Dapagliflozin

1. About dapagliflozin
Dapagliflozin is a medicine is mainly used to treat type 2 diabetes. Sometimes it can be used
together with insulin to treat type 1 diabetes.
Dapagliflozin is usually prescribed for type 2 diabetes if you cannot take metformin.
It can also be taken together with other diabetes medicines when a single medicine is not
controlling your blood sugar properly.
If you’re overweight and have type 1 diabetes, your diabetes specialist may prescribe
dapagliflozin if high doses of insulin aren’t controlling your blood sugar. This will be under
careful supervision.
Dapagliflozin is only available on prescription and it comes as tablets.
2. Key facts
 Dapagliflozin works on your kidneys. It increases the amount of sugar removed from
your body when you pee.
 If you're taking dapaglifozin with other diabetes medicines, it can sometimes cause low
blood sugar (hypoglycaemia). It's a good idea to carry some sweets or fruit juice with you in
case this happens.
 Unlike some diabetes medicines, dapagliflozin does not make you put on weight. In fact,
some people find they lose weight.
 For type 1 diabetes, always carry your alert card to say you’re taking dapagliflozin. It
increases the risk of diabetic ketoacidosis (DKA).
 Dapagliflozin can be called by the brand name Forxiga.
 Dapagliflozin also comes combined with other diabetes medicines. Brand names include
Xigduo (dapagliflozin with metformin) and Qtern (dapagliflozin with saxagliptin).
3. Who can and can't take 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
4. How and when to take it
It's 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're 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’ll 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's 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's 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's 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's 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's 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.
5. Side effects
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're 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’re taking dapagliflozin, you’re at increased risk of getting
DKA.
You’ll 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're 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's also possible for your blood sugar to go too low while you're 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 (hypothyroidism)
 have kidney or liver problems
It's important to have regular meals, including breakfast, to prevent hypoglycaemia. Never miss
or delay a meal.
If you're 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's possible to have a serious allergic reaction (anaphylaxis) to dapagliflozin.

 you get a skin rash that may include itchy, red, swollen, blistered or peeling skin
 you're 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:
You can report any suspected side effect to the UK safety scheme.
6. 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 urinary tract infection (UTI).
 peeing more than normal – this is a sign that you're 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're 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.
7. 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're trying for a baby
or as soon as you find out you're pregnant.
Dapagliflozin and breastfeeding
It's generally not recommended to take dapagliflozin while breastfeeding.
We do not know for certain whether dapagliflozin gets into breast milk. But it's possible that
dapagliflozin can affect the way babies' kidneys develop and grow.
Speak to your doctor about what's best for you and your baby. They may prescribe a different
medicine, particularly while you're breastfeeding a newborn or premature baby.
Non-urgent advice:Tell your doctor if you're:

 pregnant
 trying to get pregnant
 breastfeeding
8. 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're 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's very little information about taking herbal remedies and supplements with dapagliflozin.
Important
For safety, tell your doctor or pharmacist if you're taking any other medicines, including herbal
remedies, vitamins or supplements.
Related conditions

 Hyperglycemia
 Hypoglycemia (hypos)
 Type 1 diabetes
 Type 2 diabetes
Dapagliflozin 10 MGThis composition has 7 Products
Name Manufacturer Form Pack Size MRP

FORXIGA 10MG TAB ASTRAZENECA PHARMA INDIA LTD TABLETS 14 802.90

GLEDEPA 10MG TAB ABBOTT TABLETS 14 802.90

GLUXIT 10MG TAB ERIS LIFESCIENCES LTD TABLETS 10 145.00

DAPAGLYN 10MG TAB ZYDUS HEALTHCARE LTD TABLETS 15 255.00

DAPNAT 10MG 30S TAB NATCO PHARMA LTD CONTAINERS 1 585.00

UDAPA 10MG TAB USV PVT LTD TABLETS 10 145.00

OXRA 10MG TAB SUN PHARMACEUTICAL INDUSTRIES LTD TABLETS 14 802.90