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
<Bundle xmlns="http://hl7.org/fhir">
<id value="bundlepackageleaflet-en-0ab8cf0cd2257bee1916fb1bd19c98b3"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Bundle-uv-epi"/>
</meta>
<language value="en"/>
<identifier>
<system value="http://ema.europa.eu/identifier"/>
<value value="None"/>
</identifier>
<type value="document"/>
<timestamp value="2023-06-27T10:09:22Z"/>
<entry>
<fullUrl
value="Composition/composition-en-0ab8cf0cd2257bee1916fb1bd19c98b3"/>
<resource>
<Composition>
<id value="composition-en-0ab8cf0cd2257bee1916fb1bd19c98b3"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Composition-uv-epi"/>
</meta>
<language value="en"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml" xml:lang="en" lang="en"><a name="Composition_composition-en-0ab8cf0cd2257bee1916fb1bd19c98b3"> </a><p class="res-header-id"><b>Generated Narrative: Composition composition-en-0ab8cf0cd2257bee1916fb1bd19c98b3</b></p><a name="composition-en-0ab8cf0cd2257bee1916fb1bd19c98b3"> </a><a name="hccomposition-en-0ab8cf0cd2257bee1916fb1bd19c98b3"> </a><a name="composition-en-0ab8cf0cd2257bee1916fb1bd19c98b3-en-US"> </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>/EU/1/18/1275/001</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>: <a href="Organization-mah-ema.html">Organization ACME industry</a></p><p><b>title</b>: TEST PURPOSES ONLY - riarify</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>
</text>
<identifier>
<system value="http://ema.europa.eu/identifier"/>
<value value="EU/1/18/1275/001"/>
</identifier>
<status value="final"/>
<type>
<coding>
<system value="https://spor.ema.europa.eu/rmswi/"/>
<code value="100000155538"/>
</coding>
<text value="Package Leaflet"/>
</type>
<category>
<coding>
<system
value="http://hl7.eu/fhir/ig/gravitate-health/CodeSystem/epicategory-cs"/>
<code value="R"/>
<display value="Raw"/>
</coding>
</category>
<subject>
<reference
value="MedicinalProductDefinition/mp0ab8cf0cd2257bee1916fb1bd19c98b3"/>
</subject>
<date value="2022-02-16T13:28:17Z"/>
<author>🔗
<reference value="Organization/mah-ema"/>
</author>
<title value="TEST PURPOSES ONLY - riarify"/>
<attester>
<mode>
<coding>
<system
value="http://hl7.org/fhir/composition-attestation-mode"/>
<code value="official"/>
</coding>
</mode>
<time value="2022-02-16T13:28:17Z"/>
</attester>
<section>
<title value="B. Package Leaflet"/>
<code>
<coding>
<system value="https://spor.ema.europa.eu/rmswi/"/>
<code value="100000155538"/>
</coding>
<text value="B. Package Leaflet"/>
</code>
<text>
<status value="additional"/>
<div xmlns="http://www.w3.org/1999/xhtml">unavailable</div>
</text>
<emptyReason>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/list-empty-reason"/>
<code value="unavailable"/>
</coding>
</emptyReason>
<section>
<title value="Package leaflet: Information for the user"/>
<code>
<coding>
<system value="https://spor.ema.europa.eu/rmswi/"/>
<code value="100000155538"/>
</coding>
<text value="Package leaflet: Information for the user"/>
</code>
<text>
<status value="additional"/>
<div xmlns="http://www.w3.org/1999/xhtml"></div>
</text>
</section>
<section>
<title value="What is in this leaflet"/>
<code>
<coding>
<system value="https://spor.ema.europa.eu/rmswi/"/>
<code value="100000155538"/>
</coding>
<text value="What is in this leaflet"/>
</code>
<text>
<status value="additional"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p>What is in this leaflet</p><ol type="1"><li>What Riarify is and what it is used for</li><li>What you need to know before you use Riarify</li><li>How to use Riarify</li><li>Possible side effects</li><li>How to store Riarify</li><li>Contents of the pack and other information</li></ol></div>
</text>
</section>
<section>
<title value="1. What riarify is and what it is used for"/>
<code>
<coding>
<system value="https://spor.ema.europa.eu/rmswi/"/>
<code value="100000155538"/>
</coding>
<text value="1. What riarify is and what it is used for"/>
</code>
<text>
<status value="additional"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p>Riarify is a medicine to help breathing that contains the three active substances:</p><ul><li>beclometasone dipropionate,</li><li>formoterol fumarate dihydrate and</li><li>glycopyrronium.</li></ul><p>Beclometasone dipropionate belongs to a group of medicines called corticosteroids which act to reduce the swelling and irritation in your lungs.</p><p>Formoterol and glycopyrronium are medicines called long-acting bronchodilators. They act in different ways to relax the muscles in your airways, helping to open the airways wider and allowing you to breathe more easily.</p><p>Regular treatment with these three active substances helps to relieve and prevent symptoms such as shortness of breath, wheezing and cough in adult patients with chronic obstructive pulmonary disease (COPD). Riarify can reduce exacerbations (flare-ups) of COPD symptoms. COPD is a serious long- term disease in which the airways become blocked and air sacs inside the lungs become damaged, leading to difficulty breathing.</p></div>
</text>
</section>
<section>
<title value="2. What you need to know before you take riarify"/>
<code>
<coding>
<system value="https://spor.ema.europa.eu/rmswi/"/>
<code value="100000155538"/>
</coding>
<text value="2. What you need to know before you take riarify"/>
</code>
<text>
<status value="additional"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p>Do not use Riarify</p><p>If you are allergic to beclometasone dipropionate, formoterol fumarate dihydrate and/or glycopyrronium or any of the other ingredients of this medicine (listed in section 6).</p><p>Warnings and precautions</p><p>Riarify is used as a maintenance treatment for your obstructive lung disease. Do not use this medicine to treat a sudden attack of breathlessness or wheezing.</p><p>If your breathing gets worse</p><p>If you develop worsening shortness of breath or wheezing (breathing with a whistling sound), straight after inhaling your medicine, stop using Riarify inhaler and use your quick-acting reliever inhaler straightaway. You should contact your doctor straightaway. Your doctor will assess your symptoms and if necessary may start you on a different treatment.<br/>See also section 4, Possible side effects .</p><p>If your lung disease gets worse</p><p>If your symptoms get worse or are difficult to control (e.g. if you are using a separate reliever<br/>inhaler more frequently) or if your reliever inhaler does not improve your symptoms, see your doctor immediately. Your lung disease may be getting worse and your doctor may need to prescribe different treatment.</p><p>Talk to your doctor or pharmacist before using Riarify:</p><ul><li><p>if you have any heart problems, such as angina (heart pain, pain in the chest), a recent heart attack (myocardial infarction), heart failure, narrowing of the arteries around your heart (coronary heart disease), disease of your heart valves or any other abnormalities of your heart or if you have a condition known as hypertrophic obstructive cardiomyopathy (also known as HOCM, a condition where the heart muscle is abnormal).</p></li><li><p>if you have disorders of your heart rhythm such as irregular heart rate, a fast pulse rate or palpitations or if you have been told that your heart trace (ECG) is abnormal.</p></li><li><p>if you have narrowing of the arteries (also known as arteriosclerosis), if you have high blood pressure or if you have an aneurysm (abnormal bulging of the blood vessel wall).</p></li><li><p>if you have an overactive thyroid gland.</p></li><li><p>if you have low blood levels of potassium (hypokalaemia). The combination of Riarify with some other COPD medicines or medicines such as diuretics (medicines that make the body lose water, to treat heart disease or high blood pressure), can cause a sharp fall in your blood level of potassium. Therefore, your doctor may wish to measure the potassium levels in your blood from time to time.</p></li><li><p>if you have any disease of your liver or kidneys.</p></li><li><p>if you have diabetes. High doses of formoterol may increase your blood glucose and therefore you may need to have extra blood tests to check your blood sugar when you start using this medicine, and from time to time during treatment.</p></li><li><p>if you have a tumour of the adrenal gland (known as a phaeochromocytoma).</p></li><li><p>if you are due to have an anaesthetic. Depending on the type of anaesthetic, it may be necessary to stop using Riarify at least 12 hours before the anaesthesia.</p></li><li><p>if you are being, or have ever been, treated for tuberculosis (TB) or if you have a chest infection.</p></li><li><p>if you have an eye problem called narrow-angle glaucoma.</p></li><li><p>if you have difficulty passing urine.</p></li><li><p>if you have an infection of the mouth or throat.</p></li></ul><p>If any of the above applies to you, tell your doctor before you use Riarify.<br/>If you have or have had any medical problems or any allergies or if you are not sure if you can use Riarify, talk to your doctor or pharmacist before using the inhaler.</p><p>If you are already using Riarify</p><p>If you are using Riarify or high doses of other inhaled corticosteroids over long periods and you come into a situation of stress (e.g. being taken to hospital after an accident, having a serious injury or before an operation) you may need more of this medicine. In such a situation, your doctor may need to increase your dose of corticosteroids to cope with the stress and may prescribe them as tablets or injections. Contact your doctor if you experience blurred vision or other visual disturbances.</p><p>Children and adolescents Do not give this medicine to children and adolescents below the age of 18 years.</p><p>Other medicines and Riarify Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines similar to Riarify used for your lung disease.</p><p>Some medicines may increase the effects of Riarify and your doctor may wish to monitor you carefully if you are taking these medicines (including some medicines for HIV: ritonavir, cobicistat).</p><p>Do not use this medicine with a beta-blocker medicine (used for treating certain heart problems such as angina or for reducing blood pressure) unless your doctor has chosen a beta-blocker that does not affect your breathing. Beta-blockers (including beta-blocker eye-drops) may reduce the effects of formoterol or make it not work at all. On the other hand, using other beta2-agonist medicines (which work in the same way as formoterol) may increase the effects of formoterol.</p><p>Using Riarify together with:</p><ul><li>medicines for treating</li></ul><ul><li>abnormal heart rhythms (quinidine, disopyramide, procainamide),</li><li>allergic reactions (antihistamines),</li><li>symptoms of depression or mental disorders such as monoamine oxidase inhibitors (for example phenelzine and isocarboxazid), tricyclic antidepressants (for example amitriptyline and imipramine), phenothiazines<br/>can cause some changes in the electrocardiogram (ECG, heart trace). They may also increase the risk of disturbances of heart rhythm (ventricular arrhythmias).</li></ul><ul><li><p>medicines for treating Parkinson s disease (levodopa), to treat an underactive thyroid gland (levothyroxine), medicines containing oxytocin (which causes uterine contraction) and alcohol can increase the chances of formoterol side effects on the heart.</p></li><li><p>monoamine oxidase inhibitors (MAOIs), including medicines with similar properties like furazolidone and procarbazine, used to treat mental disorders, can cause a rise in blood pressure.</p></li><li><p>medicines for treating heart disease (digoxin) can cause a fall in your blood potassium level. This may increase the likelihood of abnormal heart rhythms.</p></li><li><p>other medicines used to treat COPD (theophylline, aminophylline or corticosteroids) and diuretics may also cause a fall in your potassium level.</p></li><li><p>some anaesthetics can increase the risk of abnormal heart rhythms.</p></li><li><p>Disulfiram, a medicine used in the treatment of people with alcoholism (drinking problems) or metronidazole, an antibiotic to treat infection in your body can cause side effects (e.g. feeling sick, being sick, stomach pain) due to the small amount of alcohol in Riarify.</p></li></ul><p>Pregnancy and breast-feeding<br/>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 using this medicine.</p><p>You should only use Riarify during pregnancy if you are advised to do so by your doctor. It is preferable to avoid the use of Riarify during labour due to the inhibitory effects of formoterol on uterine contractions. You should not use Riarify during breast-feeding. You and your doctor must make a decision whether to discontinue breast-feeding or to discontinue/abstain from Riarify therapy taking into account the benefit of breast-feeding for your child and the benefit of therapy for you.</p><p>Driving and using machines Riarify is unlikely to affect your ability to drive and use machines.</p><p>Riarify contains ethanol Riarify contains 8.856 mg of alcohol (ethanol) in each actuation, which is equivalent to 17.712 mg per dose of two actuations. The amount in two actuations of this medicine is equivalent to less than 1 ml of wine or beer. The small amount of alcohol in this medicine will not have any noticeable effects.</p></div>
</text>
</section>
<section>
<title value="3. How to take riarify"/>
<code>
<coding>
<system value="https://spor.ema.europa.eu/rmswi/"/>
<code value="100000155538"/>
</coding>
<text value="3. How to take riarify"/>
</code>
<text>
<status value="additional"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p>Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.</p><p>The recommended dose is two puffs in the morning and two puffs in the evening.</p><p>If you feel that the medicine is not very effective, talk to your doctor. If you have been using a different inhaler containing beclometasone dipropionate previously, ask your doctor for advice, as the effective dose of beclometasone dipropionate in Riarify for the treatment of COPD may be lower than that of some other inhalers.</p><p>Route of administration Riarify is for inhalation use. You should inhale the medicine through your mouth and this takes the medicine directly into your lungs.</p><p>This medicine is contained in a pressurised container in a plastic inhaler with a mouthpiece.</p><p>Riarify is available in three container sizes:</p><ul><li>a container providing 60 puffs</li><li>a container providing 120 puffs</li><li>a container providing 180 puffs.</li></ul><p>If you have been prescribed a container providing 60 puffs or 120 puffs There is a counter on the back of the inhaler, which tells you how many doses are left. Each time you press the pressurised container, a puff of medicine is released and the counter will count down by one. Take care not to drop the inhaler as this may cause the counter to count down.</p><p>If you have been prescribed a container providing 180 puffs There is an indicator on the back of the inhaler, which tells you how many doses are left. Each time you press the pressurised container, a puff of medicine is released and the dose indicator rotates by a small amount. The number of puffs remaining is displayed in intervals of 20. Take care not to drop the inhaler as this may cause the dose indicator to count down.</p><p>Testing your inhaler Before using the inhaler for the first time, you should test your inhaler to make sure that it is working properly, as follows.</p><ol type="1"><li>Depending on the container size prescribed to you, check that the dose counter reads 61 or and that the dose indicator reads 2. Remove the protective cap from the mouthpiece</li><li>Hold your inhaler upright with the mouthpiece at the bottom</li><li>Direct the mouthpiece away from yourself and firmly press the pressurised container to release one puff</li><li>Check the dose counter or dose indicator. If you are testing your inhaler for the first time, the counter should read:</li></ol><ul><li>when using the container providing 60 puffs</li><li>when using the container providing 120 puffs</li><li>when using the container providing 180 puffs</li></ul><p>How to use your inhaler Stand or sit up when inhaling.<br/>IMPORTANT: Do not perform steps 2 to 5 too quickly.</p><ol type="1"><li>Remove the protective cap from the mouthpiece and check that the mouthpiece is clean and free from dust and dirt.</li><li>Breathe out as slowly and deeply as possible, in order to empty your lungs.</li><li>Hold the inhaler upright with the mouthpiece at the bottom and place the mouthpiece between your teeth without biting it. Then place your lips around the mouthpiece, with the tongue flat under it.</li><li>Breathe in slowly and deeply through your mouth to fill your lungs with air (this should take about 4 5 seconds). Just after starting to breathe in, press down firmly on the top of the pressurised container to release one puff.</li><li>Hold your breath for as long as possible and, finally, remove the inhaler from your mouth and breathe out slowly. Do not breathe out into the inhaler.</li><li>Check that the dose counter (60/120 puffs) has moved down by one or that the dose indicator (180 puffs) has rotated by a small amount.</li></ol><p>For the second puff, keep the inhaler in the upright position for about half a minute, then repeat steps 2 to 5. If you see 'mist' coming from the top of the inhaler or the sides of your mouth, this means that Riarify will not be getting into your lungs as it should. Take another puff, following the instructions starting again from step 2. After use, replace the protective cap.</p><p>To prevent a fungal infection in the mouth and throat, rinse your mouth or gargle with water without swallowing it or brush your teeth after each use of your inhaler.</p><p>When to get a new inhaler You should get a replacement when the counter or indicator shows the number 20. Stop using the inhaler when the counter or indicator shows 0, as any medicine left in the inhaler may not be enough to give you a full puff.</p><p>If you have a weak grip, it may be easier to hold the inhaler with both hands: hold the upper part of the inhaler with both index fingers and its lower part with both thumbs.</p><p>If you find it difficult to use the inhaler while starting to breathe in, you may use the AeroChamber Plus spacer device. Ask your doctor or pharmacist about this device. It is important that you read the package leaflet which is supplied with your AeroChamber Plus spacer device and that you carefully follow the instructions on how to use the AeroChamber Plus spacer device and how to clean it.</p><p>Cleaning of the Riarify inhaler You should clean your inhaler once a week.</p><ol type="1"><li>Do not remove the pressurised container from the inhaler and do not use water or other liquids to clean your inhaler.</li><li>Remove the protective cap from the mouthpiece by pulling it away from your inhaler.</li><li>Wipe inside and outside of the mouthpiece and the inhaler with a clean, dry cloth or tissue.</li><li>Replace the mouthpiece cap.</li></ol><p>If you use more Riarify than you should It is important that you take your dose as advised by your doctor. Do not exceed your prescribed dose without talking to your doctor. If you use more Riarify than you should, side effects, as described in section 4, may occur.<br/>Tell your doctor if you have used more Riarify than you should and if you experience any of these symptoms. Your doctor may wish to carry out some blood tests.</p><p>Tell your doctor if you have any of these symptoms.</p><p>If you forget to use Riarify Use it as soon as you remember. If it is almost time for your next dose, do not take the dose you have missed, but just take the next dose at the correct time. Do not double the dose.</p><p>If you stop using Riarify It is important to use Riarify every day. Do not stop using Riarify or lower the dose, even if you are feeling better or you have no symptoms. If you want to do this, talk to your doctor.</p><p>If you have any further questions on the use of this medicine, ask your doctor or pharmacist.</p></div>
</text>
</section>
<section>
<title value="4. Possible side effects"/>
<code>
<coding>
<system value="https://spor.ema.europa.eu/rmswi/"/>
<code value="100000155538"/>
</coding>
<text value="4. Possible side effects"/>
</code>
<text>
<status value="additional"/>
<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>There is a risk of worsening shortness of breath and wheezing immediately after using Riarify and this is known as paradoxical bronchospasm (may affect up to 1 in 1,000 people). If this occurs you should stop using Riarify and use your quick-acting reliever inhaler straightaway to treat the shortness of breath and wheezing. You should contact your doctor straightaway.</p><p>Tell your doctor immediately</p><ul><li>if you experience any allergic reactions like skin allergies, hives, skin itching, skin rash (may affect up to 1 in 100 people), reddening of the skin, swelling of the skin or mucous membranes especially of the eyes, face, lips and throat (may affect up to 1 in 1,000 people).</li><li>if you experience eye pain or discomfort, temporary blurring of vision, visual halos or coloured images in association with red eyes. These may be signs of an acute attack of narrow-angle glaucoma (may affect up to 1 in 10,000 people).</li></ul><p>Tell your doctor if you have any of the following while using Riarify as they could be symptoms of a lung infection (may affect up to 1 in 10 people):</p><ul><li>fever or chills</li><li>increased mucus production, change in mucus colour</li><li>increased cough or increased breathing difficulties.</li></ul><p>Possible side effects are listed below according to their frequency.</p><p>Common (may affect up to 1 in 10 people)</p><ul><li>sore throat</li><li>runny or stuffy nose and sneezing</li><li>fungal infections of the mouth. Rinsing your mouth or gargling with water and brushing your teeth immediately after inhalation may help to prevent these side effects</li><li>hoarseness</li><li>headache</li><li>urinary tract infection.</li></ul><p>Uncommon (may affect up to 1 in 100 people)</p><ul><li>flu</li><li>inflammation of the sinuses</li><li>itchy, runny or blocked nose</li><li>fungal infections of the throat or of the food pipe (oesophagus)</li><li>fungal infections of the vagina</li><li>restlessness</li><li>trembling</li><li>dizziness</li><li>abnormal or reduced sense of taste</li><li>numbness</li><li>inflammation of the ear</li><li>irregular heart beat</li><li>changes in the electrocardiogram (heart trace)</li><li>unusually fast heart beat and disorders of the heart rhythm</li><li>palpitations (feeling of abnormal beating of the heart)</li><li>reddening of the face</li><li>increased blood flow to some tissues in the body</li><li>asthma attack</li><li>cough and productive cough</li><li>irritation of the throat</li><li>nose bleeds</li><li>redness of the pharynx</li><li>dry mouth</li><li>diarrhoea</li><li>swallowing difficulties</li><li>feeling sick</li><li>upset stomach</li><li>stomach discomfort after meals</li><li>burning sensation of the lips</li><li>tooth decay</li><li>skin rash, hives, skin itching</li><li>inflammation of the mucous membrane of the mouth with or without ulcers</li><li>increased sweating</li><li>muscle cramps and pain in muscles</li><li>pain in arms or legs</li><li>pain in muscles, bones or joints of the chest</li><li>tiredness</li><li>increase of blood pressure</li><li>fall in the level of some constituents of your blood: of certain white blood cells called granulocytes, of potassium or of cortisol</li><li>increase in the level of some constituents of your blood: glucose, C-reactive protein, number of platelets, insulin, free fatty acid or ketones.</li></ul><p>Rare (may affect up to 1 in 1,000 people)</p><ul><li>fungal infections of the chest</li><li>decreased appetite</li><li>sleep disorders (sleeping too little or too long)</li><li>crushing chest pain</li><li>sensation of a missed heart beat or of extra heart beats, unusually slow heart beat</li><li>worsening of asthma</li><li>leakage of blood from a vessel into the tissues surrounding it</li><li>decrease of blood pressure</li><li>weakness</li><li>pain in the back of the mouth and throat</li><li>inflammation of the pharynx</li><li>dry throat</li><li>painful and frequent urination</li><li>difficulty and pain when passing urine</li><li>inflammation of the kidneys.</li></ul><p>Very rare (may affect up to 1 in 10,000 people)</p><ul><li>low level in the number of certain blood cells called platelets</li><li>feeling breathless or short of breath</li><li>swelling of the hands and feet</li><li>growth retardation in children and adolescents.</li></ul><p>Not known (frequency cannot be estimated from the available data)</p><ul><li>blurred vision.</li></ul><p>Using high-dose inhaled corticosteroids over a long time can cause in very rare cases effects on the body:</p><ul><li>problems with how your adrenal glands work (adrenal suppression)</li><li>decrease in bone mineral density (thinning of the bones)</li><li>clouding of the lens of your eyes (cataract).</li></ul><p>Riarify does not contain a high-dose inhaled corticosteroid, but your doctor may wish to measure the cortisol levels in your blood from time to time.</p><p>The following side effects can also occur with high-dose inhaled corticosteroids used over a long time, but the frequency is not known (frequency cannot be estimated from the available data) at present:</p><ul><li>depression</li><li>feeling worried, nervous, over-excited or irritable. These events are more likely to occur in children.</li></ul><p>Reporting of side effects 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>
</text>
</section>
<section>
<title value="5. How to store riarify"/>
<code>
<coding>
<system value="https://spor.ema.europa.eu/rmswi/"/>
<code value="100000155538"/>
</coding>
<text value="5. How to store riarify"/>
</code>
<text>
<status value="additional"/>
<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 label and carton after EXP. The expiry date refers to the last day of that month.</p><p>Do not freeze.<br/>Do not expose to temperatures higher than 50 C.<br/>Do not pierce the pressurised container.</p><p>Prior to dispensing: Store in a refrigerator (2 C-8 C).</p><p>After dispensing (receiving this medicine from your pharmacist): 60 actuation pressurised container:<br/>Store the inhaler below 25 C for a maximum of 2 months.<br/>120 (from a single or multipack) and<br/>180 actuation pressurised container:<br/>Store the inhaler below 25 C for a maximum of 4 months.</p><p>Do not throw away any medicine 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>
</text>
</section>
<section>
<title value="6. Contents of the pack and other information"/>
<code>
<coding>
<system value="https://spor.ema.europa.eu/rmswi/"/>
<code value="100000155538"/>
</coding>
<text value="6. Contents of the pack and other information"/>
</code>
<text>
<status value="additional"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p>What Riarify contains The active substances are: beclometasone dipropionate, formoterol fumarate dihydrate and glycopyrronium.</p><p>Each delivered dose (the dose leaving the mouthpiece) contains 87 micrograms of beclometasone dipropionate, 5 micrograms of formoterol fumarate dihydrate and 9 micrograms of glycopyrronium (as 11 micrograms glycopyrronium bromide).</p><p>Each metered dose (the dose leaving the valve) contains 100 micrograms of beclometasone dipropionate, 6 micrograms of formoterol fumarate dihydrate and 10 micrograms of glycopyrronium (as 12.5 micrograms of glycopyrronium bromide).</p><p>The other ingredients are: ethanol anhydrous (see section 2), hydrochloric acid, propellant: norflurane.</p><p>What Riarify looks like and contents of the pack Riarify is a pressurised inhalation, solution.</p><p>Riarify comes in a pressurised container (coated aluminium), with a metering valve. The pressurised container is inserted in a plastic inhaler. This incorporates a mouthpiece provided with a plastic protective cap, and either a dose counter (containers with 60 and 120 puffs) or a dose indicator (containers with 180 puffs).</p><p>Each pack contains one pressurised container either providing 60 puffs, 120 puffs or 180 puffs. Additional there are multipacks containing either 240 puffs (2 pressurised containers with 120 puffs, each) or 360 puffs (3 pressurised containers with 120 puffs, each).</p><p>Not all pack sizes may be marketed.</p><p>Marketing Authorisation Holder Chiesi Farmaceutici S.p.A. Via Palermo 26/A 43122 Parma Italy</p><p>Manufacturer Chiesi Farmaceutici S.p.A. Via San Leonardo 43122 Parma Italy</p><p>Chiesi SAS 2 rue des Docteurs Alberto et Paolo Chiesi 41260 La Chauss e Saint Victor France</p><p>Chiesi Pharmaceuticals GmbH Gonzagagasse 16/1010 Wien<br/>Austria</p><p>For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:</p><p>Belgi /Belgique/Belgien Chiesi sa/nv<br/>T l/Tel: + 32 (0)2 788 42 Lietuva Chiesi Pharmaceuticals GmbH<br/>Tel: + 43 1 4073<br/>Chiesi Bulgaria EOOD<br/>Te .: + 359 29201Luxembourg/Luxemburg Chiesi sa/nv<br/>T l/Tel: + 32 (0)2 788 42 esk republika Chiesi CZ s.r.o.<br/>Tel: + 420 261221Magyarorsz g Chiesi Hungary Kft.<br/>Tel.: + 36-1-429 1Danmark Chiesi Pharma AB<br/>Tlf: + 46 8 753 35 Malta Chiesi Farmaceutici S.p.A.<br/>Tel: + 39 0521 2Deutschland Chiesi GmbH<br/>Tel: + 49 40 89724-0</p><p>Nederland Chiesi Pharmaceuticals B.V.<br/>Tel: + 31 88 501 64 Eesti Chiesi Pharmaceuticals GmbH<br/>Tel: + 43 1 4073Norge Chiesi Pharma AB<br/>Tlf: + 46 8 753 35<br/>Chiesi Hellas AEBE<br/>: + 30 210 6179 sterreich Chiesi Pharmaceuticals GmbH<br/>Tel: + 43 1 4073Espa a Covex, SA<br/>Tel: + 34 91 845 02 Polska Chiesi Poland Sp. z.o.o.<br/>Tel.: + 48 22 620 1France Chiesi S.A.S.<br/>T l: + 33 1 47688Portugal Chiesi Farmaceutici S.p.A.<br/>Tel: + 39 0521 2Hrvatska Chiesi Pharmaceuticals GmbH<br/>Tel: + 43 1 4073Rom nia Chiesi Romania S.R.L.<br/>Tel: + 40 212023Ireland Chiesi Farmaceutici S.p.A.<br/>Tel: + 39 0521 2Slovenija CHIESI SLOVENIJA, d.o.o.<br/>Tel: + 386-1-43 00 sland Chiesi Pharma AB<br/>S mi: +46 8 753 35 Slovensk republika Chiesi Slovakia s.r.o.<br/>Tel: + 421 259300Italia Chiesi Italia S.p.A. Tel: + 39 0521 2Suomi/Finland Chiesi Pharma AB<br/>Puh/Tel: +46 8 753 35<br/>Chiesi Farmaceutici S.p.A.<br/>: + 39 0521 2Sverige Chiesi Pharma AB<br/>Tel: +46 8 753 35 Latvija Chiesi Pharmaceuticals GmbH<br/>Tel: + 43 1 4073United Kingdom (Northern Ireland) Chiesi Farmaceutici S.p.A. Tel: + 39 0521 2This leaflet was last revised in:.</p><p>Other sources of information</p><p>Detailed information on this medicine is available on the European Medicines Agency website: <a href="http://www.ema.europa.eu">http://www.ema.europa.eu</a>.</p></div>
</text>
</section>
</section>
</Composition>
</resource>
</entry>
<entry>
<fullUrl
value="MedicinalProductDefinition/mp0ab8cf0cd2257bee1916fb1bd19c98b3"/>
<resource>
<MedicinalProductDefinition>
<id value="mp0ab8cf0cd2257bee1916fb1bd19c98b3"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/MedicinalProductDefinition-uv-epi"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="MedicinalProductDefinition_mp0ab8cf0cd2257bee1916fb1bd19c98b3"> </a><p class="res-header-id"><b>Generated Narrative: MedicinalProductDefinition mp0ab8cf0cd2257bee1916fb1bd19c98b3</b></p><a name="mp0ab8cf0cd2257bee1916fb1bd19c98b3"> </a><a name="hcmp0ab8cf0cd2257bee1916fb1bd19c98b3"> </a><a name="mp0ab8cf0cd2257bee1916fb1bd19c98b3-en-US"> </a><p><b>identifier</b>: <code>http://ema.europa.eu/identifier</code>/EU/1/18/1275/001</p><p><b>type</b>: <span title="Codes:{http://hl7.org/fhir/medicinal-product-type MedicinalProduct}">Medicinal Product</span></p><p><b>domain</b>: <span title="Codes:{http://hl7.org/fhir/medicinal-product-domain Human}">Human use</span></p><p><b>status</b>: <span title="Codes:{http://hl7.org/fhir/publication-status active}">active</span></p><p><b>legalStatusOfSupply</b>: <span title="Codes:{https://spor.ema.europa.eu/rmswi 100000072084}">Medicinal product subject to medical prescription</span></p><blockquote><p><b>name</b></p><p><b>productName</b>: Riarify 87 micrograms/5 micrograms/9 micrograms pressurised inhalation, solution</p><p><b>type</b>: <span title="Codes:{https://spor.ema.europa.eu/lists/220000000000 220000000001}">Full name</span></p><blockquote><p><b>part</b></p><p><b>part</b>: nan</p><p><b>type</b>: <span title="Codes:{https://spor.ema.europa.eu/lists/220000000000 220000000002}">Invented name part</span></p></blockquote><blockquote><p><b>part</b></p><p><b>part</b>: nan</p><p><b>type</b>: <span title="Codes:{https://spor.ema.europa.eu/lists/220000000000 220000000003}">Scientific name part</span></p></blockquote><blockquote><p><b>part</b></p><p><b>part</b>: nan</p><p><b>type</b>: <span title="Codes:{https://spor.ema.europa.eu/lists/220000000000 220000000004}">Strength part</span></p></blockquote><blockquote><p><b>part</b></p><p><b>part</b>: nan</p><p><b>type</b>: <span title="Codes:{https://spor.ema.europa.eu/lists/220000000000 220000000005}">Pharmaceutical dose form part</span></p></blockquote><h3>Usages</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Country</b></td><td><b>Jurisdiction</b></td><td><b>Language</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:{urn:iso:std:iso:3166 EU}">EU</span></td><td><span title="Codes:{urn:iso:std:iso:3166 EU}">EU</span></td><td><span title="Codes:{urn:ietf:bcp:47 en}">en</span></td></tr></table></blockquote></div>
</text>
<identifier>
<system value="http://ema.europa.eu/identifier"/>
<value value="EU/1/18/1275/001"/>
</identifier>
<type>
<coding>
<system value="http://hl7.org/fhir/medicinal-product-type"/>
<code value="MedicinalProduct"/>
<display value="Medicinal Product"/>
</coding>
</type>
<domain>
<coding>
<system value="http://hl7.org/fhir/medicinal-product-domain"/>
<code value="Human"/>
<display value="Human use"/>
</coding>
</domain>
<status>
<coding>
<system value="http://hl7.org/fhir/publication-status"/>
<code value="active"/>
<display value="active"/>
</coding>
</status>
<legalStatusOfSupply>
<coding>
<system value="https://spor.ema.europa.eu/rmswi"/>
<code value="100000072084"/>
<display
value="Medicinal product subject to medical prescription"/>
</coding>
</legalStatusOfSupply>
<name>
<productName
value="Riarify 87 micrograms/5 micrograms/9 micrograms pressurised inhalation, solution"/>
<type>
<coding>
<system value="https://spor.ema.europa.eu/lists/220000000000"/>
<code value="220000000001"/>
<display value="Full name"/>
</coding>
</type>
<part>
<part value="nan"/>
<type>
<coding>
<system
value="https://spor.ema.europa.eu/lists/220000000000"/>
<code value="220000000002"/>
<display value="Invented name part"/>
</coding>
</type>
</part>
<part>
<part value="nan"/>
<type>
<coding>
<system
value="https://spor.ema.europa.eu/lists/220000000000"/>
<code value="220000000003"/>
<display value="Scientific name part"/>
</coding>
</type>
</part>
<part>
<part value="nan"/>
<type>
<coding>
<system
value="https://spor.ema.europa.eu/lists/220000000000"/>
<code value="220000000004"/>
<display value="Strength part"/>
</coding>
</type>
</part>
<part>
<part value="nan"/>
<type>
<coding>
<system
value="https://spor.ema.europa.eu/lists/220000000000"/>
<code value="220000000005"/>
<display value="Pharmaceutical dose form part"/>
</coding>
</type>
</part>
<usage>
<country>
<coding>
<system value="urn:iso:std:iso:3166"/>
<code value="EU"/>
<display value="EU"/>
</coding>
</country>
<jurisdiction>
<coding>
<system value="urn:iso:std:iso:3166"/>
<code value="EU"/>
<display value="EU"/>
</coding>
</jurisdiction>
<language>
<coding>
<system value="urn:ietf:bcp:47"/>
<code value="en"/>
<display value="en"/>
</coding>
</language>
</usage>
</name>
</MedicinalProductDefinition>
</resource>
</entry>
</Bundle>