Dapagliflozin tablets

About dapagliflozin

Insulin is a hormone which is made naturally in your body, in the pancreas. It helps to control the levels of sugar (glucose) in your blood. If your body does not make enough insulin to meet its needs, or if it does not use the insulin it makes effectively, this results in the condition called diabetes (diabetes mellitus).

People with diabetes need treatment to control the amount of sugar in their blood. This is because good control of blood sugar levels reduces the risk of complications later on. Some people can control the sugar in their blood by making changes to the food they eat but, for other people, medicines like dapagliflozin are given alongside changes in diet.

Dapagliflozin works on your kidneys to increase the amount of sugar that your body removes in urine. You may be prescribed it to take on its own, or with other antidiabetic medicines. Dapagliflozin is available in combination with another antidiabetic medicine called metformin. The brand is called Xigduo®. It is also available in combination with the antidiabetic medicine saxagliptin in the brand called Qtern®.

Due to its protective effects on the kidneys and heart, dapagliflozin can also be used to treat chronic kidney disease and certain types of heart failure. Your doctor will give you more advice about treatment of these conditions.

Before taking dapagliflozin

Some medicines are not suitable for people with certain conditions, and sometimes a medicine may only be used if extra care is taken. For these reasons, before you start taking dapagliflozin it is important that your doctor or pharmacist knows:

• If you are pregnant, trying for a baby, or breastfeeding.

• If you have any problems with your kidneys or liver (unless you are taking dapagliflozin for chronic kidney disease).

• If you have low blood pressure.

• If you have heart or blood vessel disease.

• If you have problems with repeated urine infections.

• If you are taking any other medicines. This includes any medicines you are taking which are available to buy without a prescription, as well as herbal and complementary medicines.

• If you have ever had an allergic reaction to a medicine.

How to take dapagliflozin tablets

• Before you start this treatment, read the manufacturer's printed information leaflet from inside your pack. The leaflet will give you more information about dapagliflozin tablets and a full list of side-effects which you may experience from taking them.

• Take dapagliflozin exactly as your doctor has told you to. The usual dose is one 10 mg tablet daily, although some people may be asked to take a smaller 5 mg dose to begin with.

• Swallow the tablet whole with a drink of water - you can take it before or after a meal.

• You can take dapagliflozin at a time of day which suits you, but try to take your doses at the same time of day each day. This will help you to remember to take them.

• If you do forget to take a dose, take it as soon as you remember as long as it is more than 12 hours before your next dose is due. If it is less than 12 hours until your next dose, skip the missed dose but remember to take your next dose when it is due. Do not take two doses together to make up for a forgotten dose.

• If you have been prescribed a combination tablet of dapagliflozin with metformin (Xigduo® brand) you should take one tablet twice a day. Take the tablet after you have eaten a meal or with a snack, as this will help to reduce the chance of an upset stomach. There are two strengths of Xigduo® tablet - both strengths contain the same amount of dapagliflozin but the amount of metformin differs. You will be prescribed the strength of tablet that fits with your current metformin dose.

• If you forget to take a dose of Xigduo® take it as soon as you remember, unless it is nearly time for your next dose in which case miss out the forgotten dose. Do not take two doses together to make up for a forgotten dose.

• If you have been prescribed a combination tablet of dapagliflozin with saxagliptin (Qtern® brand) the usual dose is one tablet once each day. It can be taken at a time of day that suits you, either with or without food. Try to take your dose at the same time of day each day.

• If you forget to take a dose of Qtern® take it as soon as you remember, unless it is less than twelve hours until your next dose. In which case, skip the forgotten dose and take your next dose at the usual time.

Getting the most from your treatment

• Continue to take dapagliflozin regularly - do not stop taking this medicine unless your doctor tells you to.

• It is important that you keep your regular doctor's and clinic appointments. This is so your progress can be monitored.

• If you have been given advice by your doctor about changes to your diet, stopping smoking or taking regular exercise, it is important for you to follow the advice you have been given.

• Dapagliflozin is likely to make you pass more urine. If you get unusually thirsty or feel very tired then let your doctor know as your dose may need adjusting.

• It is important that your body does not lose too much water (become dehydrated) whilst you are being treated with dapagliflozin. Ask your doctor for advice on the recommended amount of fluids you should be drinking each day. Signs that you are becoming dehydrated include: dry or sticky mouth, passing little or no urine, a fast heartbeat, or feeling very sleepy or confused.

If you are taking dapagliflozin for treatment of diabetes

• You are likely to need regular check-ups with an eye clinic and a foot clinic as well as with your doctor and diabetes clinic.

• Your doctor will recommend that you test for sugar in your blood regularly to check that your diabetes is being controlled. Your doctor or diabetes nurse will show you how to do this.

• Because of the way dapagliflozin works, testing for sugar in your urine will always show that it is present. This makes urine testing unreliable.

• Check with your doctor before taking up any new physical exercise, as this will have an effect on your blood sugar levels and you may need to check your blood levels more regularly.

• It is important for you to take care of the skin on your lower limbs and to report any sores or signs of infection to your doctor. Taking medicines like dapagliflozin may make you slightly more likely to experience sores or ulcers on your feet and legs. If an ulcer is left untreated and gets worse it may put you at risk of amputation.

• Drinking alcohol while you are on dapagliflozin will affect the control of your blood sugar and can increase the risk of complications with your treatment. Ask your doctor for advice about what limits are recommended for you.

• If you are a driver you should take special care, as your ability to concentrate may be affected if your diabetes is not well controlled. Make sure you know what it feels like if your blood sugar is low. This is known as hypoglycaemia, or a 'hypo'.

• The first signs of hypoglycaemia are: feeling shaky or anxious, sweating, looking pale, feeling hungry, having a feeling that your heart is pounding (palpitations), and feeling dizzy. If these happen you should eat or drink something containing sugar or have a snack straightaway. It is advisable to check your blood sugar levels before you travel on long journeys and to have a snack with you.

• Drivers in the UK may need to inform the Driver and Vehicle Licensing Agency (DVLA) if they experience an episode of severe hypoglycaemia or experience a 'hypo' whilst driving. Ask your doctor for advice. Drivers in other countries should contact the relevant vehicle licensing agency.

Can dapagliflozin cause problems?

Along with their useful effects, all medicines can cause unwanted side-effects although not everyone experiences them. The table below lists some of the most common ones associated with dapagliflozin. You will find a full list in the manufacturer's information leaflet supplied with your medicine. The unwanted effects often improve over the first few days of taking a new medicine, but speak with your doctor or pharmacist if any of the following side-effects continue or become troublesome.

Very rarely, treatment with dapagliflozin can cause a serious condition called Fournier's gangrene. Contact your doctor straightaway if you notice any pain, tenderness or swelling in the genital or perineal areas. The perineum is the area of skin between your genitals and your back passage (anus).

If you are taking dapagliflozin for treatment of diabetes
On rare occasions, treatment with dapagliflozin can raise the levels of certain chemicals, called ketones, in your blood. This can lead to a serious condition called diabetic ketoacidosis. Contact your doctor straightaway if you notice any combination of the following symptoms:

• A sweet smell to your breath, a sweet or metallic taste in your mouth or a different smell to your sweat or urine.

• Feeling sick (nausea) or being sick (vomiting), tummy (abdominal) pains.

• Losing weight quickly, feeling very thirsty, breathing unusually quickly or difficulty breathing.

• Confusion, tiredness or sleepiness.

If you experience any other symptoms which you think may be due to this medicine, speak with your doctor or pharmacist.

How to store dapagliflozin

• Keep all medicines out of the reach and sight of children.

• Store in a cool, dry place, away from direct heat and light.

Important information about all medicines