desloratadine: package leaflet

For patients

Package leaflet, verbatim

Aerius

Package leaflet: Aerius 5 mg film-coated tablets

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. 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 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 before 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 medicine 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 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 Aerius 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.

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 medicine.

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 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 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 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 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
- 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.

5. How to store Aerius

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.

6. Contents of the pack and other information

What Aerius 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 “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 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:

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

Lietuva
Organon Pharma B.V. Lithuania atstovybė
Tel.: +370 52041693 dpoc.lithuania@organon.com

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) dpoc.benelux@organon.com

Česká republika
Organon Czech Republic s.r.o.
Tel.: +420 277 051 010 dpoc.czech@organon.com

Magyarország
Organon Hungary Kft.
Tel.: +36 1 766 1963 dpoc.hungary@organon.com

Danmark
Organon Denmark ApS
Tlf: +45 4484 6800 dpoc.dk.is@organon.com

Malta
Organon Pharma B.V., Cyprus branch
Tel: +356 2277 8116 dpoc.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 61 300 dpoc.estonia@organon.com

Norge
Organon Norway AS
Tlf: +47 24 14 56 60 dpoc.norway@organon.com

Ελλάδα
BIANEΞ Α.Ε.
Τηλ: +30 210 80091 11
Mailbox@vianex.gr

Österreich
Organon Healthcare GmbH
Tel: +49 (0) 89 2040022 10 dpoc.austria@organon.com

España
Organon Salud, S.L.
Tel: +34 91 591 12 79 organon_info@organon.com
Polska
Organon Polska Sp. z o.o.
Tel.: +48 22 306 57 64 dpoc.poland@organon.com

France
Organon France
Tél: +33 (0) 1 57 77 32 00

Portugal
Organon Portugal, Sociedade Unipessoal Lda.
Tel: +351 218705500 geral_pt@organon.com

Hrvatska
Organon Pharma d.o.o.
Tel: +385 1 638 4530 dpoc.croatia@organon.com

România
Organon Biosciences S.R.L.
Tel: +40 21 527 29 90 dpoc.romania@organon.com

Ireland
Organon Pharma (Ireland) Limited
Tel: +353 15828260 medinfo.ROI@organon.com

Slovenija
Organon Pharma B.V., Oss, podružnica
Ljubljana
Tel: +386 1 300 10 80 dpoc.slovenia@organon.com

Ísland
Vistor ehf.
Sími: +354 535 7000

Slovenská republika
Organon Slovakia s. r. o.
Tel: +421 2 44 88 98 88 dpoc.slovakia@organon.com

Italia
Organon Italia S.r.l.
Tel: +39 06 90259059 dpoc.italy@organon.com

Suomi/Finland
Organon Finland Oy
Puh/Tel: +358 (0) 29 170 3520 dpoc.finland@organon.com

Κύπρος
Organon Pharma B.V., Cyprus branch
Τηλ: +357 22866730 dpoc.cyprus@organon.com

Sverige
Organon Sweden AB
Tel: +46 8 502 597 00 dpoc.sweden@organon.com

Latvija
Ārvalsts komersanta “Organon Pharma B.V.” pārstāvniecība
Tel: +371 66968876 dpoc.latvia@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 https://www.ema.europa.eu.

Package leaflet: Aerius 0.5 mg/ml oral solution

1. What Aerius oral solution is and what it is used for

What Aerius is
Aerius contains desloratadine which is an antihistamine.

How Aerius works
Aerius oral solution is an antiallergy medicine. 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 example, 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 before 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, 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 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 caution 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 Aerius oral solution is not recommended if you are pregnant or nursing a baby.
There is no data available on male/female fertility.

Aerius oral solution contains sorbitol (E420)
This medicine contains 150 mg sorbitol (E420) in each ml 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 person 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 ml of oral solution.

Aerius oral solution contains sodium
This medicine 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 if 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 solution once a day.

Children 6 through 11 years of age:
The recommended dose is 5 ml (one 5 ml spoonful) of oral solution once a day.

Use in adults and adolescents 12 years of age and over
The recommended 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 oral 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 to 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 make 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.

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:

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

change in the way the heart beats
abnormal behaviour

aggression

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 propylene glycol (E1520)”), sucralose (E955), hypromellose 2910, sodium citrate dihydrate, natural and artificial flavour (bubblegum, which contains propylene 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 bottle, 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.