Synjardy
(Empagliflozin/Metformin Hydrochloride)

Prescription Settings Edit

Brand Name Choices

Synjardy 5/500mg
Synjardy 5/500mg

Marketed as Jardiamet in Australia

Empagliflozin/Metformin Hydrochloride

Manufactured by Boehringer Ingelheim Ltd

Product of Australia

Dispensed by an international pharmacy partner

Prescription Required

Synjardy 5/500mg
Synjardy 5/500mg

Empagliflozin/Metformin Hydrochloride

Manufactured by Boehringer Ingelheim Ltd

Product of Canada

Dispensed by an approved Canadian pharmacy partner

Prescription Required

Synjardy 12.5/500mg
Synjardy 12.5/500mg

Marketed as Jardiamet in Australia

Empagliflozin/Metformin Hydrochloride

Manufactured by Boehringer Ingelheim Ltd

Product of Australia

Dispensed by an international pharmacy partner

Prescription Required

Synjardy 12.5/500mg
Synjardy 12.5/500mg

Empagliflozin/Metformin Hydrochloride

Manufactured by Boehringer Ingelheim Ltd

Product of Canada

Dispensed by an approved Canadian pharmacy partner

Prescription Required

Synjardy 5/850mg
Synjardy 5/850mg

Empagliflozin/Metformin Hydrochloride

Manufactured by Boehringer Ingelheim Ltd

Product of United Kingdom

Dispensed by a licensed pharmacy in the United Kingdom

Prescription Required

Parallel Import

Synjardy 12.5/850mg
Synjardy 12.5/850mg

Empagliflozin/Metformin Hydrochloride

Manufactured by Boehringer Ingelheim Ltd

Product of United Kingdom

Dispensed by a licensed pharmacy in the United Kingdom

Prescription Required

Parallel Import

Synjardy 12.5/1000mg
Synjardy 12.5/1000mg

Empagliflozin/Metformin Hydrochloride

Manufactured by Boehringer Ingelheim Ltd

Product of United Kingdom

Dispensed by a licensed pharmacy in the United Kingdom

Prescription Required

Parallel Import

More Brand Name Choices

Generic Choices

No generic medication is available for Synjardy (Empagliflozin/Metformin Hydrochloride)

What Synjardy is and what it is used for

Synjardy is a diabetes medicine that contains two active substances called empagliflozin and metformin.
• Empagliflozin works by blocking a protein in the kidneys called sodium glucose co-transporter 2 (SGLT2). SGLT2 prevents glucose (blood sugar) from being lost in urine by absorbing glucose back into the bloodstream as blood is being filtered in the kidneys. By blocking this protein, the medicine causes blood sugar, sodium (salt) and water to be removed via the urine. Blood sugar levels, which are too high because of your type 2 diabetes, are thereby reduced. This medicine can also help prevent heart disease.
• Metformin works in a different way to lower blood sugar levels, mainly by blocking glucose production in the liver. Synjardy is added to diet and exercise to treat type 2 diabetes in adult patients (aged 18 years and older) whose diabetes cannot be controlled by adding metformin alone or metformin with other medicines for diabetes. Synjardy can also be combined with other medicines for the treatment of diabetes. These may be medicines taken by mouth or given by injection such as insulin. In addition, Synjardy can be used as an alternative to taking both empagliflozin and metformin as single tablets. To avoid overdose, do not continue taking empagliflozin and metformin tablets separately, if you are taking this medicine. It is important that you continue with your diet and exercise plan as told by your doctor, pharmacist or nurse.

How to take Synjardy

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. How much to take The dose of Synjardy varies depending on your condition and the doses of diabetes medicines you currently take. Your doctor will adjust your dose as necessary and tell you exactly which strength of the medicine to take. The recommended dose is one tablet twice a day. Your doctor will normally start Synjardy treatment by prescribing the strength of tablet that supplies the same dose of metformin you are already taking (850 mg or 1,000 mg twice a day), and the lowest dose of empagliflozin (5 mg twice a day). If you are already taking both medicines separately, your doctor will start treatment with tablets of Synjardy that will supply the same amount of both. If you have reduced kidney function, your doctor may prescribe a lower dose. 5 Taking this medicine
• Swallow the tablet whole with water.
• Take the tablets with meals to lower your chance of an upset stomach.
• Take the tablet twice daily by mouth. Your doctor may prescribe Synjardy together with another diabetes medicine. Remember to take all medicines as directed by your doctor to achieve the best results for your health. Your doctor may need to adjust your doses to control your blood sugar. 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. If you take more Synjardy than you should If you take more Synjardy tablets than you should have, you may experience lactic acidosis. Symptoms of lactic acidosis are non-specific such as feeling or being very sick, vomiting, stomach ache with muscle cramps, a general feeling of not being well with severe tiredness, and difficulty in breathing. Further symptoms are reduced body temperature and heartbeat. If this happens to you, you may need immediate hospital treatment, as lactic acidosis can lead to coma. Stop taking this medicine immediately and contact a doctor or the nearest hospital straight away (see section 2). Take the medicine pack with you. If you forget to take Synjardy If you miss a dose, take it as soon as you remember. If you do not remember until it is time for your next dose, skip the missed dose and go back to your regular schedule. Do not take a double dose of this medicine. If you stop taking Synjardy Do not stop taking Synjardy without first consulting your doctor. Your blood sugar levels may increase when you stop taking Synjardy. If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

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: Lactic acidosis, seen very rarely (may affect up to 1 in 10,000 people) Synjardy may cause a very rare but very serious side effect called lactic acidosis (see section ‘Warnings and precautions’). If this happens you must stop taking Synjardy and contact a doctor or the nearest hospital immediately, as lactic acidosis may lead to coma. Diabetic ketoacidosis, seen rarely (may affect up to 1 in 1,000 people) These are the signs of diabetic ketoacidosis (see section 2, ‘Warnings and precautions’): – increased levels of “ketone bodies” in your urine or blood – 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. 6 This may occur regardless of blood glucose level. Your doctor may decide to temporarily or permanently stop your treatment with Synjardy. Contact your doctor as soon as possible if you notice the following side effects: Low blood sugar (hypoglycaemia), seen very commonly (may affect more than 1 in 10 people) If you take Synjardy with another medicine that can cause low blood sugar, such as a sulfonylurea or insulin, your risk of getting low blood sugar is increased. The signs of low blood sugar may include:
• shaking, sweating, feeling very anxious or confused, fast heart beat
• excessive hunger, headache Your doctor will tell you how to treat low blood sugar levels and what to do if you get any of the signs above. If you have symptoms of low blood sugar, eat glucose tablets, a high sugar snack or drink fruit juice. Measure your blood sugar if possible and rest. Urinary tract infection, seen commonly (may affect up to 1 in 10 people) The signs of urinary tract infection are:
• burning sensation when passing urine
• urine that appears cloudy
• pain in the pelvis, or mid-back pain (when kidneys are infected) An urge to pass urine or more frequent urination may be due to the way Synjardy works, but they can also be signs of urinary tract infection. If you note an increase in such symptoms, you should also contact your doctor. Dehydration, seen uncommonly (may affect up to 1 in 100 people) The signs of dehydration are not specific, but may include:
• unusual thirst
• lightheadedness or dizziness upon standing
• fainting or loss of consciousness

Other side effects while taking Synjardy:

Very common
• feeling sick (nausea), vomiting
• diarrhoea or stomach ache
• loss of appetite

Common
• genital yeast infection (thrush)
• passing more urine than usual or needing to pass urine more often
• itching
• rash or red skin– this this may be itchy and include raised bumps, oozing fluid or blisters
• changes to the way things taste
• thirst
• blood tests may show changes in blood fat (cholesterol) levels in your blood

Uncommon
• hives
• straining or pain when emptying the bladder
• blood tests may show changes related to kidney function (creatinine or urea)
• blood tests may show increases in the amount of red blood cells in your blood (haematocrit) 7

Very rare
• decreased vitamin B12 levels in the blood
• abnormalities in liver function tests, inflammation of the liver (hepatitis)
• redness of the skin (erythema)

Not known
• severe allergic reaction (may include swelling of the face, lips, mouth, tongue, or throat that may lead to difficulty breathing or swallowing)

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. You can also report side effects directly (see details below). By reporting side effects you can help provide more information on the safety of this medicine. United Kingdom Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store Ireland HPRA Pharmacovigilance Earlsfort Terrace IRL – Dublin 2 Tel: +353 1 6764971 Fax: +353 1 6762517 Website: www.hpra.ie e-mail: [email protected] Malta ADR Reporting Website: www.medicinesauthority.gov.mt/adrportal

How to Store Synjardy

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 blister and 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 use. These measures will help protect the environment.

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