Alikval duo

Package leaflet: Information for the patient

Alikval Duo, 50 mg + 850 mg, film-coated tablets
Alikval Duo, 50 mg + 1000 mg, film-coated tablets
Vildagliptinum + Metformini hydrochloridum
Please read all of this leaflet carefully before 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 personally. 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, tell your doctor, pharmacist, or nurse. See section 4.

Leaflet contents

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

1. What Alikval Duo is and what it is used for

The active substances in Alikval Duo are vildagliptin and metformin, which belong to a group of medicines called "oral antidiabetic agents".
Alikval Duo is used to treat adult patients with type 2 diabetes. This type of diabetes is also known as insulin-independent diabetes. Alikval Duo is used when diabetes cannot be controlled by diet and physical exercise alone. The medicine helps control blood glucose levels. Your doctor may prescribe vildagliptin and metformin alone or together with other antidiabetic medicines you are already taking, if they have not been sufficiently effective in controlling your diabetes.
Type 2 diabetes is a condition in which the body either does not produce enough insulin, or the insulin produced does not work properly. Type 2 diabetes may also occur when the body produces too much glucagon.
Both insulin and glucagon are produced in the pancreas. Insulin helps lower blood glucose levels, especially after meals. Glucagon is a substance that stimulates glucose production in the liver and increases blood glucose levels.
How Alikval Duo works
Both active substances, vildagliptin and metformin, help control blood glucose levels.
Vildagliptin works by stimulating the pancreas to produce insulin and reducing glucagon production. Metformin helps the body use insulin more effectively.
The medicine has been shown to reduce blood glucose levels, which may help prevent complications associated with diabetes.

2. Important information before using Alikval Duo

When not to use Alikval Duo

• If the patient is allergic to vildagliptin, metformin, or any of the other ingredients of this medicine (listed in section 6). If the patient thinks they may be allergic to any of these ingredients, they should inform their doctor before taking Alikval Duo.
• If the patient has uncontrolled diabetes, for example severe hyperglycaemia (high blood glucose levels), nausea, vomiting, diarrhoea, sudden weight loss, lactic acidosis (see "Risk of lactic acidosis" below), or ketoacidosis. Ketoacidosis is a condition in which substances called ketone bodies accumulate in the blood and may lead to diabetic pre-coma. Symptoms include: abdominal pain, rapid and deep breathing, drowsiness, or an unusual fruity odour of the breath.
• If the patient has recently had a heart attack or if they have heart failure or severe circulatory disorders or breathing difficulties, which may be symptoms of heart failure.
• If the patient has significantly reduced kidney function.
• If the patient has a severe infection or is severely dehydrated (has lost a large amount of fluid from the body).
• If the patient is due to undergo a radiological contrast examination (a special type of imaging requiring injection of a contrast agent). For further information, see section "Warnings and precautions".
• If the patient has liver disease.
• If the patient consumes excessive amounts of alcohol (either regularly or occasionally).
• If the patient is breastfeeding (also see section "Pregnancy and breastfeeding").

Warnings and precautions
Risk of lactic acidosis
Alikval Duo may cause a very rare but serious adverse effect called lactic acidosis, especially if the patient has impaired kidney function. The risk of lactic acidosis is also increased in cases of uncontrolled diabetes, severe infection, prolonged fasting or alcohol consumption, dehydration (see further information below), impaired liver function, and any medical conditions in which a part of the body is insufficiently supplied with oxygen (e.g. acute severe heart disease).
If any of the above conditions apply to the patient, they should consult their doctor for further instructions.
Treatment with Alikval Duo should be temporarily discontinued if the patient develops a medical condition associated with dehydration (significant loss of fluid from the body), such as severe vomiting, diarrhoea, fever, exposure to high temperatures, or if the patient drinks less fluid than usual. The patient should consult their doctor for further instructions.
Treatment with Alikval Duo should be stopped and the patient should immediately contact their doctor or the nearest hospital if any symptoms of lactic acidosis occur, as this condition may lead to coma. Symptoms of lactic acidosis include:

• vomiting,
• abdominal pain,
• muscle cramps,
• general feeling of being unwell combined with profound fatigue,
• difficulty breathing,
• decreased body temperature and slowed heart rate.

Lactic acidosis is an acute, life-threatening condition requiring immediate hospital treatment.
Alikval Duo does not replace insulin. Therefore, Alikval Duo should not be used in the treatment of type 1 diabetes.
Before starting treatment with Alikval Duo, the patient should discuss with their doctor, pharmacist, or nurse if they have or have had any pancreatic disorders.
Before starting treatment with Alikval Duo, the patient should consult their doctor, pharmacist, or nurse if they are taking an antidiabetic medicine called a sulphonylurea. The doctor may wish to reduce the dose of the sulphonylurea when used together with Alikval Duo to avoid low blood glucose levels (hypoglycaemia).
If the patient previously took vildagliptin but had to stop due to liver disease, they should not take this medicine.
Diabetic skin changes are a common complication of diabetes. The patient should follow the doctor’s or nurse’s advice regarding skin and foot care. While taking Alikval Duo, the patient should pay particular attention to the development of new blisters or ulcers. If these occur, the patient should contact their doctor immediately.
If the patient is due to undergo major surgery, they must not take Alikval Duo during the procedure and for a period afterwards. The doctor will decide when the patient should stop and restart treatment with Alikval Duo.
Before starting treatment with Alikval Duo and every three months during the first year of treatment, and thereafter periodically, liver function tests should be performed. This allows early detection of signs of increased liver enzyme activity.
During treatment with Alikval Duo, the doctor will monitor the patient’s kidney function at least once a year, or more frequently if the patient is elderly and/or has worsening kidney function.
The doctor will regularly monitor blood and urine glucose levels.
Alikval Duo contains lactose and sodium
If the patient has previously been diagnosed with intolerance to certain sugars, they should consult their doctor before taking this medicine.
Alikval Duo contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".
Children and adolescents
Alikval Duo is not recommended for use in children and adolescents under 18 years of age.
Alikval Duo and other medicines
If the patient is to receive an intravenous iodinated contrast agent, for example for an X-ray or CT scan, they must stop taking Alikval Duo before or at the latest at the time of administration. The doctor will decide when the patient should stop and restart treatment with Alikval Duo.
The patient should inform their doctor or pharmacist about any medicines they are currently taking, have recently taken, or plan to take. They may require more frequent monitoring of blood glucose levels and kidney function, or a dose adjustment of Alikval Duo. It is particularly important to inform about the following medicines:

• glucocorticoids, usually used to treat inflammatory conditions
• beta-2 adrenergic receptor agonists, usually used to treat breathing disorders
• other medicines used to treat diabetes
• diuretics (medicines that increase urine production)
• medicines used to treat pain and inflammation (NSAIDs and COX-2 inhibitors such as ibuprofen and celecoxib)
• certain medicines used to treat high blood pressure (ACE inhibitors and angiotensin II receptor antagonists)
• certain medicines affecting the thyroid gland
• certain medicines affecting the nervous system
• certain medicines used to treat angina pectoris, e.g. ranolazine
• certain medicines used to treat HIV infection, e.g. dolutegravir
• certain medicines used to treat a specific type of thyroid cancer (medullary thyroid cancer), e.g. vandetanib
• certain medicines used to treat heartburn and peptic ulcers, e.g. cimetidine.

Alikval Duo and alcohol
The patient should avoid consuming excessive amounts of alcohol while taking Alikval Duo, as this may increase the risk of lactic acidosis (see section "Warnings and precautions").
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to become pregnant, she should consult her doctor before taking this medicine. The doctor will discuss the potential risks associated with taking Alikval Duo during pregnancy.

• Do not use Alikval Duo during pregnancy or breastfeeding (also see "When not to use Alikval Duo").

Before taking any medicine, consult a doctor or pharmacist.
Driving and using machines
If the patient experiences dizziness while taking Alikval Duo, they should not drive or operate machinery.
3. How to use Alikval Duo
The dose of Alikval Duo varies depending on the patient’s condition. The doctor will determine the appropriate dose of Alikval Duo.
This medicine should always be taken exactly as prescribed by the doctor. In case of doubt, consult the doctor or pharmacist.
The recommended dose is one 50 mg + 850 mg or 50 mg + 1000 mg coated tablet taken twice daily.
If the patient has reduced kidney function, the doctor may prescribe a lower dose. If the patient is taking an antidiabetic medicine called a sulphonylurea, the doctor may also prescribe a lower dose.
The doctor may prescribe this medicine to be taken alone (as monotherapy) or in combination with certain other medicines that lower blood glucose levels.
When and how to take Alikval Duo

• Swallow the tablets whole with a glass of water.
• Take one tablet in the morning and one in the evening with a meal or shortly after a meal. Taking the tablet immediately after a meal may help reduce the risk of gastrointestinal disturbances.

The patient should continue to follow any dietary advice given by their doctor. Following a diet while taking Alikval Duo is particularly important if the patient is on a weight-control diet.
The break line on the tablet is not intended for splitting the tablet.
Taking more Alikval Duo than recommended
If the patient takes too many tablets of Alikval Duo or if someone else takes this medicine, they should immediately contact their doctor or pharmacist. Medical attention may be required. If it is necessary to visit the doctor or hospital, the patient should bring the medicine pack and this leaflet.
Missing a dose of Alikval Duo
If the patient forgets to take a tablet, they should take it at the next meal, unless it is almost time for the next dose. The patient should not take a double dose (two tablets at once) to make up for a missed tablet.
Stopping treatment with Alikval Duo
To maintain control of blood glucose levels, the medicine should be taken for as long as prescribed by the doctor. Do not stop taking Alikval Duo without the doctor’s advice. If the patient has any questions about how long to take this medicine, they should consult their doctor.
If the patient has any further questions about the use of this medicine, they should consult their doctor, pharmacist, or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
You should stop taking Alikval Duo and contact your doctor immediately if any of the following adverse reactions occur:

• Lactic acidosis (very rare: may occur in no more than 1 in 10,000 patients): Alikval Duo may very rarely cause a serious adverse reaction called lactic acidosis (see section “Warnings and precautions”). If this occurs in a patient, Alikval Duo must be discontinued and medical help must be sought immediately from a doctor or the nearest hospital, as lactic acidosis may lead to coma.
• Angioedema (rare: may occur in no more than 1 in 1,000 patients): Symptoms include swelling of the face, tongue or throat, difficulty swallowing, breathing difficulties, sudden rash or hives. These may indicate a reaction known as “angioedema”.
• Liver disease (hepatitis) (uncommon: may occur in no more than 1 in 100 patients): 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 (uncommon: may occur in no more than 1 in 100 patients): Symptoms include severe and persistent abdominal pain (around the stomach area), which may radiate to the back, as well as nausea and vomiting.

Other adverse reactions
The following adverse reactions have been reported in some patients taking Alikval Duo:

• Common (may occur in up to 1 in 10 patients): sore throat, cold symptoms, fever, itchy rash, excessive sweating, joint pain, dizziness, headache, uncontrollable tremor, constipation, nausea, vomiting, diarrhoea, bloating, heartburn, stomach and abdominal pain.
• Uncommon (may occur in up to 1 in 100 patients): fatigue, weakness, metallic taste in the mouth, low blood glucose levels, loss of appetite, swelling of hands, ankles or feet (oedema), chills, pancreatitis, muscle pain.
• Very rare (may occur in up to 1 in 10,000 patients): symptoms of high levels of lactic acid in the blood (called lactic acidosis), such as drowsiness or dizziness, severe nausea or vomiting, abdominal pain, irregular heartbeat, or deep, rapid breathing; skin redness, itching; decreased vitamin B12 levels (pallor, fatigue, psychiatric symptoms such as confusion or memory disorders).

After the introduction of this medicine into the market, the following adverse reactions have also been reported:

• Frequency not known (cannot be estimated from available data): localised skin peeling or blistering, 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 adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department for Monitoring Adverse Reactions of Medicinal Products at 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.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Alikval Duo

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the blister pack 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.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the packaging and other information

What Alikval Duo contains

• The active substances in this medicine are vildagliptin and metformin hydrochloride.
• Each film-coated tablet of Alikval Duo, 50 mg + 850 mg contains 50 mg of vildagliptin and 850 mg of metformin hydrochloride (equivalent to 660 mg of metformin).
• Each film-coated tablet of Alikval Duo, 50 mg + 1000 mg contains 50 mg of vildagliptin and 1000 mg of metformin hydrochloride (equivalent to 780 mg of metformin).
• The other ingredients are: hydroxypropylcellulose, lactose (see section 2), microcrystalline cellulose, type 102, sodium croscarmellose, sodium stearyl fumarate and ready-to-use coating (hypromellose type 2910, titanium dioxide (E 171), macrogol 4000, talc, iron oxide yellow (E 172)).

What Alikval Duo looks like and contents of the pack
Alikval Duo, 50 mg + 850 mg are yellow, elongated, oval film-coated tablets with a breakline on one side and the code "VA" on the other side.
Tablet diameter: 19.4 ± 0.5 mm.
Alikval Duo, 50 mg + 1000 mg are dark yellow, elongated, oval film-coated tablets with a breakline between the letters "V" and "B" on one side and a breakline on the other side.
Tablet diameter: 21.1 ± 0.5 mm.
Aluminium/OPA-Aluminium-PVC foil blisters containing 28, 30, 56, 60, 84, 90, 112, 120, 140, 150, 168 and 180 film-coated tablets in a cardboard box.
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

Manufacturer
SAG Manufacturing S.L.U
Carretera Nacional I, Km 36
San Agustin de Guadalix
28750 Madrid
Spain
Galenicum Health, S.L.U.
Sant Gabriel, 50
Esplugues de Llobregat
08950 Barcelona
Spain

Detailed information about this medicine is available on the website of the European Medicines Agency
http://www.ema.europa.eu and on the website of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products http://www.urpl.gov.pl/pl
The package leaflet is available in all languages of the European Union and the European Economic Area on the European Medicines Agency website.