Vildagliptin Teva

PACKAGE LEAFLET:

Package leaflet: information for the user

Vildagliptin Teva 50 mg tablets

Equivalent medicine
Please read 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 others, even if their symptoms are the same as yours, because it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet

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

1. What Vildagliptin Teva is and what it is used for

The active substance in Vildagliptin Teva, vildagliptin, belongs to a group of medicines called
"oral antidiabetics".
Vildagliptin Teva 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 Vildagliptin Teva alone or together with other antidiabetic medicines you are already taking, if these have not been sufficiently effective in controlling 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 Vildagliptin Teva works
Vildagliptin Teva works by stimulating the pancreas to produce more insulin and less glucagon. This helps control blood sugar levels. It has been shown that this medicine reduces blood sugar. 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 recommended to you.

2. What you need to know before taking Vildagliptin Teva

Do not take Vildagliptin Teva:

• 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 of Vildagliptin Teva, do not take this medicine and consult your doctor.

Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Vildagliptin Teva

• 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 Vildagliptin Teva, your doctor may decide to reduce your dose of sulfonylurea to prevent low blood glucose levels [hypoglycaemia])
• if you have moderate or severe kidney disease (you will need to take a lower dose of Vildagliptin Teva)
• 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 Vildagliptin Teva. If this occurs, you should consult your doctor promptly.
Before starting treatment with Vildagliptin Teva, a liver function test will be performed. This test 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
The use of Vildagliptin Teva is not recommended in children and adolescents under 18 years of age.
Other medicines and Vildagliptin Teva
Inform 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 Vildagliptin Teva 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 affect 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.
Do not use Vildagliptin Teva during pregnancy. It is not known whether Vildagliptin Teva passes into breast milk. Do not use Vildagliptin Teva if you are breastfeeding or planning to breastfeed.
Driving and using machines
If you experience dizziness while taking Vildagliptin Teva, do not drive or operate machinery.
Vildagliptin Teva contains lactose
Vildagliptin Teva contains lactose (milk sugar). If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.
Vildagliptin Teva contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e. essentially “sodium-free”.

3. How to take Vildagliptin Teva

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

• 50 mg once daily in the morning if you are taking Vildagliptin Teva 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 Vildagliptin Teva alone, with another medicine called metformin or a glitazone, with a combination of metformin and a sulphonylurea, or with insulin.
• 50 mg once daily in the morning if you have moderate or severe kidney disease or if you are on dialysis.

How to take Vildagliptin Teva

• Swallow the tablets with some water.

How long to take Vildagliptin Teva

• Take Vildagliptin Teva every day for as long as your doctor tells you to. You may need to continue this treatment for a long time.
• Your doctor will regularly check your condition to make sure the treatment is working as expected.

If you take more Vildagliptin Teva than you should
If you take too many Vildagliptin Teva tablets, or if someone else has taken your medicine, contact your doctor immediately. Medical treatment may be needed. If you need to see a doctor or go to hospital, take the pack with you.
If you forget to take Vildagliptin Teva
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 your next dose, skip the missed dose. Do not take a double dose to make up for a forgotten tablet.
If you stop taking Vildagliptin Teva
Do not stop taking Vildagliptin Teva unless your doctor tells you to. If you have any doubts about how long you should take 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 Vildagliptin Teva and contact your doctor immediately if any of the following side effects occur:

• Angioedema (rare: may affect 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) (rare): 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) (frequency not known). 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
Some patients experienced the following side effects while taking Vildagliptin Teva (vildagliptin) and metformin:

• Common (may affect up to 1 in 10 people): Tremor, headache, dizziness, nausea, low blood glucose levels
• Uncommon (may affect up to 1 in 100 people): Fatigue.

Some patients experienced the following side effects while taking Vildagliptin Teva (vildagliptin) and a sulfonylurea:

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

Some patients experienced the following side effects while taking Vildagliptin Teva (vildagliptin) and a glitazone:

• Common: Weight gain, swelling of hands, ankles or feet (oedema)
• Uncommon: Headache, weakness, low blood glucose levels.

Some patients experienced the following side effects while taking Vildagliptin Teva (vildagliptin) alone:

• Common: Dizziness
• Uncommon: Headache, constipation, swelling of hands, ankles or feet (oedema), joint pain, low blood glucose levels
• Very rare: Sore throat, runny nose, fever.

Some patients experienced the following side effects while taking Vildagliptin Teva (vildagliptin), metformin and a sulfonylurea:

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

Some patients experienced the following side effects while taking Vildagliptin Teva (vildagliptin) and insulin (with or without metformin):

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

During the marketing of this medicine, the following side effects have also been reported:

• Frequency not known (cannot be estimated from the available data): Itchy rash, inflammation of the pancreas, localized skin peeling or blisters, muscle pain.

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 available at:
http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa . By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Vildagliptin Teva

• 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 carton and blister after 'Exp.'. The expiry date refers to the last day of that month.
• Do not store above 25°C.
• Store in the original packaging to protect the medicine from moisture.

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. Contents of the pack and other information

What Vildagliptin Teva contains

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

Description of the appearance of Vildagliptin Teva and contents of the pack
Vildagliptin Teva 50 mg tablets are flat, white, round, bevelled-edged, 8.5 mm in diameter, with the code “A013” engraved on one side.
Vildagliptin Teva 50 mg tablets are available in blisters containing 14, 28, 50, 56, 90, 100 and 180 tablets, and in divisible unit-dose blisters containing 10 x 1, 30 x 1, 56 x 1 and 60 x 1 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
TEVA B.V.
Swensweg 5,
2031 GA Haarlem
The Netherlands

Manufacturers
Balkanpharma-Dupnitsa AD
3 Samokovsko Shosse Str., Dupnitsa 2600 - Bulgaria
Merckle GmbH
Ludwig-Merckle-Strasse 3, 89143 Blaubeuren - Germany
PLIVA Hrvatska d.o.o. (PLIVA Croatia Ltd.)
Prilaz baruna Filipovica 25, 10000 Zagreb - Croatia
Teva Nederland B.V.
Swensweg 5, 2031GA Haarlem - The Netherlands
Teva Operations Poland Sp. z.o.o, ul.
Mogilska 80, 31-546 Krakow - Poland
Teva Pharma B.V.
Swensweg 5, 2031GA Haarlem - The Netherlands
TEVA UK Ltd.
Brampton Road, Hampden Park Eastbourne, East Sussex BN22 9AG - United Kingdom