2.5 mg / 850 mg film-coated tablets
saxagliptin / metformin hydrochloride

What Komboglyze is and what it is used for

This medicine contains two different substances called:

saxagliptin, which belongs to a class of drugs called DPP-4 inhibitors (dipeptidyl peptidase 4 inhibitors), and

metformin, which belongs to a class of drugs called biguanides.

Both belong to a group of medicines called oral diabetes medicines.

What Komboglyze is used for

This medicine is used to treat a type of diabetes called “type 2 diabetes”.

How Komboglyze works

Saxagliptin and metformin work by regulating your blood sugar together. They increase the levels of insulin after a meal. They also lower the amount of sugar that is formed in your body. Together with diet and exercise, this helps to lower your blood sugar. This medicine can be used alone or in combination with other diabetes medicines, including insulin.

To control your diabetes, you still need to diet and exercise, even while taking this medicine. Therefore, you must follow the advice on diet and exercise that you receive from your doctor or nurse.

What you need to know before you take 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 had a severe allergic reaction ( hypersensitivity reaction ) to any other similar medicines you are taking to control your blood sugar. Symptoms of a severe allergic reaction may include:
    • Rash
    • Elevated red spots on the skin (hives)
    • Swelling of the face, lips, tongue and throat, which may make it difficult to breathe or swallow.If you get these symptoms, stop taking this medicine and call your doctor or nurse immediately.
  • If you have ever had diabetes coma.
  • If you have uncontrolled diabetes with, for example, severe hyperglycaemia (high blood sugar), nausea, vomiting, diarrhea, rapid 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, which can lead to diabetic precoma. Symptoms include stomach pain, rapid and deep breathing, drowsiness or that your breath has a different, fruity odor.
  • If you have severely impaired kidney function or problems with your liver.
  • If you have recently had a heart attack or if you have heart failure or severe problems with your blood circulation or difficulty breathing that may be a sign of a heart problem.
  • If you have a serious infection or are dehydrated (your body has lost a lot of fluid).
  • If you are breast-feeding (see also “Pregnancy and breast-feeding”).
  • If you drink large amounts of alcohol (either every day or only occasionally) (see section “Komboglyze with alcohol”).

Do not take this medicine if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking this medicine.

Warnings and cautions

Risk of lactic acidosis

KOMBOGLYZE can cause the very rare, but very serious side effect of lactic acidosis, particularly if your kidneys are not working properly. The risk of developing lactic acidosis is also increased in uncontrolled diabetes, severe infections, prolonged fasting or alcohol intake, dehydration (see more information below), liver problems, and conditions where part of the body has reduced oxygen supply (including acute severe heart disease).

If any of the above apply to you, talk to your doctor for further information.

Stop taking Komboglyze for a short time if you have a condition that may be associated with dehydration, such as severe vomiting, diarrhea, fever, exposure to heat, or if you drink less fluid than normal. Talk to a doctor for further instructions.

Stop taking Komboglyze and contact a doctor or nearest hospital immediately if you get any of the symptoms of lactic acidosis as the condition may lead to coma.

The symptoms of lactic acidosis include:

  • vomiting
  • abdominal pain (stomach pain)
  • muscle cramps
  • a general feeling of not feeling well and pronounced fatigue
  • hard to breathe
  • lowered body temperature and heart rate .

Lactic acidosis is an acute medical condition that must be treated in a hospital.

Talk to your doctor or pharmacist before taking Komboglyze:

  • If you have type 1 diabetes (your body does not produce any insulin ). This medicine should not be used to treat this condition.
  • If you have or have had any disease of the pancreas.
  • If you are taking insulin , or a diabetes medicine called ‘sulphonylurea’, your doctor may want to lower your insulin or sulphonylurea dose when you are taking any of these medicines to avoid too low blood sugar.
  • If you have had allergic reactions to any other medicine you are taking to control the amount of sugar in your blood
  • If you have a condition or are taking a medicine that may impair your body’s defenses against infection
  • If you have ever had heart failure or have other risk factors for developing heart failure such as kidney problems. Your doctor will inform you about the signs and symptoms of heart failure . You should contact a doctor, pharmacist or nurse immediately if you get any of these symptoms. Symptoms may include, but are not limited to, increased shortness of breath, rapid weight gain, and swollen feet (foot edema).
  • If you are going to have a major operation, you must stop taking Komboglyze during the operation and for a certain period of time after it. Your doctor will decide when you need to stop taking Komboglyze and when you should start taking it again.

Diabetic skin lesions are a common complication of diabetes. Skin rash has been seen with saxagliptin and with certain antidiabetic drugs in the same class as saxagliptin. Follow the skin and foot care recommendations given to you by your doctor or nurse. Contact your doctor if you have blisters on your skin as it may be a sign of a condition called bullous pemphigoid. Your doctor may ask you to stop taking Komboglyze.

If any of the above apply to you, or if you are not sure, talk to your doctor or pharmacist before taking this medicine.

Kidney tests or kidney checks

During treatment with this medicine, your doctor will check your kidney function at least once a year or more often if you are older and/or if your kidney function is deteriorating.

Children and young people

Komboglyze is not recommended for children and adolescents under 18 years of age. It is not known if this medicine is safe and effective for use in children and adolescents under 18 years of age.

Other medicines and Komboglyze

If you need to get an injection into your blood with a contrast agent that contains iodine, for example in connection with X-rays or computed tomography, you must stop taking Komboglyze before or at the time of injection. Your doctor will decide when you need to stop taking Komboglyze and when you should start taking it again.

Tell your doctor if you are taking, have recently taken, or might take any other medicines.

You may need to have more blood sugar and kidney function tests, or your doctor may need to adjust the dose of Komboglyze. You must mention the following:

  • cimetidine, a medicine used to treat stomach problems
  • ketoconazole , which is used to treat fungal infections
  • bronchodilators (beta-2 agonists ), used to treat asthma
  • diltiazem , which is used for high blood pressure
  • rifampicin, an antibiotic used to treat infections such as tuberculosis
  • corticosteroids , which are used to treat inflammation in diseases such as asthma and arthritis
  • carbamazepine, phenobarbital or phenytoin , used to control seizures or long-term pain
  • drugs that increase urine production ( diuretics )
  • drugs 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).

If any of the above apply to you, or if you are not sure, talk to your doctor or pharmacist before taking this medicine.

Comboglyze with alcohol

Avoid high alcohol intake while taking Komboglyze as alcohol may increase the risk of lactic acidosis (see section “Warnings and precautions”).

Pregnancy and breastfeeding

Do not take this medicine if you are pregnant or could become pregnant, as it may affect your baby.

Do not take this medicine if you are breastfeeding or planning to breastfeed, as metformin in small amounts passes into breast milk.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

Saxagliptin and metformin have a negligible effect on the ability to drive and use tools or machines. Low blood sugar (hypoglycemia) can affect your ability to drive and use machines or work without a secure foothold, and there is a risk of hypoglycemia if you take this medicine in combination with medicines known to cause low blood sugar, such as insulin and sulphonylureas.

How to take Komboglyze

Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.

If your doctor prescribes this medicine together with sulphonylurea or insulin, to get the best results for your health, remember to take the other medicine as prescribed by your doctor.

How much to take

  • The amount of this medicine you will take varies depending on your condition and the doses you are currently taking of metformin and / or individual tablets of saxagliptin and metformin . Your doctor will tell you exactly what dose of this medicine to take.
  • The recommended dose is one tablet twice daily.

If you have impaired kidney function, your doctor may prescribe a lower dose.

How to take this medicine

  • Take this medicine by mouth.
  • Take the medicine with a meal to reduce the risk of stomach upset.

Diet and exercise

To control your diabetes, you still need to diet and exercise, even while taking this medicine. Therefore, you must follow the advice on diet and exercise that you receive from your doctor or nurse. In particular, if you are following a diabetic weight control diet, you should continue with this medicine while taking this medicine.

If you take more Komboglyze than you should

If you take more than this medicine, talk to a doctor or go to a hospital straight away. Take the medicine pack with you.

If you forget to take Komboglyze

  • If you forget to take a dose of this medicine, take it as soon as you remember. However, if it is time for the next dose , skip the missed dose and take the next dose at the usual time.
  • Do not take a double dose to make up for a forgotten dose .

If you stop taking Komboglyze

Keep taking this medicine until your doctor tells you to stop. This is to keep your blood sugar under control.

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

Possible side effects

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

Stop taking this medicine and contact your doctor immediately if you get any of the following serious side effects:

  • Lactic acidosis: KOMBOGLYZE can cause the very rare (may affect up to 1 in 10,000), but very serious side effect a lactic acidosis (see section “Warnings and Precautions”). If this happens to you, you must stop taking Komboglyze and contact a doctor or nearest hospital immediately as lactic acidosis may lead to coma .
  • Severe and persistent pain in the abdomen (stomach area) that may radiate to the back, as well as nausea and vomiting. This may be a sign of inflammation of the pancreas ( pancreatitis ).

You should contact your doctor if you get the following side effect:

Other side effects of Komboglyze are:

Common (may affect up to 1 in 10 people)

  • headache
  • muscle pain ( myalgia )
  • nausea or indigestion ( dyspepsia )
  • infection of the structures that line the urine (urinary tract infection)
  • infection in the upper airways
  • inflamed nose or throat as in cold or sore throat
  • inflamed stomach ( gastritis ) or intestine, sometimes caused by an infection ( gastroenteritis )
  • infection of the sinuses, sometimes with a feeling of pain and pressure behind the cheeks and eyes ( sinusitis ).
  • gas formation
  • dizziness
  • fatigue (exhaustion).

Uncommon (may affect up to 1 in 100 people)

  • joint pain ( arthralgia )
  • difficulty getting and maintaining an erection ( erectile dysfunction ).

Side effects are seen with saxagliptin alone:

Usual

  • dizziness
  • fatigue (exhaustion).

Side effects are seen with saxagliptin alone or in combination: No known frequency (can not be calculated from the available data)

  • constipation
  • blisters on the skin (bullous pemphigoid ).

Some patients have had a slight decrease in the number of a type of white blood cell ( lymphocyte ) that appears in a blood test when saxagliptin is used alone or in combination. In addition, some patients have reported rash and skin reactions (hypersensitivity) when taking saxagliptin.

When used after the approval of saxagliptin, additional side effects have been reported which include severe allergic reactions ( anaphylaxis ), as well as swelling of the face, lips, tongue, and throat, which may make it difficult to breathe or swallow. If you get an allergic reaction, stop taking this medicine and call your doctor or nurse immediately. Your doctor may prescribe a medicine to treat your allergic reaction and another medicine for your diabetes.

Side effects are seen with metformin alone:

Very common (may affect more than 1 in 10 people)

  • nausea, vomiting
  • diarrhea or abdominal pain
  • loss of appetite.

Usual

  • a metallic taste in the mouth.

Very rare

  • decreased B 12 levels
  • liver problem ( hepatitis )
  • redness (rash) or itching .

How to store Komboglyze

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 carton after EXP. The expiration date is the last day of the specified month.

Do not store above 25 ° C.

Do not use this medicine if the package is damaged or shows signs of tampering.

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 to protect the environment.

Contents of the pack and other information

Content declaration

The active substances are saxagliptin and metformin hydrochloride.

Each film-coated tablet contains 2.5 mg saxagliptin (as hydrochloride) and 850 mg metformin hydrochloride.

Other ingredients (excipients) are:

  • Tablet core: povidone K30, magnesium stearate.
  • Film coating: polyvinyl alcohol, macrogol 3350, titanium dioxide (E171), talc (E553b), red iron oxide (E172), yellow iron oxide (E172).
  • Marking inks: shellac, indigo carmine-aluminum lacquer (E132).

What the medicine looks like and contents of the pack

  • Komboglyze 2.5 mg / 850 mg film-coated tablets (“tablets”) are light brown to brown and round marked with “2.5 / 850” on one side and “4246” on the other side with blue ink.
  • Komboglyze is available in blisters of aluminum foil. The pack sizes are 14, 28, 56 and 60 film-coated tablets in unperforated blisters, multi-piece packs containing 112 (2 packs of 56) and 196 (7 packs of 28) film-coated tablets in unperforated blisters and 60×1 film-coated tablets in perforated single-dose blisters.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

AstraZeneca AB

SE-151 85 Södertälje

Sweden

Manufacturer

AstraZeneca AB

Gärtunavägen

SE-151 85 Södertälje

Sweden

AstraZeneca GmbH

Tinsdaler Weg 183

22880 Wedel

Germany

AstraZeneca UK Limited

Silk Road Business Park

Macclesfield

Cheshire

SK10 2NA

UK

Contact the representative of the marketing authorization holder to find out more about this medicine:

Belgium / Belgique / BelgienAstraZeneca SA / NVTel: +32 2 370 48 11 LithuaniaUAB AstraZeneca LietuvaTel: +370 5 2660550
BulgariaAustralia Bulgaria ЕООДTel: +359 (2) 44 55 000 Luxembourg / LuxemburgAstraZeneca SA / NVTel: +32 2 370 48 11
Czech RepublicAstraZeneca Czech Republic sroTel: +420 222 807 111 HungaryAstraZeneca Kft.Tel .: +36 1 883 6500
DenmarkAstraZeneca A / STel: +45 43 66 64 62 MaltaAssociated Drug Co. Ltd.Tel: +356 2277 8000
GermanyAstraZeneca GmbHTel: +49 41 03 7080 The NetherlandsAstraZeneca BVTel: +31 79 363 2222
EestiAstraZenecaTel: + 372 6549 600 NorwayAstraZeneca ASTel: +47 21 00 64 00
GreeceAstraZeneca AE:Ηλ: +30 2 106871500 AustriaAstraZeneca Österreich GmbHTel: +43 1 711 31 0
SpainAstraZeneca Pharmacéutica Spain, SATel: +34 91 301 91 00 PolandAstraZeneca Pharma Poland Sp. z ooTel .: +48 22 245 73 00
FranceAstraZenecaTel: +33 1 41 29 40 00 PortugalAstraZeneca Pharmaceutical Products, Lda.Tel: +351 21 434 61 00
CroatiaAstraZeneca dooTel: + 385 1 4628 000 RomaniaAstraZeneca Pharma SRLTel: +40 21 317 60 41
IrelandAstraZeneca Pharmaceuticals (Ireland) DACTel: +353 1609 7100 SloveniaAstraZeneca UK LimitedTel: +386 1 51 35 600
IcelandVistor hf.Phone: + 354 535 7000 Slovak RepublicAstraZeneca AB, ozTel: +421 2 5737 7777
ItalyAstraZeneca SpATel: +39 02 9801 1 Finland / FinlandAstraZeneca OyPuh / Tel: +358 10 23 010
.ΠροςAlexander the Great:Ηλ: +357 22490305 SwedenAstraZeneca ABTel: +46 8 553 26 000
LatviaSIA AstraZeneca LatvijaTel: + 371 67377100 United KingdomAstraZeneca UK LtdTel: +44 1582 836 836

Muhammad Nadeem

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