DIPTIVIL 50 mg/850 mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the User
2. Diptivil Duo, 50 mg + 850 mg, film-coated tablets
3. Diptivil Duo, 50 mg + 1000 mg, film-coated tablets
   1. Read all of this leaflet carefully before taking this medicine because it contains important information for you.
   2. Contents of the pack and other information
4. What Diptivil Duo is and what it is used for
   1. How Diptivil Duo works
5. What you need to know before you take Diptivil Duo
   1. Do not take Diptivil Duo
   2. Warnings and precautions
   3. Risk of lactic acidosis
   4. Stop taking Diptivil Duo temporarily if you have a condition that may lead to dehydration
   5. If you experience any of the symptoms of lactic acidosis, stop taking Diptivil Duo and contact your doctor or the nearest hospital immediately
   6. Surgery
   7. Tests
   8. Kidney function
   9. Blood sugar control
   10. Children and adolescents
   11. Diptivil Duo with other medicines
   12. Taking Diptivil Duo with food and drink
   13. Pregnancy and breast-feeding
   14. Driving and using machines
6. How to take Diptivil Duo
   1. When and how to take Diptivil Duo
   2. If you take more Diptivil Duo than you should
   3. If you forget to take Diptivil Duo
   4. If you stop taking Diptivil Duo
7. Possible side effects
   1. Other side effects
   2. Reporting of side effects
8. How to store Diptivil Duo
9. Contents of the pack and other information
   1. What Diptivil Duo contains
   2. What Diptivil Duo looks like and contents of the pack
   3. Marketing Authorisation Holder and Manufacturer
   4. Marketing Authorisation Holder:
   5. Manufacturer/Importer:
   6. This medicinal product is authorised in the Member States of the European Economic Area under the following names:
   7. Diptivil Duo is approved in the following countries:
   8. Date of last revision of the leaflet: 04/2025

Package Leaflet: Information for the User

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

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

Vildagliptin and Metformin hydrochloride

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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information

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

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

The active substances of Diptivil Duo are vildagliptin and metformin, which belong to a group of medicines called "oral antidiabetic agents".
Diptivil Duo is used to treat adults with type 2 diabetes. This type of diabetes is also called non-insulin-dependent diabetes. Diptivil Duo is used when diabetes cannot be controlled by diet and exercise alone and/or when other antidiabetic medicines (insulin or sulphonylureas) are being taken.
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 the level of sugar in the blood, especially after meals. Glucagon stimulates the liver to produce sugar, causing the level of sugar in the blood to rise.

How Diptivil Duo works

Both active substances, vildagliptin and metformin, help to control the level of sugar in the blood.
Vildagliptin works by increasing the amount of insulin produced by the pancreas and decreasing the amount of glucagon produced by the pancreas. Metformin helps the body to use insulin more effectively.
It has been shown that this medicine reduces the level of sugar in the blood, which may help to prevent complications of diabetes.

2. What you need to know before you take Diptivil Duo

Do not take Diptivil 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 Diptivil Duo.
• If you have uncontrolled diabetes, for example, severe hyperglycemia (high blood sugar), nausea, vomiting, diarrhea, rapid weight loss, lactic acidosis (see "Risk of lactic acidosis" below) or diabetic ketoacidosis. Diabetic ketoacidosis is a condition where substances called ketones build up in the blood, which can lead to diabetic pre-coma. Symptoms include abdominal pain, fast and deep breathing, drowsiness, or an unusual fruity odor from the mouth.
• If you have recently had a heart attack or have heart failure or severe circulatory or breathing problems, which may be a sign of heart failure.
• If you have significantly reduced kidney function.
• If you have a severe infection or are dehydrated (have lost too much water from your body).
• If you are going to have a contrast agent injected into a blood vessel (a type of X-ray involving the use of a contrast agent). For more information, see "Warnings and precautions" below.
• If you have liver disease.
• If you drink excessive amounts of alcohol (either regularly or from time to time).
• If you are breast-feeding (see also "Pregnancy and breast-feeding").

Warnings and precautions

Risk of lactic acidosis

Diptivil Duo may cause a very rare but very serious side effect called lactic acidosis, particularly if you have kidney problems. The risk of lactic acidosis increases with uncontrolled diabetes, severe infections, prolonged fasting or alcohol intake, dehydration (see below), liver problems, and any condition that may affect the kidneys or the heart. If any of these conditions apply to you, tell your doctor before taking Diptivil Duo.

Stop taking Diptivil Duo temporarily if you have a condition that may lead to dehydration

such as severe vomiting, diarrhea, fever, exposure to high temperatures, or if you drink less fluid than you normally would.Tell your doctor before taking Diptivil Duo.

If you experience any of the symptoms of lactic acidosis, stop taking Diptivil Duo and contact your doctor or the nearest hospital immediately

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

• vomiting
• abdominal pain
• muscle cramps
• general feeling of being unwell with severe fatigue
• difficulty breathing
• low body temperature and slow heart rate.

Lactic acidosis is a medical emergency that requires immediate hospitalization.
Tell your doctor immediately if you have hereditary diseases affecting the mitochondria (the energy-producing structures within cells), such as MELAS syndrome (mitochondrial encephalomyopathy, myopathy, lactic acidosis, and stroke-like episodes) or maternally inherited diabetes and deafness.

• If you have had any of the following symptoms after starting metformin: seizures, worsening of mental status, difficulty moving, signs of nerve damage (such as pain or numbness), migraine, or hearing loss.

Diptivil Duo does not replace insulin. Therefore, do not use Diptivil Duo to treat type 1 diabetes.
Before taking Diptivil Duo, tell your doctor if you have or have had pancreatitis (inflammation of the pancreas).
Before taking Diptivil Duo, tell your doctor if you are taking a sulphonylurea, a medicine used to treat diabetes. Your doctor may need to reduce the dose of the sulphonylurea when you take it together with Diptivil Duo to avoid low blood sugar (hypoglycaemia).
If you have taken vildagliptin before and had to stop due to liver disease, do not take this medicine.
Diabetic skin changes are a common complication of diabetes. Follow your doctor's or nurse's advice on skin and foot care. You should also pay close attention to any new blisters or ulcers while taking Diptivil Duo. If you notice any, talk to your doctor promptly.

Surgery

If you need to undergo a major surgical operation, stop taking Diptivil Duo during and for some time after the operation. Your doctor will decide when you should stop and restart taking Diptivil Duo.

Tests

Before starting treatment with Diptivil Duo and at 3-month intervals during the first year of treatment, and periodically thereafter, you will need to have liver function tests to check for any signs of liver damage as soon as possible.

Kidney function

While taking Diptivil 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.

Blood sugar control

Your doctor will regularly check your blood sugar levels and urine.

Children and adolescents

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

Diptivil Duo with other medicines

If you are going to have a contrast agent injected into a blood vessel, for example, for an X-ray or CT scan, you will need to stop taking Diptivil Duo before or at the time of the injection. Your doctor will decide when you should stop and restart taking Diptivil Duo.

Taking Diptivil Duo with food and drink

Avoid excessive alcohol intake while taking Diptivil Duo because it may increase the risk of lactic acidosis (see "Warnings and precautions").

Pregnancy and breast-feeding

• If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Your doctor will discuss with you the potential risks of taking Diptivil Duo during pregnancy.
• Do not take Diptivil Duo if you are pregnant or breast-feeding (see also "Do not take Diptivil Duo").

Before taking any medicine, consult your doctor or pharmacist.

Driving and using machines

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

3. How to take Diptivil Duo

The dose of Diptivil Duo that you take will depend on your condition. Your doctor will decide exactly what dose you should take.

When and how to take Diptivil Duo

• Swallow the tablets whole with a glass of water.
• Take one tablet in the morning and one tablet in the evening with food or shortly after food. Taking the tablet shortly after food will help to reduce the risk of stomach upset.

Continue to follow your doctor's advice on diet. In particular, if you are following a diabetic diet to manage your weight, you should continue it while taking Diptivil Duo.

If you take more Diptivil Duo than you should

If you accidentally take too many tablets of Diptivil Duo or take someone else's tablets, contact your doctor or pharmacist immediately.Medical attention may be necessary. If you need to go to a doctor or hospital, take the pack and this leaflet with you.

If you forget to take Diptivil Duo

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

If you stop taking Diptivil Duo

Keep taking this medicine for as long as your doctor recommends. Do not stop taking Diptivil Duo unless your doctor tells you to. If you have any questions about how long to take Diptivil Duo, ask your doctor.

4. Possible side effects

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

You must stop taking Diptivil Duo and contact your doctor immediatelyif you experience any of the following serious side effects:

• Lactic acidosis (very rare: may affect up to 1 in 10,000 people): Diptivil Duo may very rarely cause a very serious side effect called lactic acidosis (see "Warnings and precautions" above). If this happens, you must stop taking Diptivil Duo and contact your doctor or the nearest hospital immediatelybecause 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, difficulty breathing, sudden appearance of rash or hives, which may indicate an allergic reaction 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 urine, which may indicate liver disease (hepatitis).
• Pancreatitis (uncommon: may affect up to 1 in 100 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 who took Diptivil Duo have experienced the following side effects:

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

Since this medicine has been authorized for use in the European Union, 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, which can cause skin rash or purple spots under the skin or bruises.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in the "Further information" section.

5. How to store Diptivil Duo

• 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.
• Store in a cool, dry place below 30°C.
• Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Diptivil Duo contains

• The active substances are vildagliptin and metformin hydrochloride.
• Each film-coated tablet of Diptivil Duo 50 mg + 850 mg contains 50 mg of vildagliptin and 850 mg of metformin hydrochloride (equivalent to 663 mg of metformin).
• Each film-coated tablet of Diptivil 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: Tablet core: hydroxypropylcellulose (E 463), magnesium stearate. Tablet coating: hypromellose (E 464), yellow iron oxide (E 172), titanium dioxide (E 171), macrogol 8000 (E 1521), talc (E 553b).

What Diptivil Duo looks like and contents of the pack

Diptivil Duo 50 mg + 850 mg film-coated tablets are yellow, oval tablets with "M" engraved on one side and "V12" engraved on the other side.
Diptivil Duo 50 mg + 1000 mg film-coated tablets are dark yellow, oval tablets with "M" engraved on one side and "V13" engraved on the other side.
Diptivil Duo is available in packs of 30, 60, or 180 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

MSN Labs Europe Limited
KW20A Corradino Park
Paola, PLA 3000
Malta
tel.: (+48) 699 711 147
(logo of the Marketing Authorisation Holder)

Manufacturer/Importer:

MSN Labs Europe Limited
KW20A Corradino Park
Paola, PLA 3000
Malta
Pharmadox Healthcare Limited
KW20A Kordin Industrial Park
Paola, PLA 3000
Malta

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

Diptivil Duo is approved in the following countries:

Denmark:
Diptivil Duo
Czech Republic:
Diptivil Duo
Hungary:
Diptivil Duo 50 mg/850 mg film-coated tablets
Diptivil Duo 50 mg/1000 mg film-coated tablets
Poland:
Diptivil Duo
Romania:
Diptivil Duo 50 mg/850 mg film-coated tablets
Diptivil Duo 50 mg/1000 mg film-coated tablets
Slovakia:
Diptivil Duo 50 mg/850 mg
Diptivil Duo 50 mg/1000 mg
Bulgaria:
Diptivil Duo 50 mg/850 mg film-coated tablets
Diptivil Duo 50 mg/1000 mg film-coated tablets

Date of last revision of the leaflet: 04/2025