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AstraZeneca

Komboglyze
saxagliptin, metformin hydrochloride

Package leaflet: Information for the patient


Komboglyze 2.5 mg/850 mg film-coated tablets

saxagliptin/metformin hydrochloride


Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

If you have these symptoms, stop taking this medicine and call your doctor or nurse right away.

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.


Komboglyze with alcohol

Avoid excessive alcohol intake while taking Komboglyze since this may increase the risk of lactic acidosis (see “Warnings and precautions”).

Pregnancy and breast-feeding

Do not take this medicine if you are pregnant or might become pregnant. This is because it may affect the baby.


Do not take this medicine if you are breast-feeding or plan to breast-feed. This is because metformin passes into human milk in small amounts.


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


Driving and using machines

Saxagliptin and metformin have a negligible influence on the ability to drive and use machines. Hypoglycaemia may affect your ability to drive and use machines or work with safe foothold and there is a risk of hypoglycaemia when taking this medicine in combination with medicines known to cause hypoglycaemia such as insulin and sulphonylureas.


  1. How to take Komboglyze


    Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.


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


    How much to take

    • The amount of this medicine that you will take varies depending on your condition and the doses you currently take of metformin and/or individual tablets of saxagliptin and metformin. Your doctor will tell you exactly the dose of this medicine to take.

    • The recommended dosing is one tablet twice a day.

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


      How to take this medicine

    • Take this medicine by mouth.

    • Take with a meal to lower your chance of getting an upset stomach.


      Diet and exercise

      To control your diabetes, you still need to diet and exercise, even when you are taking this medicine. So it is important to keep following the advice about diet and exercise from your doctor or nurse. In particular, if you are following a diabetic weight control diet, keep on with this while you are taking this medicine.


      If you take more Komboglyze than you should

      If you take more Komboglyze tablets than you should, 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 your next dose, skip the missed dose and take your next dose at the usual time.

    • Do not take a double dose of this medicine 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 help keep your blood sugar under control.


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

  2. Possible side effects


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


    Stop taking Komboglyze and contact a doctor immediately if you notice any of the following serious side effects:

    • Lactic acidosis, Komboglyze may cause a very rare (may affect up to 1 user in 10,000), but very serious side effect called lactic acidosis (see section “Warnings and precautions”). If this happens you must stop taking Komboglyze and contact a doctor or the nearest hospital immediately, as lactic acidosis may lead to coma.

    • Severe and persistent pain in the abdomen (stomach area) which might reach through to your back, as well as nausea and vomiting, as it could be a sign of an inflamed pancreas (pancreatitis).


      You should call your doctor if you experience the following side effects:

    • severe joint pain.


      Other side effects of Komboglyze include:

      Common (may affect up to 1 in 10 people)

    • headache

    • muscle pain (myalgia)

    • being sick or indigestion (dyspepsia)

    • infection of the structures that carry urine (urinary tract infection)

    • infection of the upper airways

    • inflamed nose or throat such as with a cold or sore throat

    • inflamed stomach (gastritis) or gut, sometimes caused by an infection (gastroenteritis)

    • infection of your sinuses, sometimes with a feeling of pain and fullness behind your cheeks and eyes (sinusitis)

    • flatulence

    • dizziness

    • tiredness (fatigue).


      Uncommon (may affect up to 1 in 100 people)

    • joint pain (arthralgia)

    • difficulties in getting or maintaining an erection (erectile dysfunction).


      Side effects seen when taking saxagliptin alone:

      Common

    • dizziness

    • tiredness (fatigue).


      Side effects seen when taking saxagliptin alone or in combination:

      Not known (frequency cannot be estimated from the available data):

    • constipation

    • blistering of the skin (bullous pemphigoid)


      Some patients have had a small reduction in the number of one type of white blood cells (lymphocytes) shown in a blood test when saxagliptin was used alone or in combination. In addition, some patients have reported rash and skin reactions (hypersensitivity) while taking saxagliptin.


      During post-approval use of saxagliptin, additional side effects have been reported that include serious allergic reactions (anaphylaxis), and swelling of the face, lips, tongue, and throat that may cause difficulty in breathing or swallowing. If you have an allergic reaction, stop taking this medicine and call your doctor right away. Your doctor may prescribe a medicine to treat your allergic reaction and a different medicine for your diabetes.

      Side effects seen when taking metformin alone:

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

    • nausea, vomiting

    • diarrhoea or stomach pain

    • loss of appetite.


      Common

    • a metallic taste in your mouth.


      Very rare

    • decreased vitamin B12 levels

    • liver problems (hepatitis)

    • redness of the skin (rash) or itching.


      Reporting of side effects

      image

      If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.


  3. 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 the carton after EXP. The expiry date refers to the last day of that month.


    Store below 25°C.


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


    Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.


  4. Contents of the pack and other information What Komboglyze contains

The active substances are saxagliptin and metformin hydrochloride. Each film-coated tablet contains

2.5 mg saxagliptin (as hydrochloride) and 850 mg metformin hydrochloride.


The other ingredients (excipients) are:

film-coated tablets in non-perforated blisters, multipacks containing 112 (2 packs of 56) and 196 (7 packs of 28) film-coated tablets in non-perforated blisters and 60 x1 film-coated tablets in perforated unit dose blisters.

Not all pack sizes may be marketed in your country.


Marketing Authorisation Holder


AstraZeneca AB

SE-151 85 Södertälje Sweden


Manufacturer


AstraZeneca AB Gärtunavägen

SE-151 85 Södertälje Sweden


image

AstraZeneca UK Limited Silk Road Business Park Macclesfield

Cheshire SK10 2NA

United Kingdom


For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:


België/Belgique/Belgien AstraZeneca S.A./N.V. Tel: +32 2 370 48 11

Lietuva

UAB AstraZeneca Lietuva Tel: +370 5 2660550


България

АстраЗенека България ЕООД Тел.: +359 (2) 44 55 000

Luxembourg/Luxemburg AstraZeneca S.A./N.V. Tél/Tel: +32 2 370 48 11


Česká republika

AstraZeneca Czech Republic s.r.o. Tel: +420 222 807 111

Magyarország AstraZeneca Kft. Tel.: +36 1 883 6500


Danmark AstraZeneca A/S Tlf: +45 43 66 64 62

Malta

Associated Drug Co. Ltd Tel: +356 2277 8000


Deutschland AstraZeneca GmbH Tel: +49 40 809034100

Nederland

AstraZeneca BV

Tel: +31 79 363 2222


Eesti

AstraZeneca

Tel: +372 6549 600

Norge

AstraZeneca AS

Tlf: +47 21 00 64 00


Ελλάδα

AstraZeneca A.E.

Τηλ: +30 2 106871500

Österreich

AstraZeneca Österreich GmbH Tel: +43 1 711 31 0

España

AstraZeneca Farmacéutica Spain, S.A. Tel: +34 91 301 91 00

Polska

AstraZeneca Pharma Poland Sp. z o.o. Tel.: +48 22 245 73 00


France

AstraZeneca

Tél: +33 1 41 29 40 00

Portugal

AstraZeneca Produtos Farmacêuticos, Lda. Tel: +351 21 434 61 00


Hrvatska AstraZeneca d.o.o. Tel: +385 1 4628 000

România

AstraZeneca Pharma SRL Tel: +40 21 317 60 41


Ireland

AstraZeneca Pharmaceuticals (Ireland) DAC Tel: +353 1609 7100

Slovenija

AstraZeneca UK Limited Tel: +386 1 51 35 600


Ísland

Vistor hf.

Sími: +354 535 7000

Slovenská republika AstraZeneca AB, o.z. Tel: +421 2 5737 7777


Italia

AstraZeneca S.p.A. Tel: +39 02 9801 1

Suomi/Finland

AstraZeneca Oy

Puh/Tel: +358 10 23 010


Κύπρος

Αλέκτωρ Φαρµακευτική Λτδ Τηλ: +357 22490305

Sverige

AstraZeneca AB

Tel: +46 8 553 26 000


Latvija

SIA AstraZeneca Latvija Tel: +371 67377100

United Kingdom (Northern Ireland)

AstraZeneca UK Ltd Tel: +44 1582 836 836


This leaflet was last revised in


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