Aerius – Package Leaflet: InfoCons – Consumer Protection presents, in an accessible format, the official package leaflet of the medicine Aerius, as authorised in the European Union and published in the Union Register of medicinal products.
Before anything else
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 be en 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.
What is i n this leaflet 1. What Aerius is and what it is used for 2. What you need to know b efore you take Aerius 3. How to take Aerius 4. Possible side effects 5. How to store Aerius 6. Contents of the pack and other information 1. What Aerius is and what it is used for What Aerius is Aerius contains desloratadine which is an antihistamine.
How Aerius works
Aerius is an antiallergy medicine that does not make you drowsy. It helps control your allergic reaction and its symptoms.
When Aerius should be used Aerius 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.
Aerius is also used to relieve the symptoms associated with urticaria (a skin condition caused by an allergy). These symptoms include itchin g and hives.
Relief of these symptoms lasts a full day and helps you to resume your normal daily activities and sleep.
2. What you need to know b efore you take Aerius
Do not take Aerius
- 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 Aerius:
- if you have poor kidney function.
- if you have medical or familial history of seizures.
Children and adolescents
Do not give this me dicine to children less than 12 years of age .
Other medicines and Aerius
There are no known interactions of Aerius with other medicines.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Aerius with food, drink and alcohol
Aerius may be taken with or without a meal.
Use caution when taking Aerius with alcohol.
Pregnancy , breast -feeding and fertility If you are pregnan t or breast -feeding, think you may be pregnant or are planning to have a baby, a sk your doctor or pharmacist for advice before taking this medicine .
Taking Aerius is not recommended i f 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 m ost 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 medicin e.
Aerius 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 medicin e.
3. How to take Aerius 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 f or oral use.
Swallow the tablet whole .
Regarding the duration of treatment, your physician will det ermine the type of allergic rhinitis you are suffering from and will determine for how long you should take Aerius.
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 Aerius than you should
Take Aerius only as it is prescribed for you. No serious problems are expected with accidental overdose. However, if you take more Aerius than you were told to, tell your doctor , pharmacist or nurse immediately .
If you forget to take Aerius
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 Aerius
If you have any further questions on the use of this medicine, ask your doc tor, pharmacist or nurse.
4. Possible side effects Like all medicines, this medicine can cause side effects, although not everybody gets them.
During the marketing of Aerius , 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 Aerius, 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 Aerius, 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
- change s 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.
5. How to store Aerius Keep this medicine out of the sight and reach of children.
Do not use this medicine after the exp iry 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 m edicines via wastewater or household waste. Ask your pharmac ist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What Aerius contains
- The active substance is desloratadine 5 mg
- The other ingredients of the table t are calcium hydrogen phosphate dihydrate, microcrystalline
cellulose, maize starch, talc. Tablet coating contains film coat (containing lactose monohydrate (see section 2 “Aerius tablet contains lactose ”), hypromellose, titanium dioxide, macrogol 400, indigotin (E132)), clear coat (containing hypromellose, macrogol 400), carnauba wax, white wax.
What Aerius looks like and contents of the pack
Aerius 5 mg film -coated tablet is light blue, round and embossed with “C5” on one side and plain on the other.
Aerius 5 mg film -coated tablets are packed in blisters in packs of 1, 2, 3, 5, 7, 10, 14, 15, 20, 21, 30, 50, 90 or 100 tablets.
Not all pack sizes may be marketed.
Marketing Auth orisation 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 medicin e, please contact the local representative of the Marketing Authorisation Holder:
België/Belgique/Belgien Organon Belgium Tél/Tel: 0080066550123 (+32 2 2418100) [email protected] Lietuva Organon Pharma B.V. Lithuania atstovybė Tel.: +370 52041693 [email protected] България Органон (И.А.) Б.В. – клон България Тел.: +359 2 806 3030 [email protected] Luxembourg/Luxemburg Organon Belgium Tél/Tel: 0080066550123 (+32 2 2418100) [email protected] Česká republika Organon Czech Republic s.r.o.
Tel.: +420 233 010 300 [email protected] Magyarország Organon Hungary Kft.
Tel.: +36 1 766 1963 [email protected] Danmark Organon Denmark ApS Tlf: +45 448 4 6800 info.denmark @organon .com Malta Organon Pharma B .V., Cyprus branch Tel: +356 2277 8116 [email protected] Deutschland Organon Healthcare GmbH Tel: 0800 3384 726 (+49 (0) 89 2040022 10 ) [email protected] Nederland N.V. Organon Tel.: 00800 66550123 (+32 2 2418100 ) [email protected] Eesti Organon Pharma B.V. Estonian RO Tel: +372 66 61 300 [email protected] Norge Organon Norway AS Tlf: +47 24 14 56 60 [email protected] Ελλάδα BIANEΞ Α.Ε .
Τηλ: +30 210 80091 11 [email protected] Österreich Organon Healthcare GmbH Tel: +49 (0) 89 2040022 10 [email protected] España Organon Salud, S.L.
Tel: +34 91 591 12 79 [email protected] Polska Organon Polska Sp. z o.o.
Tel.: +48 22 105 50 01 [email protected] France Organon France Tél: +33 (0) 1 57 77 32 00 Portugal Organon Portugal, Sociedade Unipessoal Lda.
Tel: +351 218705500 [email protected] Hrvatska Organon Pharma d.o.o.
Tel: +385 1 638 4530 [email protected] România Organon Biosciences S.R.L.
Tel: +40 21 527 29 90 [email protected] Ireland Organon Pharma (Ireland) Limited Tel: +353 15828260 [email protected] Slovenija Organon Pharma B.V., Oss, podružnica Ljubljana Tel: +386 1 300 10 80 [email protected] Ísland Vistor hf.
Sími: +354 535 7000 Slovenská republika Organon Slovakia s. r. o.
Tel: +421 2 44 88 98 88 [email protected] Italia Organon Italia S.r.l.
Tel: +39 06 90259059 [email protected] Suomi/Finland Organon Finland Oy Puh/Tel: +358 (0) 29 170 3520 [email protected] Κύπρος Organon Pharma B.V., Cyprus branch Τηλ: +357 22866730 [email protected] Sverige Organon Sweden AB Tel: +46 8 502 597 00 [email protected] Latvija Ārvalsts komersanta “Organon Pharma B.V.” pārstāvniecība Tel: +371 66968876 [email protected] United Kingdom (Northern Ireland) Organon Pharma ( UK) Limited Tel: + 44 (0) 208 159 3593 [email protected]
This leaflet was last revised in <{MM/YYYY}><{month YYYY}>
Detailed information on this medicin e is available on the European Medicines Agency website https://www.ema.europa.eu .
Package leaflet: Information for the patient Aerius 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 rea d 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 ef fects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.
ℹ️ 1. What Aerius oral solution is and what it is used for
What Aerius is Aerius contains deslora tadine which is an antihistamine.
How Aerius works
Aerius oral solution is an antiallergy medicine that does not make you drowsy. It helps control your allergic reaction and its symptoms.
When Aerius should be used Aerius oral solution relieves symptoms associated with allergic rhinitis (inflammation of the nasal passages caused by an allergy, for exam ple, hay fever or allergy to dust mites) in adults, adolescents and children 1 year of age and older . These symptoms include sneezing, runny or itchy nose, itchy palate, and itchy, red or watery eyes.
Aerius oral solution 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.
⚠️ 2. What you need to know b efore you take Aerius oral solution
Do not take Aerius oral solution
- if you are allergic to desloratadine, or to any of the other ingredients of this medicine (listed in section 6) or to loratadine .
Warnings and precautions
Talk to your doctor, p harmacist or nurse before taking Aerius:
- 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 1 year of age .
Other medicines and Aerius
There are no known interactions of Aerius with other medicines.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Aerius oral solution with food , drink and alcohol Aerius may be taken with or without a meal.
Use ca ution when taking Aerius 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 Ae rius oral solution is not recommended i f you are pregnant or nursing a baby.
There is no data available on male/female fertility.
Driving and using machines
At the recommended d ose, 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 dr iving a car or operating machinery until you have established your own response to the medicin e.
Aerius oral solution contains sorbitol (E420)
This medicine contains 150 mg sorbitol (E420) in each m l of oral solution.
Sorbitol is a source of fructose. If your doctor has told you that you (or your child) have an intolerance to some sugars or if you have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which a pers on cannot break down fructose, talk to your doctor before you (or your child) take or receive this medicine.
Aerius oral solution contains propylene glycol (E1520)
This medicine contains 100.19 mg propylene glycol (E1520) in each m l of oral solution.
Aerius oral solution contains sodium
This medicin e contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium -free’ .
Aerius oral solution contains benzyl alcohol
This medicine contains 0. 375 mg benzyl alcohol in each ml of oral solution.
Benzyl alcohol may cause allergic reactions.
Do not use for more than a week in young children (less than 3 years old), unless advised by your doctor or pharmacist.
Ask your doctor or pharmacist for advice i f you have a liver or kidney disease. This is because large amounts of benzyl alcohol can build -up in your body and may cause side effects (called “metabolic acidosis”).
Ask your doctor or pharmacist for advice if you are pregnant or breast -feeding. This is because large amounts of benzyl alcohol can build -up in your body and may cause side effects (called “metabolic acidosis”).
💊 3. How to take Aerius oral solution
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 children Children 1 through 5 years of age:
The recommended dose is 2.5 ml (½ of a 5 ml spoonful) of oral so lution once a day.
Children 6 through 11 years of age:
The recommended dose is 5 ml (one 5 ml spoon ful) of oral solution once a day.
Use in adults and adolescents 12 years of age and over The recomm ended dose is 10 ml (two 5 ml spoonfuls) of oral solution once a day.
In case an oral measuring syringe is provided with the bottle of oral solution, you can alternatively use it to take the appropriate amount of oral solution.
This medicine is for oral use.
Swallow the dose of oral solution and then drink some water. You can take this medicine with or without food.
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 Aerius ora l solution.
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 Aerius oral solution than you should
Take Aerius oral solution only as it is prescribed for you. No serious problems are expected with accidental overdose. However, if you take more Aerius oral solution than you were told to, tell your doctor, pharmacist or nurse immediately .
If you forget t o take Aerius oral solution 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 ma ke up for a forgotten dose.
If you stop taking Aerius oral solution
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
❗ 4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
During the marketing of Aerius, 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 most children and adults, side effects with Aerius were about the same as with a dummy solution or tablet. However, common side effects in children less than 2 years of age were diarrhoea, fever and insomnia while in adults, fatigue, dry mouth and headache were reported more often than with a dummy tablet.
In clinical studies with Aerius, the following side effects were reported as:
Common: the following may affect up to 1 in 10 people
- fatigue
- dry mouth
- headache
Children
Common in children less than 2 years of age: the following may affect up to 1 in 10 children
- diarrhoea
- fever
- insomnia During the marketing of Aerius, the following side effects were reported as:
Very rare: the following may aff ect 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 haz y sun, and to UV light, for instance to UV lights of a solarium
- change s 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 direc tly 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.
🌡️ 5. How to store Aerius oral solution
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 bottle after EXP. The expiry date refers to the last day of that month.
Do not freeze. Store in the original package.
Do not use this medicine if you notice any change in the appearance of the oral solution.
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.
📦 6. Contents of the pack and other information
What Aerius oral solution contains
- The active substance is desloratadine 0.5 mg/ml
- The other ingredients of the oral solution are sorbitol (E420) , propylene glycol (E1520) (see
section 2 “Aerius oral solution contains sorbitol (E420) and propyl ene glycol (E1520) ”), sucralose (E955 ), hypromellose 2910, sodium citrate dihydrate, natural and artificial flavour
(bubblegum , which contains propyle ne glycol (E1520) and benzyl alcohol (see section 2
“Aerius oral solution contains benzyl alcohol”) ), citric acid anhydrous, disodium edetate and purified water.
What Aerius oral solution looks like and contents of the pack
Aerius oral solution is a clear, colourless solution.
Aerius oral solution is available in bottles of 30, 50, 60, 100, 120, 150, 225 and 300 ml, with a childproof cap. For all packages except the 150 ml bottl e, a measuring spoon is provided, marked for doses of 2.5 ml and 5 ml. For the 150 ml package, a measuring spoon or an oral measuring syringe is provided, marked for doses of 2.5 ml and 5 ml.
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 medicin e, please contact the local representative of the Marketing Authorisation Holder:
België/Belgique/Belgien Organon Belgium Tél/Tel: 0080066550123 (+32 2 2418100) [email protected] Lietuva Organon Pharma B.V. Lithuania atstovybė Tel.: +370 52041693 [email protected] България Органон (И.А.) Б.В. – клон България Тел.: +359 2 806 3030 dpoc .bulgaria @organon .com Luxembourg/Luxemburg Organon Belgium Tél/Tel: 0080066550123 (+32 2 2418100) [email protected] Česká republika Organon Czech Republic s.r.o.
Tel.: +420 233 010 300 [email protected] Magyarország Organon Hungary Kft.
Tel.: +36 1 766 1963 [email protected] Danmark Organon Denmark ApS Tlf: +45 448 4 6800 info.denmark @organon .com Malta Organon Pharma B.V., Cyprus branch Tel: +356 2277 8116 [email protected] Deutschland Organon Healthcare GmbH Tel: 0800 3384 726 (+49 (0) 89 2040022 10 ) [email protected] Nederland N.V. Organon Tel.: 00800 66550123 (+32 2 2418100 ) [email protected] Eesti Organon Pharma B.V. Estonian RO Tel: +372 66 61 300 [email protected] Norge Organon Norway AS Tlf: +47 24 14 56 60 [email protected] Ελλάδα BIANEΞ Α.Ε .
Τηλ: +30 210 80091 11 [email protected] Österreich Organon Healthcare GmbH Tel: +49 (0) 89 2040022 10 [email protected] España Organon Salud, S.L.
Tel: +34 91 591 12 79 [email protected] Polska Organon Polska Sp. z o.o.
Tel.: +48 22 105 50 01 [email protected] France Organon France Tél: +33 (0) 1 57 77 32 00 Portugal Organon Portugal, Sociedade Unipessoal Lda.
Tel: +351 218705500 [email protected] Hrvatska Organon Pharma d.o.o.
Tel: +385 1 638 4530 [email protected] România Organon Biosciences S.R.L.
Tel: +40 21 527 29 90 [email protected] Ireland Organon Pharma (Ireland) Limited Tel: +353 15828260 [email protected] Slovenija Organon Pharma B.V., Oss, podružnica Ljubljana Tel: +386 1 300 10 80 [email protected] Ísland Vistor hf.
Sími: + 354 535 7000 Slovenská republika Organon Slovakia s. r. o.
Tel: +421 2 44 88 98 88 [email protected] Italia Organon Italia S.r.l.
Tel: +39 06 90259059 [email protected] Suomi/Finland Organon Finland Oy Puh/Tel: +358 (0) 29 170 3520 [email protected] Κύπρος Organon Pharma B.V., Cyprus branch Τηλ: +357 22866730 [email protected] Sverige Organon Sweden AB Tel: +46 8 502 597 00 [email protected] Latvija Ārvalsts komersanta “Organon Pharma B.V.” pārstāvniecība Tel: +371 66968876 [email protected] United Kingdom (Northern Ireland) Organon Pharma ( UK) Limited Tel: + 44 (0) 208 159 3593 [email protected]
This leaflet was last revised in <{MM/YYYY}><{month YYYY}>
Detailed information on this medicin e is available on the European Medicines Agency website https://www.ema.e uropa.eu .
📄 Package Leaflet – official source
This article reproduces the information in the official package leaflet, as authorised in the European Union. You can consult the original document here: Product information Aerius (PDF, ec.europa.eu).
You can check this medicine at any time in the Union Register of medicinal products (EU number EU/1/00/160).
⚠️ Important: This article is for information purposes only and does not replace medical advice or the package leaflet inside the medicine box. Read the leaflet carefully before use. For any questions about your treatment, talk to your doctor or pharmacist. If you experience side effects, tell your doctor or pharmacist and report them through your national reporting system.