VILDAGLIPTIN 50 mg Таблетки

Содержание инструкции

1. Vildagliptin Teva 50 mg tablets
   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

Vildagliptin Teva 50 mg tablets

Generic medicine

Read this leaflet carefully before you start taking this medicine as 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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even 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 you take 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 of 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 the
diabetes cannot be controlled only by diet and exercise. It helps to control the level of
blood sugar. Your doctor will prescribe Vildagliptin Teva alone or together with other antidiabetic
medicines that you are already taking, if these have not proven to be sufficiently effective for
controlling diabetes.
Type 2 diabetes develops when the body does not produce enough insulin, or if the insulin
produced by the body does not work as it should. It can also develop when the body
produces too much glucagon.
Insulin is a substance that helps to lower blood sugar levels, especially after
meals. Glucagon is a substance that triggers the production of sugar by the liver,
causing an increase in blood sugar levels. The pancreas produces both of these
substances.

How Vildagliptin Teva works
Vildagliptin Teva works by inducing the pancreas to produce more insulin and less glucagon. This helps to
control the level of blood sugar. This medicine has been shown to reduce blood
sugar. This can help prevent complications resulting from your diabetes. Even if you now
start taking a medicine for diabetes, it is important that you continue to follow the diet and/or
exercise that has been 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 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 suffer from a condition called diabetic ketoacidosis
• if you are taking a medicine for diabetes known as a sulfonylurea (if you take it together with Vildagliptin Teva, your doctor may decide to reduce your dose of sulfonylurea to avoid low blood glucose levels [hypoglycemia])
• 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 have previously taken vildagliptin but had to stop due to liver disease, you should not
take this medicine.
Skin lesions are a common complication of diabetes. It is advisable to follow the
recommendations for skin and foot care that are provided to you by your doctor or nurse.
It is also advisable to pay particular attention to the appearance of blisters or ulcers while taking
Vildagliptin Teva. If this occurs, you should consult your doctor quickly.
Before starting treatment with Vildagliptin Teva, a test will be performed to assess the
functioning of the liver, which will be repeated every three months during the first year of treatment and then
periodically. This is to detect as early as possible 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
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines. Your doctor may want to adjust the dose of Vildagliptin Teva if you are
taking other medicines such as for example:

• thiazides or other diuretics (also called water tablets)
• corticosteroids (generally used for the treatment of inflammation)
• medicines for the thyroid
• certain medicines that affect the nervous system.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning to become pregnant, or if you are breastfeeding
with breast milk, ask your doctor or pharmacist for advice 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 feel dizzy while taking Vildagliptin Teva, do not drive or use machines.

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 following exactly the instructions of your doctor. If you have any doubts, ask your
doctor or pharmacist.

How much to take and when
The amount of Vildagliptin Teva that you need to take varies depending on individual conditions. Your
doctor will tell you exactly how many tablets of Vildagliptin Teva you need to take. The maximum
daily dose is 100 mg.
The usual dose of Vildagliptin Teva is:

• 50 mg per day taken as a single dose in the morning if you take Vildagliptin Teva with another medicine called a sulfonylurea.
• 100 mg per day taken as 50 mg in the morning and 50 mg in the evening if you take Vildagliptin Teva alone, with another medicine called metformin or a glitazone, with a combination of metformin and a sulfonylurea, or with insulin.
• 50 mg per day 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 a little water.

For how long to take Vildagliptin Teva

• Take Vildagliptin Teva every day for as long as your doctor tells you to. It is possible that you may need to continue this treatment for a long period of time.
• Your doctor will check your condition regularly to verify that the treatment is having the desired effect.

If you take more Vildagliptin Teva than you should
If you take too many tablets of Vildagliptin Teva, or if someone else has taken your medicine, contact
your doctor immediately. Medical care may be needed. If you need to see a
doctor or go to hospital, take the packaging 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
your next dose at the usual time. If it is almost time for your next dose, skip the dose you have
forgotten. Do not take a double dose to make up for a missed tablet.

If you stop taking Vildagliptin Teva
Do not stop taking Vildagliptin Teva unless your doctor tells you to. If you have doubts
about the duration of treatment with this medicine, ask your doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets 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 onset of skin rashes or hives, which may indicate a reaction called “angioedema”.
• Liver disease (hepatitis) (rare): Symptoms include yellowing of the skin and eyes, nausea, loss of appetite or dark urine, which may indicate liver disease (hepatitis).
• Inflammation of the pancreas (pancreatitis) (frequency not known). Symptoms include severe and persistent abdominal pain (stomach area), which may extend to the back, as well as nausea and vomiting.

Other side effects
Some patients have 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 have 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): Sore throat, runny nose.

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

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

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

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

Some patients have 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 have 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 skin rash, inflammation of the pancreas, localized skin scaling or blisters, muscle pain.

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. You can also report side effects
directly through 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 pack 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 package to protect the medicine from moisture.

Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6Contents of the pack and other information
What Vildagliptin Teva contains

• The active ingredient is vildagliptin. Each tablet contains 50 mg of vildagliptin.
• The other ingredients 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, with a bevelled edge, diameter of
8.5 mm and with the inscription “A013” 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 blisters for a single dose 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
Netherlands

Manufacturer
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 - Netherlands
Teva Operations Poland Sp. z.o.o, ul.
Mogilska 80, 31-546 Krakow - Poland
Teva Pharma B.V.
Swensweg 5, 2031GA Haarlem - Netherlands
TEVA UK Ltd.
Brampton Road, Hampden Park Eastbourne, East Sussex BN22 9AG - United Kingdom