Pernuvi

Package Leaflet: Information for the User

PERNUVI 50 mg tablets

vildagliptin

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

• 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, please tell your doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Package Leaflet:

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

1. What is PERNUVI and what is it used for

The active substance of PERNUVI is vildagliptin, which belongs to a group of medicines called "oral anti-diabetic medicines".
PERNUVI is used to treat adults with type 2 diabetes, who cannot control their blood sugar levels by diet and exercise alone. PERNUVI helps to control blood sugar levels. Your doctor will prescribe PERNUVI either alone or in combination with other anti-diabetic medicines that you may already be taking, if they are not sufficient to control your blood sugar levels.
Type 2 diabetes develops when your body does not produce enough insulin or when the insulin produced by your body does not work properly. Diabetes can also develop when your body produces too much glucagon.
Insulin is a substance that helps to 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 substances are produced in the pancreas.

How PERNUVI works

PERNUVI works by stimulating the pancreas to produce insulin and reducing the production of glucagon. The medicine helps to control blood sugar levels. It has been shown that the medicine lowers blood sugar levels, which can help to prevent complications of diabetes. Despite starting to take anti-diabetic medicine, it is important that you continue to follow a suitable diet and/or exercise as recommended by your doctor.

2. Important information before taking PERNUVI

When not to take PERNUVI

• 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 PERNUVI, do not take this medicine, but talk to your doctor.

Warnings and precautions

Before taking PERNUVI, talk to your doctor, pharmacist, or nurse if you:

• have type 1 diabetes (your body does not produce insulin) or have been diagnosed with diabetic ketoacidosis.
• are taking a sulphonylurea (a type of anti-diabetic medicine), as your doctor may want to reduce the dose of the sulphonylurea taken with PERNUVI to avoid low blood sugar levels (hypoglycaemia).
• have moderate or severe kidney disease (your doctor may need to reduce the dose of PERNUVI).
• are on dialysis,
• have liver disease,
• have heart failure,
• have or have had pancreatitis.

If you have taken vildagliptin before, but had to stop due to liver disease, you should not take this medicine.
Skin disorders are a common complication of diabetes. You should follow your doctor's advice on skin and foot care. While taking PERNUVI, you should pay particular attention to the appearance of new blisters or ulcers. If you notice any, you should contact your doctor immediately.
Before starting treatment with PERNUVI and at 3-month intervals during the first year of treatment, and periodically thereafter, you should have liver function tests. This is to detect any increase in liver enzymes as soon as possible.

Children and adolescents

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

PERNUVI with other medicines

Tell your doctor or pharmacist about all the medicines you are taking, have recently taken, or might take, including those you have bought without a prescription. Your doctor may want to change the dose of PERNUVI 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 disease
• certain medicines that affect the nervous system

Pregnancy and breastfeeding

If you are pregnant, 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 PERNUVI if you are pregnant. It is not known if PERNUVI passes into breast milk. Do not take PERNUVI if you are breastfeeding or planning to breastfeed.

Driving and using machines

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

PERNUVI contains lactose

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

PERNUVI contains sodium

PERNUVI contains less than 1 mmol (23 mg) of sodium per tablet, which is essentially "sodium-free".

3. How to take PERNUVI

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 PERNUVI will vary depending on your condition. Your doctor will tell you exactly how many tablets of PERNUVI to take. The maximum daily dose is 100 mg.
The usual dose of PERNUVI is:

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

How to take PERNUVI

• Swallow the tablets whole with water.

How long to take PERNUVI

• Take PERNUVI once daily, for as long as your doctor has told you. Treatment may be long-term.
• Your doctor will regularly check your condition to ensure that the treatment is working.

If you take more PERNUVI than you should

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

If you forget to take PERNUVI

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

If you stop taking PERNUVI

Do not stop taking PERNUVI unless your doctor tells you to. If you have any questions about how long to take this medicine, ask your doctor.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, PERNUVI 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 PERNUVI 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. These may be signs of an allergic reaction called angioedema.
• Liver disease (hepatitis) (rare). Symptoms include yellowing of the skin and the whites of the eyes, nausea, loss of appetite, or dark-colored urine. These may be signs of liver disease (hepatitis).
• Pancreatitis (frequency not known): Symptoms include severe and persistent abdominal pain (in the area of the stomach), which may radiate to the back, as well as nausea and vomiting.

Other side effects

Some patients taking PERNUVI (vildagliptin) and metformin have experienced the following side effects:

• common (may affect up to 1 in 10 people): tremor, headache, dizziness, nausea, low blood sugar levels,
• uncommon (may affect up to 1 in 100 people): fatigue.

Some patients taking PERNUVI (vildagliptin) and a sulphonylurea have experienced the following side effects:

• common: tremor, headache, dizziness, weakness, low blood sugar levels,
• uncommon: constipation,
• very rare (may affect up to 1 in 10,000 people): sore throat, runny nose.

Some patients taking PERNUVI (vildagliptin) and a glitazone have experienced the following side effects:

• common: weight gain, swollen hands, ankles, or feet (oedema),
• uncommon: headache, weakness, low blood sugar levels.

Some patients taking PERNUVI (vildagliptin) alone have experienced the following side effects:

• common: dizziness,
• uncommon: headache, constipation, swollen hands, ankles, or feet (oedema), joint pain, low blood sugar levels,
• very rare: sore throat, runny nose, fever.

Some patients taking PERNUVI (vildagliptin), metformin, and a sulphonylurea have experienced the following side effects:

• common: dizziness, tremor, weakness, low blood sugar levels, excessive sweating.

Some patients taking PERNUVI (vildagliptin) and insulin (with or without metformin) have experienced the following side effects:

• common: headache, chills, nausea (vomiting), low blood sugar levels, heartburn.
• uncommon: diarrhea, bloating.

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): itching rash, pancreatitis, local skin peeling or blistering, muscle pain.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety, 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.
By reporting side effects, you can help provide more information on the safety of this medicine.
Side effects can also be reported to the marketing authorization holder.

5. How to store PERNUVI

Keep this medicine out of the sight and reach of children.
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 that month.
Store in a cool, dry place, below 25°C.
Keep the blister in the outer carton in order to protect from moisture.
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 PERNUVI contains

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

What PERNUVI looks like and contents of the pack

PERNUVI 50 mg tablets are white, round, flat tablets with a bevelled edge, 8.5 mm in diameter, with the inscription "A013" on one side.
PERNUVI 50 mg tablets are available in:

• blister packs containing 10, 14, 28, 30, 50, 56, 60, 90, 100, or 180 tablets, in a cardboard box,
• perforated unit dose blisters containing 10 x 1, 30 x 1, 56 x 1, or 60 x 1 tablets, in a cardboard box.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Teva B.V.
Swensweg 5
2031 GA Haarlem
Netherlands

Manufacturer

Balkanpharma-Dupnitsa AD
3 Samokovsko Shosse Str.
2600 Dupnitsa
Bulgaria
Merckle GmbH
Ludwig-Merckle-Strasse 3
89143 Blaubeuren, Baden-Wuerttemberg
Germany
PLIVA Hrvatska d.o.o. (PLIVA Croatia Ltd.)
Prilaz baruna Filipovića 25
10000 Zagreb
Croatia
Teva Nederland B.V.
Swensweg 5
2031 GA Haarlem
Netherlands
Teva Operations Poland Sp. z o.o.
ul. Mogilska 80
31-546 Kraków
Teva Pharma B.V.
Swensweg 5
2031 GA Haarlem
Netherlands

To obtain more information on this medicine and its authorized names in other European Economic Area countries, contact the representative of the marketing authorization holder:

Teva Pharmaceuticals Polska Sp. z o.o., ul. Emilii Plater 53, 00-113 Warszawa, tel. (22) 345 9300

Date of last revision of the leaflet: March 2022