Patient Information Leaflet

Diptivil, 50 mg, tablets
Vildagliptinum
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, ask 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, tell your doctor, pharmacist, or nurse. See section 4.

Leaflet Contents:

What Diptivil is and what it is used for
What you need to know before taking Diptivil
How to take Diptivil
Possible side effects
How to store Diptivil
Contents of the pack and other information

1. What Diptivil is and what it is used for

The active substance in this medicine is vildagliptin, which belongs to a group of medicines called "oral antidiabetic agents".
Diptivil is used to treat adult patients with type 2 diabetes mellitus. It is used when diabetes cannot be controlled by diet and physical exercise alone. It helps control blood glucose levels. Your doctor may prescribe Diptivil either as the only antidiabetic medicine or in combination with other antidiabetic medicines you may be taking, if they have not been sufficiently effective in controlling blood glucose levels.
Type 2 diabetes develops when the body does not produce enough insulin, or when the insulin produced does not work as well as it should. It may also develop when the body produces too much glucagon.
Insulin is a substance that helps lower blood glucose levels, especially after meals.
Glucagon is a substance that stimulates glucose production in the liver and increases blood glucose levels. Both of these substances are produced in the pancreas.

How Diptivil works
Diptivil works by stimulating the pancreas to produce insulin and by reducing glucagon production. This helps control blood glucose levels. This medicine has been shown to reduce blood glucose levels, which may help prevent complications associated with diabetes. Even if you are now starting antidiabetic medication, it remains important to continue following the recommended diet and (or) physical exercise regimen.

2. Important information before using Diptivil

When not to use Diptivil:

If the patient is allergic to vildagliptin or to any of the other ingredients of this medicine (listed in section 6). If the patient thinks they may be allergic to vildagliptin or to any of the other ingredients of Diptivil, they should not take this medicine and must inform their doctor.

Warnings and precautions
Before starting Diptivil, discuss this with your doctor, pharmacist or
nurse

If the patient has type 1 diabetes (i.e. if their body does not produce insulin) or if the patient has a condition called diabetic ketoacidosis.
If the patient is taking a diabetes medicine called a sulfonylurea (the doctor may wish to reduce the dose of the sulfonylurea taken together with Diptivil to avoid low blood glucose levels [hypoglycaemia]).
If the patient has moderate or severe kidney disease (a lower dose of Diptivil should be used).
If the patient is on dialysis.
If the patient has liver disease.
If the patient has heart failure.
If the patient has or has had pancreatic diseases.

If the patient previously took vildagliptin but had to stop due to liver disease, they should not use this medicine.
Skin changes are a common complication of diabetes. The patient should follow the advice of their doctor or nurse regarding skin and foot care. While taking Diptivil, the patient should pay particular attention to the development of new blisters or ulcers. If these occur, the patient should contact their doctor immediately.
Before starting treatment with Diptivil and every three months during the first year of treatment, and periodically thereafter, liver function tests should be performed. This allows any signs of increased liver enzyme activity to be detected as early as possible.
Children and adolescents
Diptivil is not recommended for use in children and adolescents under 18 years of age.
Diptivil with other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines they plan to take.
The doctor may adjust the dose of Diptivil if the patient is taking other medicines such as:

thiazides or other diuretics (also known as water tablets)
corticosteroids (usually used to treat inflammatory conditions)
medicines used to treat thyroid disorders
certain medicines affecting the nervous system.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before using this medicine.
Diptivil must not be used during pregnancy. It is unknown whether vildagliptin passes into human milk. Diptivil should not be used during breastfeeding or if breastfeeding is planned.
Driving and operating machinery
If the patient experiences dizziness while taking Diptivil, they should not drive or operate machinery.
Diptivil contains lactose
If the patient has previously been diagnosed with an intolerance to certain sugars, they should consult their doctor before taking this medicine.

3. How to use Diptivil

This medicine should always be taken exactly as prescribed by your doctor. If in doubt, consult your doctor or pharmacist.
What dose to take and when
The dose of Diptivil varies depending on the patient's condition. Your doctor will determine exactly how many Diptivil tablets you should take. The maximum daily dose is 100 mg.
The usual dose of Diptivil is:

50 mg once daily in the morning, when Diptivil is used in combination with a medicine called sulfonylurea.
100 mg daily, taken as 50 mg in the morning and 50 mg in the evening, when Diptivil is used alone, with metformin, with a glitazone, in combination with metformin and a sulfonylurea derivative, or with insulin.
50 mg once daily in the morning, if the patient has moderate or severe kidney disease or is undergoing dialysis.

How to take Diptivil

Swallow the tablets whole with water.

How long to take Diptivil

Diptivil should be taken daily for as long as your doctor recommends. You may need to take it for a long time.
Your doctor will regularly monitor your health to check whether the treatment is achieving the desired effect.

Taking more Diptivil than prescribed
If you take too many Diptivil tablets or if someone else takes this medicine, contact your doctor immediately. Medical attention may be required. If you need to see a doctor or go to hospital, bring the medicine pack with you.
Missing a dose of Diptivil
If you forget to take a dose of this medicine, take it as soon as you remember. Then take the next dose at your usual time. If it is almost time for your next dose, skip the missed dose. Do not take a double dose to make up for a missed tablet.
Stopping Diptivil
Do not stop taking Diptivil unless your doctor tells you to. If you have any questions about how long to take this medicine, consult your doctor.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Some adverse reactions require immediate medical attention:
If any of the following adverse reactions occur, stop taking Diptivil immediately
and consult a doctor:

Angioedema (rare: may occur in no more than 1 in 1,000 people): Symptoms include swelling of the face, tongue or throat, difficulty swallowing, difficulty breathing, sudden onset of rash or hives, which may indicate a reaction called "angioedema".
Liver disease (hepatitis) (frequency not known): Symptoms include yellowing of the skin and eyes, nausea, loss of appetite, or dark-colored urine, which may indicate liver disease (hepatitis).
Inflammation of the pancreas (pancreatitis) (rare: may occur in no more than 1 in 1,000 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 adverse reactions
The following adverse reactions have been reported in some patients treated with vildagliptin:

Very common (may affect more than 1 in 10 people): sore throat, runny nose, fever.
Common (may affect up to 1 in 10 people): itchy rash, tremor, headache, dizziness, muscle pain, joint pain, constipation, swollen hands, ankles or feet (oedema), excessive sweating, vomiting, stomach and abdominal pain (abdominal pain), diarrhoea, heartburn, nausea, blurred vision.
Uncommon (may affect up to 1 in 100 people): weight gain, chills, fatigue, sexual dysfunction, low blood glucose levels, bloating.
Rare (may affect up to 1 in 1,000 people): pancreatitis.

After this medicine was placed on the market, the following adverse reactions have also been reported:

Frequency not known (frequency 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 surface 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, 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 provide more information on the safety of this medicine.

5. How to store Diptivil

Keep this medicine out of sight and reach of children.
There are no special storage instructions for this medicine.
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 stated month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures help protect the environment.

6. Contents of the pack and other information

What Diptivil contains

The active substance is vildagliptin. Each tablet contains 50 mg of vildagliptin.
The other ingredients are lactose, microcrystalline cellulose, low-substituted hydroxypropyl cellulose, and magnesium stearate.

What Diptivil looks like and contents of the pack
Diptivil 50 mg tablets are white or almost white, round, flat, with bevelled edges, embossed with the code "M" on one side and "V11" on the other side.
Diptivil 50 mg tablets are available in blister packs containing 7, 14, 28, 30, 56, 60, 90, 112, 180, 336 tablets, and in multi-packs consisting of 3 packs, each containing 112 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

Manufacturer/Importer:
Pharmadox Healthcare Limited
KW20A Kordin Industrial Estate
Paola, PLA 3000
Malta
MSN Labs Europe Limited
KW20A Corradino Park
Paola, PLA 3000
Malta

This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Germany: Vildagliptin MSN 50 mg Tabletten
Czech Republic: Diptivil
Hungary: Diptivil 50 mg tabletta
Poland: Diptivil
Romania: Diptivil 50 mg comprimate
Slovakia: Diptivil
Bulgaria: Diptivil 50 mg таблетки
Cyprus: Diptivil