ALIKVAL 50 mg/850 mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the Patient
2. Alikval Duo, 50 mg + 850 mg, film-coated tablets
3. Alikval Duo, 50 mg + 1000 mg, film-coated tablets
   1. Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of Contents of the Package Leaflet
4. What is Alikval Duo and what is it used for
   1. How Alikval Duo works
5. Important information before taking Alikval Duo
   1. When not to take Alikval Duo
   2. Warnings and precautions
   3. Risk of lactic acidosis
   4. You must stop taking Alikval Duo temporarily if you have a condition that may lead to dehydration
   5. You must stop taking Alikval Duo and contact your doctor or the nearest hospital immediately if you experience any symptoms of lactic acidosis
   6. Alikval Duo contains lactose and sodium
   7. Children and adolescents
   8. Alikval Duo with other medicines
   9. Alikval Duo with alcohol
   10. Pregnancy and breastfeeding
   11. Driving and using machines
6. How to take Alikval Duo
   1. When and how to take Alikval Duo
   2. What to do if you take more Alikval Duo than you should
   3. What to do if you forget to take Alikval Duo
   4. What to do if you stop taking Alikval Duo
7. Possible side effects
   1. Other side effects
   2. Reporting side effects
8. How to store Alikval Duo
9. Contents of the pack and other information
   1. What Alikval Duo contains
   2. What Alikval Duo looks like and contents of the pack
   3. Marketing authorization holder and manufacturer
   4. Marketing authorization holder
   5. Manufacturer
   6. Date of last revision of the leaflet: 09.07.2024

Package Leaflet: Information for the Patient

Alikval Duo, 50 mg + 850 mg, film-coated tablets

Alikval Duo, 50 mg + 1000 mg, film-coated tablets

Vildagliptin and Metformin hydrochloride

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 Package Leaflet

• 1. What is Alikval Duo and what is it used for
• 2. Important information 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 is Alikval Duo and what is it used for

The active substances of Alikval Duo are vildagliptin and metformin, which belong to a group of medicines called "oral antidiabetic medicines".
Alikval Duo is used to treat adult patients with type 2 diabetes. This type of diabetes is also called non-insulin-dependent diabetes. Alikval Duo is used when diabetes cannot be controlled by diet and exercise alone. The medicine helps to control blood sugar levels. Your doctor will prescribe vildagliptin and metformin either alone or in combination with other antidiabetic medicines that you are already taking, if they are not sufficient to control your diabetes.
Type 2 diabetes is a condition in which the body does not produce enough insulin, or the insulin produced by the body does not work properly. Type 2 diabetes can also occur when the body produces too much glucagon.
Both insulin and glucagon are produced in the pancreas. Insulin helps to 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.

How Alikval Duo works

Both active substances, vildagliptin and metformin, help to control blood sugar levels.
Vildagliptin works by stimulating the pancreas to produce insulin and reducing the production of glucagon. Metformin helps the body to use insulin more effectively.
It has been shown that the medicine reduces blood sugar levels, which can help to prevent complications in diabetes.

2. Important information before taking Alikval Duo

When not to take Alikval Duo

• If you are allergic to vildagliptin, metformin, or any of the other ingredients of this medicine (listed in section 6). If you think you may be allergic to any of these ingredients, tell your doctor before taking Alikval Duo.
• If you have uncontrolled diabetes, such as severe hyperglycemia (high blood sugar levels), nausea, vomiting, diarrhea, sudden weight loss, lactic acidosis (see "Risk of lactic acidosis" below), or diabetic ketoacidosis. Diabetic ketoacidosis is a condition in which substances called ketone bodies accumulate in the blood and can lead to diabetic pre-coma. Symptoms include abdominal pain, rapid and deep breathing, drowsiness, or a fruity odor from the mouth.
• If you have recently had a heart attack or if you have heart failure or severe circulatory problems or breathing difficulties, which may be a sign of heart failure.
• If you have significantly reduced kidney function.
• If you have a severe infection or are severely dehydrated (have lost a lot of water from your body).
• If you are going to have a contrast radiology test (a special type of test that requires the injection of a contrast agent). For more information, see also section "Warnings and precautions".
• If you have liver disease.
• If you drink excessive amounts of alcohol (both regularly and from time to time).
• If you are breastfeeding (see also section "Pregnancy and breastfeeding").

Warnings and precautions

Risk of lactic acidosis

Alikval Duo may cause a very rare but very serious side effect called lactic acidosis, especially if you have kidney problems. The risk of lactic acidosis also increases if you have uncontrolled diabetes, severe infection, prolonged fasting, or drink alcohol, dehydration (see more information below), liver disease, or any condition in which a part of the body is not getting enough oxygen (e.g., severe heart disease).
If any of these conditions apply to you, you should consult your doctor for more detailed instructions.

You must stop taking Alikval Duo temporarily if you have a condition that may lead to dehydration

(significant loss of water from the body), such as severe vomiting, diarrhea, fever, exposure to high temperatures, or if you drink less fluid than usual. You should consult your doctor for more detailed instructions.

You must stop taking Alikval Duo and contact your doctor or the nearest hospital immediately if you experience any symptoms of lactic acidosis

, as this condition can lead to coma. Symptoms of lactic acidosis include:

• vomiting,
• abdominal pain,
• muscle cramps,
• general feeling of being unwell, accompanied by severe fatigue,
• breathing difficulties,
• decreased body temperature and slowed heart rate.

Lactic acidosis is a life-threatening condition that requires immediate treatment in a hospital.
Alikval Duo does not replace insulin. Therefore, you should not take Alikval Duo to treat type 1 diabetes.
Before taking Alikval Duo, you should discuss it with your doctor, pharmacist, or nurse if you have or have had pancreatitis.
Before taking Alikval Duo, you should tell your doctor, pharmacist, or nurse if you are taking a diabetes medicine called a sulfonylurea. Your doctor may want to reduce the dose of the sulfonylurea you are taking with Alikval Duo to avoid low blood sugar levels (hypoglycemia).
If you have taken vildagliptin before but had to stop taking it because of liver disease, you should not take this medicine.
Diabetic skin changes are a common complication of diabetes. You should follow your doctor's or nurse's advice on skin and foot care. While taking Alikval Duo, you should pay particular attention to the development of new blisters or ulcers. If they occur, you should contact your doctor immediately.
If you are going to have a major surgical procedure, you should not take Alikval Duo during the procedure and for some time after it. Your doctor will decide when you should stop and restart treatment with Alikval Duo.
Before taking Alikval Duo and at 3-month intervals during the first year of treatment, and periodically thereafter, you should have liver function tests to detect any signs of increased liver enzyme activity as soon as possible.
During treatment with Alikval Duo, your doctor will check your kidney function at least once a year or more often if you are elderly and/or have worsening kidney function.
Your doctor will regularly check your blood sugar levels and urine.

Alikval Duo contains lactose and sodium

If you have been diagnosed with an intolerance to some sugars, you should contact your doctor before taking this medicine.
Alikval Duo contains less than 1 mmol (23 mg) of sodium per tablet, which means that the medicine is considered "sodium-free".

Children and adolescents

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

Alikval Duo with other medicines

If you are going to have a contrast agent injected into your bloodstream, for example, for an X-ray or CT scan, you should stop taking Alikval Duo before or at the latest at the time of the injection. Your doctor will decide when you should stop and restart treatment with Alikval Duo.
You should tell your doctor or pharmacist about all the medicines you are taking or have recently taken, as well as any medicines you plan to take. You may need more frequent blood sugar checks or kidney function tests, or your doctor may need to adjust the dose of Alikval Duo. It is especially important to inform your doctor about the following medicines:

• corticosteroids, usually used to treat inflammatory conditions
• beta-2-adrenergic receptor agonists, usually used to treat respiratory 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 that affect the thyroid gland
• certain medicines that affect the nervous system
• certain medicines used to treat angina, such as ranolazine
• certain medicines used to treat HIV infection, such as dolutegravir
• certain medicines used to treat a specific type of thyroid cancer (medullary thyroid cancer), such as vandetanib
• certain medicines used to treat heartburn and stomach ulcers, such as cimetidine.

Alikval Duo with alcohol

You should avoid drinking 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 you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, you should ask your doctor for advice before taking this medicine. Your doctor will discuss with you the possible risks of taking Alikval Duo during pregnancy.

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

Before taking any medicine, you should consult your doctor or pharmacist.

Driving and using machines

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

3. How to take Alikval Duo

The dose of Alikval Duo varies depending on your condition. Your doctor will determine the dose of Alikval Duo you should take.
This medicine should always be taken exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
The recommended dose is one 50 mg + 850 mg or 50 mg + 1000 mg film-coated tablet twice a day.
If you have reduced kidney function, your doctor may prescribe a lower dose. If you are taking a diabetes medicine called a sulfonylurea, your doctor may also prescribe a lower dose.
Your doctor may prescribe this medicine alone (as monotherapy) or with certain other medicines that lower blood sugar 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 immediately after a meal. Taking the tablet immediately after a meal will help reduce the risk of stomach upset.

You should continue to follow your doctor's advice on diet while taking Alikval Duo. Diet is especially important when you are taking a weight-controlling diet while taking Alikval Duo.
The score line on the tablet is not intended to break the tablet.

What to do if you take more Alikval Duo than you should

If you take too many Alikval Duo tablets or if someone else takes your medicine, you should contact your doctor or pharmacist immediately. You may need medical attention. If you need to go to a doctor or hospital, take the medicine pack and this leaflet with you.

What to do if you forget to take Alikval Duo

If you forget to take a tablet, you should take it with your next meal, unless it is time for your next dose. Do not take a double dose (two tablets at once) to make up for a forgotten tablet.

What to do if you stop taking Alikval Duo

To maintain control of your blood sugar levels, you should take the medicine for as long as your doctor tells you. Do not stop taking Alikval Duo without your doctor's advice. If you have any questions about how long to take this medicine, ask your doctor.
If you have any further questions about taking this medicine, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, Alikval Duo can cause side effects, although not everybody gets them.
You should stop taking Alikval Duo and contact your doctor immediatelyif you experience any of the following side effects:

• Lactic acidosis(very rare: may affect up to 1 in 10,000 people): Alikval Duo may very rarely cause a very serious side effect called lactic acidosis (see section "Warnings and precautions"). If this happens to you, you should stop taking Alikval Duo and contact your doctor or the nearest hospital immediately, as lactic acidosis can lead to coma.
• Angioedema (rare: may affect up to 1 in 1,000 people): Symptoms include swelling of the face, tongue, or throat, difficulty swallowing, breathing difficulties, sudden onset of rash or hives. These may indicate a condition called "angioedema".
• Liver disease (hepatitis) (uncommon: may affect up to 1 in 100 people). Symptoms include yellowing of the skin and the whites of the eyes, nausea, loss of appetite, or dark-colored urine. These may indicate liver disease (hepatitis).
• Pancreatitis (uncommon: may affect up to 1 in 100 people): Symptoms include severe and persistent abdominal pain (in the stomach area), which may radiate to the back, as well as nausea and vomiting.

Other side effects

Some patients taking Alikval Duo have experienced the following side effects:

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

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

• Frequency not known (cannot be estimated from the available data): localized skin peeling or blistering, vasculitis, which can cause a skin rash or purpura (red spots under the skin) or red, flat, round patches under the skin.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, you should tell your doctor or pharmacist. 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, 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 Duo

Keep this medicine out of the 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 month.
This medicine does not require any special storage conditions.
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 Duo contains

• The active substances are vildagliptin and metformin hydrochloride.
• Each 50 mg + 850 mg film-coated tablet of Alikval Duo contains 50 mg of vildagliptin and 850 mg of metformin hydrochloride (which corresponds to 660 mg of metformin).
• Each 50 mg + 1000 mg film-coated tablet of Alikval Duo contains 50 mg of vildagliptin and 1000 mg of metformin hydrochloride (which corresponds to 780 mg of metformin).
• The other excipients are: hydroxypropylcellulose, lactose (see section 2), microcrystalline cellulose, type 102, sodium carboxymethylcellulose, sodium stearyl fumarate, and film coating (hypromellose type 2910, titanium dioxide (E 171), macrogol 4000, talc, yellow iron oxide (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 score line on one side and the inscription "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 score line between the letters "V" and "B" on one side and a score line on the other side.
Tablet diameter: 21.1 ± 0.5 mm.
Blisters of aluminum/OPA-aluminum-PVC 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 authorization holder and manufacturer

Marketing authorization 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

Date of last revision of the leaflet: 09.07.2024

Detailed information on this medicine is available on the European Medicines Agency website http://www.ema.europe.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 leaflet is available in all languages of the European Union and the European Economic Area on the European Medicines Agency website.