Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - qtern

Document Subject

Generated Narrative: MedicinalProductDefinition mp7735eb5a61959c532a72049da08ec908

identifier: http://ema.europa.eu/identifier/EU/1/16/1108/001 14 film-coated tablets

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Qtern 5 mg/10 mg film-coated tablets

type: Full name

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part: nan

type: Invented name part

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part: nan

type: Scientific name part

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type: Strength part

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type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-7735eb5a61959c532a72049da08ec908

identifier: http://ema.europa.eu/identifier/EU/1/16/1108/001 14 film-coated tablets

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - qtern

Attesters

What is in this leaflet:

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

Qtern contains the active substances saxagliptin and dapagliflozin. Each belongs to a group of medicines called oral anti-diabetics . These medicines are taken by mouth for diabetes. Qtern is used for a type of diabetes called type 2 diabetes mellitus in adult patients (aged 18 years and older). If you have type 2 diabetes, your pancreas does not make enough insulin or your body is not able to use the insulin it produces properly. This leads to a high level of sugar in your blood. The two active substances in Qtern work in different ways to help control the level of sugar in your blood and remove excess sugar from your body via your urine. Qtern is used to treat type 2 diabetes when:

saxagliptin or dapagliflozin alone together with metformin and/or sulphonylurea cannot control your diabetes.

you are already being treated with saxagliptin and dapagliflozin as single tablets. Your doctor may ask you to switch to this medicine. It is important to continue to follow the advice on diet and exercise given to you by your doctor, pharmacist or nurse.

Do not take Qtern:

if you are allergic to saxagliptin, dapagliflozin or any of the other ingredients of this medicine (listed in section 6).

if you have had a serious allergic reaction to any other similar medicines (for example DPP-4 inhibitors like sitagliptin, linagliptin, alogliptin, or SGLT2 inhibitors like canagliflozin, empagliflozin) that you take to control your blood sugar. Do not take Qtern if any of the above apply to you. If you are not sure, talk to your doctor, pharmacist, or nurse before taking this medicine. Warnings and precautions Talk to your doctor, pharmacist or nurse before taking Qtern, and during treatment:

if you have or have had a disease of the pancreas called pancreatitis. Possible signs of pancreatitis are listed in section 4. - if you are on medicines to lower your blood pressure (anti-hypertensives) and have a history of low blood pressure (hypotension). For more information, see section Other medicines and Qtern below.

if you have very high levels of sugar in your blood which may make you dehydrated (lose too much body fluid). Possible signs of dehydration are listed at the top of section 4. Tell your doctor before you start taking Qtern if you have any of these signs.

if you have or develop nausea (feeling sick), vomiting or fever or if you are not able to eat or drink. These conditions can cause dehydration. Your doctor may ask you to stop taking Qtern until you recover to prevent dehydration.

if you have moderate or severe liver problem.

if you experience rapid weight loss, feeling sick or being sick, stomach pain, excessive thirst, fast and deep breathing, confusion, unusual sleepiness or tiredness, a sweet smell to your breath, a sweet or metallic taste in your mouth, or a different odour to your urine or sweat, contact a doctor or the nearest hospital straight away. These symptoms could be a sign of diabetic ketoacidosis a rare but serious, sometimes life-threatening problem you can get with diabetes because of increased levels of ketone bodies in your urine or blood, seen in tests. The risk of developing diabetic ketoacidosis may be increased with prolonged fasting, excessive alcohol consumption, dehydration, sudden reductions in insulin dose, or a higher need of insulin due to major surgery or serious illness.

if you have type 1 diabetes your body does not produce any insulin. Qtern should not be used to treat this condition.

if you have or have had a serious hypersensitivity (allergic) reaction or is suspected. Signs of a serious allergic reaction are listed in section 4. - if you often get infections of the urinary tract.

if you have a history of serious heart disease.

if you suffer from heart failure or you have other risk factors for developing heart failure such as problems with your kidneys. Your doctor will advise you of the signs and symptoms of heart failure. Symptoms can include, but are not limited to, increasing shortness of breath, rapid increase in weight and swelling of the feet (pedal oedema). You should call your doctor, pharmacist or nurse immediately if you experience any of these symptoms.

if you have severe joint pain.

if your body s ability to fight infections is reduced, for example if you have a disease like AIDS or have undergone an organ transplant.

if you are taking a medicine to lower your blood sugar, such as sulphonylureas (see Other medicines and Qtern ). If any of the above apply to you (or you are not sure), talk to your doctor, pharmacist or nurse before taking Qtern. Diabetic skin lesions (skin damage such as sores or ulcers) are a common complication of diabetes. Rash has been seen with both saxagliptin and dapagliflozin when given separately (see section 4). You are advised to follow the recommendations for skin care that you are given by your doctor or nurse. Contact your doctor if you encounter blistering of the skin, as it may be a sign for a condition called bullous pemphigoid. Your doctor may ask you to stop Qtern. Like for all diabetic patients it is important to check your feet regularly and adhere to any other advice regarding foot care given by your health care professional. Talk to your doctor immediately if you develop a combination of symptoms of pain, tenderness, redness, or swelling of the genitals or the area between the genitals and the anus with fever or feeling generally unwell. These symptoms could be a sign of a rare but serious or even life-threatening infection, called necrotising fasciitis of the perineum or Fournier s gangrene which destroys the tissue under the skin. Fournier s gangrene has to be treated immediately. Kidney function Your kidneys should be checked before you start taking Qtern. During treatment with this medicine, your doctor will check your kidney function once a year or more frequently if you have worsening kidney function. Urine tests Because of how Qtern works, your urine will test positive for sugar while you are on this medicine. Children and adolescents Qtern is not recommended for children and adolescents under 18 years of age, because it has not been studied in these patients. Other medicines and Qtern Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines. Especially tell your doctor:

if you are taking a medicine used to increase the amount of water you pass out of the body (diuretic). Your doctor may ask you to stop taking Qtern. Possible signs of losing too much fluid from your body are listed at the top of section 4. - if you are taking another medicine that lowers the amount of sugar in your blood such as a sulphonylurea (for example glimepiride). Your doctor may want to lower the dose of this other medicine, to prevent you from getting low blood sugar levels (hypoglycaemia).

if you are using medicines containing any of the following active substances, that might have an effect on the breakdown of Qtern in your body. Your doctor may ask you to check your blood sugar levels more often while taking these medicines.

Carbamazepine, phenobarbital or phenytoin. These may be used to control fits (seizures) or chronic pain.

Dexamethasone a steroid medicine. This may be used to treat inflammation in different body parts and organs.

Rifampicin. This is an antibiotic used to treat infections such as tuberculosis.

Ketoconazole. This may be used to treat fungal infections.

Diltiazem. This is a medicine used to treat angina (chest pain) and lower blood pressure. If any of the above apply to you (or if you are not sure), talk to your doctor before taking Qtern. Pregnancy and breast-feeding If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Qtern is not recommended during pregnancy and your doctor will ask you to stop taking this medicine if you become pregnant. Talk to your doctor about the best way to control your blood sugar while you are pregnant. You should not use Qtern if you are breast-feeding. It is not known if this medicine passes into human breast milk. Talk to your doctor if you would like to or are breast-feeding before taking this medicine. Driving and using machines Qtern is not expected to affect you being able to drive a car or use any tools or machines. If you feel dizzy while taking this medicine, do not drive or use any tools or machines. Taking this medicine together with another medicine that lowers your blood sugar, such as a sulphonylurea, can cause too low blood sugar levels (hypoglycaemia). This may cause symptoms such as shaking, sweating and change in vision, and may affect your ability to drive and use machines. Qtern contains lactose Qtern contains lactose (milk sugar). If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine. Qtern contains sodium Qtern contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially sodium-free .

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

The recommended dose is one tablet a day. Taking this medicine

Swallow the tablet whole with half a glass of water.

You can take your tablet with or without food.

You can take the tablet at any time of the day. However, try to take it at the same time each day. This will help you to remember to take it. Your doctor may prescribe other medicines to lower the amount of sugar in your blood. Remember to take other medicine(s) as your doctor has told you. This will help get the best results for your health. Diet and exercise To control your diabetes, you still need to keep 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, pharmacist or nurse. In particular, if you are following a diabetic weight control diet, continue to follow it while you are taking Qtern. If you take more Qtern than you should If you take more Qtern 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 Qtern What to do if you forget to take a tablet.

If it is less than 12 hours since you should have taken your dose, take a dose of Qtern as soon as you remember. Then take your next dose at the usual time.

If it is more than 12 hours since you should have taken your dose, skip the missed dose. Then take your next dose at the usual time.

Do not take a double dose of Qtern to make up for a forgotten dose. If you stop taking Qtern Do not stop taking Qtern without talking to your doctor first. Your blood sugar may increase without this medicine. If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

Like all medicines, this medicine can cause side effects, although not everybody gets them. Stop taking Qtern and see a doctor straight away if you notice any of the following serious side effects:

Symptoms of a serious allergic reaction (anaphylactic reaction, angioedema) seen rarely, (may affect up to 1 in 1 000 people), which may include:

rash,

raised red patches on your skin (hives),

swelling of the face, lips, tongue, and throat that may cause difficulty in breathing or swallowing. Your doctor may prescribe a medicine to treat your allergic reaction and a different medicine for your diabetes.

Pancreatitis, seen uncommonly (may affect up to 1 in 100 people): 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.

Dehydration, (loss of too much fluid from your body), seen uncommonly. These are signs of dehydration:

very dry or sticky mouth, feeling very thirsty,

feeling very sleepy or tired,

passing little or no water (urine),

fast heart beat.

Urinary tract infection, seen commonly (may affect up to 1 in 10 people). These are signs of a severe infection of the urinary tract:

fever and/or chills,

burning sensation when passing water (urinating),

pain in your back or side. Although uncommon, if you see blood in your urine, tell your doctor immediately.

Low blood sugar levels (hypoglycaemia), seen very commonly (may affect more than 1 in 10 people) if used with other diabetes medicines known to cause hypoglycaemia. These are the signs of low blood sugar:

shaking, sweating, feeling very anxious, fast heart beat,

feeling hungry, headache, change in vision,

a change in your mood or feeling confused. Your doctor will tell you how to treat low blood sugar levels and what to do if you get any of the signs above.

Diabetic ketoacidosis, seen rarely. These are the signs of diabetic ketoacidosis (see also section 2 Warnings and precautions):

increased levels of ketone bodies in your urine or blood,

rapid weight loss,

feeling sick or being sick,

stomach pain,

excessive thirst,

fast and deep breathing,

confusion,

unusual sleepiness or tiredness,

a sweet smell to your breath, a sweet or metallic taste in your mouth or a different odour to your urine or sweat. This may occur regardless of blood glucose level. Your doctor may decide to temporarily or permanently stop your treatment with Qtern.

Necrotising fasciitis of the perineum or Fournier s gangrene, a serious soft tissue infection of the genitals or the area between the genitals and the anus, seen very rarely (may affect up to 1 in 10 000 people). Stop taking Qtern and see a doctor or nurse straight away, if you notice any of the serious side effects above. Other side effects when taking Qtern alone or in combination with metformin: Very common

upper respiratory tract infection including:

infection of the upper chest or lungs,

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

inflamed nose or throat (nasopharyngitis) (signs of this may include a cold or a sore throat). Common

genital infection (thrush) of your penis or vagina (signs may include irritation, itching, unusual discharge or odour)

back pain

passing more water (urine) than usual or needing to pass water more often

changes in the amount of cholesterol or fats in your blood (shown in tests)

increases in the amount of red blood cells in your blood (shown in tests)

decreases in creatinine renal clearance (shown in tests) in the beginning of treatment

dizziness

tiredness

severe joint pain (arthralgia)

stomach ache and indigestion (dyspepsia)

nausea

diarrhoea

inflamed stomach or gut usually caused by an infection (gastroenteritis)

headache, muscle pain (myalgia)

vomiting, inflammation of the stomach (gastritis)

rash Uncommon

thirst

constipation

awakening from sleep at night to pass urine

dry mouth

weight decreased

increases in creatinine (shown in laboratory blood tests) in the beginning of treatment

increases in urea (shown in laboratory blood tests)

skin rash that may include raised bumps, skin irritation, or unpleasant itchiness

difficulties in getting or maintaining an erection (erectile dysfunction)

fungal infection

hypersensitivity reactions

itching in the genital area (pruritus genital or vulvovaginal pruritus) or discomfort while urinating Not known (frequency cannot be estimated from the available data)

blistering of the skin (bullous pemphigoid) Reporting of side effects 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.

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 expiry date refers to the last day of that month. This medicine does not require any special storage conditions. 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.

What Qtern contains

The active substances are saxagliptin and dapagliflozin. Each tablet contains saxagliptin hydrochloride equivalent to 5 mg saxagliptin and dapagliflozin propanediol monohydrate equivalent to 10 mg dapagliflozin.

The other ingredients are:

tablet core: microcrystalline cellulose (E460i), croscarmellose sodium (E468) (see section 2 Qtern contains sodium ), lactose (see section 2 Qtern contains lactose ), magnesium stearate (E470b), dental type silica (E551).

film-coating: poly(vinyl alcohol) (E1203), macrogol (3350), titanium dioxide (E171), talc (E553b), yellow iron oxide (E172), red iron oxide (E172).

printing ink: shellac, indigo carmine aluminium lake (E132). What Qtern looks like and contents of the pack Qtern 5 mg/10 mg film-coated tablets are light brown to brown, biconvex, 0.8 cm round, film-coated tablets, with 5/10 printed on one side, and 1122 printed on the other side, in blue ink. Qtern 5 mg/10 mg tablets are available in aluminium blisters in pack sizes of 14, 28, or 98 film-coated tablets in calendar blisters and 30 film-coated tablets in blister. Not all pack sizes may be marketed in your country. Marketing Authorisation Holder AstraZeneca AB SE-151 85 S dert lje Sweden Manufacturer AstraZeneca AB G rtunav gen SE-152 57 S dert lje Sweden For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder: Belgi /Belgique/Belgien AstraZeneca S.A./N.V. Tel: +32 2 370 48 Lietuva UAB AstraZeneca Lietuva Tel: +370 5 2660

.: +359 2 4455Luxembourg/Luxemburg AstraZeneca S.A./N.V. T l/Tel: +32 2 370 48 esk republika AstraZeneca Czech Republic s.r.o. Tel: +420 222 807 Magyarorsz g AstraZeneca Kft. Tel.: +36 1 883 6Danmark AstraZeneca A/S Tlf: +45 43 66 64 Malta Associated Drug Co. Ltd Tel: +356 2277 8Deutschland AstraZeneca GmbH Tel: +49 40 809034Nederland AstraZeneca BV Tel: +31 85 808 9Eesti AstraZeneca Tel: +372 6549 Norge AstraZeneca AS Tlf: +47 21 00 64
AstraZeneca A.E. : +30 2 106871 sterreich AstraZeneca sterreich GmbH Tel: +43 1 711 31 0 Espa a AstraZeneca Farmac utica Spain, S.A. Tel: +34 91 301 91 Polska AstraZeneca Pharma Poland Sp. z o.o. Tel.: +48 22 245 73 France AstraZeneca T l: +33 1 41 29 40 Portugal AstraZeneca Produtos Farmac uticos, Lda. Tel: +351 21 434 61 Hrvatska AstraZeneca d.o.o. Tel: +385 1 4628 Rom nia AstraZeneca Pharma SRL Tel: +40 21 317 60 Ireland AstraZeneca Pharmaceuticals (Ireland) DAC Tel: +353 1609 7Slovenija AstraZeneca UK Limited Tel: +386 1 51 35 sland Vistor hf. S mi: +354 535 7Slovensk republika AstraZeneca AB, o.z. Tel: +421 2 5737 7Italia AstraZeneca S.p.A. Tel: +39 02 00704Suomi/Finland AstraZeneca Oy Puh/Tel: +358 10 23

: +357 22490Sverige AstraZeneca AB Tel: +46 8 553 26 Latvija SIA AstraZeneca Latvija Tel: +371 67377United Kingdom (Northern Ireland) AstraZeneca UK Ltd Tel: +44 1582 836 This leaflet was last revised in Other sources of information Detailed information on this medicine is available on the European Medicines Agency web site: