Dapagliflozin

Dapagliflozin can be taken by adults. Dapagliflozin is not suitable for some people. Tell your doctor before starting the medicine if you:

• have had an allergic reaction to dapagliflozin or any other medicines in the past
• have sugar (glucose) and ketones (a type of chemical) in your pee – there are home tests for this
• have severe kidney or liver disease
• have a heart condition
• often get urinary tract infections (UTIs) 
• are due to have surgery
• are pregnant, trying to get pregnant or breastfeeding

Pregnancy and breastfeeding

Dapagliflozin is generally not recommended during pregnancy or while breastfeeding. We do not know whether dapagliflozin can harm an unborn baby. For safety, your doctor will probably change your medicine to insulin if you are trying for a baby or as soon as you find out you are pregnant.

Dapagliflozin and breastfeeding

It is generally not recommended to take dapagliflozin while breastfeeding. We do not know for certain whether dapagliflozin gets into breast milk. But it is possible that dapagliflozin can affect the way babies’ kidneys develop and grow.

Speak to your doctor about what is best for you and your baby. They may prescribe a different medicine, particularly while you are breastfeeding a newborn or premature baby.

Non-urgent advice:Tell your doctor if you are:

• pregnant
• trying to get pregnant
• breastfeeding

It is usual to take Dapagliflozin once a day. You can take it any time of day – just try to take it at the same time every day. Dapagliflozin can be taken with or without food. Swallow the tablets whole with a glass of water. Do not chew them.

How much will I take?

For type 2 diabetes, the usual dose of dapagliflozin is 10mg, taken once a day. Your doctor may start you off on a lower dose of 5mg. If you are taking a combination tablet (dapagliflozin with metformin or dapagliflozin with saxagliptin), the doses may vary.

For type 1 diabetes, the usual dose is 5mg, taken once a day. You will take this as well as your insulin.

Taking dapagliflozin with metformin (Xigduo)

There are 2 different strengths of Xigduon. Each tablet contains 5mg of dapagliflozin and the amount of metformin is either 850mg or 1g. Your doctor will prescribe the strength with the right amount of metformin for you.

The usual dose is 1 tablet taken twice a day. It is a good idea to take your medicine with a meal. This means the metformin is less likely to affect your stomach.

Taking dapagliflozin with saxagliptin (Qtern)

There is only 1 strength of Qtern – each tablet contains 10mg of dapagliflozin and 5mg of saxagliptin. The usual dose is 1 tablet taken once a day. You can take it any time of day – just try to take it at the same time every day.

Qtern can be taken with or without food. Swallow the tablets whole with a glass of water. Do not chew them.

What if I forget to take it?

Dapagliflozin, or dapagliflozin with saxagliptin (Qtern)

If you miss a dose of dapagliflozin or Qtern and it is 12 hours or more until your next dose, take it as soon as you remember. Then take your next dose at the usual time. If it is less than 12 hours until your next dose, skip the missed dose. Then take your next dose at the usual time.

Dapagliflozin with metformin (Xigduo)

If you miss a dose of Xigduo, take it as soon as you remember, unless it is nearly time for your next dose, in which case skip the missed dose and take your next dose at the usual time.

Important

Do not take a double dose to make up for a forgotten dose. If you forget doses often, it may help to set an alarm to remind you. You could also ask your pharmacist for advice on other ways to help you remember to take your medicine.

What if I take too much?

If you take too many dapagliflozin tablets, contact your doctor straight away. An overdose of dapagliflozin can cause low blood sugar. If you think you have low blood sugar, have some food or drink that quickly gets sugar into your bloodstream (like sugar cubes or fruit juice). This type of sugar will not stay in your blood for long. You may also need to eat a starchy carbohydrate, like a sandwich or a couple of biscuits.

Like all medicines, Dapagliflozin can cause side effects, although not everyone gets them.

Side effects often improve as your body gets used to the medicine. Diabetic ketoacidosis (DKA) can be a common side effect for people taking dapagliflozin for type 1 diabetes. DKA is a serious condition.

Common side effects

These common side effects happen in more than 1 in 100 people. They are usually mild and short-lived.

Talk to your doctor or pharmacist if these side effects bother you or do not go away:

• thrush
• back pain
• peeing more than normal
• feeling dizzy
• mild skin rash

Diabetic ketoacidosis (DKA)

If you have type 1 diabetes and you are taking dapagliflozin, you’re at increased risk of getting DKA.

You all be shown how to monitor your ketone and blood sugar levels, and what to do if you have a “sick day”. You’ll learn how to recognise the symptoms of DKA and what to do about it.

You will also get an alert card. Show this to any health professionals involved in your care.

Other serious side effects

Apart from DKA for people with type 1 diabetes, serious side effects are rare and happen in less than 1 in 10,000 people. Tell your doctor or go to A&E straight away if:

• you are feeling or being sick, feel very thirsty, confused or unusually tired, have stomach pain, your breath smells fruity, and your breathing is deep or fast – these can be signs of diabetic ketoacidosis, which can also happen in people with type 2 diabetes. Symptoms usually develop over 24 hours, but can come on faster
• you have a very dry or sticky mouth, feel very thirsty, sleepy or tired, are not peeing (or peeing very little), and have a fast heart beat – these can be signs of dehydration
• you have a high temperature or feel cold and shivery, get a burning feeling when peeing, have pain in your back or side, or blood in your urine – these can be signs of a urinary tract infection (UTI) 
• your genital area is painful, sore, red or swollen and you have a high temperature or feel unwell – these can be signs of gangrene 

Low blood sugar

If you take dapagliflozin with other diabetes medicines, including insulin or sulphonylureas like gliclazide, your blood sugar can sometimes go too low.

This is called hypoglycaemia or a “hypo”.

Early warning signs of low blood sugar include:

• feeling hungry
• trembling or shaking
• sweating
• confusion
• difficulty concentrating

It is also possible for your blood sugar to go too low while you are asleep. If this happens, it can make you feel sweaty, tired and confused when you wake up.

Low blood sugar may happen if you:

• take too much of some types of diabetes medicines
• eat meals irregularly or skip meals
• are fasting
• do not eat a healthy diet and are not getting enough nutrients
• change what you eat
• increase your physical activity without eating more to compensate
• drink alcohol, especially after skipping a meal
• take some other medicines or herbal medicines at the same time
• have a hormone disorder, such as an underactive thyroid
• have kidney or liver problems

It is important to have regular meals, including breakfast, to prevent hypoglycaemia. Never miss or delay a meal. If you are planning to exercise more than usual, make sure you eat carbohydrates like bread, pasta or cereals before, during or after exercise.

Always carry a fast-acting carbohydrate with you, like sugar cubes, fruit juice or some sweets, in case your blood sugar level gets low. Artificial sweeteners will not help.

You may also need to eat a starchy carbohydrate, like a sandwich or a biscuit, to maintain your blood sugar for longer.

If taking in sugar does not help or the hypo symptoms come back, contact your doctor or the nearest hospital.

Make sure your friends and family know about your diabetes and the symptoms of low blood sugar levels so they can recognise a hypo if it happens.

Serious allergic reaction

In rare cases, it is possible to have a serious allergic reaction to dapagliflozin.

Immediate action required

Call or go to A&E if:

• you get a skin rash that may include itchy, red, swollen, blistered or peeling skin
• you are wheezing
• you get tightness in the chest or throat
• you have trouble breathing or talking
• your mouth, face, lips, tongue or throat start swelling

You could be having a serious allergic reaction and may need immediate treatment in hospital.

These are not all the side effects of dapagliflozin. For a full list, see the leaflet inside your medicines packet.

Information:

How to cope with side effects

What to do about:

• thrush – ask your pharmacist to recommend an antifungal treatment for thrush. Speak to your doctor if it does not work within a week or you get thrush often. There are also things you can do to prevent thrush returning.
• back pain – if you get sudden unexpected back pain, do not try to treat it yourself. Contact your doctor – it might be a sign of a UTI
• peeing more than normal – this is a sign that you are peeing out more sugar in your urine. If this side effect bothers you, talk to your doctor or pharmacist.
• feeling dizzy – if dapagliflozin makes you feel dizzy, stop what you are doing and sit or lie down until you feel better. Do not drive or use tools or machines if you feel dizzy or shaky.
• mild skin rash – it may help to take an antihistamine. Check with a pharmacist to see what type is suitable for you. Speak to your doctor if the rash does not go away or gets worse.

 Cautions with other medicines

There are some medicines that may increase the effects of dapagliflozin. This can make you more likely to get side effects.

Tell your doctor if you are taking any of these medicines before you start taking dapagliflozin:

• medicines that make you pee more (diuretics), like furosemide – these can increase your risk of dehydration and lower your blood pressure
• high blood pressure medicine
• other medicines that can lower your blood pressure – including some antidepressants, nitrates (for chest pain), baclofen (a muscle relaxant), tamsulosin (for an enlarged prostate), or co-careldopa or levodopa (for Parkinson’s disease)
• medicines that cause low blood sugar, such as insulin or gliclazide – your doctor may lower your dose of these other medicines to prevent hypos

Mixing dapagliflozin with herbal remedies and supplements

There is very little information about taking herbal remedies and supplements with dapagliflozin.

What is it?

Dapagliflozin is a type of medicine known as a sodium-glucose cotransporter-2 (SGLT2) inhibitor. It lowers blood sugar levels in people with diabetes. It does this by helping remove excess sugar from your body through your pee.

How long does it take to work?

Dapagliflozin starts to work after about 2 hours to reduce your blood glucose levels, but it may take a week for it to take full effect. You may not have had any symptoms of diabetes, so you will not necessarily feel any different when you take dapagliflozin. This does not mean that dapagliflozin is not working, so it is important to keep taking it. Dapagliflozin will help keep your blood sugar level stable and reduce your chances of diabetes-related problems in the future.

How long will I take it for?

Treatment for diabetes is usually for life. Do not stop taking your dapagliflozin tablets without talking to your doctor first.

Is it safe to take for a long time?

Dapagliflozin is safe to take for a long time. There is no evidence that this medicine harms your general health.

Can I come off dapagliflozin?

Do not stop taking dapagliflozin without talking to your doctor first. If you stop taking it suddenly, your diabetes may get worse. If this medicine is not working for you or you are bothered by side effects, speak to your doctor. They may be able to recommend another medicine to treat your diabetes.

Are there other medicines for type 2 diabetes?

There are different groups of medicines that can lower blood sugar levels if you have type 2 diabetes:

• metformin
• pioglitazone
• DPP-4 inhibitors or gliptins, such as saxagliptin
• GLP-1 agonists, such as exenatide
• SGLT2 inhibitors, such as dapagliflozin
• insulin

Dapagliflozin is usually prescribed for type 2 diabetes if you cannot take metformin, or if metformin is no longer keeping your blood sugar level under control. It can be prescribed on its own or in combination with some of these other medicines.

SGLT2 inhibitors all work in the same way: by increasing the amount of sugar removed from your body when you pee. These medicines can cause urinary tract infections because of the way they work.

Can I take dapagliflozin before surgery?

If you are going to have an operation, tell the doctor that you are taking dapagliflozin. If you have type 2 diabetes, they may tell you to stop taking your dapagliflozin tablets if you need to stop eating before your operation. If you have type 1 diabetes, discuss this with your doctor. You will need to stop taking your dapagliflozin before surgery.

This is because there is a risk of diabetic ketoacidosis.  

Can I take painkillers with dapagliflozin?

It is OK to take paracetamol with dapagliflozin. But ask your doctor or pharmacist before taking ibuprofen or aspirin with this medicine. This is because ibuprofen and aspirin can sometimes lower your blood sugar levels.

Will it make me lose weight or put on weight?

Dapagliflozin can cause weight loss by increasing the amount of sugar that is removed from your body when you pee.

Can I drink alcohol with it? If so, how much?

Yes, you can drink alcohol in moderation while taking dapagliflozin. However, if you have type 1 diabetes drinking alcohol can increase your risk of dehydration. Be careful not to get dehydrated as this can cause diabetic ketoacidosis. Alcohol can also increase the risk of low blood sugar.

Try not to drink on an empty stomach, and try to stick to no more than 2 units of alcohol a day. A standard glass of wine (175ml) is 2 units. A pint of lager or beer is usually 2 to 3 units of alcohol.

Is there any food or drink I need to avoid?

It is a good idea to cut down on foods with added sugar. However ask your doctor for advice before starting a low calorie, reduced carbohydrate or “ketogenic” diet. This is especially important if you have type 1 diabetes, as this type of diet could increase your risk of diabetic ketoacidosis.

Check the nutrition labels, as many foods and drinks are high in sugar.

These include:

• sweets
• cakes
• biscuits
• chocolate
• some fizzy drinks
• juice drinks

Be careful when eating food and drink containing karela (also called bitter gourd). This is because it can lower your blood sugar levels, so your diabetes is not controlled as well as it could be.

Karela is used to flavour foods, such as curries like bitter gourd masala. It has a bitter taste, and is also made into juice and tea.

Will it affect my fertility?

There is no firm evidence that dapagliflozin affects either male or female fertility.

Will it affect my contraception?

Dapagliflozin does not interfere with any type of contraception, including the combined pill and emergency.  

Can I drive or ride a bike?

Dapagliflozin does not affect your ability to drive or ride a bike. But if you are taking dapagliflozin together with other diabetes medicines, such as sulphonylureas or insulin, it can cause your blood sugar levels to go too low (hypoglycaemia or a “hypo”). Hypos can reduce your concentration. If this happens to you, do not drive, cycle or use machines or tools until you feel better.

Can lifestyle changes help?

There are some lifestyle changes you can make to help control the symptoms of diabetes.

These include:

• eating a health diet
• losing any excess weight
• not smoking
• cutting down on alcohol -try to keep to the recommended guidelines of no more than 14 units of alcohol a week. A standard glass of wine (175ml) is 2 units. A pint of lager or beer is usually 2 to 3 units of alcohol.
• exercising – up to 30 minutes a day, 5 times a week is ideal