Synjardy® 500 mg Film-Coated Tablets

SYNJARDY is used to lower blood sugar levels in patients with type 2 diabetes mellitus. SYNJARDY contains two different active ingredients:

• empagliflozin, which belongs to a group of medicines called SGLT2 (sodium - glucose co - transporter 2) inhibitors, and
• metformin, which belongs to a class of medicines called biguanides.

• alone as a single medicine, or
• in combination with certain other anti - diabetic medicines such as:
• sulphonylureas
• pioglitazone
• insulin
• linagliptin.

Do not take SYNJARDY

• if you are hypersensitive (allergic) to empagliflozin, metformin or any of the other ingredients of SYNJARDY (listed in Section 6)
• if you have type 1 diabetes mellitus
• if you have any type of metabolic acidosis such as lactic acidosis, or diabetic ketoacidosis (a symptom of uncontrolled diabetes, in which substances called ketone bodies build up in the blood - you may notice this as an unusual fruity odour on your breath, difficulty breathing, confusion and frequent urination)
• if you have had a diabetic pre - coma
• if you have severe problems with your kidneys
• if you have problems with your liver
• if you have a severe infection
• if you are dehydrated
• if you are treated for acute heart failure or have recently had a heart attack
• if you have severe problems with your circulation (such as shock)
• if you have severe breathing difficulties
• if you have blood clots in the lungs (symptoms include coughing, shortness of breath, chest pain and a fast heart rate)
• if you have significant blood loss
• if you have gangrene
• if you have inflammation of the pancreas (pancreatitis), symptoms include severe upper stomach pain, often with nausea and vomiting
• if you drink excessive alcohol (all the time or ‘binge’ drinking)
• if you are pregnant or are breastfeeding your baby.

• are going to have an X - ray where you will be injected with an iodinated contrast (dye)
• are planning to have surgery (including where the use of insulin is essential).

• Discard any other medicines containing metformin or empagliflozin that your doctor might have prescribed to you in the past and that you may still have in your possession. SYNJARDY contains empagliflozin and metformin. If you have more than one metformin - containing medicine in your possession you may accidentally take too much (overdose). Accidentally taking too much metformin can cause a very serious side effect called lactic acidosis. Accidental metformin overdosing is a significant safety risk. Ask your doctor or pharmacist if you are unsure if you have any other medicines containing metformin.
• Tell your doctor if you have allergies to any other medicines, foods, preservatives or dyes.
• Tell your doctor if you have type 1 diabetes, a condition where your body does not produce insulin. SYNJARDY should not be used to treat type 1 diabetes.
• Tell your doctor if you are sick, have diarrhoea or fever, or if you are not able to eat or drink. These conditions can cause dehydration. Your doctor may ask you to stop taking SYNJARDY until you recover to prevent loss of too much body fluid.
• Tell your doctor if you have a serious infection of the kidney or the urinary tract with fever. Your doctor may ask you to stop taking SYNJARDY until you have recovered.
• Tell your doctor if you have heart problems, history of low blood pressure, or are 75 years of age or older. Increased passing of urine due to the medicine may affect fluid balance in your body and increase your risk of dehydration.
• Tell your doctor if you are 85 years of age or older. You should not start taking SYNJARDY if you are over 85 years of age.

• If you are about to be started on any new medicine, remind your doctor and pharmacist that you are taking SYNJARDY.
• Tell any other doctors, dentists, and pharmacists who treat you that you are taking SYNJARDY.
• Talk to your doctor about when to stop taking SYNJARDY and when to start taking it again if you are about to have surgery or an examination such as an X - ray or scan requiring an injection of iodinated contrast (dye).
• If you become pregnant while taking SYNJARDY, tell your doctor immediately.
• If you are about to have any blood tests, tell your doctor that you are taking SYNJARDY. It may interfere with the results of some tests.
• Keep all of your doctor's appointments so that your progress can be checked. Your doctor may want to perform blood tests to check your kidneys and vitamin B12 levels while you are taking SYNJARDY.
• Follow your doctor's and/or dietician's advice on diet, drinking alcohol and exercise. Diet and exercise can help your body use its blood sugar better. It is important to stay on the diet and exercise program recommended by your doctor while taking SYNJARDY.
• Make sure you check your blood glucose regularly. This is the best way to tell if your diabetes is being controlled properly. Your doctor or diabetes educator will show you how and when to do this.
• Check your feet regularly and see your doctor if you notice any problems. Follow any other advice regarding foot care given by your doctor.
• Tell your doctor if you become ill or dehydrated, or experience stress, injury, fever, infection, or need surgery. Your blood glucose may become difficult to control at these times. You may also be at greater risk of developing a serious condition called lactic acidosis or diabetic ketoacidosis. During these times, your doctor may temporarily replace SYNJARDY with insulin.
• Make sure that you, your friends, family and work colleagues can recognise the symptoms of hypoglycaemia and hyperglycaemia and know how to treat them.

Do not share medicines prescribed for you with any other person. Always take SYNJARDY exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. The usual dose is one SYNJARDY tablet twice daily. Swallow the tablet whole with a full glass of water during or after meals. This will lessen the chance of a stomach upset. Take your medicine at about the same time each day. Taking it at the same time each day will have the best effect. It will also help you remember when to take it. It is important that you take SYNJARDY every day. Your doctor will tell you how long your treatment with SYNJARDY will last. Do not stop treatment early because your blood sugar levels may increase if you stop taking SYNJARDY. SYNJARDY helps to control your condition but does not cure it. It is important to keep taking your medicine even if you feel well. If you have the impression that the effect of SYNJARDY is too strong, or too weak, tell your doctor or pharmacist. If you take more SYNJARDY than you should In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison centre. Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention. If you forget to take SYNJARDY If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to. Otherwise, take it as soon as you remember, and then go back to taking your medicine as you would normally. Do not take a double dose to make up for the dose that you missed. This may increase the chance of you getting an unwanted side effect. If you are not sure what to do, ask your doctor or pharmacist. If you stop taking SYNJARDY Do not stop taking SYNJARDY or lower the dosage without checking with your doctor.

SYNJARDY can have side effects. Not all side effects reported for SYNJARDY are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking SYNJARDY, please consult your healthcare provider for advice. Metformin, one of the active substances in SYNJARDY can cause a serious side effect called lactic acidosis. This is a medical emergency that can cause death. It is caused by build - up of lactic acid in your blood. Stop taking SYNJARDY if you get any of the following symptoms of lactic acidosis and go to the casualty department at your nearest hospital immediately:

• feeling cold (especially in your arms and legs)
• feeling very weak, tired
• feeling light - headed, dizzy
• severe nausea or vomiting
• feeling uncomfortable
• muscle pain
• drowsiness
• abdominal pain
• unexplained weight loss
• irregular heartbeat
• rapid or difficult breathing.

• rapid weight loss
• feeling sick or being sick
• stomach pain
• excessive thirst
• fast and deep breathing
• confusion
• unusual sleepiness or tiredness
• a sweet smell to your breath, a sweet or metallic taste in your mouth or a different odour to your urine or sweat.

• sudden onset of hives, itching or skin rash
• swelling of the face, lips or tongue or other parts of the body
• shortness of breath
• wheezing or difficulty breathing.

• sweating
• weakness
• hunger
• dizziness
• trembling
• headache
• flushing or paleness
• numbness
• a fast pounding heartbeat.

• burning sensation when passing urine
• urine that appears cloudy
• pain in the pelvis, or mid - back pain
• straining or pain when passing urine
• unusual thirst
• light - headedness, or dizziness upon standing
• fainting or loss of consciousness.

• genital burning, redness, pain and discharge which may be signs of a genital yeast infection
• passing more urine than normal
• itching
• loss of appetite
• loss of taste
• thirst
• diarrhoea or stomach - ache
• feeling sick (nausea), vomiting
• constipation.

Store at or below 30 °C. Store all medicines out of reach of children. Keep your tablets in the pack until it is time to take them. If you take the tablets out of the pack they may not keep well. Do not store SYNJARDY or any other medicine in the bathroom or near a sink. Do not leave it on a windowsill or in the car. Heat and dampness can destroy some medicines. Do not take SYNJARDY after the expiry date printed on the pack or if the packaging is torn or shows signs of tampering. If it has expired or is damaged, return it to your pharmacist for disposal. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewage systems (e.g. toilets).