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/hl7-eu/gravitate-health/ and changes regularly. See the Directory of published versions
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<div xmlns="http://www.w3.org/1999/xhtml" xml:lang="en" lang="en"><a name="Composition_composition-en-ramipril"> </a><p class="res-header-id"><b>Generated Narrative: Composition composition-en-ramipril</b></p><a name="composition-en-ramipril"> </a><a name="hccomposition-en-ramipril"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px">Language: en</p><p style="margin-bottom: 0px">Profile: <a href="https://build.fhir.org/ig/HL7/emedicinal-product-info/StructureDefinition-Composition-uv-epi.html">Composition (ePI)</a></p></div><p><b>identifier</b>: <code>http://ema.europa.eu/identifier</code>/himss-ramipril</p><p><b>status</b>: Final</p><p><b>type</b>: <span title="Codes:{https://spor.ema.europa.eu/rmswi/ 100000155538}">Package Leaflet</span></p><p><b>category</b>: <span title="Codes:{http://hl7.eu/fhir/ig/gravitate-health/CodeSystem/epicategory-cs R}">Raw</span></p><p><b>date</b>: 2022-02-16 13:28:17+0000</p><p><b>author</b>: EMA</p><p><b>title</b>: TEST PURPOSES ONLY - ramipril</p><h3>Attesters</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Mode</b></td><td><b>Time</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:{http://hl7.org/fhir/composition-attestation-mode official}">Official</span></td><td>2022-02-16 13:28:17+0000</td></tr></table></div>
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<div xmlns="http://www.w3.org/1999/xhtml"><h2>Ramipril 1.25 mg Capsules</h2><h2>Ramipril 2.5 mg Capsules</h2><h2>Ramipril 5 mg Capsules</h2><h2>Ramipril 10 mg Capsules</h2><h2>(Ramipril)</h2><p>Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.</p><ul><li>Keep this leaflet. You may need to read it again.</li><li>If you have any further questions, ask your doctor or pharmacist.</li><li>This medicine has been prescribed for you only. Do not pass it on to others. It may harm them even if their symptoms are the same as yours.</li><li>If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.</li></ul></div>
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<div xmlns="http://www.w3.org/1999/xhtml"><ol><li>What Ramipril Capsules is and what it is used for</li><li>What you need to know before you take Ramipril Capsules</li><li>How to take Ramipril Capsules</li><li>Possible side effects</li><li>How to store Ramipril Capsules</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>Ramipril Capsules contains a medicine called ramipril. This belongs to a group of medicines called ACE inhibitors (Angiotensin Converting Enzyme Inhibitors).</p><p>Ramipril Capsules work by:</p><ul><li>Decreasing your body’s production of substances that could raise your blood pressure</li><li>Making your blood vessels relax and widen</li><li>Making it easier for your heart to pump blood around your body</li></ul><p>Ramipril Capsules can be used for:</p><ul><li>Treating high blood pressure (hypertension)</li><li>Reducing the risk of having a heart attack or stroke</li><li>Reducing the risk or delaying worsening of kidney problems (with or without diabetes)</li><li>Treating heart failure</li><li>Treatment following a heart attack complicated with heart failure</li></ul></div>
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<div xmlns="http://www.w3.org/1999/xhtml"><p><strong>Do not take Ramipril Capsules if you:</strong></p><ul><li>Are allergic to ramipril, any other ACE inhibitor, or any of the ingredients (see section 6)</li><li>Have ever had a serious allergic reaction called “angioedema”</li><li>Have taken or are taking sacubitril/valsartan</li><li>Are on dialysis or other blood filtration</li><li>Have kidney problems with reduced blood supply (renal artery stenosis)</li><li>Are in the last 6 months of pregnancy</li><li>Have abnormally low or unstable blood pressure</li><li>Have diabetes or impaired kidney function treated with aliskiren-containing medicine</li><li>Are taking racecadotril, mTOR inhibitors (e.g. temsirolimus, sirolimus, everolimus), or vildagliptin</li></ul><h3>Warnings and precautions</h3><p>Talk to your doctor or pharmacist before taking Ramipril Capsules if you:</p><ul><li>Have heart, liver or kidney problems</li><li>Have lost a lot of salts or fluids (vomiting, diarrhoea, sweating, low-salt diet, long-term diuretics, dialysis)</li><li>Are undergoing bee/wasp sting desensitisation</li><li>Will receive an anaesthetic</li><li>Have high potassium levels</li><li>Are taking medicines or have conditions that reduce blood sodium levels</li><li>Are on mTOR inhibitors, vildagliptin, racecadotril, or sacubitril/valsartan</li><li>Have collagen vascular disease (e.g. scleroderma, lupus)</li><li>Are pregnant, might become pregnant, or are breast-feeding (see “Pregnancy and breast-feeding”)</li><li>Are taking angiotensin II receptor blockers (sartans) or aliskiren</li></ul><p>Your doctor may check your kidney function, blood pressure, and electrolytes regularly.</p><h3>Children and adolescents</h3><p>Not recommended for use in those under 18 years; safety and efficacy not established.</p><h3>Other medicines and Ramipril Capsules</h3><p>Tell your doctor or pharmacist if you are taking any other medicines:</p><p><strong>May make Ramipril less effective:</strong></p><ul><li>NSAIDs (e.g. ibuprofen, indometacin, aspirin)</li><li>Pressor agents (e.g. ephedrine, noradrenaline, adrenaline)</li></ul><p><strong>May increase side effect risk:</strong></p><ul><li>Sacubitril/valsartan</li><li>Ciclosporin, chemotherapy agents</li><li>Diuretics (e.g. furosemide)</li><li>Potassium supplements or potassium-sparing diuretics</li><li>Steroids (e.g. prednisolone)</li><li>Allopurinol, procainamide</li><li>mTOR inhibitors, vildagliptin, racecadotril</li><li>ARBs or aliskiren</li></ul><p><strong>May be affected by Ramipril:</strong></p><ul><li>Diabetes medicines (insulin, oral agents)</li><li>Lithium</li></ul><h3>Ramipril Capsules with food, alcohol</h3><ul><li>Alcohol may increase dizziness or light-headedness</li><li>Can be taken with or without food</li></ul><h3>Pregnancy and breast-feeding</h3><p>Do not take during pregnancy (especially after 13 weeks) or while breast-feeding. Tell your doctor if you are pregnant or planning a pregnancy.</p><h3>Driving and using machines</h3><p>You may feel dizzy, especially when starting treatment or after a dose increase. If affected, do not drive or use machinery.</p></div>
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<div xmlns="http://www.w3.org/1999/xhtml"><p>Always take exactly as your doctor has told you.</p><ul><li>Take by mouth at the same time each day with water</li><li>Do not crush or chew the capsules</li></ul><h3>Dosage:</h3><ul><li><strong>High blood pressure:</strong> start 1.25 mg or 2.5 mg once daily; adjust up to 10 mg once daily</li><li><strong>Risk reduction (heart attack/stroke):</strong> start 2.5 mg once daily; usual 10 mg once daily</li><li><strong>Kidney protection:</strong> start 1.25 mg or 2.5 mg once daily; usual 5 mg–10 mg once daily</li><li><strong>Heart failure:</strong> start 1.25 mg once daily; adjust up to 10 mg daily (preferably divided doses)</li><li><strong>After heart attack:</strong> start 1.25 mg once daily to 2.5 mg twice daily; usual 10 mg daily (preferably divided)</li><li><strong>Elderly:</strong> start lower dose and titrate more slowly</li></ul><h3>If you take too much</h3><p>Go to your nearest casualty department immediately (do not drive yourself). Take the medicine pack with you.</p><h3>If you forget a dose</h3><p>Take it when you remember unless it is almost time for your next dose. Do not double up.</p><h3>If you stop taking Ramipril Capsules</h3><p>Do not stop without consulting your doctor or pharmacist.</p></div>
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<div xmlns="http://www.w3.org/1999/xhtml"><p>Like all medicines, this can cause side effects, although not everyone gets them.</p><h3>Stop and see a doctor straight away if you:</h3><ul><li>Develop swelling of face, lips, throat (angioedema)</li><li>Have severe skin reactions (Stevens–Johnson syndrome, toxic epidermal necrolysis)</li></ul><h3>Tell your doctor immediately if you experience:</h3><ul><li>Chest pain, palpitations, heart attack, stroke</li><li>Shortness of breath, cough (lung problems)</li><li>Easy bruising/bleeding, fever, sore throat (blood/bone marrow issues)</li><li>Severe stomach pain (pancreatitis)</li><li>Jaundice, liver inflammation or damage</li></ul><h3>Other side effects</h3><h4>Common (up to 1 in 10)</h4><ul><li>Headache, tiredness</li><li>Dizziness, fainting, low blood pressure</li><li>Dry cough, sinusitis, bronchitis</li><li>Stomach pain, diarrhoea, indigestion, nausea, vomiting</li><li>Skin rash, chest pain, muscle cramps or pain</li><li>Elevated potassium in blood tests</li></ul><h4>Uncommon (up to 1 in 100)</h4><ul><li>Vertigo, paraesthesia</li><li>Taste changes, sleep problems, mood changes</li><li>Asthma worsening, intestinal angioedema</li><li>Heartburn, constipation, dry mouth</li><li>Increased urination, sweating, anorexia</li><li>Flushing, blurred vision, joint pain</li><li>Sexual dysfunction, eosinophilia</li><li>Abnormal liver/pancreas/kidney tests</li></ul><h4>Rare (up to 1 in 1,000)</h4><ul><li>Shakiness, confusion, red/swollen tongue</li><li>Severe skin peeling, nail problems</li><li>Hearing disturbances, weakness</li><li>Blood cell count changes</li></ul><h4>Very rare (up to 1 in 10,000)</h4><ul><li>Sun sensitivity</li></ul><h3>Reporting of side effects</h3><p>If you get any side effects, talk to your doctor, pharmacist or nurse. You can also report side effects via the Yellow Card Scheme at <a rel="noopener noreferrer" href="https://www.mhra.gov.uk/yellowcard" target="_blank">www.mhra.gov.uk/yellowcard</a>.</p></div>
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<div xmlns="http://www.w3.org/1999/xhtml"><ul><li>Keep out of sight and reach of children.</li><li>Do not store above 25 °C. Store in original packaging.</li><li>Do not use after the expiry date on the carton or blister.</li><li>Do not dispose via wastewater or household waste; ask your pharmacist how.</li></ul></div>
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<div xmlns="http://www.w3.org/1999/xhtml"><h3>What Ramipril Capsules contain</h3><ul><li><strong>Active substance:</strong> Ramipril</li><li><strong>Other ingredients:</strong> Pregelatinised starch, gelatin, polyethylene glycol, iron oxides (E 172), titanium dioxide (E 171), plus colourants in specific strengths as listed in section 6.</li></ul><h3>What Ramipril Capsules look like and pack sizes</h3><ul><li><strong>1.25 mg:</strong> Light grey cap (“R”) and 1.25 on body.</li><li><strong>2.5 mg:</strong> Light green cap (“R”) and 2.5 on body.</li><li><strong>5 mg:</strong> Green cap (“R”) and 5 on body.</li><li><strong>10 mg:</strong> Dark green cap (“R”) and 10 on body.</li><li>Pack sizes: Blisters of 7, 21, 28, 30, 50 or 100 capsules (not all sizes marketed).</li></ul><h3>Marketing Authorisation Holder & Manufacturer</h3><p>Brown & Burk UK Ltd</p><p>5 Marryat Close, Hounslow West, Middlesex TW4 5DQ, United Kingdom</p><p>This leaflet was last updated in June 2020.</p></div>
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IG © 2021+ Gravitate Health Project. Package hl7.eu.fhir.gh#0.1.0 based on FHIR 5.0.0. Generated 2025-07-25
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.
