InfoCons Consumer Protection informs you – Jalra – Package Leaflet

Before anything else

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you .

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects , talk to your doctor , pharmacist or nurse . This includes any possible side effects not listed in this leaflet. See section 4.

What is i n this leaflet 1. What Jalra is and what it is used for 2. What you need to know b efore you take Jalra 3. How to take Jalra 4. Possible side effects 5. How to store Jalra 6. Contents of the pack and other information

ℹ️ 1. What Jalra is and what it is used for

The active substance of Jalra , vildagliptin, belongs to a group of medicines called “oral antidiabetics”.

Jalra 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 Jalra 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 substa nces.

How Jalra works

Jalra 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 Jalra

Do not take Jalra

• 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 Jalra , do not take this medicine and talk to your doctor.

Warnings and precautions

Talk to your doctor , pharmacist or nurse before taking Jalra .

• if you have type 1 diabetes (i.e. your body does not produce insulin) or if you have a condition 31 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 Jalra 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 Jalra) .
• 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 ulcer s while taking Jalra . Should these occur, you should promptly consult your doctor.

A test to determine your liver function will be performed before the start of Jalra treatment, at three – month 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 Jalra in children and adolescents up to 18 years of age is not recommended.

Other medicines and Jalra

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

Driving and using machines

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

Jalra contains lactose

Jalra 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.

Jalra 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 Jalra

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist 32 if you are not sure.

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

The usual dose of Jalra is either:

• 50 mg daily taken as one dose in the morning if you are taking Jalra 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 Jalra 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 Jalra

• Swallow the tablets whole with some water.

How long to take Jalra

• Take Jalra 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 Jalra than you should

If you take too many Jalra 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 Jalra

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 Jalra

Do not stop taking Jalra 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 Jalra 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 s wollen face, tongue or throat , difficulty swallowing , difficulties breathing , sudden onset rash or hives , which may indicate a reaction called “angioedema” .
• Liver disease (hepatitis) ( frequency not known ): Symptoms include y ellow skin and eyes, nausea, loss of appetite or dark -coloured urine, which may indicate liver disease (hepatitis) .
• Inflammation of the pancreas (pancreatitis) ( rare: may affect up to 1 in 1 000 people ):

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 Jalra :

• Very common ( may affect more than 1 in 10 people ): sore throat, runny nose, fever.
• Common (may affect up to 1 in 10 people ): itchy rash, trembling, headache, dizziness, muscle pain, joint pain, constipation, swollen hands, ankles or feet (oedema), excessive sweating, vomiting, pain in and around the stomach (abdominal pain), diarrhoea, heartburn, nausea (feeling sick), blurre d vision.
• Uncommon (may affect up to 1 in 100 people) : weight increase, chills, weakness, sexual dysfunction , joint pain , low blood glucose , flatulence .
• Rare (may affect up to 1 in 1 000 people) : inflammation of the pancreas .

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

• Frequency not known (cannot be estimated from the available data ): localised peeling of skin or blisters , blood vessel inflammation (vasculitis) which may result in skin rash or pointed, flat, red, round spots under the skin’s surface or bruising .

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 Jalra

• 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 Jalra 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 Jalra contains

• The active substance is vildagliptin.

Each tablet contains 50 mg vildagliptin.

• The other ingredients are l actose anhydrous, microcrystalline cellulose, sodium starch glycolate (type A) and magnesium stearate.

What Jalra looks like and contents of the pack

Jalra 50 mg tablets are round, white to light yellowish and flat, with “NVR” on one side and “FB” on the other.

Jalra 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.

34 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 Pharmaceutical Manufacturing LLC Verovskova ulica 57 Ljubljana 1000 Slovenia Novartis Pharma GmbH Sophie -Germain -Strasse 10 90443 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 България Novartis Bulgaria EOOD Тел.: +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 35 Ελλάδα Novartis (Hellas) A.E.B.E.

Τηλ: +30 210 281 17 12 ή WIN MEDICA ΦΑΡΜΑΚΕΥΤΙΚΗ A.E.

Tηλ: +30 210 74 88 821 Österreich Novartis Pharma GmbH Tel: +43 1 86 6570 España Esteve Pharmaceuticals, S.A.

Tel: +34 93 446 60 00 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 Bialport -Produtos Farmacêuticos, S.A.

Tel: +351 22 986 61 00 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 Κύπρος Novartis Pharma Services Inc.

Τηλ: +357 22 690 690 Sverige Novartis Sverige AB Tel: +46 8 732 32 00 Latvija SIA Novartis Baltics Tel: +371 67 887 070

This leaflet was last revised in

Other sources of information Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu

📄 Package Leaflet – official source

This article reproduces the information in the official package leaflet, as authorised in the European Union. You can consult the original document here: Product information Jalra (PDF, ec.europa.eu).

You can check this medicine at any time in the Union Register of medicinal products (EU number EU/1/08/485).

⚠️ Important: This article is for information purposes only and does not replace medical advice or the package leaflet inside the medicine box. Read the leaflet carefully before use. For any questions about your treatment, talk to your doctor or pharmacist. If you experience side effects, tell your doctor or pharmacist and report them through your national reporting system.