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 Fampridine Accord is and what it is used for</li><li>What you need to know before you take Fampridine Accord</li><li>How to take Fampridine Accord</li><li>Possible side effects</li><li>How to store Fampridine Accord</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>Fampridine Accord is a medicine used to improve walking in adults (18 years and over) with Multiple Sclerosis (MS) related walking disability. In multiple sclerosis, inflammation destroys the protective sheath around the nerves leading to muscle weakness, muscle stiffness and difficulty walking.</p><p>Fampridine Accord contains the active substance fampridine which belongs to a group of medicines called potassium channel blockers. They work by stopping potassium leaving the nerve cells which have been damaged by MS. This medicine is thought to work by letting signals pass down the nerve more normally, which allows you to walk better.</p></div>
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<div xmlns="http://www.w3.org/1999/xhtml"><p>Do not take Fampridine Accord</p><p>if you are allergic to fampridine or any of the other ingredients of this medicine (listed in section 6)</p><p>if you have a seizure or have ever had a seizure (also referred to as a fit or convulsion)</p><p>if your doctor or nurse has told you that you have moderate or severe kidney problems</p><p>if you are taking a medicine called cimetidine</p><p>if you are taking any other medicine containing fampridine. This may increase your risk of serious side effects</p><p>Tell your doctor and do not take Fampridine Accord if any of these apply to you.</p><p>Warnings and precautions</p><p>Talk to your doctor or pharmacist before taking Fampridine Accord:</p><p>if you feel aware of your heartbeat (palpitations)</p><p>if you are prone to infections</p><p>you should use a walking aid, such as a cane, as needed</p><p>because this medicine may make you feel dizzy or unsteady this may result in an increased risk of falls</p><p>if you have any factors or are taking any medicine which affects your risk of fits (seizure).</p><p>if you have been told by a doctor that you have mild problems with your kidneys.</p><p>Tell your doctor before you take Fampridine Accord if any of these apply to you.</p><p>Children and in adolescents</p><p>Do not give Fampridine Accord to children or adolescents under the age of 18 years.</p><p>Elderly Before starting treatment and during treatment your doctor may check that your kidneys are working properly.</p><p>Other medicines and Fampridine Accord</p><p>Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.</p><p>Do not take Fampridine Accord if you are taking any other medicine containing fampridine.</p><p>Other medicines that affect the kidneys</p><p>Your doctor will be especially careful if fampridine is given at the same time as any medicine which may affect how your kidneys eliminate medicines for example carvedilol, propranolol and metformin.</p><p>Fampridine Accord with food and drink</p><p>Fampridine Accord should be taken without food, on an empty stomach.</p><p>Pregnancy and breast-feeding</p><p>If you are pregnant, or are planning to become pregnant, tell your doctor before you take Fampridine Accord.<br/>Fampridine Accord is not recommended during pregnancy.</p><p>Your doctor will consider the benefit of you being treated with Fampridine Accord against the risk to your baby.</p><p>You should not breast-feed whilst taking this medicine.</p><p>Driving and using machines</p><p>Fampridine Accord may have an effect on people s ability to drive or use machines, it can cause dizziness. Make sure you re not affected before you start driving or use machinery.</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. Fampridine Accord is only available by prescription and under the supervision of doctors experienced in MS.</p><p>Your doctor will give you an initial prescription for 2 to 4 weeks. After 2 to 4 weeks the treatment will be reassessed.</p><p>The recommended dose is</p><p>One tablet in the morning and one tablet in the evening (12 hours apart). Do not take more than two tablets in a day. You must leave 12 hours between each tablet. Do not take the tablets more often than every 12 hours.</p><p>Swallow each tablet whole, with a drink of water. Do not divide, crush, dissolve, suck or chew the tablet. This may increase your risk of side effects.</p><p>If you take more Fampridine Accord than you should</p><p>Contact your doctor immediately if you take too many tablets. Take the Fampridine Accord box with you if you go to see the doctor. In overdose you may notice sweating, minor shaking (tremor), dizziness, confusion, memory loss (amnesia) and fits (seizure). You may also notice other effects not listed here.</p><p>If you forget to take Fampridine Accord If you forget to take a tablet, do not take two tablets at once to make up for a missed dose. You must always leave 12 hours between each tablet.</p><p>If you have any further questions on the use of this medicine, ask your doctor or pharmacist.</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.</p><p>If you have a seizure, stop taking Fampridine Accord and tell your doctor immediately.</p><p>If you experience one or more of the following allergic (hypersensitivity) symptoms: swollen face, mouth, lips, throat or tongue, reddening or itching of the skin, chest tightness and breathing problems stop taking Fampridine Accord and see your doctor immediately.</p><p>Side effects are listed below by frequency:</p><p>Very Common side effects</p><p>May affect more than 1 in 10 people:</p><ul><li>Urinary tract infection</li></ul><p>Common side effects</p><p>May affect up to 1 in 10 people:</p><ul><li>Feeling unsteady</li><li>Dizziness</li><li>Spinning sensation (vertigo)</li><li>Headache</li><li>Feeling weak and tired</li><li>Difficulty sleeping</li><li>Anxiety</li><li>Minor shaking (tremor)</li><li>Numbness or tingling of skin</li><li>Sore throat</li><li>Common cold (nasopharyngitis)</li><li>Flu (influenza)</li><li>Difficulty breathing (shortness of breath)</li><li>Feeling sick (nausea)</li><li>Being sick (vomiting)</li><li>Constipation</li><li>Upset stomach</li><li>Back pain</li><li>Heartbeat that you can feel (palpitations)</li></ul><p>Uncommon side effects</p><p>May affect up to 1 in 100 people</p><ul><li>Fits (seizure)</li><li>Allergic reaction (hypersensitivity)</li><li>New onset or worsening of nerve pain in the face (trigeminal neuralgia)</li><li>Fast heart rate (tachycardia)</li></ul><p>Reporting of side effects</p><p>If you get any side effects, talk to your doctor or pharmacist. 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.</p><p>Do not use this medicine after the expiry date which is stated on the packaging after EXP. The expiry date refers to the last day of that month.</p><p>This medicinal product does not require any special storage conditions.</p><p>Do not throw away any medicines via waste water or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.</p></div>
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<div xmlns="http://www.w3.org/1999/xhtml"><p>What Fampridine Accord contains</p><ul><li><p>The active substance is fampridine.</p></li><li><p>Each prolonged-release tablet contains 10 mg of fampridine</p></li><li><p>The other ingredients are:</p></li><li><p>Tablet core: Hypromellose (E464), silica, colloidal anhydrous (E551), cellulose microcrystalline (E460), magnesium stearate (E572);</p></li><li><p>Film coating: hypromellose (E464), titanium dioxide (E171), macrogol (E1521)</p></li></ul><p>What Fampridine Accord looks like and contents of the pack</p><p>White to off white, oval shaped, biconvex, bevel-edged, film coated tablets, approximately 13.1 x 8.1 mm in dimensions, debossed with FH6 on one side and plain on other side.</p><p>Fampridine Accord 10 mg prolonged-release tablets are packed in perforated unit-dose blister packs containing 28 x1 or 56 x 1 tablets</p><p>Not all pack sizes may be marketed.</p><p>Marketing Authorisation Holder</p><p>Accord Healthcare S.L.U. World Trade Center, Moll de Barcelona s/n,<br/>Edifici Est, 6a Planta,<br/>Barcelona, 08Spain</p><p>Manufacturer Accord Healthcare Polska Sp.z.o.o. Ul. Lutomierska 50, 95-200, Pabianice, Poland</p><p>Pharmadox Healthcare Ltd. KW20A Kordin Industrial Park, Paola PLA3000, Malta</p><p>Laboratori Fundaci DAU C/ C, 12-14 Pol. Ind. Zona Franca, 08040 Barcelona, Spain</p><p>This leaflet was last revised in</p><p>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.
