Gluadda

Package Leaflet: Information for the User

Gluadda, 50 mg, tablets

Vildagliptin

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• -Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor, pharmacist, or nurse.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Leaflet

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

1. What is Gluadda and what is it used for

The active substance of Gluadda is vildagliptin, which belongs to a group of medicines called oral antidiabetic medicines.
Gluadda is a medicine used to treat adult patients with type 2 diabetes, who cannot control their condition with diet and exercise alone. Gluadda helps to normalize blood sugar levels. The doctor may prescribe Gluadda to be taken either as the only antidiabetic medicine or in combination with other antidiabetic medicines that the patient is already taking, if they are not sufficient to normalize blood sugar levels.
Type 2 diabetes is a disease in which the body does not produce enough insulin or the insulin produced by the body does not work properly. Diabetes 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 stimulates the production of glucose in the liver and increases blood sugar levels. Both of these substances are produced in the pancreas.

How Gluadda works

Gluadda works by stimulating the pancreas to produce insulin and reducing the production of glucagon. This allows for the normalization of blood sugar levels. It has been shown that Gluadda reduces blood sugar levels, which can help prevent complications of diabetes. Despite starting to take antidiabetic medicine, it is important for the patient to continue to follow a proper diet and (or) perform recommended physical exercises.

2. Important information before taking Gluadda

When not to take Gluadda

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• if the patient is allergic to vildagliptin or any of the other ingredients of this medicine (listed in section 6). If the patient thinks they may be allergic to vildagliptin or any of the other ingredients of Gluadda, they should not take this medicine and inform their doctor.

Warnings and precautions

Before starting to take Gluadda, the patient should discuss it with their doctor, pharmacist, or nurse:

• if the patient has type 1 diabetes (i.e., if the body does not produce insulin) or if the patient has diabetic ketoacidosis;
• if the patient is taking a sulfonylurea-containing antidiabetic medicine [the doctor may reduce the dose of the sulfonylurea-containing medicine taken with Gluadda to avoid low blood sugar levels (hypoglycemia)];
• if the patient has moderate or severe kidney disease (a lower dose of Gluadda should be used);
• if the patient is undergoing dialysis;
• if the patient has liver disease;
• if the patient has heart failure;
• if the patient has or has had pancreatitis.

If the patient has previously taken vildagliptin but had to stop due to liver disease, they should not take this medicine.
Skin conditions are a common complication of diabetes. The patient should follow the doctor's or nurse's recommendations regarding skin and foot care. While taking Gluadda, the patient should pay special attention to the development of new blisters or ulcers. If they occur, the patient should immediately contact their doctor.
Before starting to take Gluadda and at three-month intervals during the first year of treatment, and then periodically, the patient should undergo liver function tests. This will help to detect any signs of increased liver enzyme activity as soon as possible.

Children and adolescents

Gluadda is not recommended for children and adolescents under 18 years of age.

Gluadda and other medicines

The patient should tell their doctor or pharmacist about all medicines they are taking or have recently taken, as well as any medicines they plan to take.
The doctor may change the dose of Gluadda if the patient is taking other medicines such as:

• thiazides or other diuretics (also known as water pills),
• corticosteroids (usually used to treat inflammatory conditions),
• medicines used to treat thyroid disorders,
• certain medicines that affect the nervous system.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.
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Gluadda should not be taken during pregnancy. It is not known whether Gluadda passes into human milk. Gluadda should not be taken during breastfeeding or if the patient plans to breastfeed.

Driving and using machines

If the patient experiences dizziness while taking Gluadda, they should not drive or operate machinery.

Gluadda contains lactose

Gluadda contains lactose (milk sugar). If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking this medicine.

Gluadda contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is essentially 'sodium-free'.

3. How to take Gluadda

This medicine should always be taken exactly as prescribed by the doctor. In case of doubts, the patient should consult their doctor or pharmacist.

What dose to take and when

The dose of Gluadda varies depending on the patient's condition. The doctor will determine the exact dose of Gluadda to be taken. The maximum daily dose is 100 mg.
Typically, the dose of Gluadda is:

• a dose of 50 mg per day taken as a single dose in the morning, when Gluadda is taken with a sulfonylurea-containing medicine;
• a dose of 100 mg per day taken in two doses of 50 mg, one in the morning and one in the evening, when Gluadda is taken alone or with metformin or a glitazone, in combination with metformin and sulfonylurea, or with insulin;
• a dose of 50 mg per day taken in the morning, if the patient has moderate or severe kidney disease or is undergoing dialysis.

How to take Gluadda

• Tablets should be swallowed whole with water.

How long to take Gluadda

• Gluadda should be taken every day, for as long as the doctor recommends. The doctor may decide on long-term treatment.
• The doctor will regularly check the patient's health to see if the treatment is working.

Taking a higher dose of Gluadda than recommended

If the patient takes too many Gluadda tablets or if someone else takes this medicine,
they should immediately inform their doctor. The patient may need medical attention. If they need to visit a doctor's office or hospital, they should take the medicine packaging with them.

Missing a dose of Gluadda

If the patient forgets to take a dose of this medicine, they should do so as soon as they remember. Then, they should take the next dose at the usual time. However, if it is almost time for the next dose, they should skip the missed dose. They should not take a double dose to make up for the missed tablet.

Stopping treatment with Gluadda

The patient should not stop taking Gluadda unless their doctor tells them to. If they have questions about how long to take this medicine, they should consult their doctor.

4. Possible side effects

Like all medicines, Gluadda can cause side effects, although not everybody gets them.

Some side effects require immediate medical attention

If the patient experiences any of the following side effects, they should stop taking Gluadda and consult their doctor immediately:

• angioedema (rare: may affect up to 1 in 1,000 patients): symptoms include swelling of the face, tongue, or throat, difficulty swallowing, difficulty breathing, sudden onset of rash or hives. These may indicate a reaction known as "angioedema";
• liver disease (hepatitis) (rare): symptoms include yellowing of the skin and whites of the eyes, nausea, loss of appetite, or dark-colored urine. These may indicate liver disease (hepatitis);
• pancreatitis (frequency not known): symptoms include severe and persistent abdominal pain (around the stomach area), which may radiate to the back, as well as nausea and vomiting.

Other side effects

In some patients taking vildagliptin and metformin, the following side effects have occurred:

• common (may affect up to 1 in 10 patients): tremor, headache, dizziness, nausea, low blood sugar levels;
• uncommon (may affect up to 1 in 100 patients): fatigue.

In some patients taking vildagliptin and sulfonylurea, the following side effects have occurred:

• common: tremor, headache, dizziness, weakness, low blood sugar levels;
• uncommon: constipation;
• very rare (may affect up to 1 in 10,000 patients): sore throat, runny nose.

In some patients taking vildagliptin and glitazone, the following side effects have occurred:

• common: weight gain, swollen hands, ankles, or feet (edema);
• uncommon: headache, weakness, low blood sugar levels.

In some patients taking vildagliptin alone, the following side effects have occurred:

• common: dizziness;
• uncommon: headache, constipation, swollen hands, ankles, or feet (edema), joint pain, low blood sugar levels;
• very rare: sore throat, runny nose, fever.

In some patients taking vildagliptin, metformin, and sulfonylurea, the following side effects have occurred:

• common: dizziness, tremor, weakness, low blood sugar levels, excessive sweating.

In some patients taking vildagliptin and insulin (with or without metformin), the following side effects have occurred:

• common: headache, chills, nausea (vomiting), low blood sugar levels, heartburn;
• uncommon: diarrhea, bloating.

After this medicine has been marketed, the following side effects have also been reported:

• frequency not known (frequency cannot be estimated from the available data): itchy rash, pancreatitis, local skin peeling or blistering, muscle pain.

Reporting side effects

If the patient experiences any side effects, including any not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw, Poland
phone: +48 22 49 21 301
fax: +48 22 49 21 309
website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Gluadda

• The medicine should be stored out of sight and reach of children.
• Do not use this medicine after the expiry date stated on the blister and carton after "EXP"/"Expiry Date (EXP)". The expiry date refers to the last day of the month stated.
• There are no special storage precautions for this medicine.
• Do not use Gluadda packaging that is damaged or shows signs of opening.
• Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Gluadda contains

• The active substance is vildagliptin. Each tablet contains 50 mg of vildagliptin.
• The other ingredients are: microcrystalline cellulose PH200, lactose, low-substituted hydroxypropylcellulose, and magnesium stearate.

What Gluadda looks like and contents of the pack

Gluadda, 50 mg are white to light yellowish, round, flat tablets with beveled edges.
Gluadda, 50 mg is available in packs containing: 7, 14, 15, 28, 30, 56, 60, 90, or 112 tablets.
Not all pack sizes may be marketed.
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Marketing Authorization Holder

Merck Sp. z o.o.
Al. Jerozolimskie 142B
02-305 Warsaw, Poland

Manufacturer

Combino Pharm (Malta) Ltd
HF60, Hal Far Industrial Estate
BBG3000, Hal Far, Malta
Pharmacare Premium Ltd
Hal Far Industrial Estate, HHF003
BBG3000, Birzebbugia, Malta
Bluepharma Industria Farmaceutica S.A.
Rua Da Bayer, Sao Martinho do Bispo
3045-016 Coimbra, Portugal

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Gluadda: Denmark, Malta, Poland, Romania

Date of last revision of the leaflet: April 2022

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