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-finasteride"> </a><p class="res-header-id"><b>Generated Narrative: Composition composition-en-finasteride</b></p><a name="composition-en-finasteride"> </a><a name="hccomposition-en-finasteride"> </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>https://www.gravitatehealth.eu/sid/doc</code>/himss-finasteride</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 - finasteride</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>Finasteride 5 mg film-coated tablets</h2><h2>(Finasteride)</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, pharmacist or nurse.</li><li>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.</li><li>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.</li></ul> <!-- [oai_citation:0‡pil.13543.pdf](file-service://file-JCS7gTrRt25FFSUPp8bKGr) --></div>
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<div xmlns="http://www.w3.org/1999/xhtml"><ol><li>What Finasteride is and what it is used for</li><li>What you need to know before you take Finasteride</li><li>How to take Finasteride</li><li>Possible side effects</li><li>How to store Finasteride</li><li>Contents of the pack and other information</li></ol> <!-- [oai_citation:1‡pil.13543.pdf](file-service://file-JCS7gTrRt25FFSUPp8bKGr) --></div>
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<div xmlns="http://www.w3.org/1999/xhtml"><p>Finasteride contains the active substance finasteride which belongs to the group of medicines called 5-alpha reductase inhibitors. They act by reducing the size of the prostate gland in men.</p><p>Finasteride is used in the treatment and control of benign (non-cancerous) enlargement of the prostate (benign prostatic hyperplasia BPH). It reduces the risk of you developing a sudden inability to pass urine (acute urinary retention) and the need for surgery.</p> <!-- [oai_citation:2‡pil.13543.pdf](file-service://file-JCS7gTrRt25FFSUPp8bKGr) --></div>
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<div xmlns="http://www.w3.org/1999/xhtml"><h3>Do not take Finasteride if you:</h3><ul><li>are allergic to finasteride or any of the other ingredients (listed in section 6)</li><li>are a woman (see also under ‘Pregnancy, breast-feeding and fertility’)</li><li>are a child</li></ul> <!-- [oai_citation:3‡pil.13543.pdf](file-service://file-JCS7gTrRt25FFSUPp8bKGr) --><h3>Warnings and precautions</h3><ul><li>reduced liver function</li><li>difficulty emptying your bladder completely or greatly reduced urine flow (exclude other urinary obstruction first)</li><li>any changes in breast tissue (lumps, pain, enlargement, nipple discharge)—report these promptly</li></ul> <!-- [oai_citation:4‡pil.13543.pdf](file-service://file-JCS7gTrRt25FFSUPp8bKGr) --><p>If your sexual partner is or may be pregnant, avoid exposing her to your semen which could contain a tiny amount of the drug.</p> <!-- [oai_citation:5‡pil.13543.pdf](file-service://file-JCS7gTrRt25FFSUPp8bKGr) --><h3>Mood alterations and depression</h3><p>Mood alterations such as depressed mood, depression and, less frequently, suicidal thoughts have been reported. If you experience these, contact your doctor as soon as possible.</p> <!-- [oai_citation:6‡pil.13543.pdf](file-service://file-JCS7gTrRt25FFSUPp8bKGr) --><h3>Other medicines and Finasteride</h3><p>Finasteride does not usually interfere with other medicines. Tell your doctor or pharmacist if you are taking any other medicines.</p> <!-- [oai_citation:7‡pil.13543.pdf](file-service://file-JCS7gTrRt25FFSUPp8bKGr) --><h3>Finasteride with food and drink</h3><p>Finasteride can be taken with or without food.</p> <!-- [oai_citation:8‡pil.13543.pdf](file-service://file-JCS7gTrRt25FFSUPp8bKGr) --><h3>Pregnancy, breast-feeding and fertility</h3><ul><li>Finasteride is only intended for men.</li><li>Women who are or may be pregnant should not handle broken or crushed tablets—absorption may cause fetal genital malformation.</li></ul> <!-- [oai_citation:9‡pil.13543.pdf](file-service://file-JCS7gTrRt25FFSUPp8bKGr) --><h3>Driving and using machines</h3><p>No evidence suggests Finasteride affects driving or machine use.</p> <!-- [oai_citation:10‡pil.13543.pdf](file-service://file-JCS7gTrRt25FFSUPp8bKGr) --><h3>Finasteride contains lactose</h3><p>If you have an intolerance to some sugars, contact your doctor before taking this medicine.</p> <!-- [oai_citation:11‡pil.13543.pdf](file-service://file-JCS7gTrRt25FFSUPp8bKGr) --><h3>Finasteride contains sodium</h3><p>This medicine contains less than 1 mmol sodium (23 mg) per tablet (essentially ‘sodium-free’).</p> <!-- [oai_citation:12‡pil.13543.pdf](file-service://file-JCS7gTrRt25FFSUPp8bKGr) --></div>
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<div xmlns="http://www.w3.org/1999/xhtml"><p>The recommended dose is one tablet daily (5 mg finasteride). Swallow the film-coated tablet whole; do not break or crush. It may be taken with or without food.</p> <!-- [oai_citation:13‡pil.13543.pdf](file-service://file-JCS7gTrRt25FFSUPp8bKGr) --><h3>If you take more Finasteride than you should</h3><p>Contact a doctor, hospital casualty department or poison centre immediately.</p> <!-- [oai_citation:14‡pil.13543.pdf](file-service://file-JCS7gTrRt25FFSUPp8bKGr) --><h3>If you forget to take Finasteride</h3><p>Do not take a double dose. Take the next dose when it is due.</p> <!-- [oai_citation:15‡pil.13543.pdf](file-service://file-JCS7gTrRt25FFSUPp8bKGr) --><h3>If you stop taking Finasteride</h3><p>Although improvement may be noticed shortly, treatment should continue for at least 6 months. Do not alter or stop without medical advice.</p> <!-- [oai_citation:16‡pil.13543.pdf](file-service://file-JCS7gTrRt25FFSUPp8bKGr) --></div>
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<title value="4. Possible side effects"/>
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<div xmlns="http://www.w3.org/1999/xhtml"><h3>Stop using and contact your doctor immediately if you experience any of the following (angioedema):</h3><ul><li>Swelling of face, tongue or throat; difficulty swallowing; hives; breathing difficulties</li></ul> <!-- [oai_citation:17‡pil.13543.pdf](file-service://file-JCS7gTrRt25FFSUPp8bKGr) --><h3>Common (may affect up to 1 in 10 people):</h3><ul><li>Decreased ejaculate volume</li><li>Impotence</li><li>Reduced sex drive</li></ul><h3>Uncommon (may affect up to 1 in 100 people):</h3><ul><li>Rash</li><li>Ejaculation problems that may continue after stopping</li><li>Breast swelling or tenderness</li></ul><h3>Not known (frequency cannot be estimated):</h3><ul><li>Itching, hives</li><li>Palpitations</li><li>Increased liver enzymes</li><li>Testicular pain</li><li>Male infertility or poor semen quality</li><li>Depression, anxiety</li></ul> <!-- [oai_citation:18‡pil.13543.pdf](file-service://file-JCS7gTrRt25FFSUPp8bKGr) --><h3>Combination therapy with doxazosin</h3><p>When used with doxazosin, higher incidence of asthenia (16.8%), postural hypotension (17.8%), dizziness (23.2%) and ejaculation disorders (14.1%) versus placebo.</p> <!-- [oai_citation:19‡pil.13543.pdf](file-service://file-JCS7gTrRt25FFSUPp8bKGr) --><h3>Reporting of side effects</h3><p>Talk to your doctor or pharmacist about any side effects. You can also report them 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> <!-- [oai_citation:20‡pil.13543.pdf](file-service://file-JCS7gTrRt25FFSUPp8bKGr) --></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>No special storage conditions required.</li><li>Do not use after the expiry date on the label (last day of that month).</li><li>Do not dispose via wastewater or household waste; ask your pharmacist.</li></ul> <!-- [oai_citation:21‡pil.13543.pdf](file-service://file-JCS7gTrRt25FFSUPp8bKGr) --></div>
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<div xmlns="http://www.w3.org/1999/xhtml"><h3>What Finasteride contains</h3><ul><li><strong>Active substance:</strong> finasteride 5 mg per film-coated tablet.</li><li><strong>Other ingredients:</strong><ul><li>Tablet core: lactose monohydrate, microcrystalline cellulose, pregelatinised starch, sodium starch glycolate, docusate sodium, magnesium stearate.</li><li>Film coating: hypromellose (E 464), titanium dioxide (E 171), indigo carmine aluminium lake (E 132), talc, iron oxide yellow (E 172).</li></ul></li></ul> <!-- [oai_citation:22‡pil.13543.pdf](file-service://file-JCS7gTrRt25FFSUPp8bKGr) --><h3>What Finasteride looks like and pack sizes</h3><p>Blue, round, film-coated tablets debossed ‘H’ and ‘37’. Available in blister packs of 15, 28, 30, 50, 90, 98 or 100 tablets.</p> <!-- [oai_citation:23‡pil.13543.pdf](file-service://file-JCS7gTrRt25FFSUPp8bKGr) --><h3>Marketing Authorisation Holder and Manufacturer</h3><p><strong>Marketing Authorisation Holder:</strong></p><p>Amarox Limited, Congress House, 14 Lyon Road, Harrow, Middlesex HA1 2EN, United Kingdom</p><p><strong>Manufacturer:</strong></p><p>Pharmadox Healthcare Ltd, Kordin Industrial Park, Paola PLA 3000, Malta</p><p>or</p><p>Amarox Limited, Congress House, 14 Lyon Road, Harrow, Middlesex HA1 2EN, United Kingdom</p> <!-- [oai_citation:24‡pil.13543.pdf](file-service://file-JCS7gTrRt25FFSUPp8bKGr) --><h3>Authorisations in the EEA</h3><ul><li>Germany: Finasterid Amarox 5 mg Filmtabletten</li><li>Denmark: Finasterid Amarox 5 mg Filmovertrukne tabletter</li><li>France: Finasteride Amarox 5 mg comprimé pelliculé</li><li>Spain: Finasterida Tarbis 5 mg comprimidos recubiertos con película EFG</li><li>Italy: Finasterida Amarox</li><li>Netherlands: Finasteride Amarox 5 mg filmomhulde tabletten</li><li>Portugal: Finasterida Amarox</li><li>Sweden: Finasteride Amarox 5 mg Filmdragerad tablett</li><li>United Kingdom: Finasteride 5 mg film-coated tablets</li></ul> <!-- [oai_citation:25‡pil.13543.pdf](file-service://file-JCS7gTrRt25FFSUPp8bKGr) --><p>This leaflet was last revised in 09/2021.</p> <!-- [oai_citation:26‡pil.13543.pdf](file-service://file-JCS7gTrRt25FFSUPp8bKGr) --></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.
