Tutecvi Combi 50 mg./1000 mg. 60 tablets

What Tutekvi Combi is and what it is used for
The active substances in Tutekvi Combi, vildagliptin and metformin, belong to a group of medicines called 'oral antidiabetics'.
Tutekvi Combi is used to treat adult patients with type 2 diabetes. This type of diabetes is also known as non-insulin-dependent diabetes mellitus.

Tutekwi Combi is used when diabetes cannot be controlled by diet and exercise alone and/or with other medicines used to treat diabetes (insulin or sulphonylureas).

Type 2 diabetes develops if the body does not produce enough insulin, or if the insulin the body produces does not work as well as it should. It can also develop if the body produces too much glucagon.

Both insulin and glucagon are produced in the pancreas. Insulin helps lower blood sugar levels, especially after eating. Glucagon unlocks the liver's process of producing sugar, which causes the blood sugar level to rise.

How Tutekvi Kombi works
The two active substances vildagliptin and metformin help control blood sugar levels. The substance vildagliptin works by making the pancreas produce more insulin and less glucagon. The substance metformin works by helping the body use insulin in a better way. This drug has been found to lower blood sugar levels, which can help prevent diabetes complications.

2. What you need to know before you take Tutekvi Combi
Do not take Tutekvi Combi
if you are allergic to vildagliptin, metformin or any of the other ingredients of this medicine (listed in section 6). If you think you are allergic to any of them, talk to your doctor before taking Tutekvi Combi;
if you have uncontrolled diabetes, for example with severe hyperglycaemia (high blood sugar), nausea, vomiting » diarrhoea, rapid weight loss, lactic acidosis (see 'Risk of lactic acidosis' below) or ketoacidosis. Ketoacidosis is a condition in which substances called 'ketone bodies' build up in the blood and this can lead to a diabetic coma. Symptoms include stomach pain, rapid and deep breathing, drowsiness, or an unusual fruity smell on your breath;
if you have recently had a heart attack, or if you have heart failure, or serious circulation problems, or breathing difficulties, which may be a sign of heart problems; if you have severely reduced kidney function;
if you have a severe infection or severe dehydration (you have lost a lot of water from your body);
if you are due to have a contrast X-ray (a specific type of X-ray which involves the injection of a dye). Please also see the information about this in the section “Warnings and Precautions”; if you have liver problems;
if you drink too much alcohol (whether every day or only occasionally);
if you are breast-feeding (see also "Pregnancy and breast-feeding").
Warnings and precautions
Talk to your doctor or pharmacist before taking Tutekvi Combi.

Risk of lactic acidosis
Tutekvi Kombi can cause a very rare but very serious side effect called lactic acidosis, especially if your kidneys are not working properly. The risk of developing lactic acidosis is also increased with uncontrolled diabetes, severe infections, prolonged fasting or alcohol intake, dehydration (see more information below), liver problems, and any condition where part of the body has a reduced supply of oxygen ( such as acute severe heart disease).

If any of the above applies to you, talk to your doctor for further guidance.

Stop taking Tutekvi Combi for a short time if you have an illness that may be associated with dehydration (significant loss of body fluids), such as severe vomiting, diarrhoea, fever, exposure to heat or if you drink less fluid than normal . Talk to your doctor for further instructions.

Stop taking Tutekvi Combi and contact a doctor or the nearest hospital immediately if you have any of the symptoms of lactic acidosis, as this condition can lead to coma.

Symptoms of lactic acidosis include:
vomiting;
stomach pain (abdominal pain);
muscle spasms;
a general feeling of malaise, accompanied by severe fatigue;
difficulty breathing;
decreased body temperature and pulse.
Lactic acidosis is a medical emergency and must be treated in a hospital.

Tutekvi Kombi does not replace insulin. For this reason, Tutekvi Combi should not be used to treat type 1 diabetes mellitus.

Talk to your doctor, pharmacist or nurse before taking Tutekvi Combi if you have or have had pancreatic disease.

Talk to your doctor, pharmacist or nurse before taking Tutekvi Combi if you are taking an anti-diabetic medicine known as sulphones
It is extremely important that you mention the following:

glucocorticoids, which are mainly used to treat inflammation
beta-2 agonists, which are mainly used to treat respiratory diseases
other medicines used to treat diabetes;
drugs that increase urine output (diuretics);
medicines used to treat pain and inflammation (NSAIDs and COX-2 inhibitors such as ibuprofen and celecoxib);
certain medicines for the treatment of high blood pressure (ACE inhibitors and angiotensin II receptor antagonists);
some medicines acting on the thyroid gland; some drugs acting on the nervous system;
certain medicines used to treat angina (eg ranolazine); certain medicines used to treat HIV infection (eg dolutegravir);
certain medicines used to treat a specific type of thyroid cancer (medullary thyroid carcinoma) (eg vandetanib);
certain medicines used to treat heartburn and peptic ulcers (eg cimetidine).
Tutekvi Combi with alcohol
Avoid excessive alcohol consumption while taking Tutekvi Combi, as this may increase the risk of lactic acidosis (please see section "Warnings and precautions").

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant or are planning to become pregnant, consult your doctor before using this medicine. Your doctor will discuss with you the possible risk of taking Tutekvi Kombi during pregnancy.

Do not take Tutekvi Kombi if you are pregnant or breast-feeding (see also section "Do not take Tutekvi Kombi"). Ask your doctor or pharmacist before using any medicine.

Driving and using machines
If you feel dizzy while taking Tutekvi Kombi, do not drive or work with tools and machines.

3. How to take Tutekvi Kombi
The amount of Tutekwi Combi that people should take varies and depends on their condition. Your doctor will tell you exactly what dose of Tutekvi Kombi to take.

Always take this medicine exactly as your doctor has told you. If you are not sure, ask 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 reduced kidney function, your doctor may prescribe a lower dose. Also, if you are taking an anti-diabetic medicine known as a sulphonylurea, your doctor may prescribe a lower dose.

Your doctor may prescribe this medicine alone or with certain other medicines that lower blood sugar.

When and how to take Tutekvi Kombi
Swallow the tablet whole with a glass of water.

Take one tablet in the morning and the other in the evening during or immediately after a meal. Taking the tablet immediately after a meal will reduce the risk of stomach irritation.

Continue to follow any dietary advice your doctor has given you. Especially if you are on a diabetes weight control diet, continue to follow it while taking Tutekvi Combi.

If you have taken more than the required dose of Tutekvi Combi
If you have taken too many Tutekwi Kombi tablets or if someone else takes your tablets, contact your doctor or pharmacist immediately. You may need medical attention. Take the package and this leaflet with you if you need to see a doctor or go to hospital.

If you forget to take Tutekvi Combi
If you forget to take a tablet, take it with the next meal, unless you have to take the next one then. Do not take a double dose (two tablets at once) to make up for a missed tablet.

If you have stopped taking Tutekvi Combi
Keep taking this medicine for as long as your doctor prescribes to keep your blood sugar under control. Do not stop taking Tutekvi Combi unless your doctor tells you to. If you have questions about how long to take this medicine, talk to your doctor.

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

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

You should stop taking Tutekvi Combi and contact your doctor immediately if you experience the following side effects:

Lactic acidosis (very rare: may affect up to 1 in 10,000 people): Tutekvi Combi can cause a very rare but very serious side effect called lactic acidosis (see section "Warnings and precautions"). If this happens, you must stop taking Tutekvi Kombi and contact a doctor or the nearest hospital immediately, as lactic acidosis can lead to coma.
Angioedema (rare: may affect up to 1 in 1,000 people): Symptoms include swelling of the face, tongue or throat
Some patients experience the following side effects while taking vildagliptin and metformin hydrochloride with a sulfonylurea medicine:
Common: dizziness, tremor, weakness, low blood sugar, excessive sweating.
Some patients experience the following side effects while taking vildagliptin and metformin hydrochloride with insulin:
Common: headache, chills, nausea (feeling sick), low blood sugar, heartburn.
Uncommon: diarrhea, flatulence.
The following side effects have also been reported:
With an unknown frequency (an estimate cannot be made from the available data): itchy rash, inflammation of the pancreas, localized skin peeling or blistering, muscle pain.
5. How to store Tutekvi Combi
Keep out of the reach of children.
Do not use this medicine after the expiry date which is stated on the blister and carton after EXP. The expiration date corresponds to the last day of the specified month.
This medicinal product does not require special temperature storage conditions. Store in original packaging to protect from moisture.
Do not dispose of medicines down the drain or in the household waste container. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help protect the environment.

6. Contents of the package and additional information
What Tutekvi Combi contains
The active substances are vildagliptin and metformin hydrochloride.

Each Tutekvi Combi 50 mg/850 mg film-coated tablet contains 50 mg vildagliptin and 850 mg metformin hydrochloride (equivalent to 660 mg metformin).

Each Tutekvi Combi 50 mg/1000 mg film-coated tablet contains 50 mg vildagliptin and 1000 mg metformin hydrochloride (equivalent to 780 mg metformin).

Other ingredients: microcrystalline cellulose, copovidone K 25, crospovidone (type B), hydroxypropylcellulose, hypromellose, magnesium stearate, titanium dioxide (E 171), yellow iron oxide (E 172), macrogol/PEG 8000 and talc.

What Tutekvi Kombi looks like and what the package contains
Tutekvi Combi 50 mg/850 mg film-coated tablets are yellow, elliptical, with beveled edges, smooth on both sides and approximate dimensions of 20.7 x 8.8 mm.

Tutekvi Combi 50 mg/1000 mg film-coated tablets are dark yellow, elliptical, with beveled edges, smooth on both sides and approximate dimensions 21.3 x 10.1 mm.

Tutekvi Kombi is available in packs containing 10, 30, 56, 60, 120, 180 or 360 film-coated tablets.

Not all types of packaging can be marketed.

 

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