SYKURZUKI 50 mg/850 mg Film-Coated Tablets

Зміст інструкції

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

Dagatalze 50 mg tablets
Vildagliptin
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 Dagatalze is and what it is used for
• 2. What you need to know before you take Dagatalze
• 3. How to take Dagatalze
• 4. Possible side effects
• 5. How to store Dagatalze
• 6. Contents of the pack and other information

1. What Dagatalze is and what it is used for

The active substance of Dagatalze, vildagliptin, belongs to a group of medicines called “oral
antidiabetics”.
Dagatalze is used to treat adult patients with type 2 diabetes. It is used when diabetes cannot be
controlled only by diet and exercise. It helps to control the level of sugar in the
blood. Your doctor will prescribe Dagatalze alone or together with other antidiabetic medicines that you are already
taking, if these have not proven sufficiently effective in 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 induces the production of sugar by the liver, causing
an increase in blood sugar levels. The pancreas produces both of these substances.

How Dagatalze works
Dagatalze works by inducing the pancreas to produce more insulin and less glucagon. This helps to
control the level of sugar in the blood. This medicine has been shown to reduce blood sugar,
which can help prevent complications resulting from your diabetes. Even if you are now starting to
take 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 Dagatalze

Do not take Dagatalze

• 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 Dagatalze, do not take this medicine and consult your doctor.

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

• 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 (your doctor may want to reduce your dose of sulfonylurea while you are taking Dagatalze at the same time to avoid low blood glucose [hypoglycemia]);
• if you have moderate or severe kidney disease (you will need to take a lower dose of Dagatalze);
• 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
skin and foot care recommendations provided by your doctor or nurse.
It is also advisable to pay particular attention to the appearance of blisters or ulcers while
taking Dagatalze. If this occurs, you should consult your doctor immediately.
Before starting treatment with Dagatalze, a test will be performed to assess liver function, which will be repeated every three months during the first year of treatment and subsequently
periodically. This is to detect any increase in liver enzymes as early as possible.

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

Other medicines and Dagatalze
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 Dagatalze if you are taking
other medicines such as, for example:

• thiazides or other diuretics (also called water tablets);
• corticosteroids (usually used for the treatment of inflammation);
• medicines for the thyroid;
• some medicines that act on the nervous system.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant or are planning to become pregnant, or if you are breastfeeding,
ask your doctor or pharmacist for advice before taking this medicine.
You should not use Dagatalze during pregnancy. It is not known whether Dagatalze passes into breast milk.
You should not use Dagatalze if you are breastfeeding or planning to breastfeed.

Driving and using machines
If you feel dizzy while taking Dagatalze, do not drive or use machines.

Dagatalze contains lactose
Dagatalze contains lactose (a sugar from milk). If your doctor has told you that you have an intolerance to
some sugars, contact your doctor before taking this medicine.

Dagatalze contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e. it is essentially
“sodium-free”.

3. How to take Dagatalze

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 Dagatalze that patients must take varies depending on the conditions. Your doctor will
tell you exactly how many Dagatalze tablets you must take. The maximum daily dose is 100
mg.
The usual dose of Dagatalze is:

• 50 mg per day taken as a single dose in the morning if you are taking Dagatalze with another medicine called sulfonylurea;
• 100 mg per day taken as 50 mg in the morning and 50 mg in the evening if you are taking Dagatalze 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 a moderate or severe kidney disease or if you are on dialysis.

How to take Dagatalze

• Swallow the tablets whole with a little water.

For how long to take Dagatalze

• Take Dagatalze every day until your doctor advises you to do so. You may need to continue this treatment for a long period of time.
• Your doctor will regularly check your condition to verify that the treatment has the desired effect.

If you take more Dagatalzethan you should
If you take too many Dagatalze tablets, or if someone else takes your tablets, seek
medical attention immediately. Medical care may be necessary. If you need to go to a
doctor or hospital, take the packaging with you.

If you forget to take Dagatalze
If you forget to take a dose of this medicine, take it as soon as you remember. Then take
the 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 the forgotten tablet.

If you stop taking Dagatalze
Do not stop treatment with Dagatalze unless your doctor tells you to do so. If you have any doubts
about how long to take this medicine, ask your doctor.

4. Possible side effects

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

Some symptoms require immediate medical attention:
You should stop taking Dagatalze 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-colored 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 spread to the back, as well as nausea and vomiting.

Other side effects
Some patients have experienced the following side effects while taking Dagatalze (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 Dagatalze (vildagliptin) and
a sulfonylurea:

• Common: tremor, headache, 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 Dagatalze (vildagliptin) and
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 Dagatalze (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 Dagatalze (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 Dagatalze (vildagliptin) and
insulin (with or without metformin):

• Common: headache, chills, nausea (feeling unwell), low blood glucose levels, heartburn;
• Uncommon: diarrhea, flatulence.

The following side effects have also been reported during the post-marketing of this medicine:

• Frequency not known (cannot be estimated from available data): itchy rash, inflammation of the pancreas, localized skin peeling 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 at https://www.aifa.gov.it/content/segnalazioni-
reazioni-avverse. By reporting side effects you can help provide more information
on the safety of this medicine.

5. How to store Dagatalze

• 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 package and on the blister pack after “Exp”. The expiry date refers to the last day of that month.
• Do not store at a temperature above 25°C.
• Store in the original package to protect the medicine from moisture.

Do not dispose of any medicine in 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 Dagatalze 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 Dagatalze and contents of the pack
Dagatalze 50 mg tablets are white, round, flat tablets, with bevelled edges with a diameter
of 8.5 mm and with “A013” imprinted on one side.
Dagatalze 50 mg tablets is available in blister packs containing 56 tablets and in unit dose perforated blisters
containing 56 x 1 tablets.
Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer
Sigillata Limited
Block A
15 Castleforbes Square
Sheriff Street
Dublin 1
Dublin
Ireland

This medicinal product is authorised in the Member States of the European Economic Area with the
following denominations: