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Package leaflet: Information for the user

Dagatalze 50 mg tablets
Vildagliptin
Equivalent medicine
Please 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 give it to other people, even if they have the same symptoms as you, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, inform 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 taking 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 in 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 by diet and exercise alone. It helps control blood sugar levels. Your doctor will prescribe Dagatalze alone or in combination with other antidiabetic medicines you are already taking, if these have not been sufficiently effective in controlling your 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 stimulates the liver to produce sugar, leading to increased blood sugar levels. The pancreas produces both of these substances.

How Dagatalze works
Dagatalze works by prompting 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 may help prevent complications arising from your diabetes. Even though you are now starting a medicine for diabetes, it remains important that you continue following the diet and/or exercise regimen recommended for you.

2. What you need to know before taking Dagatalze

Do not take Dagatalze

• 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 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 have a condition called diabetic ketoacidosis;
• if you are taking an antidiabetic medicine known as a sulfonylurea (your doctor may want to reduce your dose of sulfonylurea while taking Dagatalze concomitantly to avoid low blood sugar [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 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 Dagatalze. If this occurs, you must consult your doctor immediately.
Before starting treatment with Dagatalze, a liver function test will be performed, which 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 Dagatalze is not recommended in children and adolescents under 18 years of age.
Other medicines and Dagatalze
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 Dagatalze 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 acting on 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.
You must not use Dagatalze during pregnancy. It is not known whether Dagatalze passes into breast milk.
You must not use Dagatalze if you are breastfeeding or plan to breastfeed.
Driving and using machines
If you experience dizziness while taking Dagatalze, do not drive or operate machinery.
Dagatalze contains lactose
Dagatalze contains lactose (a milk sugar). If your doctor has diagnosed you with an intolerance to certain sugars, consult 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 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 Dagatalze that patients should take varies depending on individual conditions. Your doctor will tell you exactly how many Dagatalze tablets you should take. The maximum daily dose is 100 mg.

The usual dose of Dagatalze is:

• 50 mg once daily in the morning if you are taking Dagatalze together with another medicine called a sulfonylurea;
• 100 mg daily 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 once daily in the morning if you have moderate or severe kidney disease or if you are on dialysis.

How to take Dagatalze

• Swallow the tablets whole with some water.

How long to take Dagatalze

• Take Dagatalze every day for as long as your doctor recommends. You may need to continue this treatment for a long time.
• Your doctor will regularly monitor your condition to ensure the treatment is working as expected.

If you take more Dagatalze than you should
If you take too many Dagatalze tablets, or if someone else takes your tablets, contact your doctor immediately. Medical treatment may be required. If you need to go to a doctor or hospital, bring the pack 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 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 the forgotten tablet.

If you stop taking Dagatalze
Do not stop taking Dagatalze unless your doctor tells you to. If you have any doubts about how long you should take this medicine, consult 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 Dagatalze and contact your doctor immediately if you experience any of the
following side effects:

• 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 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 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 people): sore throat, runny nose.

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

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

Some patients 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: 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 blistering, 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 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 stated on the carton and on the blister pack 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 any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Dagatalze contains

• The active substance is vildagliptin. Each tablet contains 50 mg of vildagliptin.
• The other components are microcrystalline cellulose, lactose, sodium glycolate starch (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, 8.5 mm in diameter,
and marked with "A013" on one side.
Dagatalze 50 mg tablets are available in blister packs containing 56 tablets and in unit-dose perforated
blister packs 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 under the following names: