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KOMBOGLYZE. 2.5 mg. / 1,000 mg. 60 tablets

Product Code: KOMBOGLYZE. 2.5 mg. / 1,000 mg. 60 tablets
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KOMBOGLYZE. 2.5 mg. / 1,000 mg. 60 tablets

KOMBOGLYZE. 2.5 mg. / 1,000 mg. 60 tablets



What Komboglyze and what it is used
Komboglyze contains two different substances known as :
Saxagliptin , which is of the class of drugs known as inhibitors of DPP- 4 ( dipeptidyl peptidase - 4 ) , and
Metformin, which is a class of drugs called biguanides .
Both belong to the group of medicines called "oral antidiabetics ."

What is it used Komboglyze
Komboglyze is used to treat a particular type of diabetes mellitus, called type 2 diabetes mellitus .

How does Komboglyze
And saxagliptin and metformin lower your blood sugar. They cause an increase in insulin secretion after meals . Also, the lower the amount of glucose that is formed in your body. This, together with the maintenance of diet and physical activity helps to lower your blood sugar. Komboglyze can be used alone or in combination with insulin .
The control of diabetes requires attention to diet and exercise , even when taking this medicine. It is important to follow the advice of the doctor or nurse about your diet and physical activity.

2 . What you should know before taking Komboglyze
Do not take Komboglyze:
if you are allergic to saxagliptin , metformin or any of the other ingredients of this medicine (listed in Section 6) ;
if you have ever had a serious allergic reaction ( hypersensitivity reaction ) to any other similar drug you take to control your blood sugar. Symptoms of a serious allergic reaction may include:
rash ;
raised red patches on your skin (hives) ;
swelling of your face , lips, tongue , and throat that may cause difficulty breathing or swallowing;
If you have these symptoms , stop taking Komboglyze and immediately call your doctor or nurse.
If you've ever been in a diabetic coma ;
if you have a condition known as " diabetic ketoacidosis ," which can occur in humans with diabetes . Signs include a sudden weight loss, nausea or vomiting ;
if you have problems with your kidneys or liver;
if you have recently had a heart attack if you have severe heart failure or circulation problems or have shortness of breath , which may be a sign of heart problems ;
if you have a severe infection or are dehydrated (have lost a lot of fluid ) ;
if breast-feeding ( see also "Pregnancy and lactation " ) ;
if you drink large amounts of alcohol (as every day , and from time to time) (please see section "Komboglyze and alcohol " ) ;
if you are an X-ray test in which you will be injected X-ray contrast agent. In this case , you should tell your doctor and stop taking Komboglyze during X-ray and for 2 or more days , depending on your kidney function.
If any of the above apply to you , do not take Komboglyze. If you are not sure, talk to your doctor or pharmacist before taking Komboglyze.

Warnings and Precautions
Before you start using Komboglyze, talk to your doctor or pharmacist :
if you have type 1 diabetes ( your body does not produce insulin). Komboglyze should not be used to treat this condition ;
if you are taking insulin or diabetes medicine known as a sulphonylurea , your doctor may decide to reduce the dose of insulin or sulphonylurea , when used with Komboglyze, to avoid low blood sugar;
if you have had an allergic reaction to any other medicine you take to lower your blood sugar;
If you have a problem with the body's defense against infection or taking medicine that may suppress it ;
if you have an operation under anesthetic. You should stop taking Komboglyze at least 48 hours before elective surgery under general anesthesia and should not resume taking it for at least 48 hours after surgery ; Follow the doctor's instructions when you pause and resume taking your medicine .
If you have symptoms of acute pancreatitis , such as persistent severe abdominal pain, you should consult your doctor.
Diabetic skin lesions are a common complication of diabetes. In saxagliptin and certain antidiabetic drugs of the same class , there was a development of rashes.
Follow the recommendations for the care of the skin and feet that your doctor or nurse if you are .

If any of the above apply to you, or you are unsure, consult your doctor or pharmacist before taking Komboglyze.

A study of kidney function
During treatment with Komboglyze:
Your doctor will check how well your kidneys ;
he will do this at least once a year.
Your kidney function should be monitored more frequently:
if you are elderly ;
If your kidneys are not working properly ( or at risk of worsening their function ) .
Children and adolescents
Not recommended intake Komboglyze in children and adolescents under 18 years. It is not known whether this drug is safe and effective in children and adolescents under 18 years.

Other medicines and Komboglyze
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines .

In particular, tell your doctor or pharmacist if you are taking any of the following medicines:
medicines containing alcohol;
cimetidine, a medicine used to treat stomach problems;
ketoconazole , which was used for the treatment of fungal infections ;
bronchodilators ( beta2- agonists) , which are used for the treatment of asthma ;
water tablets ( diuretics) , which are used to increase the fluid , which separate the urine ;
diltiazem , which is used for lowering high blood pressure ;
rifampicin, an antibiotic which is used for treatment of infections, such as tuberculosis ;
corticosteroids, which are used for the suppression of the inflammation in such diseases as asthma or arthritis ;
carbamazepine , phenobarbital and phenytoin, which are used for the treatment of convulsions or chronic pain .
If any of the above apply to you, or you are not sure , check with your doctor or pharmacist before taking Komboglyze.

Komboglyze and alcohol
While taking Komboglyze Avoid alcohol as alcohol may increase the risk of lactic acidosis (please see section 4 " Possible side effects").

Pregnancy and lactation
Do not take Komboglyze, if you are pregnant or could become pregnant. The reason for this is that Komboglyze can affect the infant .
Do not take Komboglyze, if you are breastfeeding or plan to breastfeed . The reason for this is that small amounts of metformin passes into breast milk.
Ask your doctor or pharmacist before taking any medicine .

Driving and using machines
Saxagliptin and metformin may have a negligible influence on the ability to drive and use machines. If you feel dizzy while taking Komboglyze, do not drive or use any tools or machines. Hypoglycemia can affect your ability to drive or operate machinery , and stable your position at work , while taking this medicine with other medicines known to cause hypoglycaemia - insulin and sulfonylurea compositions can develop such .

3 . How to take Komboglyze
Always take this medicine exactly as your doctor tells you . If you are not sure, ask your doctor or pharmacist.
If your doctor prescribes Komboglyze with insulin , do not forget to take these medications exactly as you prescribed it by your doctor to achieve the best results for your health .

How much to take
The amount Komboglyze, which will take will depend on your condition and the doses of metformin and / or individual tablets saxagliptin or metformin are taking at the moment . Your doctor will tell you what is the right dose Komboglyze, you should take ;
The recommended dosage is one tablet twice daily.
How to take this medicine
This medicine is taken orally ;
Take this medicine with meals to reduce the risk of stomach upset .
Diet and exercise
Even while taking this medication to control your diabetes is important to follow a diet and be physically active . It is important to continue to follow the advice of the doctor and his medical nurse on diet and exercise . In particular, if you are on a diet for weight control , you should continue to follow while taking Komboglyze.

If you take more than the amount of Komboglyze
If you take more tablets Komboglyze than necessary, talk to a doctor or hospital . Take the medicine pack with you.

If you forget to take Komboglyze
If you miss a dose Komboglyze, take it as soon as you remember. However, if it is time to take your next dose, skip the missed and directly take your next dose at the usual time .
Do not take a double dose Komboglyze, to make up for a missed dose.

If you stop taking Komboglyze
Continue to take Komboglyze, unless your doctor tells you to stop . This will help you control your blood sugar.

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

4 . Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them .
Metformin - one of constituting the Komboglyze substances can cause a very rare ( affects less than 1 user in 10,000 ) but serious side effect called " lactic acidosis " . It is expressed in the accumulation of lactic acid in the blood, which may cause death . Lactic acidosis is a medical emergency and must be treated in hospital. Develops mainly in patients whose kidneys are not working well.

Stop taking Komboglyze and immediately go to the doctor if you notice any of the following signs of lactic acidosis :
feeling cold or uncomfortable ;
severe nausea or vomiting, or abdominal pain ;
unexplained weight loss ;
muscle cramps ;
tachypnea .
Other side effects of Komboglyze include:
Common (affects 1 to 10 users in 100):
headache ;
muscle pain ( myalgia ) ;
vomiting or indigestion (dyspepsia ) ;
urinary tract ( urinary tract infections ) ;
infections of the upper respiratory tract ;
inflammation of the nose or throat, such as for a cold ;
inflammation of the stomach ( gastric ) or the intestine , sometimes the result of infection ( gastroenteritis ) ;
sinus infections , sometimes with a sense of pain and fullness behind your cheeks and eyes ( sinusitis ) ;
flatulence ;
dizziness ;
fatigue (tiredness ) .
Uncommon ( affects 1 to 10 users in 1000 ):
joint pain ( arthralgia ) ;
difficulty getting or maintaining an erection ( erectile dysfunction) .
Side effects while taking only saxagliptin :
dizziness ;
fatigue (tiredness ) .
In some patients there was a slight reduction in the number of certain white blood cells (lymphocytes ) , which are detectable by examination of the blood . In addition , some patients have reported that after saxagliptin develop rashes and skin reactions ( hypersensitivity) .
During post-approval use of saxagliptin were reported additional side effects include serious adverse reactions ( anaphylaxis) and swelling of the face , lips, tongue , and throat that may cause difficulty breathing or swallowing.
If you have an allergic reaction , stop taking Komboglyze and immediately contact your doctor. Your doctor may prescribe a medicine to treat your allergic reaction and a different medicine for your diabetes.

Cases of inflammation of the pancreas ( pancreatitis) (frequency : uncommon ) . Pancreatitis can be a serious, potentially life-threatening medical condition. Tell your doctor if you experience severe and persistent stomach pain accompanied by vomiting or not because it may be symptoms of pancreatitis.

Side effects while taking metformin only :
Very common (affects more than 1 user in 10):
nausea , vomiting ;
diarrhea or stomach pain ;
loss of appetite .
metallic taste in the mouth.
Very rare:
decreases in vitamin B12;
liver problems (hepatitis) ;
redness of the skin ( rash) or itching.
If you get any side effects, tell your doctor, pharmacist or nurse. This includes all listed in this leaflet .

5 . How to store Komboglyze
Keep out of reach of children.
Do not use this medicine after the expiry date stated on the blister and carton respectively after "EXP" and " EXP" . The expiry date refers to the last day of that month.
Do not store above 25 ° C.
Do not use this medicine if you notice that the packaging is damaged or has signs of tampering .
Do not dispose of medications in wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required . These measures will help to protect the environment.

6 . Contents of the pack and other information
What does Komboglyze
The active substances are saxagliptin and metformin hydrochloride.
Each tablet contains 2,5 mg saxagliptin (as hydrochloride) and 1000 mg of metformin hydrochloride.

Other ingredients ( excipients ) are:
Core: povidone K30, magnesium stearate.
Film coating : polyvinyl alcohol, macrogol 3350 , titanium dioxide (E171), talc (E553b), yellow iron oxide (E172).
Ink : shellac , indigo carmine aluminum lake (E132).
Komboglyze looks like and contents of the pack
Komboglyze 2,5 mg/1000 mg film-coated tablets ( " tablets ") are pale yellow to light yellow , round , imprinted with blue ink " 2.5 / 100 " on one side and " 4247 " on the other .
Komboglyze is available in aluminum blisters. Packages of 14 , 28, 56 and 60 tablets in non-perforated blister -packs containing 112 (2 packs of 56 ) and 196 ( 7 packs of 28 ) film-coated tablets in non-perforated blisters and 60x1 film-coated tablets in perforated unit dose blisters.
Not all pack sizes may be marketed in your country.



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