rise. Both of these substances are produced by the pancreas.
How Xiliarx works
Xiliarx 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 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 to any of the excipients in Xiliarx, do not take this medicine and consult your doctor.

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before taking 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 (if taken together with Xiliarx, your doctor may want to reduce your dose of sulfonylurea 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 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 Xiliarx. If this occurs, you should consult your doctor promptly.
Before starting treatment with Xiliarx, a liver function test will be performed, 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
Xiliarx is not recommended for use in children and adolescents under 18 years of age.

Other medicines and Xiliarx
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Your doctor may need to adjust the dose of Xiliarx 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, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
You must not use Xiliarx during pregnancy. It is not known whether Xiliarx passes into breast milk. You must not use Xiliarx if you are breastfeeding or planning to breastfeed.

Driving and using machines
If you experience dizziness while taking Xiliarx, do not drive or operate machinery.

Xiliarx contains lactose
Xiliarx contains lactose (milk sugar). If your doctor has diagnosed you with an intolerance to certain sugars, contact your doctor before taking this medicine.

Xiliarx contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, therefore it is essentially ‘sodium-free’.

3. How to take Xiliarx

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

• 50 mg once daily in the morning if you are taking Xiliarx 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 Xiliarx 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 kidney disease or are on dialysis.

How to take Xiliarx

• Take the tablets with some water.

How long to take Xiliarx

• Take Xiliarx 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 check your condition to ensure the treatment is working as intended.

If you take more Xiliarx than you should
If you take too many Xiliarx 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, bring 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 your next dose at the 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 tablet.
If you stop taking Xiliarx
Do not stop taking Xiliarx unless your doctor tells you to. If you have any doubts about how long you should continue treatment with this medicine, speak to your doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
Some symptoms require immediate medical attention:
You must stop taking Xiliarx and contact your doctor immediately if you experience any of the
following side effects:

• Angioedema (rare: may occur in 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) (frequency not known): 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) (rare: may occur in up to 1 in 1,000 people). Symptoms include severe and persistent pain in the abdomen (stomach area), which may extend to the back, as well as nausea and vomiting.

Other side effects
While taking Xiliarx, some patients have experienced the following side effects:

• Very common (may occur in more than 1 in 10 people): sore throat, runny nose, fever
• Common (may occur in up to 1 in 10 people): itchy rash, tremor, headache, dizziness, muscle pain, joint pain, constipation, swelling of hands, ankles or feet (oedema), excessive sweating, vomiting, stomach and abdominal pain (abdominal pain), diarrhoea, heartburn, nausea (feeling sick), blurred vision.
• Uncommon (may occur in up to 1 in 10 people): weight gain, chills, weakness, sexual dysfunction, low blood sugar levels, flatulence.
• Rare (may occur in up to 1 in 1,000 people): inflammation of the pancreas.

The following side effects have also been reported during the marketing of this medicine:

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

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. You can also report side effects directly via the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Xiliarx

• 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 carton after "EXP"/"Scad.". The expiry date refers to the last day of that month.
• Store in the original packaging to protect the medicine from moisture.
• Do not use any Xiliarx pack that is damaged or shows signs of tampering.
• Do not dispose of medicines 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 Xiliarx contains

• The active substance is vildagliptin. Each tablet contains 50 mg of vildagliptin.
• The other ingredients are anhydrous lactose, microcrystalline cellulose, sodium starch glycolate (type A), and magnesium stearate.

Description of the appearance of Xiliarx and pack sizes
Xiliarx 50 mg tablets are round, flat, white to slightly yellowish, with "NVR" engraved 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 containing 3 boxes, each box containing 112 tablets.
Not all pack sizes may be marketed in your country.

Marketing Authorization Holder
Novartis Europharm Limited
Vista Building
Elm Park, Merrion Road
Dublin 4
Ireland

Manufacturers
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

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

België/Belgique/Belgien Lietuva
Novartis Pharma N.V. SIA Novartis Baltics Lietuvos filialas
Tél/Tel: +32 2 246 16 11 Tel: +370 5 269 16 50

България Luxembourg/Luxemburg
Novartis Bulgaria EOOD Novartis Pharma N.V.
Тел.: +359 2 489 98 28 Tél/Tel: +32 2 246 16 11

Česká republika Magyarország
Novartis s.r.o. Novartis Hungária Kft.
Tel: +420 225 775 111 Tel.: +36 1 457 65 00

Danmark Malta
Novartis Healthcare A/S Novartis Pharma Services Inc.
Tlf: +45 39 16 84 00 Tel: +356 2122 2872

Deutschland Nederland
Novartis Pharma GmbH Novartis Pharma B.V.
Tel: +49 911 273 0 Tel: +31 88 04 52 111

Eesti Norge
SIA Novartis Baltics Eesti filiaal Novartis Norge AS
Tel: +372 66 30 810 Tlf: +47 23 05 20 00

Ελλάδα Österreich
Novartis (Hellas) A.E.B.E. Novartis Pharma GmbH
Τηλ: +30 210 281 17 12 Tel: +43 1 86 6570

España Polska
Laboratorios Gebro Pharma, S.A. Novartis Poland Sp. z o.o.
Tel: +34 93 205 86 86 Tel.: +48 22 375 4888

France Portugal
Novartis Pharma S.A.S. Laboratório Normal – Produtos Farmacêuticos
Tél: +33 1 55 47 66 00 Lda.
Tel. +351 21 000 8600

Hrvatska România
Novartis Hrvatska d.o.o. Novartis Pharma Services Romania SRL
Tel. +385 1 6274 220 Tel: +40 21 31299 01

Ireland Slovenija
Novartis Ireland Limited Novartis Pharma Services Inc.
Tel: +353 1 260 12 55 Tel: +386 1 300 75 50

Ísland Slovenská republika
Vistor hf. Novartis Slovakia s.r.o.
Sími: +354 535 7000 Tel: +421 2 5542 5439

Italia Suomi/Finland
Novartis Farma S.p.A. Novartis Finland Oy
Tel: +39 02 96 54 1 Puh/Tel: +358 (0)10 6133 200

Κύπρος Sverige
Novartis Pharma Services Inc. Novartis Sverige AB
Τηλ: +357 22 690 690 Tel: +46 8 732 32 00

Latvija United Kingdom (Northern Ireland)
SIA Novartis Baltics Novartis Ireland Limited
Tel: +371 67 887 070 Tel: +44 1276 698370

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