Alikval

Package Leaflet: Information for the Patient

Alikval, 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.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please tell your doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Leaflet

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

1. What is Alikval and what is it used for

The active substance of Alikval is vildagliptin, which belongs to a group of medicines called "oral antidiabetic medicines".
Vildagliptin is used to treat adult patients with type 2 diabetes, who cannot control their condition with diet and exercise alone. It helps control blood sugar levels. Your doctor may prescribe Alikval as the only antidiabetic medicine or in combination with other antidiabetic medicines that you may be taking, if they have not been sufficiently effective in controlling your blood sugar levels.
Type 2 diabetes is a condition where the body does not produce enough insulin, or the insulin produced by the body does not work as it should. Diabetes can also develop when the body produces too much glucagon.
Insulin is a substance that helps lower blood sugar levels, especially after a meal.
Glucagon is a substance that stimulates the production of sugar in the liver and increases blood sugar levels. Both of these substances are produced in the pancreas.

How Alikval works

Alikval works by stimulating the pancreas to produce insulin and reducing the production of glucagon. Therefore, Alikval helps control blood sugar levels. It has been shown that the medicine lowers blood sugar levels, which can help prevent complications of diabetes. Despite starting pharmacological treatment for diabetes, it is important for the patient to continue to follow a suitable diet and (or) perform recommended physical exercises.

2. Important information before taking Alikval

When not to take Alikval

• 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 Alikval, do not take this medicine, but tell your doctor.

Warnings and precautions

Before taking Alikval, discuss with your doctor, pharmacist, or nurse:

• 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 a sulfonylurea (a type of antidiabetic medicine), your doctor may want to reduce the dose of the sulfonylurea to avoid low blood sugar levels (hypoglycemia),
• if you have moderate or severe kidney disease (you may need to take a lower dose of Alikval),
• if you are on dialysis,
• if you have liver disease,
• if you have heart failure,
• if you have or have had pancreatitis.

If you have previously taken vildagliptin but had to stop due to liver disease, you should not take this medicine.
Skin conditions are a common complication of diabetes. You should follow your doctor's or nurse's advice on skin and foot care. While taking Alikval, you should pay particular attention to the development of new blisters or ulcers. If they occur, you should contact your doctor immediately.
Before starting treatment with Alikval and at 3-month intervals during the first year of treatment, and periodically thereafter, you should have liver function tests. This will help to detect any signs of increased liver enzyme activity as soon as possible.

Children and adolescents

Alikval should not be used in children and adolescents under 18 years of age.

Alikval and other medicines

Tell your doctor or pharmacist about all the medicines you are taking, have recently taken, or might take.
Your doctor may need to adjust the dose of Alikval if you are taking other medicines such as:

• thiazides or other diuretics (also known as water tablets)
• corticosteroids (usually used to treat inflammation)
• medicines used to treat thyroid disease
• certain medicines that affect the nervous system.

Pregnancy and breastfeeding

If you are pregnant, breastfeeding, or think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Alikval should not be used during pregnancy. It is not known if Alikval passes into breast milk. Alikval should not be used while breastfeeding or if you are planning to breastfeed.

Driving and using machines

If you experience dizziness while taking Alikval, do not drive or operate machinery.

Alikval contains lactose and sodium

Alikval contains lactose (a sugar). If you have been told that you have an intolerance to some sugars, contact your doctor before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which is essentially sodium-free.

3. How to take Alikval

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.

What dose to take and when

The dose of Alikval varies depending on your condition. Your doctor will decide exactly how many Alikval tablets to take. The maximum daily dose is 100 mg.
The usual dose of Alikval is:

• 50 mg once daily, taken in the morning, if you are taking Alikval with a sulfonylurea.
• 100 mg once daily, taken as two doses of 50 mg, one in the morning and one in the evening, if you are taking Alikval alone, with metformin, or with a glitazone, in combination with metformin and a sulfonylurea or insulin.
• 50 mg once daily, taken in the morning, if you have moderate or severe kidney disease or if you are on dialysis.

How to take Alikval

Swallow the tablets whole with water.

How long to take Alikval

• Alikval should be taken every day, as long as your doctor has prescribed it. Your doctor may decide on long-term treatment.
• Your doctor will regularly check your condition to see if the treatment is working.

What to do if you take more Alikval than you should

If you take too many Alikval tablets or if someone else has taken your medicine, contact your doctor immediately. You may need medical attention. If you need to go to a doctor or hospital, take the package leaflet with you.

What to do if you forget to take Alikval

If you forget to take a dose, take it as soon as you remember. Then take the next dose at the usual time. However, if it is almost time for the next dose, skip the missed dose.
Do not take a double dose to make up for a forgotten tablet.

What to do if you stop taking Alikval

Do not stop taking Alikval without talking to your doctor first. If you have any questions about how long to take your medicine, ask your doctor.

4. Possible side effects

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

Some side effects need immediate medical attention:

If you experience any of the following side effects, stop taking Alikval and contact your doctor immediately:

• 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 rash or hives. These may be signs of angioedema.
• Liver disease (hepatitis) (frequency not known): symptoms include yellowing of the skin and the whites of the eyes, nausea, loss of appetite, or dark-colored urine. These may be signs of liver disease (hepatitis).
• Pancreatitis (rare: may affect up to 1 in 1,000 people): symptoms include severe and persistent abdominal pain (stomach area), which may radiate to the back, as well as nausea and vomiting.

Other side effects

Some patients taking vildagliptin have experienced the following side effects:

• Very common (may affect more than 1 in 10 people): sore throat, runny nose, fever.
• Common (may affect up to 1 in 10 people): itchy rash, tremor, headache, dizziness, muscle pain, joint pain, constipation, swollen hands, ankles, or feet (edema), excessive sweating, vomiting, stomach pain or discomfort (abdominal pain), diarrhea, heartburn, nausea (feeling sick).
• Uncommon (may affect up to 1 in 100 people): weight gain, chills, weakness, sexual dysfunction, low blood sugar levels, bloating.
• Rare (may affect up to 1 in 1,000 people): pancreatitis.

After vildagliptin was made available, the following side effects have also been reported:

• Frequency not known (frequency cannot be estimated from the available data): localized skin peeling or blistering, vasculitis (inflammation of blood vessels), which can cause skin rash or purpura (red spots on the skin).

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +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. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Alikval

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 blister and carton after "EXP".
The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not use Alikval if the packaging is damaged or shows signs of tampering.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Alikval contains

• The active substance is vildagliptin. Each tablet contains 50 mg of vildagliptin.
• The other ingredients are: lactose, sodium stearyl fumarate, microcrystalline cellulose PH102, and croscarmellose sodium.

What Alikval looks like and contents of the pack

Alikval, 50 mg.
Round, biconvex tablets, white or almost white in color, with a diameter of about 8.0 mm.
Available in aluminum/OPA/Aluminum/PVC blisters in a cardboard box containing 28, 30, 56, 60, 84, 90, 112, 120, 140, 150, 168, or 180 tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Egis Pharmaceuticals PLC
Keresztúri út 30-38
1106 Budapest
Hungary

Manufacturer

SAG MANUFACTURING, S.L.U.
Ctra. N-I, km 36 28750 San Agustín de Guadalix
Madrid
Spain
GALENICUM HEALTH, S.L.U.
Sant Gabriel, 50
Esplugues de Llobregat
08950 Barcelona
Spain

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

Malta
Alikval 50 mg tablets
Hungary
Alikval 50 mg tabletta
Czech Republic
Alikval 50 mg tablets
Poland
Alikval

Date of last revision of the leaflet: 09.07.2024