Jardiance: what it is used for, dosage and side effects

What Jardiance is and which active substance it contains

Jardiance contains empagliflozin, an active substance from the group of sodium-glucose co-transporter 2 inhibitors, usually shortened to SGLT2 inhibitors. In the Maltese register of medicines it is recorded with empagliflozin as its active substance and the oral route of administration. It is a tablet, not an injection, and it is not insulin.

The register also carries fixed combinations built around the same substance: Synjardy, which contains empagliflozin with metformin hydrochloride, and Glyxambi, which contains empagliflozin with linagliptin. This is worth checking before anything is added to your treatment, because taking a combination tablet together with plain Jardiance would mean taking empagliflozin twice. Read the composition on the pack rather than relying on the name, and ask a pharmacist if the packs look different from what you expected.

Empagliflozin was authorised for the whole European Union through the central procedure, so the European Medicines Agency publishes the full product information for it, and the leaflet inside your pack repeats the same content in a shorter form. Read that leaflet before you start a new pack, because the wording on warnings is revised from time to time. Authorised products in Malta and their product information are listed by the Medicines Authority.

The authorised indications for your own product are set out in that product information. We describe the use in type 2 diabetes here, and the groups of medicines used alongside it are compared at /diabetes-and-blood-sugar/; how the disease itself presents is described at /health-guide/type-2-diabetes-symptoms/.

What it is used for

In type 2 diabetes the medicine is used to bring blood sugar towards target, either on its own or together with other medicines for diabetes, including metformin and insulin. It is very often added when blood sugar stays above target on metformin alone, which is why the two so frequently appear on the same prescription and why a fixed combination of them exists.

Which medicine is added, and in what order, is decided by the doctor on the basis of your test results, your kidney function, your weight, your blood pressure and your other conditions. The choice is not made from a single blood sugar reading, and it is not a matter of preference between brands: the groups behave differently and the differences matter more in some patients than in others.

The medicine does not replace diet and physical activity, and it does not remove the need for the checks that belong to the disease. Type 2 diabetes often produces no symptoms for years, so treatment is judged on measurements rather than on how you feel, and feeling well is not evidence that blood sugar is where it should be.

How empagliflozin works

The kidneys filter a large amount of glucose out of the blood every day and then reabsorb almost all of it through a transporter in the kidney tubules. Empagliflozin blocks that transporter, so part of the filtered glucose is not taken back and leaves the body in the urine instead. Blood sugar falls as a direct consequence, and it falls without the pancreas being pushed to release more insulin.

That single mechanism explains most of what follows. Because insulin release is not forced, the medicine on its own does not usually cause hypoglycaemia; the risk appears when it is combined with insulin or a sulfonylurea, and in those combinations the doctor often reduces the dose of the other medicine. Because glucose in the urine drags water with it, the medicine also has a mild diuretic effect, which is why blood pressure and body weight may fall a little and why dehydration matters.

And because there is more sugar in the urine and on the genital skin, organisms that feed on it multiply more readily. That is the honest explanation for the urinary and genital infections that show up in the side effect lists, rather than any suggestion of poor hygiene.

The effect on blood sugar builds up rather than appearing with the first tablet, and the doctor judges it from HbA1c, a laboratory test that reflects average blood sugar over a period of weeks, compared with the result before treatment.

How it is taken and what to watch for

The dose is set by the doctor and written in the leaflet supplied with your pack. The tablet is taken once a day, with or without food, and it is swallowed whole. Drinking enough fluid is part of the treatment rather than general advice, because the medicine increases fluid loss; in hot weather, during exercise and during any illness with vomiting or diarrhoea this becomes more important.

The medicine is not used where there is hypersensitivity to empagliflozin or to any of the excipients in your pack, in type 1 diabetes, in diabetic ketoacidosis, or where kidney function is below the limit given in the product information for your product. Those are contraindications, not reasons to be more careful. Particular care and a decision by the doctor are needed in older patients, in patients taking diuretics, where blood pressure is already low, where there is a history of genital or urinary infection and where there is a condition or a diet that predisposes to ketoacidosis.

The warning that matters most is ketoacidosis, and the reason it needs stating plainly is that with this group it can occur while blood sugar is only modestly raised or even close to normal. Nausea and vomiting, abdominal pain, unusual thirst, laboured breathing, drowsiness, confusion, a sweet or fruity smell on the breath and unusual tiredness are its warning signs. Stop the medicine and seek urgent medical help; do not wait for a high reading on a home meter, because you may not get one.

The doctor may also ask you to pause the medicine before surgery, during a serious illness and where you cannot eat or drink normally. In pregnancy, when planning a pregnancy and while breastfeeding the treatment is reviewed by the doctor. Do not stop the medicine on your own initiative because blood sugar has come to target, because the result reflects the treatment rather than the absence of the disease.

Interactions with other medicines

The most important group is the diuretics. Both a diuretic and empagliflozin increase fluid loss, so together they can cause dehydration and a fall in blood pressure, with dizziness on standing and a risk of falls, particularly in older patients. The combination is often planned and useful, but the doctor may adjust one of the two and will say what to do during an illness with vomiting or diarrhoea.

With insulin and with sulfonylureas the risk of hypoglycaemia rises, so the doctor usually lowers the dose of those medicines rather than the empagliflozin. Knowing the signs of a low blood sugar, such as trembling, sweating, confusion and sudden hunger, is part of treatment in those combinations.

Care is needed with non-steroidal anti-inflammatory medicines and with blood pressure medicines from the angiotensin-converting enzyme inhibitor and sartan groups, because all of them can affect kidney function, and kidney function governs this medicine. Lithium levels may also change, and the doctor may ask for them to be monitored.

List for your doctor and your pharmacist everything you take, including medicines bought without a prescription, food supplements and herbal products. One review of the whole list by a pharmacist is more useful than checking items one at a time, particularly when several medicines act on the kidneys.

Side effects and when to seek help

The effects described most often follow from the mechanism: urinary tract infections and genital fungal infections, passing more urine than before, thirst and, in some patients, dizziness from a fall in blood pressure. Genital infections are more frequent in women, and they respond to treatment, so they are worth reporting rather than enduring.

Less often, constipation, itching, rash, raised blood fats and changes in blood test results are reported. Serious but rare events include diabetic ketoacidosis, which with this group can occur at near-normal blood sugar, severe dehydration, and a severe infection of the skin and soft tissue of the perineum, which begins with pain, redness or swelling in the genital area together with fever and feeling unwell.

Seek urgent medical help if you develop nausea and vomiting with abdominal pain, laboured breathing, drowsiness or confusion, if you have pain, redness or swelling in the genital area with fever, if you cannot keep fluids down, or if the face, lips or tongue swell with difficulty breathing. In a life-threatening situation call 112 or go to Accident and Emergency.

The complete list of side effects with information on how often each occurs is in the leaflet supplied with your pack and in the product information published by the European Medicines Agency. A suspected side effect can be reported to your doctor or pharmacist, and safety of medicines on the Maltese market is monitored by the Medicines Authority.

Prescription status and what we can do

Jardiance is a prescription-only medicine in Malta, so the decision to start it and the dose belong to a doctor. We do not sell medicines and we cannot send you one. What we offer is a written medical questionnaire and a doctor review of your answers. There is no video call, no telephone consultation and no live chat.

We are not part of any Maltese state health record and we write nothing into one. The doctor issues a cross-border prescription in the format set out in the Annex to Directive 2012/52/EU, which reaches you as a PDF by e-mail. You print it or show it on screen at the pharmacy, together with a photo identity document. There is no code and no number to quote, and a pharmacy in Malta may dispense it; the decision rests with the pharmacist, who can refuse if the document is illegible or if its authenticity is in doubt. What a pharmacist looks at is described at /blog/eu-prescription-maltese-pharmacy/.

If empagliflozin has already been started for you and this is a continuation of established treatment, you can fill in the questionnaire at /repeat-prescription/. The review is carried out by lek. Damian Wojno, a doctor registered with the Polish Medical Chamber, licence no. 3211301; he is not registered with the Medical Council of Malta. A recent HbA1c and a recent measure of kidney function are the results the doctor asks for most often. We do not start this treatment for the first time from a questionnaire, and we do not deal this way with the warning signs described above, because they call for examination.

The assessment costs 24,90 €, with an optional priority surcharge of 9,90 €. The fee covers the medical consultation, not the issuing of a document, and it is not funded by the Maltese public health system. If the doctor declines on medical or legal grounds, we refund the fee. If the doctor asks for documents, you have at least seven days to send them in, and if the consultation cannot be completed, we close the request and refund the fee in full. The medicine itself is paid for separately at the pharmacy, and whether a product is government funded in Malta is decided under the Government Formulary List and the POYC scheme, not by us.