Jalra 50 mg tablets

Patient Information Leaflet

Introduction

Patient Information Leaflet

Jalra 50mg tablets

vildagliptin

Read all of this 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 others, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if these effects are not listed in this leaflet. See section 4.

Leaflet contents:

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

1. What Jalra is and what it is used for

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

Jalra 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 Jalra 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 lower 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 Jalra works

Jalra 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 you have been advised to follow.

2. What you need to know before taking Jalra

Do not take Jalra

• 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 Jalra, do not take this medicine and consult 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 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 Jalra to avoid low blood sugar levels [hypoglycaemia]).
• if you have moderate or severe kidney disease (you will need to take a lower dose of Jalra).
• 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 advice regarding skin and foot care, paying special attention to the appearance of blisters or ulcers while taking Jalra. If this occurs, you should consult your doctor as soon as possible.

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

Children and adolescents

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

Taking Jalra 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 change 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 that affect the nervous system.

Pregnancy and breastfeeding

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

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

Driving and using machines

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

Jalra contains lactose

Jalra contains lactose (milk sugar). If your doctor has told you that you have an intolerance to certain sugars, consult with him before taking this medicine.

Jalra contains sodium

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

3. How to take Jalra

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

How much to take and when

The dose of Jalra varies from person to person, depending on your condition. Your doctor will tell you exactly how many tablets of Jalra you should take. The maximum daily dose is 100 mg.

The recommended dose of Jalra is:

• 50 mg once daily in the morning, if you are taking Jalra together with another medicine known as a sulfonylurea.
• 100 mg daily in two doses of 50 mg in the morning and evening if you are taking Jalra alone, with another medicine known as 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 if you are undergoing dialysis.

How to take Jalra

• Swallow the tablet whole with some water.

Duration of treatment with Jalra

• Take Jalra every day for 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 Jalra than you should

If you have taken too many Jalra tablets, or if someone else has taken your medicine, consult your doctor immediately. Medical attention may be required. If you need to visit a doctor or go to the nearest 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 missed dose. Do not take a double dose to make up for forgotten doses.

If you stop taking Jalra

Do not stop taking Jalra unless your doctor tells you to. If you have any doubts about how long you should continue treatment with Jalra, 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 Jalra 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 dark-colored 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 (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 Jalra:

• 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 blisters, 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 can 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 Jalra

• 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 outer carton following “EXP”/”CAD”. The expiry date refers to the last day of the month indicated.
• Store in the original packaging to protect it from moisture.
• Do not use Jalra 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 properly dispose of unused medicines and their packaging. This helps protect the environment.

6. Contents of the pack and other information

Composition of Jalra

• 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.

Nature of the product and pack contents

Jalra 50 mg tablets are white to slightly yellowish, flat, round tablets, marked 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 multiple packs consisting of 3 packs, each containing 112 tablets.

Only certain pack sizes may be marketed.

Marketing Authorization 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 Nürnberg

Germany

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

Date of the most recent revision of this leaflet:

Other sources of information

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