Vildagliptin + metformin hydrochloride +pharma

Package leaflet: Information for the user

Vildagliptin + Metformin hydrochloride +pharma, 50 mg + 850 mg, film-coated tablets
Vildagliptin + Metformin hydrochloride +pharma, 50 mg + 1000 mg, film-coated tablets
vildagliptin + metformin hydrochloride

Please read carefully the entire leaflet before taking this medicine, as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, please ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm other people, 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

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

1. What Vildagliptin + Metformin hydrochloride +pharma is and what it is used for

The active substances in Vildagliptin + Metformin hydrochloride +pharma are vildagliptin and metformin hydrochloride, which belong to a group of medicines called oral antidiabetic drugs.
Vildagliptin + Metformin hydrochloride +pharma is used to treat adult patients with type 2 diabetes. This type of diabetes is also known as non-insulin-dependent diabetes. Vildagliptin + Metformin hydrochloride +pharma is used when diabetes cannot be controlled by diet and physical exercise alone, and (or) when it is administered together with other antidiabetic medicines (insulin or sulfonylureas).
Type 2 diabetes is a condition in which the body either does not produce enough insulin or the insulin produced does not work properly. Type 2 diabetes may also occur when the body produces too much glucagon.
Both insulin and glucagon are produced in the pancreas. Insulin helps lower blood glucose levels, especially after meals. Glucagon is a substance that stimulates glucose production in the liver and causes an increase in blood glucose levels.

How Vildagliptin + Metformin hydrochloride +pharma works
Both active substances, vildagliptin and metformin, help control blood glucose levels.
Vildagliptin works by stimulating the pancreas to produce insulin and reducing glucagon production. Metformin helps the body to use insulin more effectively.
It has been shown that this medicine reduces blood glucose levels, which may help prevent complications associated with diabetes.

2. Important information before using Vildagliptin + Metformin hydrochloride +pharma

+pharma
When not to use Vildagliptin + Metformin hydrochloride +pharma

• if the patient is allergic to vildagliptin, metformin, or any of the other ingredients of this medicine (listed in section 6). If the patient thinks they may be allergic to any of these ingredients, they should inform their doctor before taking Vildagliptin + Metformin hydrochloride +pharma
• if the patient has uncontrolled diabetes, for example severe hyperglycaemia (high blood glucose levels), nausea, vomiting, diarrhoea, sudden weight loss, lactic acidosis (see "Risk of lactic acidosis" below), or ketoacidosis. Ketoacidosis is a condition in which substances called ketone bodies accumulate in the blood and may lead to a diabetic pre-coma state. Symptoms include: abdominal pain, rapid and deep breathing, drowsiness, or an unusual fruity odour of the breath.
• if the patient has recently had a heart attack or if they have heart failure, severe circulatory problems, or breathing difficulties which may be symptoms of heart failure
• if the patient has significantly reduced kidney function
• if the patient has a severe infection or is severely dehydrated (has lost a lot of body fluid)
• if the patient is due to undergo a radiological contrast procedure (a special type of examination requiring injection of a contrast agent). For further information on this, see section "Warnings and precautions".
• if the patient has liver disease
• if the patient consumes excessive amounts of alcohol (either regularly or occasionally)
• if the patient is breastfeeding (also see section "Pregnancy and breastfeeding")

Warnings and precautions
Risk of lactic acidosis
Vildagliptin + Metformin hydrochloride +pharma may cause a very rare but serious adverse reaction called lactic acidosis, especially if the patient has impaired kidney function. The risk of lactic acidosis is also increased in cases of uncontrolled diabetes, severe infection, prolonged fasting or alcohol consumption, dehydration (see more detailed information below), impaired liver function, and any medical conditions in which a part of the body is inadequately supplied with oxygen (e.g. acute severe heart disease).
If any of the above conditions apply to the patient, they should consult their doctor for further instructions.
The use of Vildagliptin + Metformin hydrochloride +pharma should be temporarily discontinued
if the patient develops a medical condition that may lead to dehydration (significant loss of body fluid), such as severe vomiting, diarrhoea, fever, or exposure to high temperatures, or if the patient is drinking less fluid than usual. The patient should consult their doctor for further instructions.
The use of Vildagliptin + Metformin hydrochloride +pharma should be discontinued
and the patient should contact their doctor or the nearest hospital immediately if any symptoms of lactic acidosis occur, as this condition may lead to coma. Symptoms of lactic acidosis include:

• vomiting
• abdominal pain
• muscle cramps
• general malaise accompanied by profound fatigue
• difficulty breathing
• decreased body temperature and slowed heart rate.

Lactic acidosis is an acute, life-threatening condition requiring immediate hospital treatment.
Vildagliptin + Metformin hydrochloride +pharma does not replace insulin. Therefore, Vildagliptin + Metformin hydrochloride +pharma must not be used in the treatment of type 1 diabetes.
Before starting treatment with Vildagliptin + Metformin hydrochloride +pharma, the patient should discuss with their doctor, pharmacist, or nurse if they have or have had any pancreatic disorders.
Before starting treatment with Vildagliptin + Metformin hydrochloride +pharma, the patient should consult their doctor, pharmacist, or nurse if they are taking an antidiabetic medicine called a sulphonylurea. The doctor may wish to reduce the dose of the sulphonylurea taken together with Vildagliptin + Metformin hydrochloride +pharma to avoid low blood glucose levels (hypoglycaemia).
If the patient previously took vildagliptin but had to discontinue it due to liver disease, they should not take this medicine again.
Diabetic skin changes are a common complication of diabetes. The patient should follow the advice of their doctor or nurse regarding skin and foot care. It is also recommended that the patient pay particular attention to the development of new blisters or ulcers while taking Vildagliptin + Metformin hydrochloride +pharma. If these occur, the patient should promptly consult their doctor.
If the patient is undergoing major surgery, they must not take Vildagliptin + Metformin hydrochloride +pharma during the procedure and for some time afterwards. The doctor will decide when the patient should stop and restart treatment with Vildagliptin + Metformin hydrochloride +pharma.
Before starting treatment with Vildagliptin + Metformin hydrochloride +pharma and every three months during the first year of treatment, and periodically thereafter, liver function tests should be performed. This allows early detection of signs of increased liver enzyme activity.
During treatment with Vildagliptin + Metformin hydrochloride +pharma, the doctor will monitor the patient's kidney function at least once a year, or more frequently if the patient is elderly and/or has worsening kidney function.
The doctor will regularly monitor blood and urine glucose levels.
Children and adolescents
Vildagliptin + Metformin hydrochloride +pharma is not recommended for use in children and adolescents under 18 years of age.
Vildagliptin + Metformin hydrochloride +pharma and other medicines
If the patient is to receive an intravascular iodinated contrast agent, for example for an X-ray or CT scan, they must stop taking Vildagliptin + Metformin hydrochloride +pharma before or at the latest at the time of injection. The doctor will decide when the patient should stop and restart treatment with Vildagliptin + Metformin hydrochloride +pharma.
The patient should inform their doctor about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. The patient may require more frequent monitoring of blood glucose levels and kidney function, or a dose adjustment of Vildagliptin + Metformin hydrochloride +pharma by their doctor. It is especially important to inform the doctor about the following medicines:

• glucocorticoids, usually used to treat inflammatory conditions
• beta-2 adrenergic receptor agonists, usually used to treat breathing disorders
• other medicines used to treat diabetes
• diuretics (medicines that increase urine production)
• medicines used to treat pain and inflammation (NSAIDs and COX-2 inhibitors, such as ibuprofen and celecoxib)
• certain medicines used to treat high blood pressure (ACE inhibitors and angiotensin II receptor antagonists)
• certain medicines affecting the thyroid gland
• certain medicines affecting the nervous system
• certain medicines used to treat angina (e.g. ranolazine)
• certain medicines used to treat HIV infection (e.g. dolutegravir)
• certain medicines used to treat a specific type of thyroid cancer (medullary thyroid cancer) (e.g. vandetanib)
• certain medicines used to treat heartburn and peptic ulcers (e.g. cimetidine).

Using Vildagliptin + Metformin hydrochloride +pharma with alcohol
The patient should avoid consuming excessive amounts of alcohol while taking Vildagliptin + Metformin hydrochloride +pharma, as this may increase the risk of lactic acidosis (see section "Warnings and precautions").
Pregnancy and breastfeeding
If the patient is pregnant, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor before using this medicine. The doctor will discuss with her the possible risks associated with taking Vildagliptin + Metformin hydrochloride +pharma during pregnancy.

• Vildagliptin + Metformin hydrochloride +pharma must not be used during pregnancy or breastfeeding (also see "When not to use Vildagliptin + Metformin hydrochloride +pharma").

Before taking any medicine, the patient should consult their doctor or pharmacist.
Driving and using machines
If the patient experiences dizziness while taking Vildagliptin + Metformin hydrochloride +pharma, they should not drive or operate machinery.
Vildagliptin + Metformin hydrochloride +pharma contains lactose and sodium
If the patient has been previously diagnosed with an intolerance to certain sugars, they should consult their doctor before taking this medicine.
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, meaning it is considered "sodium-free".

3. How to take Vildagliptin + Metformin hydrochloride +pharma

The dose of Vildagliptin + Metformin hydrochloride +pharma varies depending on the patient's condition. Your doctor will determine the appropriate dose of Vildagliptin + Metformin hydrochloride +pharma for you.
This medicine should always be taken as prescribed by your doctor. If in doubt, consult your doctor or pharmacist.
The recommended dose is one 50 mg + 850 mg or 50 mg + 1000 mg film-coated tablet taken twice daily.
If you have impaired kidney function, your doctor may prescribe a lower dose. If you are taking a diabetes medicine called a sulfonylurea, your doctor may also prescribe a lower dose.
Your doctor may prescribe this medicine to be taken alone (as monotherapy) or in combination with certain other medicines that lower blood glucose levels.

When and how to take Vildagliptin + Metformin hydrochloride +pharma

• Swallow the tablets whole with a glass of water.
• Take one tablet in the morning and one in the evening, with a meal or immediately after a meal. Taking the tablet just after a meal may help reduce the risk of gastrointestinal disturbances.

Continue to follow all dietary advice given by your doctor. Following a diet while taking Vildagliptin + Metformin hydrochloride +pharma is particularly important if you are on a weight-control diet.
The breakline on the tablet is not intended for splitting the tablet.

Taking more Vildagliptin + Metformin hydrochloride +pharma than prescribed
If you accidentally take too many tablets of Vildagliptin + Metformin hydrochloride +pharma, or if someone else takes these tablets, contact your doctor or pharmacist immediately. You may require medical attention. If you need to see a doctor or go to hospital, bring the medicine pack and the package leaflet with you.

Missing a dose of Vildagliptin + Metformin hydrochloride +pharma
If you forget to take a tablet, take it with your next meal, unless it is almost time for your next dose.
Do not take a double dose (two tablets at once) to make up for a missed dose.

Stopping treatment with Vildagliptin + Metformin hydrochloride +pharma
To maintain blood glucose control, continue taking this medicine for as long as your doctor recommends. Do not stop taking Vildagliptin + Metformin hydrochloride +pharma without consulting your doctor. If you have any questions about how long to take this medicine, consult your doctor.

If you have any further questions about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Stop taking Vildagliptin + Metformin hydrochloride +pharma
and contact a doctor immediately if any of the following adverse reactions occur:

• Lactic acidosis (very rare: may occur in up to 1 in 10,000 patients).

Vildagliptin + Metformin hydrochloride +pharma may very rarely cause a very serious adverse reaction known as lactic acidosis (see section “Warnings and precautions”). If this occurs in a patient, treatment with Vildagliptin + Metformin hydrochloride +pharma must be stopped and the patient must immediately contact a doctor or the nearest hospital, as lactic acidosis may lead to coma.

• Angioedema (rare: may occur in up to 1 in 1,000 patients). Symptoms include swelling of the face, tongue or throat, difficulty swallowing, difficulty breathing, sudden appearance of rash or hives. These may indicate a reaction known as "angioedema".
• Liver disease (hepatitis) (uncommon: may occur in up to 1 in 100 patients). 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 (uncommon: may occur in up to 1 in 100 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 + Metformin hydrochloride +pharma:

• Common (may occur in up to 1 in 10 patients): sore throat, nasal congestion, fever, itchy rash, excessive sweating, joint pain, dizziness, headache, uncontrollable tremor, constipation, nausea, vomiting, diarrhoea, bloating, heartburn, stomach and abdominal pain.
• Uncommon (may occur in up to 1 in 100 patients): fatigue, weakness, metallic taste in the mouth, low blood glucose levels, loss of appetite, swelling of hands, ankles or feet (oedema), chills, pancreatitis, muscle pain.
• Very rare (may occur in up to 1 in 10,000 patients): symptoms of high levels of lactic acid in the blood (called lactic acidosis), such as drowsiness or dizziness, severe nausea or vomiting, abdominal pain, irregular heartbeat, or deep, rapid breathing; skin redness, itching; decreased vitamin B12 levels (pallor, fatigue, psychiatric symptoms such as confusion or memory disorders).

Since the medicine has been placed on the market, the following adverse reactions have also been reported:

• Frequency not known (frequency cannot be estimated from the 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 a doctor or pharmacist. 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 4921301, fax: +48 22 4921309, website: https://smz.ezdrowie.gov.pl. Adverse reactions can also be reported to the marketing authorisation holder. By reporting adverse reactions, additional information on the safety of this medicine can be collected.

5. How to store Vildagliptin + Metformin hydrochloride +pharma

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister or carton following "EXP". The expiry date refers to the last day of the stated month.
No special storage conditions apply for this medicine.
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 Vildagliptin + Metformin hydrochloride +pharma contains

• The active substances in this medicine are vildagliptin and metformin hydrochloride.
• Each film-coated tablet of Vildagliptin + Metformin hydrochloride +pharma, 50 mg + 850 mg contains 50 mg of vildagliptin and 850 mg of metformin hydrochloride (equivalent to 663 mg of metformin).
• Each film-coated tablet of Vildagliptin + Metformin hydrochloride +pharma, 50 mg + 1000 mg contains 50 mg of vildagliptin and 1000 mg of metformin hydrochloride (equivalent to 780 mg of metformin).
• Other ingredients are: hydroxypropylcellulose, lactose (see section 2), microcrystalline cellulose, sodium croscarmellose, sodium stearyl fumarate and ready-to-use coating material (hypromellose, titanium dioxide, macrogol, talc, yellow iron oxide (E 172)).

What Vildagliptin + Metformin hydrochloride +pharma looks like and contents of the pack
Vildagliptin + Metformin hydrochloride +pharma, 50 mg + 850 mg, film-coated tablets
Yellow, elongated, oval film-coated tablet with a notch on one side and the inscription “VA” on the other side of the tablet. Tablet length: 19.4 ± 0.5 mm.
Vildagliptin + Metformin hydrochloride +pharma, 50 mg + 1000 mg, film-coated tablets
Dark yellow, elongated, oval film-coated tablet with a notch between the inscription “V” and “B” on one side of the tablet and a notch on the other side of the tablet. Tablet length: 21.1 ± 0.5 mm.
Aluminium/OPA/Aluminium/PVC foil blisters in cardboard packaging containing 30 or 60 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
+pharma arzneimittel gmbh
Hafnerstraße 211
8054 Graz
Austria

Manufacturer
SAG Manufacturing, S.L.U
Carretera Nacional I, Km 36
San Agustin de Guadalix
28750 Madrid
Spain
Galenicum Health, S.L.
Avda. Cornellá 144, 7º-1ª, Edificio Lekla
Esplugues de Llobregat
08950 Barcelona
Spain

This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Croatia Vildagliptin/metforminklorid Genericon 50 mg/850 mg filmom obložene tablete
Vildagliptin/metforminklorid Genericon 50 mg/1000 mg filmom obložene tablete
Czech Republic Vildagliptin/Metformin +pharma
Poland Vildagliptin + Metformin hydrochloride +pharma

For further information about this medicinal product, please contact the Marketing Authorisation Holder's representative:
+pharma Polska sp. z o.o.
ul. Podgórska 34
31-536 Kraków, Poland
tel: +48 12 262 32 36
e-mail: [email protected]