Package leaflet: Information for the patient

Alikval, 50 mg, tablets
Vildagliptinum
Please read this leaflet carefully before taking this medicine, as it contains important information for you.

Keep this leaflet, as you may need to read it again.
If you have any further questions, please ask your doctor, pharmacist, or nurse.
This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same as yours.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Leaflet contents

What Alikval is and what it is used for
Important information before taking Alikval
How to take Alikval
Possible side effects
How to store Alikval
Contents of the pack and other information

1. What Alikval is and what it is used for

The active substance in Alikval is vildagliptin, which belongs to a group of medicines called "oral antidiabetic agents".
Vildagliptin is used in the treatment of adult patients with type 2 diabetes mellitus in whom blood glucose control has not been achieved by diet and exercise alone. It helps control blood glucose levels. Your doctor may prescribe Alikval either as the only antidiabetic medicine or in combination with other antidiabetic medicines you may be taking, if they have not been sufficiently effective in controlling your blood glucose levels.
Type 2 diabetes is a condition in which the body either does not produce enough insulin or the insulin produced does not work properly. Diabetes may also develop when the body produces too much glucagon.
Insulin is a substance that helps lower blood glucose levels, especially after a meal.
Glucagon is a substance that stimulates glucose production in the liver and increases blood glucose levels. Both of these substances are produced in the pancreas.
How Alikval works
Alikval works by stimulating the pancreas to produce insulin and by reducing the production of glucagon. Therefore, Alikval helps control blood glucose levels. It has been shown that the medicine reduces blood glucose levels, which may help prevent complications associated with diabetes. Even after starting pharmacological treatment for diabetes, it remains important for the patient to continue following an appropriate diet and (or) performing recommended physical exercise.

2. Important information before using Alikval

When not to use Alikval

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 Alikval, they should not take this medicine and should inform their doctor.

Warnings and precautions
Before starting treatment with Alikval, discuss this with your doctor, pharmacist, or
nurse:

if the patient has type 1 diabetes (i.e. if the patient's body does not produce insulin) or if the patient has a condition called diabetic ketoacidosis,
if the patient is taking an antidiabetic medicine called a sulfonylurea [the doctor may wish to reduce the dose of the sulfonylurea when used together with Alikval to avoid low blood glucose levels (hypoglycaemia)],
if the patient has moderate or severe kidney disease (a lower dose of Alikval should be used),
if the patient is on dialysis,
if the patient has liver disease,
if the patient has heart failure,
if the patient has had or currently has pancreatic disorders.

If the patient previously took vildagliptin but had to stop due to liver disease, they should not use this medicine.
Skin changes are a common complication of diabetes. The patient should follow the advice of their doctor or nurse regarding skin and foot care. While taking Alikval, the patient should pay particular attention to the development of new blisters or ulcers. If these occur, the patient should contact their doctor immediately.
Before starting treatment with Alikval and every three months during the first year of treatment, and periodically thereafter, liver function tests should be performed. This allows symptoms of increased liver enzyme activity to be detected as early as possible.
Children and adolescents
Alikval is not recommended for use in children and adolescents under 18 years of age.
Alikval and other medicines
Tell your doctor or pharmacist about any medicines you are currently taking, have recently taken, or plan to take.
Your doctor may 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 inflammatory conditions),
medicines used to treat thyroid disorders,
certain medicines affecting the nervous system.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before using this medicine.
Alikval should not be used during pregnancy. It is not known whether Alikval passes into human breast milk. Alikval should not be used if breastfeeding or planning to breastfeed.
Driving and operating machinery
If the patient experiences dizziness while taking Alikval, they should not drive or operate machinery.
Alikval contains lactose and sodium
Alikval contains lactose (milk sugar). If the patient has previously been diagnosed with intolerance to certain sugars, they should consult their doctor before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".
3. How to use Alikval
This medicine should always be used exactly as prescribed by the doctor. In case of doubt, consult the doctor or pharmacist.
What dose to take and when
The dose of Alikval varies depending on the patient's condition. The doctor will determine exactly how many Alikval tablets should be taken. The maximum daily dose is 100 mg.
The usual dose of Alikval is:

50 mg once daily in the morning, when Alikval is used together with a medicine called a sulfonylurea.
100 mg daily, taken as 50 mg in the morning and 50 mg in the evening, when Alikval is used alone, with metformin, with a glitazone, or in combination with metformin and a sulfonylurea or insulin.
50 mg once daily in the morning, if the patient has moderate or severe kidney disease or if the patient is on dialysis.

How to take Alikval
Tablets should be swallowed whole with water.
How long to take Alikval

Alikval should be taken every day for as long as prescribed by the doctor. The doctor may decide on long-term treatment.
The doctor will regularly monitor the patient's health to check whether the treatment is achieving the desired effect.

Taking more Alikval than prescribed
If too many Alikval tablets are taken or if someone else takes this medicine, speak to a doctor immediately. The patient may require medical attention. If it is necessary to visit a doctor's office or hospital, bring the medicine packaging with you.
If a dose of Alikval is missed
If the patient forgets to take a dose of this medicine, they should take it as soon as they remember. Then the next dose should be taken at the usual time. However, if it is almost time for the next dose, the missed dose should be skipped.
Do not take a double dose to make up for a missed tablet.
Stopping Alikval
Do not stop taking Alikval without consulting your doctor. If you have any questions about how long to take this medicine, consult your doctor.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Some adverse reactions require immediate medical attention:
If any of the following adverse reactions occur, stop taking
the medicine Alikval immediately and consult a doctor:

Angioedema (rare: may occur in no more than 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 called "angioedema".
Liver disease (hepatitis) (frequency not known): symptoms include yellowing of the skin and whites of the eyes, nausea, loss of appetite, or dark-coloured urine. These may indicate liver disease (hepatitis).
Pancreatitis (rare: may occur in up to 1 in 1,000 patients): symptoms include severe and persistent abdominal pain (in the stomach area), which may radiate to the back, as well as nausea and vomiting.

Other adverse reactions
Some patients taking wildagliptin have experienced the following adverse reactions:

Very common (may occur in more than 1 in 10 patients): sore throat, runny nose, fever.
Common (may occur in up to 1 in 10 patients): itchy rash, tremor, headache, dizziness, muscle pain, joint pain, constipation, swollen hands, ankles or feet (oedema), excessive sweating, vomiting, stomach and abdominal pain (abdominal pain), diarrhoea, heartburn, nausea (feeling unwell), blurred vision.
Uncommon (may occur in up to 1 in 100 patients): weight gain, chills, fatigue, sexual dysfunction, low blood glucose levels, bloating.
Rare (may occur in up to 1 in 1,000 patients): pancreatitis.

After wildagliptin was introduced to the market, the following adverse reactions have also been reported:

Frequency not known (frequency cannot be estimated from available data): localised peeling of the skin or formation of blisters, vasculitis, which may cause skin rash or small, flat, red, round spots under the skin or bruising.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed
in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported
directly to the Department of Monitoring Adverse Drug Reactions of the 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
Adverse reactions can also be reported to the marketing authorisation holder.
By reporting adverse reactions, additional information on the safety of the medicine can be collected.

5. How to store Alikval

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and carton after "EXP".
The expiry date refers to the last day of the stated month.
This medicine does not require any special storage conditions.
Do not use Alikval if the packaging is damaged or shows signs of having been opened.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Following this advice helps 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.
Other ingredients (excipients) are: lactose, sodium stearyl fumarate, microcrystalline cellulose PH102, and sodium croscarmellose.

What Alikval looks like and contents of the pack
Alikval, 50 mg.
White or almost white, round, biconvex tablets, approximately 8.0 mm in diameter.
Available in blisters made of Aluminium/OPA/Aluminium/PVC, in cardboard cartons containing 28, 30, 56, 60, 84, 90, 112, 120, 140, 150, 168 or 180 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Egis Pharmaceuticals PLC
Keresztúri út 30-38
1106 Budapest
Hungary

Manufacturers
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 medicinal product is authorised 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 tablet
Poland Alikval