Diptivil

Package Leaflet: Information for the User

Diptivil, 50 mg, Tablets

Vildagliptin

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this package 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, tell your doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Package Leaflet:

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

1. What is Diptivil and what is it used for

The active substance of this medicine is vildagliptin, which belongs to a group of medicines called "oral antidiabetic medicines".
Diptivil is used to treat adult patients with type 2 diabetes. It is used when diabetes cannot be controlled by diet and exercise alone. It helps to control blood sugar levels. Your doctor may prescribe Diptivil to take on its own or in combination with other antidiabetic medicines that you are already taking, if they are not enough to control your blood sugar levels.
Type 2 diabetes develops when the body does not produce enough insulin or when the insulin produced by the body does not work properly. It can also develop when the body produces too much glucagon.
Insulin is a substance that helps to lower blood sugar levels, especially after meals.
Glucagon is a substance that stimulates the production of sugar in the liver and increases blood sugar levels. Both of these substances are produced in the pancreas.

How Diptivil works

Diptivil works by stimulating the pancreas to produce insulin and reducing the production of glucagon. This helps to control blood sugar levels. It has been shown that this medicine lowers blood sugar levels, which can help to prevent complications of diabetes. Even if you are starting to take diabetes medicines for the first time, it is important to continue to follow the diet and (or) exercise recommended by your doctor.

2. Important information before taking Diptivil

When not to take Diptivil:

• If you are allergic to vildagliptin or any of the other ingredients of this medicine (listed in section 6). If you think you may be allergic to vildagliptin or any of the other ingredients of Diptivil, do not take this medicine. Tell your doctor.

Warnings and precautions

Before taking Diptivil, discuss with your doctor, pharmacist, or nurse

• If you have type 1 diabetes (i.e., your body does not produce insulin) or if you have a condition called diabetic ketoacidosis.
• If you are taking a sulfonylurea (a type of antidiabetic medicine). Your doctor may want to reduce the dose of the sulfonylurea you are taking when you start taking Diptivil, to avoid low blood sugar levels (hypoglycemia).
• If you have moderate or severe kidney disease (you may need to take a lower dose of Diptivil).
• If you are on dialysis.
• If you have liver disease.
• If you have heart failure.
• If you have or have had pancreatitis.

If you have taken vildagliptin before but had to stop because of liver disease, do not take this medicine.
Skin conditions are a common complication of diabetes. You should follow your doctor's or nurse's advice on skin and foot care. While taking Diptivil, you should pay particular attention to any new blisters or ulcers. If you notice any, you should contact your doctor immediately.
Before starting treatment with Diptivil and at 3-month intervals during the first year of treatment, and periodically thereafter, you should have liver function tests. This will help to find out as soon as possible if you have any signs of liver damage.

Children and adolescents

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

Diptivil with other medicines

Tell your doctor or pharmacist about all the medicines you are taking, or have recently taken, and any you plan to take.
Your doctor may need to adjust the dose of Diptivil if you are taking other medicines, such as:

• Thiazides or other diuretics (also known as water tablets)
• Corticosteroids (usually used to treat inflammation)
• Medicines used to treat thyroid disorders
• Certain medicines that affect the nervous system.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Do not take Diptivil if you are pregnant. It is not known if vildagliptin passes into human breast milk. Do not take Diptivil if you are breastfeeding or plan to breastfeed.

Driving and using machines

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

Diptivil contains lactose

If you have been told you have an intolerance to some sugars, contact your doctor before taking this medicine.

3. How to take Diptivil

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.

What dose to take and when

The dose of Diptivil is different for each patient. Your doctor will decide exactly how many tablets of Diptivil to take. The maximum daily dose is 100 mg.
The usual dose of Diptivil is:

• 50 mg once daily, taken in the morning, when Diptivil is taken with a sulfonylurea.
• 100 mg once daily, taken as two doses of 50 mg, one in the morning and one in the evening, when Diptivil is taken alone or with metformin or a glitazone, or in combination with metformin and a sulfonylurea or with insulin.
• 50 mg once daily, taken in the morning, if you have moderate or severe kidney disease or if you are on dialysis.

How to take Diptivil

• Swallow the tablets whole with water.

How long to take Diptivil

• Take Diptivil every day, for as long as your doctor recommends. You may need to take it for a long time.
• Your doctor will regularly check your condition to ensure that the treatment is working.

What to do if you take more Diptivil than you should

If you take too many tablets, or if someone else takes your medicine, contact your doctor immediately.
You may need medical attention. If you go to a doctor or hospital, take the pack of Diptivil with you.

What to do if you forget to take Diptivil

If you forget to take a dose, take it as soon as you remember. Then take the next dose at the usual time. Do not take a double dose to make up for a forgotten tablet.

Stopping treatment with Diptivil

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

4. Possible side effects

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

Some side effects need immediate medical attention:

If you experience any of the following side effects, stop taking Diptivil and contact your doctor immediately:

• 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 onset of rash or hives, which may indicate angioedema.
• Liver disease (hepatitis) (frequency not known): symptoms include yellowing of the skin and eyes, nausea, loss of appetite, or dark urine, which may indicate liver disease (hepatitis).
• Pancreatitis (rare: may affect up to 1 in 1,000 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 taking vildagliptin have experienced the following side effects:

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

After this medicine has been marketed, 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 purpura.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Medicinal Product Monitoring, Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych, 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 Diptivil

Keep this medicine out of the sight and reach of children.
There are no special storage instructions for this medicine.
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.
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 contains

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

What Diptivil looks like and contents of the pack

Diptivil 50 mg tablets are white or almost white, round, flat, with beveled edges, with the inscription "M" on one side and "V11" on the other side.
Diptivil 50 mg tablets are available in blisters containing 7, 14, 28, 30, 56, 60, 90, 112, 180, 336 tablets, and in multipacks consisting of 3 packs, each containing 112 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

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 medicine is authorized in the Member States of the European Economic Area under the following names:

Germany:
Vildagliptin MSN 50 mg Tablets
Czech Republic:
Diptivil
Hungary:
Diptivil 50 mg tablet
Poland:
Diptivil
Romania:
Diptivil 50 mg tablets
Slovakia:
Diptivil
Bulgaria:
Diptivil 50 mg tablets
Cyprus:
Diptivil

Date of last revision of the package leaflet: