Vildagliptin olpha

Package leaflet: Information for the user

Vildagliptin Olpha, 50 mg, tablets
Vildagliptinum
Please 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 someone else 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.

Contents of the leaflet

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

1. What Vildagliptin Olpha is and what it is used for

The active substance in Vildagliptin Olpha is vildagliptin, which belongs to a group of medicines called
"oral antidiabetic agents".
Vildagliptin Olpha is a medicine used to treat adult patients with type 2 diabetes who cannot control
their condition with diet and exercise alone. This medicine helps control blood sugar levels. Your
doctor may prescribe Vildagliptin Olpha as the only antidiabetic medicine or in combination with
other antidiabetic medicines you may already be taking, if they have not been sufficiently effective in
controlling your blood sugar levels.
Type 2 diabetes is a condition in which the body does not produce enough insulin, or the insulin the
body produces does not work as well as it should. Type 2 diabetes may also develop when the body
produces too much glucagon.
Insulin is a substance that helps lower blood sugar levels, especially after a meal.
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 Vildagliptin Olpha works
Vildagliptin Olpha works by stimulating the pancreas to produce insulin and by reducing the
production of glucagon. This medicine helps control blood sugar levels.
It has been shown that this medicine reduces blood sugar levels, which may help prevent
complications associated with diabetes. Even after starting pharmacological treatment for diabetes, it
remains important for the patient to continue following an appropriate diet and (or) performing
recommended physical exercise.

2. Important information before using Vildagliptin Olpha

When not to use Vildagliptin Olpha:

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

Warnings and precautions
Before starting treatment with Vildagliptin Olpha, 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 an antidiabetic medicine called a sulfonylurea (the doctor may wish to reduce the dose of the sulfonylurea taken together with Vildagliptin Olpha to avoid low blood glucose levels [hypoglycaemia]),
• if the patient has moderate or severe kidney disease (a lower dose of Vildagliptin Olpha 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 diseases of the pancreas.

If the patient previously took vildagliptin but had to discontinue it 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 Vildagliptin Olpha, 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 Vildagliptin Olpha and every three months during the first year of treatment, and periodically thereafter, liver function tests should be performed. This allows signs of increased liver enzyme activity to be detected as early as possible.

Children and adolescents
Vildagliptin Olpha must not be used in children and adolescents under 18 years of age.

Vildagliptin Olpha and other medicines
The patient should tell their doctor or pharmacist about any medicines they are currently taking, have recently taken, or plan to take.
The doctor may adjust the dose of Vildagliptin Olpha 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, breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before using this medicine.
Vildagliptin Olpha must not be used during pregnancy. It is not known whether Vildagliptin Olpha passes into human breast milk. Vildagliptin Olpha should not be used during breastfeeding or when planning to breastfeed.

Driving and using machines
If the patient experiences dizziness while taking Vildagliptin Olpha, they should not drive or operate machinery.

Vildagliptin Olpha contains lactose
Vildagliptin Olpha contains lactose (milk sugar). If the patient has previously been diagnosed with an intolerance to certain sugars, they should consult their doctor before taking this medicine.

Vildagliptin Olpha contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to use Vildagliptin Olpha

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 Vildagliptin Olpha varies depending on the patient's condition. Your doctor will determine exactly how many tablets of Vildagliptin Olpha you should take. The maximum daily dose is 100 mg.

The usual dose of Vildagliptin Olpha is:

• 50 mg once daily in the morning, when Vildagliptin Olpha is used in combination with a medicine called a sulfonylurea.
• 100 mg daily, taken as 50 mg in the morning and 50 mg in the evening, when Vildagliptin Olpha is used either alone, with a medicine called metformin, with a glitazone, in combination with metformin and a sulfonylurea, 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 Vildagliptin Olpha

• The tablets should be swallowed whole with water.

How long to take Vildagliptin Olpha

• Vildagliptin Olpha should be taken every day for as long as your doctor recommends. Your doctor may decide on long-term treatment with Vildagliptin Olpha.
• Your doctor will regularly monitor your health to check whether the treatment is achieving the desired effect.

Taking more Vildagliptin Olpha than prescribed

If you take too many Vildagliptin Olpha tablets or if someone else takes this medicine, you should speak to a doctor immediately. Medical care may be required. If you need to see a doctor or go to hospital, bring the medicine pack with you.

Missing a dose of Vildagliptin Olpha

If you forget to take a dose of this medicine, take it as soon as you remember. Then take the next dose at the usual time. However, if it is almost time for the next dose, skip the missed dose. Do not take a double dose to make up for a forgotten tablet.

Stopping Vildagliptin Olpha

Do not stop taking Vildagliptin Olpha 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 everybody will experience them.
Some adverse reactions require immediate medical attention:
If any of the following adverse reactions occur, stop taking
Vildagliptin Olpha immediately and contact your doctor:

• Angioedema (rare: may occur in up to 1 in 1,000 patients): Symptoms include swelling of the face, tongue or throat, difficulty swallowing, breathing difficulties, sudden onset of rash or hives. These may indicate a reaction called "angioedema".
• Liver disease (hepatitis) (frequency unknown): Symptoms include yellowing of the skin and whites of the eyes, nausea, loss of appetite, or dark-coloured urine. These may indicate liver disease (hepatitis).
• Pancreatitis (rare: may occur in up to 1 in 1,000 patients): 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 Vildagliptin Olpha:

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

After the introduction of this medicine into the market, the following adverse reactions have also been reported:

• Frequency not known (frequency cannot be estimated from the available data): localised peeling of the skin or formation of blisters, vasculitis which may cause skin rash or spiky, flat, red, round spots under the skin or bruising.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed
in this leaflet, inform your doctor or pharmacist. Adverse reactions can
be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products at the 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 the medicine Vildagliptin Olpha

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister pack and the outer carton
after "EXP". The expiry date refers to the last day of the stated month.
No special storage conditions are required for this medicine.
Medicines must not be disposed of via the sewage system or household waste. Ask
your pharmacist how to dispose of medicines no longer required. Such measures will help
protect the environment.

6. Contents of the pack and other information

What Vildagliptin Olpha contains

• The active substance is vildagliptin. Each tablet contains 50 mg of vildagliptin.
• The other ingredients are: lactose, microcrystalline cellulose, sodium carboxymethyl starch (type A), and magnesium stearate.

What Vildagliptin Olpha looks like and contents of the pack
Vildagliptin Olpha 50 mg tablets are white or almost white, round, flat, with bevelled edges,
uncoated, marked with "L 45" on one side and smooth on the other side
(approximate diameter 8 mm).
Vildagliptin Olpha 50 mg tablets are available in packs containing 28, 30, 56, 60 or 90 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Olpha AS,
Rupnicu iela 5,
Olaine, Olaines novads, LV-2114,
Latvia
E-mail: [email protected]
This medicinal product is authorised in the European Economic Area countries under the following names:
Czech Republic, Germany, Estonia,
Italy, Poland, Slovakia: Vildagliptin Olpha
France: VILDAGLIPTINE OLPHA 50 mg, comprimé
Latvia: Vildagliptin Olpha 50 mg tabletes
Lithuania: Vildagliptin Olpha 50 mg tabletės