Diptivil Duo

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.

How Diptivil Duo works

Both active substances, vildagliptin and metformin, help to control blood sugar levels.
Vildagliptin works by increasing the amount of insulin produced by the pancreas and decreasing the amount of glucose produced by the liver.
Metformin works by improving the body's sensitivity to insulin, allowing it to use insulin more effectively.

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 the body produces substances called ketones, which 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 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 (lost a lot of water from your body).
• If you are going to have a contrast agent injected into your bloodstream, for example, for an X-ray or CT scan. For more information, see also section "Warnings and precautions".
• If you have liver disease.
• If you drink excessive amounts of alcohol (either regularly or from time to time).
• If you are breastfeeding (see also "Pregnancy and breastfeeding").

Warnings and precautions

Risk of lactic acidosis

Diptivil 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 infections, prolonged fasting, or excessive alcohol consumption, dehydration (see below), liver disease, or any condition where part of the body is not getting enough oxygen (e.g., severe heart disease).
If any of these situations apply to you, you should contact your doctor for further instructions.

Temporarily stop taking Diptivil Duo if you have a condition that may lead to dehydration

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

If you experience any 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, combined with severe fatigue
• difficulty breathing
• decreased body temperature and slowed heart rate.

Lactic acidosis is a life-threatening condition that requires hospital treatment.
You should contact your doctor immediately if:

• you have a genetically inherited disease affecting the mitochondria (energy-producing structures in cells), such as MELAS syndrome (mitochondrial encephalopathy, myopathy, lactic acidosis, and stroke-like episodes) or maternally inherited diabetes and deafness (MIDD).
• you experience any of the following symptoms after starting metformin: seizures, worsening of cognitive function, difficulty moving, signs of nerve damage (e.g., pain or numbness), migraine, or hearing loss.

Diptivil Duo does not replace insulin. Therefore, you should not take Diptivil Duo to treat type 1 diabetes.
Before taking Diptivil Duo, you should discuss this with your doctor, pharmacist, or nurse if you have or have had pancreatitis.
Before taking Diptivil Duo, you should tell your doctor, pharmacist, or nurse if you are taking a sulphonylurea, a type of antidiabetic medicine.
Your doctor may want to reduce the dose of sulphonylurea you are taking with Diptivil Duo to avoid low blood sugar (hypoglycaemia).
If you have taken vildagliptin before but had to stop due to 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. You should also pay particular attention to the occurrence of new blisters or ulcers while taking Diptivil Duo. If they occur, you should discuss them with your doctor promptly.
If you need to undergo a major surgical procedure, you should stop taking Diptivil Duo during and for some time after the procedure. Your doctor will decide when you should stop and restart treatment with Diptivil Duo.
Before and during treatment with Diptivil Duo, and at intervals of 3 months during the first year of treatment, and periodically thereafter, you should have your liver function tested to detect any increase in liver enzymes as soon as possible.
During treatment with 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.
Your doctor will regularly check your blood sugar and urine levels.

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 your bloodstream, for example, for an X-ray or CT scan, you should stop taking Diptivil Duo before or at the latest at the time of the injection. Your doctor will decide when you should stop and restart treatment with Diptivil Duo.
You should tell your doctor about all the medicines you are taking or have recently taken, as well as any medicines you plan to take. You may need to have more frequent blood sugar tests or kidney function tests, or your doctor may need to adjust the dose of Diptivil Duo. In particular, you should inform your doctor about:

• corticosteroids, which are often used to treat inflammatory conditions
• beta-2-adrenergic receptor agonists, which are often used to treat respiratory diseases
• other antidiabetic medicines
• 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 (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 carcinoma) (e.g., vandetanib)
• certain medicines used to treat heartburn and stomach ulcers (e.g., cimetidine).

Taking Diptivil Duo with alcohol

You should avoid excessive alcohol consumption while taking Diptivil Duo, as this may increase the risk of lactic acidosis (see "Warnings and precautions").

Pregnancy and breastfeeding

• If you are pregnant or think you may be pregnant, or if you 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 breastfeeding (see also "Do not take Diptivil Duo").

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

Driving and using machines

If you experience dizziness while taking Diptivil Duo, you should 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 determine the exact dose of Diptivil Duo that you should take.
Always take this medicine exactly as your doctor or pharmacist 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 kidney problems, your doctor may prescribe a lower dose. If you are taking a sulphonylurea, a type of antidiabetic medicine, your doctor may also prescribe a lower dose.
Your doctor may prescribe Diptivil Duo alone (as monotherapy) or with other medicines that lower blood sugar.

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 a meal or shortly after a meal. Taking the tablet shortly after a meal will help reduce the risk of stomach upset.

You should continue to follow your doctor's advice on diet. In particular, if you are following a diabetic diet to control 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 Diptivil Duo tablets or if someone else takes your tablets, 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 pack and this leaflet with you.

If you forget to take Diptivil Duo

If you forget to take a tablet, take it at the next mealtime, 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 tablet.

If you stop taking Diptivil Duo

You should continue to take 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.
If you have any further questions about taking this medicine, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, Diptivil Duo can cause side effects, although not everybody gets them.
You should stop taking Diptivil 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): Diptivil Duo may very rarely cause a very serious side effect called lactic acidosis (see "Warnings and precautions"). In this case, 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 a rash or hives, which 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 urine, which may indicate liver disease (hepatitis).
• Pancreatitis (uncommon: may affect up to 1 in 100 people): Symptoms include severe and persistent abdominal pain (around the stomach area), which may radiate to the back, as well as nausea and vomiting.

Other side effects

Some patients taking 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 in the mouth, 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; decreased vitamin B12 levels (pallor, fatigue, psychological symptoms, such as confusion or memory problems).

After this medicine was made available, 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 or purple spots) under the skin.

Reporting side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse. You can also report side effects directly to the national reporting system (see below for contact information).
Side effects can be reported 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.

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 or carton after EXP. The expiry date refers to the last day of that month.
• Store in a temperature below 30°C.
• 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 Diptivil Duo contains

• The active substances are vildagliptin and metformin hydrochloride.
• Each 50 mg + 850 mg film-coated tablet contains 50 mg vildagliptin and 850 mg metformin hydrochloride (equivalent to 663 mg metformin).
• Each 50 mg + 1000 mg film-coated tablet contains 50 mg vildagliptin and 1000 mg metformin hydrochloride (equivalent to 780 mg 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" 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" 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 authorization holder and manufacturer

Marketing authorization holder:

MSN Labs Europe Limited
KW20A Corradino Park
Paola, PLA 3000
Malta
tel.: (+48) 699 711 147
(logo of the marketing authorization 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 medicine is authorized in the Member States of the European Economic Area under the following names:

Diptivil Duo is authorized in the following countries:

Denmark:
Diptivil Duo
Czech Republic:
Diptivil Duo
Hungary:
Diptivil Duo 50 mg/850 mg filmtabletta
Diptivil Duo 50 mg/1000 mg filmtabletta
Poland:
Diptivil Duo
Romania:
Diptivil Duo 50 mg/850 mg comprimate filmate
Diptivil Duo 50 mg/1000 mg comprimate filmate
Slovakia:
Diptivil Duo 50 mg/850 mg
Diptivil Duo 50 mg/1000 mg
Bulgaria:
Diptivil Duo 50 mg/850 mg филмирани таблетки
Diptivil Duo 50 mg/1000 mg филмирани таблетки

Date of last revision of the leaflet: 04/2025