Xiliarx - patient leaflet, side effects, dosage

1. What Xiliarx is and what it is used for

The active substance of 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 to control the level of sugar in the blood. Your doctor will prescribe Xiliarx either alone or together with certain other antidiabetic medicines which you will already be taking, if these have not proved sufficiently effective to control diabetes.

Type 2 diabetes develops if the body does not make enough insulin or if the insulin that the body makes does not work as well as it should. It can also develop if the body produces too much glucagon.

Insulin is a substance which helps to lower the level of sugar in the blood, especially after meals. Glucagon is a substance which triggers the production of sugar by the liver, causing the blood sugar level to rise. The pancreas makes both of these substances.

How Xiliarx works

Xiliarx works by making the pancreas produce more insulin and less glucagon. This helps to control the blood sugar level. This medicine has been shown to reduce blood sugar, which may help to prevent complications from your diabetes. Even though you are now starting a medicine for your diabetes, it is important that you continue to follow the diet and/or exercise which has been recommended for you.

2. What you need to know before you take Xiliarx

Do not take Xiliarx:

• if you are allergic to vildagliptin or any of the other ingredients of this medicine (listed in

section 6). If you think you may be allergic to vildagliptin or any of the other ingredients of Xiliarx, do not take this medicine and talk to 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 anti-diabetic medicine known as a sulphonylurea (your doctor may want to

reduce your dose of the sulphonylurea when you take it together with Xiliarx in order to avoid low blood glucose [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 have previously taken vildagliptin but had to stop taking it because of liver disease, you should not take this medicine.

Diabetic skin lesions are a common complication of diabetes. You are advised to follow the recommendations for skin and foot care that you are given by your doctor or nurse. You are also advised to pay particular attention to new onset of blisters or ulcers while taking Xiliarx. Should these occur, you should promptly consult your doctor.

A test to determine your liver function will be performed before the start of Xiliarx treatment, at threemonth intervals for the first year and periodically thereafter. This is so that signs of increased liver enzymes can be detected as early as possible.

Children and adolescents

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

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 wish to alter 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 medicines

• – certain medicines affecting the nervous system.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

You should not use Xiliarx during pregnancy. It is not known if Xiliarx passes into breast milk. You should not use Xiliarx if you are breast-feeding or plan to breast-feed.

Driving and using machines

If you feel dizzy while taking Xiliarx, do not drive or use machines.

Xiliarx contains lactose

Xiliarx contains lactose (milk sugar). If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

Xiliarx contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium free’.

3. How to take Xiliarx

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

How much to take and when

The amount of Xiliarx people have to take varies depending on their condition. Your doctor will tell you exactly how many tablets of Xiliarx to take. The maximum daily dose is 100 mg.

The usual dose of Xiliarx is either:

• 50 mg daily taken as one dose in the morning if you are taking Xiliarx with another medicine

called a sulphonylurea.

• 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 sulphonylurea, or with insulin.

• 50 mg daily in the morning if you have moderate or severe kidney disease or if you are on

dialysis.

How to take Xiliarx

• Swallow the tablets whole with some water.

How long to take Xiliarx

• Take Xiliarx every day for as long as your doctor tells you. You may have to take this treatment

over a long period of time.

• Your doctor will regularly monitor your condition to check that the treatment is having the

desired effect.

If you take more Xiliarx than you should

If you take too many Xiliarx tablets, or if someone else has taken your medicine, talk to your doctor straight away. Medical attention may be needed. If you need to see a doctor or go to the 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 your next dose at the usual time. If it is almost time for your next dose, skip the dose you missed. Do not take a double dose to make up for a forgotten tablet.

If you stop taking Xiliarx

Do not stop taking Xiliarx unless your doctor tells you to. If you have questions about how long to take this medicine, talk to your doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Some symptoms need immediate medical attention:

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

• Angioedema (rare: may affect up to 1 in 1,000 people): Symptoms include swollen face, tongue

or throat, difficulty swallowing, difficulties breathing, sudden onset rash or hives, which may indicate a reaction called “angioedema”.

• Liver disease (hepatitis) (rare): Symptoms include yellow skin and 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 might reach through to your back, as well as nausea and vomiting.

Other side effects

Some patients have had the following side effects while taking Xiliarx and metformin:

• Common (may affect up to 1 in 10 people): Trembling, headache, dizziness, nausea, low blood

glucose

• Uncommon (may affect up to 1 in 100 people): Tiredness

Some patients have had the following side effects while taking Xiliarx and a sulphonylurea:

• Common: Trembling, headache, dizziness, weakness, low blood glucose
• Uncommon: Constipation
• Very rare (may affect up to 1 in 10,000 people): Sore throat, runny nose

Some patients have had the following side effects while taking Xiliarx and a glitazone:

• Common: Weight increase, swollen hands, ankle or feet (oedema)
• Uncommon: Headache, weakness, low blood glucose

Some patients have had the following side effects while taking Xiliarx alone:

• Common: Dizziness
• Uncommon: Headache, constipation, swollen hands, ankle or feet (oedema), joint pain, low

blood glucose

• Very rare: Sore throat, runny nose, fever

Some patients have had the following side effects while taking Xiliarx, metformin and a sulphonylurea:

• Common: Dizziness, tremor, weakness, low blood glucose, excessive sweating

Some patients have had the following side effects while taking Xiliarx and insulin (with or without metformin):

• Common: Headache, chills, nausea (feeling sick), low blood glucose, heartburn
• Uncommon: Diarrhoea, flatulence

Since this product has been marketed, the following side effects have also been reported:

• Frequency not known (cannot be estimated from the available data): Itchy rash, inflammation of

the pancreas, localised peeling of skin or blisters, muscle pain

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix 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 the carton after

“EXP”. The expiry date refers to the last day of that month.

• Store in the original package in order to protect from moisture.
• Do not use any Xiliarx pack that is damaged or shows signs of tampering.
• Do not throw away any medicines via wastewater or household waste. Ask your pharmacist

how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Xiliarx contains

• The active substance is vildagliptin.

Each tablet contains 50 mg vildagliptin.

• The other ingredients are lactose anhydrous, microcrystalline cellulose, sodium starch glycolate

What Xiliarx looks like and contents of the pack

Xiliarx 50 mg tablets are round, white to light yellowish and flat, 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 multipacks comprising 3 cartons, each containing 112 tablets.

Not all pack sizes may be marketed in your country.

Marketing Authorisation Holder

Novartis Europharm Limited

Vista Building

Elm Park, Merrion Road

Dublin 4

Ireland

Manufacturer

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

RoonstraBe 25

D-90429 Nuremberg

Germany

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

België/Belgiqu­e/Belgien Novartis Pharma N.V. Tél/Tel: +32 2 246 16 11	Lietuva SIA Novartis Baltics Lietuvos filialas Tel: +370 5 269 16 50
Et^rapuH Novartis Bulgaria EOOD Ten.: +359 2 489 98 28	Luxembourg/Lu­xemburg Novartis Pharma N.V. Tél/Tel: +32 2 246 16 11
Česká republika Novartis s.r.o. Tel: +420 225 775 111	Magyarország Novartis Hungária Kft. Tel.: +36 1 457 65 00
Danmark Novartis Healthcare A/S Tlf: +45 39 16 84 00	Malta Novartis Pharma Services Inc. Tel: +356 2122 2872
Deutschland Novartis Pharma GmbH Tel: +49 911 273 0	Nederland Novartis Pharma B.V. Tel: +31 88 04 52 111
Eesti SIA Novartis Baltics Eesti filiaal Tel: +372 66 30 810	Norge Novartis Norge AS Tlf: +47 23 05 20 00
EZ/.áňa Novartis (Hellas) A.E.B.E. Tqk +30 210 281 17 12	Österreich Novartis Pharma GmbH Tel: +43 1 86 6570
España Mylan Pharmaceuticals, S.L. Tel: +34 900 102 712	Polska Novartis Poland Sp. z o.o. Tel.: +48 22 375 4888
France Novartis Pharma S.A.S. Tél: +33 1 55 47 66 00	Portugal Laboratório Normal – Produtos Farmacêuticos Lda. Tel. +351 21 000 8600
Hrvatska Novartis Hrvatska d.o.o. Tel. +385 1 6274 220	România Novartis Pharma Services Romania SRL Tel: +40 21 31299 01
Ireland Novartis Ireland Limited Tel: +353 1 260 12 55	Slovenija Novartis Pharma Services Inc. Tel: +386 1 300 75 50
Ísland Vistor hf. Sími: +354 535 7000	Slovenská republika Novartis Slovakia s.r.o. Tel: +421 2 5542 5439
Italia Novartis Farma S.p.A. Tel: +39 02 96 54 1	Suomi/Finland Novartis Finland Oy Puh/Tel: +358 (0)10 6133 200

United Kingdom (Northern Ireland)

Novartis Ireland Limited

Tel: +44 1276 698370

This leaflet was last revised in

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency website:

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