Diptivil duo

Patient Information Leaflet

Diptivil Duo, 50 mg + 850 mg, film-coated tablets
Diptivil Duo, 50 mg + 1000 mg, film-coated tablets
Vildagliptin + Metformini hydrochloridum
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 consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm them, even if their symptoms are the same.
• If you experience any side effects, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Leaflet Contents:

1. What Diptivil Duo is and what it is used for
2. What you need to know before taking 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 in Diptivil Duo are vildagliptin and metformin, which belong to a group of medicines called oral antidiabetic agents.
Diptivil Duo is used to treat adult patients with type 2 diabetes mellitus. This type of diabetes is also known as non-insulin-dependent diabetes. Diptivil Duo is used when diabetes cannot be controlled by diet and physical exercise alone, and/or when used in combination with other antidiabetic medicines (such as insulin or sulfonylurea derivatives).
Type 2 diabetes is a condition in which the body either does not produce enough insulin or the insulin produced does not work as effectively as it should. 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 stimulates the liver to produce glucose, thereby increasing blood glucose levels.

How Diptivil Duo works
Both active substances, vildagliptin and metformin, help control blood glucose levels.
Vildagliptin works by stimulating the pancreas to produce more insulin and by reducing glucagon production. Metformin helps the body use insulin more effectively.
This medicine has been shown to reduce blood glucose levels, which may help prevent complications associated with diabetes.

2. Important information before using Diptivil Duo

When not to use Diptivil 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 Diptivil 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 medical condition in which substances called ketone bodies accumulate in the blood, which may lead to diabetic pre-coma. Symptoms include abdominal pain, rapid deep breathing, drowsiness, or an unusual fruity odour of the breath.
• If the patient has recently had a heart attack or has heart failure or severe circulatory problems 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 procedure (a special type of X-ray examination 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 (see also section "Pregnancy and breastfeeding").

Warnings and precautions
Risk of lactic acidosis
Diptivil Duo may cause a very rare but serious adverse effect called lactic acidosis, particularly if the patient has impaired kidney function. The risk of lactic acidosis is also increased in cases of uncontrolled diabetes, severe infections, prolonged fasting or alcohol consumption, dehydration (see further information below), impaired liver function, and any medical conditions in which part of the body is inadequately 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.
Diptivil 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 guidance.
If any symptoms of lactic acidosis occur, the patient must stop taking Diptivil Duo and immediately contact their doctor or the nearest hospital, as this condition may lead to coma.
Symptoms of lactic acidosis include:

• vomiting
• stomach pain (abdominal pain)
• muscle cramps
• general malaise associated with profound fatigue
• difficulty breathing
• decreased body temperature and slowed heart rate.

Lactic acidosis is an acute, life-threatening condition requiring hospital treatment.
The patient should contact their doctor immediately for further instructions if:

• they have a genetically inherited disease affecting 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).
• after starting metformin, they experience any of the following symptoms: seizures, worsening of cognitive function, difficulty moving, symptoms indicating nerve damage (e.g. pain or numbness), migraine, or deafness.

Diptivil Duo does not replace insulin. Therefore, Diptivil Duo must not be used in the treatment of type 1 diabetes.
Before starting Diptivil Duo, the patient should discuss with their doctor, pharmacist, or nurse if they have or have had any pancreatic disorders.
Before starting Diptivil Duo, the patient should consult their doctor, pharmacist, or nurse if they are taking an antidiabetic medicine called a sulfonylurea.
The doctor may wish to reduce the dose of the sulfonylurea taken together with Diptivil 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 advice of their doctor or nurse regarding skin and foot care. The patient should also pay particular attention to the development of new blisters or ulcers while taking Diptivil Duo. If these occur, the patient should consult their doctor promptly.
If the patient requires major surgery, they must stop taking Diptivil Duo during and for some time after the procedure. The doctor will decide when the patient should stop and restart treatment with Diptivil Duo.
Before starting treatment with Diptivil 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 symptoms indicating increased liver enzyme activity.
While being treated with Diptivil Duo, the patient's doctor will monitor 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.
Children and adolescents
Diptivil Duo is not recommended for use in children and adolescents under 18 years of age.
Diptivil Duo and other medicines
If the patient is to receive an iodine-containing contrast agent injected into the bloodstream, for example for an X-ray or CT scan, they must stop taking Diptivil Duo before or at the latest at the time of administration of the contrast agent. The doctor will decide when the patient should stop and restart treatment with Diptivil Duo.
The patient should inform their doctor about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. It may be necessary to perform more frequent blood glucose and kidney function tests or for the doctor to adjust the dose of Diptivil Duo. It is particularly important to inform the doctor about the following medicines:

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

Use of Diptivil Duo with alcohol
The patient should avoid consuming excessive amounts of alcohol while taking Diptivil Duo, as this may increase the risk of lactic acidosis (see section "Warnings and precautions").
Pregnancy and breastfeeding

• If the patient is pregnant, suspects she may be pregnant, or plans to become pregnant, she should consult her doctor before using this medicine. The doctor will discuss with the patient the potential risks associated with taking Diptivil Duo during pregnancy.
• Do not use Diptivil Duo if the patient is pregnant or breastfeeding (see also "When not to use Diptivil Duo").

Before taking any medicine, consult a doctor or pharmacist.
Driving and operating machinery
If the patient experiences dizziness while taking Diptivil Duo, they should not drive or operate machinery.

3. How to take Diptivil Duo

The dose of Diptivil Duo that a patient should take varies depending on their condition. The doctor will precisely determine the appropriate dose of Diptivil Duo to take.
This medicine should always be taken exactly as prescribed by the doctor or pharmacist. If in 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 impaired kidney function, the doctor may prescribe a lower dose. If the patient is taking an antidiabetic medicine called a sulfonylurea, the doctor may also prescribe a lower dose.
The doctor may prescribe this medicine to be taken alone (as monotherapy) or together with certain other medicines that lower blood sugar levels.
When and how to take Diptivil Duo

• Tablets should be swallowed 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 right after a meal may help reduce the risk of gastrointestinal disturbances.

Continue to follow all dietary advice given by the doctor. In particular, if the patient is following a diabetic diet aimed at controlling body weight, this diet should be continued during treatment with Diptivil Duo.
Taking more Diptivil Duo than prescribed
If too many tablets of Diptivil Duo are taken by accident, or if someone else takes the tablets, contact the doctor or pharmacist immediately. Medical care may be necessary. If it is necessary to visit a doctor or hospital, bring the medicine pack and the leaflet with you.
If a dose of Diptivil Duo is missed
If the patient forgets to take a tablet, it should be taken during the next meal, unless it is already time to take the next tablet.
Do not take a double dose (two tablets at the same time) to make up for a missed tablet.
Stopping Diptivil Duo treatment
Continue taking this medicine for as long as the doctor recommends, in order to maintain control of blood sugar levels. Do not stop taking Diptivil Duo unless instructed by the doctor. If there are any questions about how long to continue taking Diptivil Duo, consult the doctor.
If there are any further doubts about the use of this medicine, consult the 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 Diptivil Duo and contact a doctor immediately if any of the following adverse reactions occur:

• Lactic acidosis (very rare: may occur in no more than 1 in 10,000 people): Diptivil Duo may very rarely cause a very serious adverse reaction called lactic acidosis (see section “Warnings and precautions”). In such a case, the patient must stop taking Diptivil Duo and immediately contact 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 people): Symptoms include swelling of the face, tongue or throat, difficulty swallowing, breathing difficulties, sudden onset of rash or urticaria, which may indicate a reaction known as “angioedema”.
• Liver disease (hepatitis) (uncommon: may occur in no more than 1 in 100 people): Symptoms include yellowing of the skin and whites of the eyes, nausea, loss of appetite, or dark urine, which may indicate liver disease (hepatitis).
• Pancreatitis (uncommon: may occur in no more than 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 adverse reactions
The following adverse reactions have been reported in some patients taking Diptivil Duo:

• Common (may affect up to 1 in 10 people): sore throat, cold, fever, itchy rash, excessive sweating, joint pain, dizziness, headache, uncontrollable tremor, constipation, nausea, vomiting, diarrhoea, bloating, heartburn, stomach and abdominal pain.
• Uncommon (may affect up to 1 in 100 people): 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 affect up to 1 in 10,000 people): symptoms of high blood lactic acid levels (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 disturbances).

Since this medicine has been placed on the market, the following adverse reactions have also been reported:

• Frequency not known (frequency cannot be estimated from available data): local skin peeling or blister formation, 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, pharmacist or nurse. 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, phone: +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 provide more information on the safety of the medicine.

5. How to store Diptivil Duo

• Keep this medicine out of sight and reach of children.
• Do not use this medicine after the expiry date stated on the blister or carton after EXP. The expiry date refers to the last day of the stated month.
• Store below 30°C.
• 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 Diptivil Duo contains

• The active substances in this medicinal product are vildagliptin and metformin hydrochloride.
• Each Diptivil Duo 50 mg + 850 mg film-coated tablet contains 50 mg of vildagliptin and 850 mg of metformin hydrochloride (equivalent to 663 mg of metformin).
• Each Diptivil Duo 50 mg + 1000 mg film-coated tablet contains 50 mg of vildagliptin and 1000 mg of metformin hydrochloride (equivalent to 780 mg of metformin).
• Other components are:
  Tablet core: hydroxypropylcellulose (E 463), magnesium stearate.
  Tablet coating: hypromellose (E 464), iron oxide yellow (E 172), titanium dioxide (E 171), polyethylene glycol 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, embossed with the mark "M" on one side and "V12" on the other side.
Diptivil Duo 50 mg + 1000 mg film-coated tablets are dark yellow, oval tablets, embossed with the mark "M" on one side and "V13" on the other side.
Diptivil Duo is available in packs containing 30, 60 or 180 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer/Importer

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:
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