Zynquista - patient leaflet, side effects, dosage

Patient leaflet - Zynquista

B. PACKAGE LEAFLET

Package leaflet: Information for the patient

Zynquista 200 mg film-coated tablets sotagliflozin

This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects.

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

– Keep this leaflet. You may need to read it again.
– If you have any further questions, ask your doctor, pharmacist or nurse.
– This medicine has been prescribed for you only. Do not pass it on to others. It may harm them,

even if their signs of illness are the same as yours.

- If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

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

1. What Zynquista is and what it is used for

Zynquista contains the active substance sotagliflozin, a medicine which lowers blood glucose (blood sugar) levels. Sotagliflozin works by slowing and reducing the absorption of glucose from food, and by increasing the amount of glucose that is passed out in urine. Together these actions help to lower the increased amount of glucose in the blood that occurs in patients with diabetes.

Zynquista is used as an addition to insulin treatment in adults with type 1 diabetes with a body mass index (BMI) greater than or equal to 27. BMI is a measure of your weight in relation to your height.Type 1 diabetes is a disease where your body’s immune system destroys the insulin-producing cells in the pancreas and the body produces little to no insulin, the hormone that normally controls the level of your blood sugar.

It is important that you also continue with your diet and exercise plan and insulin treatment as agreed with your doctor, pharmacist or nurse.

2. What you need to know before you take Zynquista

Do not take Zynquista:

if you are allergic to sotagliflozin or any of the other ingredients of this medicine (listed in

section 6).

Warnings and precautions

Diabetic ketoacidosis (DKA) is a potentially life-threatening problem you can get with diabetes because of increased levels of “ketone bodies” in your urine or blood, seen in tests. If you develop symptoms contact your doctor or go to the nearest hospital right away.

The risk of developing diabetic ketoacidosis may be increased with prolonged fasting, excessive alcohol consumption, drug abuse, dehydration, sudden reductions in insulin dose, or a higher need for insulin due to major surgery, serious illness or infection. See also section 4.

In addition to this leaflet, a patient alert card is included in the packaging which contains important safety information that you need before and during treatment with Zynquista. Your doctor will schedule a dedicated education session, to discuss the risk of DKA, how to recognize DKA risk factors, signs or symptoms, how and when to monitor ketone levels and what actions to take when ketone levels are elevated.

Talk to your doctor, pharmacist or nurse before taking Zynquista, and during treatment:

if you have the following symptoms, which may be a sign of a serious condition, diabetic ketoacidosis (see also section 4):

o nausea, vomiting, or abdominal pain

o excessive thirst

o constantly feeling tired

o high levels of ketones in urine tests or beta-hydroxybutyrate (BHB) in blood tests

o difficulty breathing/rapid, deep breathing

o breath with fruity odour

o difficulty paying attention, or confusion

o rapid weight loss

if you have an acute medical illness or surgery
if you have no access to ketone testing materials or no immediate access to a doctor if blood or urine ketones are elevated
if you are using a low dose of insulin
if you are on caloric restriction, carbohydrate restriction or ketogenic diet
if you had a recent or recurrent history of diabetic ketoacidosis (e.g. 1 episode in the past 3 months or more than 1 episode in the past 6 months)
if you have kidney problems
if you have liver problems
if you have an infection of the kidney or the urinary tract. Your doctor may ask you to stop taking Zynquista until you have recovered
if you have a history of chronic or recurrent yeast infections of the genitals (thrush)
if you might be at risk of dehydration (for example, if you are taking medicines that increase urine production [diuretics] or lower blood pressure or if you are over 65 years old). Ask about ways to prevent dehydration.
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 necrotizing fasciitis of the perineum or Fournier’s gangrene which destroys the tissue under the skin. Fournier's gangrene has to be treated immediately.

Foot care

For all patients with diabetes it is important to check your feet regularly and follow any other advice on foot care from your doctor or nurse.

Urine glucose

Because of how Zynquista works, your urine will test positive for sugar while you are on this medicine.

Children and adolescents

Zynquista is not recommended for children and adolescents under 18 years of age, because it has not been studied in these patients.

Other medicines and Zynquista

Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines.

In particular, tell your doctor if you are taking any of the following medicines:

digoxin or digitoxin (medicines used for heart problems). The level of digoxin or digitoxin in your blood may need to be checked if you take these medicines with Zynquista.
phenytoin or phenobarbital (epilepsy medicines used to control fits)
ritonavir (a medicine used to treat HIV infection)
rifampicin (an antibiotic used to treat tuberculosis and some other infections).

As sotagliflozin is taken together with insulin, hypoglycaemia may occur during treatment.

Your doctor may reduce the dose of insulin.

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. Talk to your doctor about the best way to control your blood sugar while you are pregnant. Zynquista should not be used during the last six months of pregnancy.

Talk to your doctor before taking this medicine if you would like to breast-feed or if you are breastfeeding. It is not known if this medicine passes into breast milk. You should not take this medicine if you are breast-feeding.

Driving and using machines

Zynquista is not likely to affect your ability to drive and use machines. However, Zynquista is taken with insulin, which can cause your blood sugar levels to fall too low (hypoglycaemia) resulting in symptoms such as shaking, sweating and change in vision, and this may affect your ability to drive and use machines. Do not drive or use any tools or machines, if you feel dizzy during diabetes treatment.

3. How to take Zynquista

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 of Zynquista is one 200-mg tablet once a day before the first meal of the day.

Your doctor will decide whether to increase your dose to 400 mg once a day.

Your doctor will prescribe the dose that is right for you. Do not change your dose unless your doctor has told you to.

Taking this medicine

Zynquista should be taken once daily by mouth.
The tablet should be taken before the first meal of the day
Follow your doctor’s instructions about insulin dose while taking Zynquista.

Your doctor will prescribe Zynquista together with insulin treatment to lower the amount of sugar in your blood. Follow your doctor’s instructions on taking these other medicine(s) to achieve the best results for your health.

If you take more Zynquista than you should

If you take more Zynquista tablets than you should, talk to a doctor or go to a hospital immediately. Take the medicine pack with you.

If you forget to take Zynquista

If a dose is missed, it should be taken as soon as you remember the missed dose.

Do not take a double dose of Zynquista o make up the forgotten dose.

If you stop taking Zynquista

Do not stop taking Zynquista without first checking with your doctor. Your blood sugar levels may increase when you stop taking Zynquista.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Contact a doctor or the nearest hospital straight away if you have any of the following side effects:

Diabetic ketoacidosis (DKA), seen commonly (may affect up to 1 in 100 people)

These are the signs and symptoms of diabetic ketoacidosis (see also section 2 under ‘Warnings and precautions ’):

o nausea, vomiting, or abdominal pain

o excessive thirst

o constantly feeling tired

o high levels of ketones in urine tests or beta-hydroxybutyrate (BHB) in blood tests

o difficulty breathing/rapid, deep breathing

o breath with fruity odour

o difficulty paying attention, or confusion o rapid weight loss.

While treated with Zynquista the risk of DKA is increased and may occur with low, normal or high blood glucose level. Check your ketones regularly during the first two weeks after starting Zynquista. If you have any of these symptoms, or if you are in a situation that could increase your risk for DKA, you must check your ketones, either in the blood or in the urine. If you are using an insulin pump, monitor your ketones levels three to four hours after changing pump materials.

In case of a potential DKA or elevated ketone levels are elevated contact your doctor immediately or go to the nearest hospital right away. The doctor may decide to temporarily stop the treatment with Zynquista.

During a dedicated session your doctor may schedule, discuss how to manage elevated ketone levels to prevent DKA (see section 2).

Make sure you carry the Patient Alert Card, that was given to you by your physician and that is also enclosed in the product packaging, with you at all times. Share it with all of your doctors, nurses or pharmacists when you need any treatment. You can also get the Patient Alert Card by scanning the QR code or by visiting the website below:

Other side effects:

Very common (may affect more than 1 in 10 people)

yeast infection (thrush) of the vagina (signs may include irritation, itching, unusual discharge or odour)

Common (may affect more than 1 in 100 people)

diarrhoea
raised ketone levels in your blood
yeast infection (thrush) of the penis (signs may include irritation, itching, unusual discharge or odour)
passing more urine than usual or needing to pass it more often
urinary tract infection, signs include burning sensation when passing urine, urine that appears cloudy, pain in the pelvis, or mid back pain (when kidneys are infected)
dehydration (losing too much water from your body, symptoms include dry mouth, feeling dizzy, light-headed, or weak, especially when you stand up, fainting)
flatulence
blood tests may show increase in the amount of bad cholesterol (called LDL – a type of fat in your blood)
blood tests may show increase in the amount of red blood cells in your blood (called haematocrit) blood tests may show increase related to kidney function (such as ‘creatinine’).

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. Y ou can also report side effects directly via the national reporting system listed inBy reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Zynquista

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 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 use this medicine if you notice that the packaging is damaged or shows signs of tampering.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer used. These measures will help protect the environment.

6. Contents of the pack and other information

What Zynquista contains

The active substance is sotagliflozin.

Each tablet contains 200 mg sotagliflozin.

The other ingredients are:
– tablet core: microcrystalline cellulose (E460i), croscarmellose sodium, colloidal anhydrous silica; magnesium stearate; talc.
– film-coating: poly(vinyl alcohol); macrogol; titanium dioxide (E 171); talc; indigo carmine aluminium lake (E132).
– Printing ink: shellac; iron oxide black (E172); propylene glycol.

What Zynquista looks like and contents of the pack

Zynquista 200 mg film-coated tablets (tablets) are oval, blue, with “2456” on one side printed in black ink (tablet length: 14.2 mm, tablet width: 8.7 mm).

Zynquista is available in PVC/PCTFE/Aluminium opaque blisters.

Pack sizes of 10, 20, 30, 60, 90, 100, 180 film-coated tablets, and a multipack of 200 film-coated tablets (2 packs of 100 film-coated tablets).

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Guidehouse Germany GmbH

Albrechtstr. 10c

10117 Berlin

Germany

Manufacturer :

Sanofi Winthrop Industrie 1, rue de la Vierge Ambares et Lagrave F – 33565 Carbon Blanc France

This leaflet was last revised in.

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site: