Gravitate Health FHIR Implementation Guide
0.1.0 - CI Build
Gravitate Health FHIR Implementation Guide
0.1.0 - CI Build
Gravitate Health FHIR Implementation Guide, published by Gravitate Health Project. This guide is not an authorized publication; it is the continuous build for version 0.1.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/joofio/test-epi-composition/ and changes regularly. See the Directory of published versions
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<div xmlns="http://www.w3.org/1999/xhtml"><p>What is in this leaflet</p><ol type="1"><li>What Synjardy is and what it is used for</li><li>What you need to know before you take Synjardy</li><li>How to take Synjardy</li><li>Possible side effects</li><li>How to store Synjardy</li><li>Contents of the pack and other information</li></ol></div>
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<div xmlns="http://www.w3.org/1999/xhtml"><p>What Synjardy is Synjardy contains two active substances empagliflozin and metformin. Each belongs to a group of medicines called oral anti-diabetics . These are medicines taken by mouth to treat type 2 diabetes. What is type 2 diabetes? Type 2 diabetes is a disease that comes from both your genes and your lifestyle. If you have type 2 diabetes, your pancreas does not make enough insulin to control the level of glucose in your blood, and your body is unable to use its own insulin effectively. This results in high levels of glucose in your blood which can lead to medical problems like heart disease, kidney disease, blindness, and poor circulation in your limbs. How Synjardy works Empagliflozin belongs to a group of medicines called sodium glucose co-transporter-2 (SGLT2) inhibitors. It works by blocking the SGLT2 protein in your kidneys. This causes blood sugar (glucose) to be removed in your urine. Metformin works in a different way to lower blood sugar levels, mainly by blocking glucose production in the liver. Thereby Synjardy lowers the amount of sugar in your blood. This medicine can also help prevent heart disease. What Synjardy is used for</p><p>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.</p><p>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.</p><p>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.</p></div>
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<div xmlns="http://www.w3.org/1999/xhtml"><p>Do not take Synjardy</p><p>if you are allergic to empagliflozin, metformin or any of the other ingredients of this medicine (listed in section 6);</p><p>if you have uncontrolled diabetes, with, for example, severe hyperglycaemia (very high blood glucose), nausea, vomiting, diarrhoea, rapid weight loss, lactic acidosis (see Risk of lactic acidosis below) or ketoacidosis. Ketoacidosis is a condition in which substances called ketone bodies accumulate in the blood and which can lead to diabetic pre-coma. Symptoms include stomach pain, fast and deep breathing, sleepiness or your breath developing an unusual fruity smell;</p><p>if you have had a diabetic pre-coma;</p><p>if you have serious kidney problems. Your doctor may limit your daily dose or ask you to take a different medicine (see also section 3, How to take Synjardy ).</p><p>if you have a severe infection such as an infection affecting your lung or bronchial system or your kidney. Severe infections may lead to kidney problems, which can put you at risk for lactic acidosis (see 'Warnings and precautions');</p><p>if you have lost a lot of water from your body (dehydration), e.g. due to long-lasting or severe diarrhoea, or if you have vomited several times in a row. Dehydration may lead to kidney problems, which can put you at risk for lactic acidosis (see 'Warnings and precautions');</p><p>if you are treated for acute heart failure or have recently had a heart attack, have severe problems with your circulation (such as shock) or have breathing difficulties. This may lead to a lack in oxygen supply to tissue which can put you at risk for lactic acidosis (see section Warnings and precautions');</p><p>if you have problems with your liver;</p><p>if you drink large amounts of alcohol, either every day or only from time to time (see section Synjardy with alcohol ). Warnings and precautions Risk of lactic acidosis Synjardy may cause a very rare, but very serious side effect called lactic acidosis, particularly if your kidneys are not working properly. The risk of developing lactic acidosis is also increased with uncontrolled diabetes, serious infections, prolonged fasting or alcohol intake, dehydration (see further information below), liver problems and any medical conditions in which a part of the body has a reduced supply of oxygen (such as acute severe heart diseases). If any of the above apply to you, talk to your doctor for further instructions. Stop taking Synjardy for a short time if you have a condition that may be associated with dehydration (significant loss of body fluids) such as severe vomiting, diarrhoea, fever, exposure to heat or if you drink less fluid than normal. Talk to your doctor for further instructions. Stop taking Synjardy and contact a doctor or the nearest hospital immediately if you experience some of the symptoms of lactic acidosis, as this condition may lead to coma. Symptoms of lactic acidosis include:</p><p>vomiting</p><p>stomach ache (abdominal pain)</p><p>muscle cramps</p><p>a general feeling of not being well with severe tiredness</p><p>difficulty in breathing</p><p>reduced body temperature and heartbeat Lactic acidosis is a medical emergency and must be treated in a hospital. Talk to your doctor, pharmacist or nurse before taking this medicine, and during treatment:</p><p>if you experience 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, contact a doctor or the nearest hospital straight away. These symptoms could be a sign of diabetic ketoacidosis a rare, but serious, sometines life-threatening problem you can get with diabetes because of increased levels of ketone bodies in your urine or blood, seen in tests. The risk of developing diabetic ketoacidosis may be increased with prolonged fasting, excessive alcohol consumption, dehydration, sudden reductions in insulin dose, or a higher need of insulin due to major surgery or serious illness;</p><p>if you have type 1 diabetes this type usually starts when you are young and your body does not produce any insulin. You should not take Synjardy if you have type 1 diabetes;</p><p>might be at risk of dehydration, for example:* if you are being sick, have diarrhoea or fever, or if you are not able to eat or drink* if you are taking medicines that increase urine production [diuretics] or lower blood pressure* if you are 75 years old or older. Possible signs are listed in section 4 under dehydration . Your doctor may ask you to stop taking Synjardy until you recover to prevent loss of too much body fluid. Ask about ways to prevent dehydration.</p><p>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;</p><p>if you need to undergo an examination with iodination contrast agents (such as X-ray or scan). More information is given below in Other medicines and Synjardy . Talk to your doctor immediately 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 necrotising fasciitis of the perineum or Fournier s gangrene which destroys the tissue under the skin. Fournier s gangrene has to be treated immediately. Surgery If you need to have major surgery you must stop taking Synjardy during and for some time after the procedure. Your doctor will decide when you must stop and when to restart your treatment with Synjardy. Kidney function During treatment with Synjardy, your doctor will check your kidney function at least once a year or more frequently if you are elderly and/or if you have worsening kidney function. Foot care Like for all diabetic patients it is important to check your feet regularly and adhere to any other advice regarding foot care given by your health care professional. Urine glucose Because of how this medicine works, your urine will test positive for sugar while you are taking this medicine. Children and adolescents This medicine is not recommended for use in children and adolescents under 18 years, because it has not been studied in these patients. Other medicines and Synjardy If you need to have an injection of a contrast medium that contains iodine into your bloodstream, for example in the context of an X-ray or scan, you must stop taking Synjardy before or at the time of the injection. Your doctor will decide when you must stop and when to restart your treatment with Synjardy. Tell your doctor if you are taking, have recently taken or might take any other medicines. You may need more frequent blood glucose and kidney function tests, or your doctor may need to adjust the dosage of Synjardy. It is especially important to mention the following:</p><p>medicines which increase urine production (diuretics), as Synjardy may increase the risk of losing too much fluid. Your doctor may ask you to stop taking Synjardy. Possible signs of losing too much fluid from your body are listed in section 4.<br/>other medicines that lower the amount of sugar in your blood such as insulin or a sulphonylurea medicine. Your doctor may want to lower the dose of these other medicines, to prevent your blood sugar levels from getting too low (hypoglycaemia).</p><p>medicines that may change the amount of metformin in your blood, especially if you have reduced kidney function (such as verapamil, rifampicin, cimetidine, dolutegravir, ranolazine, trimethoprime, vandetanib, isavuconazole, crizotinib, olaparib).</p><p>bronchodilators (beta-2 agonists) which are used to treat asthma.</p><p>corticosteroids (given by mouth, as an injection, or inhaled), which are used to treat inflammation in diseases like asthma and arthritis.</p><p>medicines used to treat pain and inflammation (NSAID and COX-2-inhibitors, such as ibuprofen and celecoxib).</p><p>certain medicines for the treatment of high blood pressure (ACE inhibitors and angiotensin II receptor antagonists).</p><p>medicines that contain alcohol (see section Synjardy with alcohol ).</p><p>iodinated contrast agents (medicines used during an X-ray, see section Warnings and precautions .</p><p>if you are taking lithium because Synjardy can lower the amount of lithium in your blood. Synjardy with alcohol Avoid excessive alcohol intake while taking Synjardy since this may increase the risk of lactic acidosis (see section Warnings and precautions ). 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. Do not take Synjardy if you are pregnant. It is unknown if this medicine is harmful to the unborn child. Metformin passes into human milk in small amounts. It is not known whether empagliflozin passes into human breast milk. Do not take Synjardy if you are breast-feeding. Driving and using machines Synjardy has minor influence on the ability to drive and use machines. Taking this medicine in combination with medicines called sulphonylureas or with insulin can cause blood sugar levels to drop too low (hypoglycaemia), which may cause symptoms such as shaking, sweating and change in vision, and may affect your ability to drive and use machines. Do not drive or use any tools or machines if you feel dizzy while taking Synjardy.</p></div>
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<div xmlns="http://www.w3.org/1999/xhtml"><p>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 or decide to use an alternative medicine. Taking this medicine</p><p>Swallow the tablet whole with water.</p><p>Take the tablets with meals to lower your chance of an upset stomach.</p><p>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. Appropriate diet and exercise 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.</p></div>
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<div xmlns="http://www.w3.org/1999/xhtml"><p>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: Severe allergic reaction, seen with uncommon frequency (may affect up to 1 in 100 people) Possible signs of severe allergic reaction may include:</p><p>swelling of the face, lips, mouth, tongue, or throat that may lead to difficulty breathing or swallowing) 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 2). 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):</p><p>increased levels of ketone bodies in your urine or blood</p><p>rapid weight loss</p><p>feeling sick or being sick</p><p>stomach pain</p><p>excessive thirst</p><p>fast and deep breathing</p><p>confusion</p><p>unusual sleepiness or tiredness</p><p>a sweet smell to your breath, a sweet or metallic taste in your mouth or a different odour to your urine or sweat. 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:</p><p>shaking, sweating, feeling very anxious or confused, fast heart beat</p><p>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:</p><p>burning sensation when passing urine</p><p>urine that appears cloudy</p><p>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:</p><p>unusual thirst</p><p>lightheadedness or dizziness upon standing</p><p>fainting or loss of consciousness Other side effects while taking Synjardy: Very common</p><p>feeling sick (nausea), vomiting</p><p>diarrhoea or stomach ache</p><p>loss of appetite Common</p><p>genital yeast infection (thrush)</p><p>passing more urine than usual or needing to pass urine more often</p><p>itching</p><p>rash or red skin this may be itchy and include raised bumps, oozing fluid or blisters</p><p>changes to the way things taste</p><p>thirst</p><p>blood tests may show an increase in blood fat (cholesterol) levels in your blood</p><p>constipation</p><p>decreased or low vitamin B12 levels in the blood (symptoms may include extreme tiredness (fatigue), a sore and red tongue (glossitis), pins and needles (paraesthesia) or pale or yellow skin). Your doctor may arrange some tests to find out the cause of your symptoms because some of these may also be caused by diabetes or due to other unrelated health problems. Uncommon</p><p>hives</p><p>straining or pain when emptying the bladder</p><p>blood tests may show a decrease in kidney function (creatinine or urea)</p><p>blood tests may show increases in the amount of red blood cells in your blood (haematocrit) Rare</p><p>necrotising fasciitis of the perineum or Fournier s gangrene, a serious soft tissue infection of the genitals or the area between the genitals and the anus Very rare</p><p>abnormalities in liver function tests, inflammation of the liver (hepatitis)</p><p>redness of the skin (erythema)</p><p>inflammation of the kidneys (tubulointerstitial nephritis) 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 via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.</p></div>
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<div xmlns="http://www.w3.org/1999/xhtml"><p>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.</p></div>
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<div xmlns="http://www.w3.org/1999/xhtml"><p>What Synjardy contains The active substances are empagliflozin and metformin. Each Synjardy 5 mg/850 mg film-coated tablet (tablet) contains 5 mg empagliflozin and 850 mg metformin hydrochloride. Each Synjardy 5 mg/1,000 mg film-coated tablet (tablet) contains 5 mg empagliflozin and 1,000 mg metformin hydrochloride. Each Synjardy 12.5 mg/850 mg film-coated tablet (tablet) contains 12.5 mg empagliflozin and 850 mg metformin hydrochloride. Each Synjardy 12.5 mg/1,000 mg film-coated tablet (tablet) contains 12.5 mg empagliflozin and 1,000 mg metformin hydrochloride. The other ingredient(s) are:</p><p>Tablet core: maize starch, copovidone, colloidal anhydrous silica, magnesium stearate.</p><p>Film coating: hypromellose, macrogol 400, titanium dioxide (E171), talc. Synjardy 5 mg/850 mg and Synjardy 5 mg/1,000 mg tablets also contain iron oxide yellow (E172). Synjardy 12.5 mg/850 mg and Synjardy 12.5 mg/1,000 mg tablets also contain iron oxide black (E172) and iron oxide red (E172). What Synjardy looks like and contents of the pack Synjardy 5 mg/850 mg film-coated tablets are yellowish white, oval, biconvex. They have S5 and the Boehringer Ingelheim logo on one side and 850 on the other. The tablet is 19.2 mm long and has a width of 9.4 mm. Synjardy 5 mg/1,000 mg film-coated tablets are brownish yellow, oval, biconvex. They have S5 and the Boehringer Ingelheim logo on one side and 1000 on the other. The tablet is 21.1 mm long and has a width of 9.7 mm. Synjardy 12.5 mg/850 mg film-coated tablets are pinkish white, oval, biconvex. They have S12 and the Boehringer Ingelheim logo on one side and 850 on the other. The tablet is 19.2 mm long and has a width of 9.4 mm. Synjardy 12.5 mg/1,000 mg film-coated tablets are dark brownish purple, oval, biconvex. They have S12 and the Boehringer Ingelheim logo on one side and 1000 on the other. The tablet is 21.1 mm long and has a width of 9.7 mm. The tablets are available in PVC/PVDC/aluminium perforated unit dose blisters. The pack sizes are 10 x 1, 14 x 1, 30 x 1, 56 x 1, 60 x 1, 90 x 1 and 100 x 1 film-coated tablets and multipacks containing 120 (2 packs of 60 x 1), 180 (2 packs of 90 x 1) and 200 (2 packs of 100 x 1) film-coated tablets. Not all pack sizes may be marketed in your country. Marketing Authorisation Holder Boehringer Ingelheim International GmbH Binger Strasse 55216 Ingelheim am Rhein Germany Manufacturer Boehringer Ingelheim Pharma GmbH & Co. KG Binger Strasse 55216 Ingelheim am Rhein Germany Boehringer Ingelheim Hellas Single Member S.A. 5th km Paiania Markopoulo Koropi Attiki, 19Greece Patheon France 40 boulevard de Champaret Bourgoin Jallieu, 38France Boehringer Ingelheim France 100-104 Avenue de France 75013 Paris France For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder: Belgi /Belgique/Belgien Boehringer Ingelheim SComm T l/Tel: +32 2 773 33 Lietuva Boehringer Ingelheim RCV GmbH & Co KG Lietuvos filialas Tel.: +370 5 2595 -</p><p>: +359 2 958 79 Luxembourg/Luxemburg Boehringer Ingelheim SComm T l/Tel: +32 2 773 33 esk republika Boehringer Ingelheim spol. s r.o. Tel: +420 234 655 Magyarorsz g Boehringer Ingelheim RCV GmbH & Co KG Magyarorsz gi Fi ktelepe Tel.: +36 1 299 89 Danmark Boehringer Ingelheim Danmark A/S Tlf: +45 39 15 88 Malta Boehringer Ingelheim Ireland Ltd. Tel: +353 1 295 9Deutschland Boehringer Ingelheim Pharma GmbH & Co. KG Tel: +49 (0) 800 77 90 Lilly Deutschland GmbH Tel. +49 (0) 6172 273 2Nederland Boehringer Ingelheim B.V. Tel: +31 (0) 800 22 55 Eesti Boehringer Ingelheim RCV GmbH & Co KG Eesti filiaal Tel: +372 612 8Norge Boehringer Ingelheim Norway KS Tlf: +47 66 76 13<br/>Boehringer Ingelheim A.E. T : +30 2 10 89 06 sterreich Boehringer Ingelheim RCV GmbH & Co KG Tel: +43 1 80 105-7Espa a Boehringer Ingelheim Espa a, S.A. Tel: +34 93 404 51 Lilly S.A. Tel: +34 91 663 50 Polska Boehringer Ingelheim Sp.zo.o. Tel.: +48 22 699 0 France Boehringer Ingelheim France S.A.S. T l: +33 3 26 50 45 Lilly France SAS T l: +33 1 55 49 34 Portugal Boehringer Ingelheim Portugal, Lda. Tel: +351 21 313 53 Lilly Portugal Produtos Farmac uticos, Lda Tel: +351 21 412 66 Hrvatska Boehringer Ingelheim Zagreb d.o.o. Tel: +385 1 2444 Rom nia Boehringer Ingelheim RCV GmbH & Co KG Viena - Sucursala Bucure ti Tel: +40 21 302 28 Ireland Boehringer Ingelheim Ireland Ltd. Tel: +353 1 295 9Eli Lilly and Company (Ireland) Limited Tel: +353 1 661 4Slovenija Boehringer Ingelheim RCV GmbH & Co KG Podru nica Ljubljana Tel: +386 1 586 40 sland Vistor hf. S mi: +354 535 7Slovensk republika Boehringer Ingelheim RCV GmbH & Co KG organiza n zlo ka Tel: +421 2 5810 1Italia Boehringer Ingelheim Italia S.p.A. Tel: +39 02 5355 1 Eli Lilly Italia S.p.A. Tel: +39 055 42Suomi/Finland Boehringer Ingelheim Finland Ky Puh/Tel: +358 10 3102<br/>Boehringer Ingelheim A.E. T : +30 2 10 89 06 Sverige Boehringer Ingelheim AB Tel: +46 8 721 21 Latvija Boehringer Ingelheim RCV GmbH & Co KG Latvijas fili le Tel: +371 67 240 United Kingdom (Northern Ireland) Boehringer Ingelheim Ireland Ltd. Tel: +353 1 295 9Eli Lilly and Company (Ireland) Limited Tel: +353 1 661 4This leaflet was last revised in {MM/YYYY}. Detailed information on this medicine is available on the European Medicines Agency web site:</p></div>
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IG © 2021+ Gravitate Health Project. Package hl7.eu.fhir.ghepi#0.1.0 based on FHIR 5.0.0. Generated 2024-10-14
Links: Table of Contents |
QA Report
The Gravitate Health project has received funding from the IMI 2 Joint Undertaking under grant agreement No 945334.
This joint undertaking receives support from the EU H2020 research and innovation programme and EFPIA.
