Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - azomyr

Document Subject

Generated Narrative: MedicinalProductDefinition mp49a6edf85307fce92cb7f88732583618

identifier: http://ema.europa.eu/identifier/EU/1/00/157/001-013

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Azomyr 5 mg film-coated tablets

type: Full name

part

part: nan

type: Invented name part

part

part: nan

type: Scientific name part

part

part: nan

type: Strength part

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part: nan

type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-49a6edf85307fce92cb7f88732583618

identifier: http://ema.europa.eu/identifier/EU/1/00/157/001-013

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - azomyr

Attesters

What is in this leaflet

1. What Azomyr is and what it is used for
2. What you need to know before you take Azomyr
3. How to take Azomyr
4. Possible side effects
5. How to store Azomyr
6. Contents of the pack and other information

What Azomyr is
Azomyr contains desloratadine which is an antihistamine.

How Azomyr works
Azomyr is an antiallergy medicine that does not make you drowsy. It helps control your allergic reaction and its symptoms.

When Azomyr should be used
Azomyr relieves symptoms associated with allergic rhinitis (inflammation of the nasal passages caused by an allergy, for example, hay fever or allergy to dust mites) in adults and adolescents 12 years of age and older. These symptoms include sneezing, runny or itchy nose, itchy palate, and itchy, red or watery eyes.

Azomyr is also used to relieve the symptoms associated with urticaria (a skin condition caused by an allergy). These symptoms include itching and hives.

Relief of these symptoms lasts a full day and helps you to resume your normal daily activities and sleep.

Do not take Azomyr

• if you are allergic to desloratadine, or any of the other ingredients of this medicine (listed in section 6) or to loratadine.

Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Azomyr:

• if you have poor kidney function.
• if you have medical or familial history of seizures.

Children and adolescents
Do not give this medicine to children less than 12 years of age.

Other medicines and Azomyr
There are no known interactions of Azomyr with other medicines.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Azomyr with food, drink and alcohol
Azomyr may be taken with or without a meal.
Use caution when taking Azomyr with alcohol.

Pregnancy, breast-feeding and fertility
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.
Taking Azomyr is not recommended if you are pregnant or nursing a baby.
There is no data available on male/female fertility.

Driving and using machines
At the recommended dose, this medicine is not expected to affect your ability to drive or use machines. Although most people do not experience drowsiness, it is recommended not to engage in activities requiring mental alertness, such as driving a car or operating machinery until you have established your own response to the medicine.

Azomyr tablet contains lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Use in adults and adolescents 12 years of age and over
The recommended dose is one tablet once a day with water, with or without food.

This medicine is for oral use.
Swallow the tablet whole.

Regarding the duration of treatment, your physician will determine the type of allergic rhinitis you are suffering from and will determine for how long you should take Azomyr. If your allergic rhinitis is intermittent (presence of symptoms for less than 4 days per week or for less than 4 weeks), your physician will recommend you a treatment schedule that will depend on the evaluation of the history of your disease. If your allergic rhinitis is persistent (presence of symptoms for 4 days or more per week and for more than 4 weeks), your physician may recommend you a longer term treatment.

For urticaria, the duration of treatment may be variable from patient to patient and therefore you should follow the instructions of your physician.

If you take more Azomyr than you should
Take Azomyr only as it is prescribed for you. No serious problems are expected with accidental overdose. However, if you take more Azomyr than you were told to, tell your doctor, pharmacist or nurse immediately.

If you forget to take Azomyr
If you forget to take your dose on time, take it as soon as possible and then go back to your regular dosing schedule. Do not take a double dose to make up for a forgotten dose.

If you stop taking Azomyr
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

Like all medicines, this medicine can cause side effects, although not everybody gets them.

During the marketing of Azomyr, cases of severe allergic reactions (difficulty in breathing, wheezing, itching, hives and swelling) have been reported very rarely. If you notice any of these serious side effects, stop taking the medicine and seek urgent medical advice straight away.

In clinical studies in adults, side effects were about the same as with a dummy tablet. However, fatigue, dry mouth and headache were reported more often than with a dummy tablet. In adolescents, headache was the most commonly reported side effect.

In clinical studies with Azomyr, the following side effects were reported as:

Common: the following may affect up to 1 in 10 people

• fatigue
• dry mouth
• headache

During the marketing of Azomyr, the following side effects were reported as:

Very rare: the following may affect up to 1 in 10,000 people

• severe allergic reactions
• rash
• pounding or irregular heartbeat
• fast heartbeat
• stomach ache
• feeling sick (nausea)
• vomiting
• upset stomach
• diarrhoea
• dizziness
• drowsiness
• inability to sleep
• muscle pain
• hallucinations
• seizures
• restlessness with increased body movement
• liver inflammation
• abnormal liver function tests

Not known: frequency cannot be estimated from the available data

• unusual weakness

• yellowing of the skin and/or eyes

• increased sensitivity of the skin to the sun, even in case of hazy sun, and to UV light, for instance to UV lights of a solarium

• changes in the way the heart beats

• abnormal behaviour

• aggression

• weight increased, increased appetite

• depressed mood

• dry eyes

Children Not known: frequency cannot be estimated from the available data

• slow heartbeat
• change in the way the heart beats
• abnormal behaviour
• aggression

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.

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 carton and blister after EXP. The expiry date refers to the last day of that month.

Do not store above 30 C. Store in the original package.

Do not use this medicine if you notice any change in the appearance of the tablets.

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.

What Azomyr contains

• The active substance is desloratadine 5 mg
• The other ingredients of the tablet are calcium hydrogen phosphate dihydrate, microcrystalline cellulose, maize starch, talc. Tablet coating contains film coat (containing lactose monohydrate (see section 2 Azomyr tablet contains lactose ), hypromellose, titanium dioxide, macrogol 400, indigotin (E132)), clear coat (containing hypromellose, macrogol 400), carnauba wax, white wax.

What Azomyr looks like and contents of the pack
Azomyr 5 mg film-coated tablet is light blue, round and embossed with elongated letters S and P
on one side and plain on the other. Azomyr 5 mg film-coated tablets are packed in blisters in packs of 1, 2, 3, 5, 7, 10, 14, 15, 20, 21, 30, 50 or 100 tablets. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:

N.V. Organon Kloosterstraat 6 5349 AB Oss The Netherlands

Manufacturer: Organon Heist bv, Industriepark 30, 2220 Heist-op-den-Berg, Belgium.

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

Belgi /Belgique/Belgien Organon Belgium T l/Tel: 0080066550123 (+32 2 2418100)
dpoc.benelux@organon.com

Lietuva Organon Pharma B.V. Lithuania atstovyb
Tel.: +370 52041dpoc.lithuania@organon.com

( . .) . . -
.: +359 2 806 3dpoc.bulgaria@organon.com

Luxembourg/Luxemburg Organon Belgium T l/Tel: 0080066550123 (+32 2 2418100)
dpoc.benelux@organon.com

esk republika Organon Czech Republic s.r.o. Tel.: +420 233 010 dpoc.czech@organon.com

Magyarorsz g Organon Hungary Kft. Tel.: +36 1 766 1dpoc.hungary@organon.com

Danmark Organon Denmark ApS Tlf: +45 4484 6info.denmark@organon.com

Malta Organon Pharma B.V., Cyprus branch Tel: +356 2277 8dpoc.cyprus@organon.com

Deutschland Organon Healthcare GmbH Tel: 0800 3384 726 (+49 (0) 89 2040022 10) dpoc.germany@organon.com

Nederland N.V. Organon Tel.: 00800 66550123 (+32 2 2418100) dpoc.benelux@organon.com

Eesti Organon Pharma B.V. Estonian RO Tel: +372 66 61 dpoc.estonia@organon.com

Norge Organon Norway AS Tlf: +47 24 14 56 info.norway@organon.com

N.V. Organon : +30-216 6008 sterreich Organon Austria GmbH Tel: +43 (0) 1 263 28 dpoc.austria@organon.com

Espa a Organon Salud, S.L. Tel: +34 91 591 12 organon_info@organon.com Polska Organon Polska Sp. z o.o. Tel.: +48 22 105 50 organonpolska@organon.com

France Organon France T l: +33 (0) 1 57 77 32 Portugal Organon Portugal, Sociedade Unipessoal Lda. Tel: +351 218705geral_pt@organon.com

Hrvatska Organon Pharma d.o.o. Tel: +385 1 638 4dpoc.croatia@organon.com

Rom nia Organon Biosciences S.R.L. Tel: +40 21 527 29 dpoc.romania@organon.com

Ireland Organon Pharma (Ireland) Limited Tel: +353 15828medinfo.ROI@organon.com

Slovenija Organon Pharma B.V., Oss, podru nica Ljubljana Tel: +386 1 300 10 dpoc.slovenia@organon.com

sland Vistor hf. S mi: +354 535 7Slovensk republika Organon Slovakia s. r. o. Tel: +421 2 44 88 98 dpoc.slovakia@organon.com

Italia Organon Italia S.r.l. Tel: +39 06 90259dpoc.italy@organon.com

Suomi/Finland Organon Finland Oy Puh/Tel: +358 (0) 29 170 3dpoc.finland@organon.com

Organon Pharma B.V., Cyprus branch : +357 22866dpoc.cyprus@organon.com

Sverige Organon Sweden AB Tel: +46 8 502 597 dpoc.sweden@organon.com

Latvija rvalsts komersanta Organon Pharma B.V.
p rst vniec ba Tel: +371 66968dpoc.latvia@organon.com

United Kingdom (Northern Ireland) Organon Pharma (UK) Limited Tel: +44 (0) 208 159 3medicalinformationuk@organon.com

This leaflet was last revised in <{MM/YYYY}><{month YYYY}>

Detailed information on this medicine is available on the European Medicines Agency website http://www.ema.europa.eu.

Package leaflet: Information for the patient

Azomyr 0.5 mg/ml oral solution
desloratadine

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist or nurse.
• 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.
• 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.