Vildagliptin Olpha

Package leaflet: Information for the user

Vildagliptin Olpha 50 mg tablets

vildagliptin
Generic medicine
Please read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this 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, vildagliptin, belongs to a group of medicines called
"oral antidiabetics".
Vildagliptin Olpha 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 control blood sugar levels. Your doctor will prescribe Vildagliptin Olpha alone or together with other antidiabetic medicines you are already taking, if these have not been sufficiently effective in controlling diabetes.
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 may also develop when the body produces too much glucagon.
Insulin is a substance that helps lower blood sugar levels, especially after meals.
Glucagon is a substance that triggers the liver to produce sugar, causing blood sugar levels to rise. The pancreas produces both of these substances.
How Vildagliptin Olpha works
Vildagliptin Olpha works by stimulating the pancreas to produce more insulin and less glucagon. This helps control blood sugar levels. This medicine has been shown to reduce blood sugar levels. This may help prevent complications arising from your diabetes. Even though you are now starting to take a medicine for diabetes, it is important that you continue to follow the diet and/or exercise regimen recommended to you.

2. What you need to know before taking Vildagliptin Olpha

Do not take Vildagliptin Olpha:

• if you are allergic to vildagliptin or to any of the other ingredients of this medicine
  (listed in section 6). If you think you may be allergic to vildagliptin or to any of the
  excipients in Vildagliptin Olpha, do not take this medicine and consult your doctor.

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before taking Vildagliptin Olpha

• 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 an antidiabetic medicine known as a sulfonylurea (if taken together with Vildagliptin Olpha, your doctor may need to reduce your dose of sulfonylurea to prevent low blood glucose levels [hypoglycaemia]).
• if you have moderate or severe kidney disease (a lower dose of Vildagliptin Olpha will be required).
• if you are on dialysis.
• if you have liver disease.
• if you suffer from heart failure.
• if you have or have had a disease of the pancreas.

If you previously took vildagliptin but had to stop due to liver disease, you must not take this medicine.
Skin lesions are a common complication of diabetes. It is advisable to follow the skin and foot care recommendations provided by your doctor or nurse. You should also pay particular attention to the development of blisters or ulcers while taking Vildagliptin Olpha. If this occurs, you should consult your doctor promptly.
Before starting treatment with Vildagliptin Olpha, a liver function test will be performed. This test will be repeated every three months during the first year of treatment and periodically thereafter. This is to detect as early as possible any signs of increased liver enzymes.

Children and adolescents
Vildagliptin Olpha is not recommended for use in children and adolescents under 18 years of age.

Other medicines and Vildagliptin Olpha
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Your doctor may need to adjust the dose of Vildagliptin Olpha if you are taking other medicines such as:

• thiazides or other diuretics (also known as water tablets)
• corticosteroids (generally used to treat inflammation)
• thyroid medicines
• certain medicines acting on the nervous system

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
You must not use Vildagliptin Olpha during pregnancy. It is not known whether Vildagliptin Olpha passes into breast milk. You must not use Vildagliptin Olpha if you are breastfeeding or planning to breastfeed.

Driving and using machines
If you experience dizziness while taking Vildagliptin Olpha, do not drive or operate machinery.

Vildagliptin Olpha contains lactose
Vildagliptin Olpha contains lactose (milk sugar). If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.

Vildagliptin Olpha contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, therefore it is essentially 'sodium-free'.

3. How to take Vildagliptin Olpha

Take this medicine exactly as instructed by your doctor. If you have any doubts, consult your doctor or pharmacist.
How much to take and when
The amount of Vildagliptin Olpha you need to take depends on your individual condition.
Your doctor will tell you 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 if you are taking Vildagliptin Olpha with another medicine called a sulphonylurea.
• 100 mg daily taken as 50 mg in the morning and 50 mg in the evening if you are taking Vildagliptin Olpha alone, with another medicine called metformin or a glitazone, with a combination of metformin and a sulphonylurea, or with insulin.
• 50 mg once daily in the morning if you have moderate or severe kidney disease or are on dialysis.

How to take Vildagliptin Olpha

• Swallow the tablets with some water.

How long to take Vildagliptin Olpha

• Take Vildagliptin Olpha every day for as long as your doctor recommends. You may need to continue this treatment for a long period of time.
• Your doctor will regularly monitor your condition to check that the treatment is working as expected.

If you take more Vildagliptin Olpha than you should
If you take too many Vildagliptin Olpha tablets, or if someone else has taken your medicine, contact your doctor immediately. Medical treatment may be necessary. If you need to see a doctor or go to hospital, bring the pack with you.
If you forget to take 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 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 forgotten tablet.
If you stop taking Vildagliptin Olpha
Do not stop taking Vildagliptin Olpha unless your doctor tells you to. If you have any doubts about how long you should take this medicine, speak to your doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Some symptoms require immediate medical attention:
You must stop taking Vildagliptin Olpha and contact your doctor immediately if you experience any of the following side effects:

• Angioedema (rare: may occur in up to 1 in 1,000 people): Symptoms include swelling of the face, tongue or throat, difficulty swallowing, difficulty breathing, sudden appearance of skin rashes or hives, which may indicate a reaction called "angioedema".
• Liver disease (hepatitis) (frequency not known): Symptoms include yellowing of the skin or eyes, nausea, loss of appetite, or dark-coloured urine, which may indicate liver disease (hepatitis).
• Inflammation of the pancreas (pancreatitis) (rare: may occur in up to 1 in 1,000 people). Symptoms include severe and persistent stomach pain (in the abdominal area), which may extend to the back, as well as nausea and vomiting.

Other side effects
While taking Vildagliptin Olpha, some patients have experienced the following side effects:

• Very common (may occur in more than 1 in 10 people): sore throat, runny nose, fever
• Common (may occur in up to 1 in 10 people): itchy rash, tremor, headache, dizziness, muscle pain, joint pain, constipation, swelling of hands, ankles or feet (oedema), excessive sweating, vomiting, stomach and around-the-stomach pain (abdominal pain), diarrhoea, heartburn, nausea (feeling sick), blurred vision.
• Uncommon (may occur in up to 1 in 10 people): weight gain, chills, weakness, sexual dysfunction, low blood sugar levels, flatulence.
• Rare (may occur in up to 1 in 1,000 people): inflammation of the pancreas

The following side effects have also been reported during post-marketing experience with this medicine:

• Frequency not known (cannot be estimated from the available data): localized skin peeling or blisters, inflammation of blood vessels (vasculitis), which may cause skin rash or round, red, flat, raised spots under the skin surface or bruising.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Vildagliptin Olpha

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 and the carton after
“EXP” / “Scad.”. The expiry date refers to the last day of that month.
This medicine requires no special storage conditions.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Vildagliptin Olpha contains

• The active substance is vildagliptin.

Each tablet contains 50 mg of vildagliptin.

• The other components are lactose, microcrystalline cellulose, sodium starch glycolate (type A) and magnesium stearate.

Description of the appearance of Vildagliptin Olpha and pack sizes
Vildagliptin Olpha 50 mg tablets are white to almost white, round, flat, bevelled-edged, uncoated tablets,
imprinted with "L 45" on one side and plain on the other (approximately 8 mm in diameter).
Vildagliptin Olpha 50 mg tablets are available in packs containing 28, 30, 56, 60 or 90 tablets.
Not all pack sizes may be marketed in your country.

Marketing Authorisation Holder and Manufacturer:
Olpha AS,
Rupnicu iela 5,
Olaine, Olaines novads, LV-2114,
Latvia

This medicinal product is authorised in the European Economic Area countries under the
following names:
Latvia: Vildagliptin Olpha 50 mg tabletes
Czech Republic, Germany, Estonia, Italy, Poland, Slovakia: Vildagliptin Olpha
France: VILDAGLIPTINE OLPHA 50 mg, comprimé
Lithuania: Vildagliptin Olpha 50 mg tabletės