Aerius: detailed information

Package leaflet: Information for the patient

Aerius 5 mg film-coated tablets

desloratadine
Please read this leaflet carefully before taking this medicine because it contains
important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor, pharmacist, or nurse.
This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as yours, because it could be harmful.
If you experience any side effects, including those not listed in this leaflet, consult your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet

What Aerius is and what it is used for
What you need to know before taking Aerius
How to take Aerius
Possible side effects
How to store Aerius
Contents of the pack and other information

1. What is Aerius and what is it used for

What is Aerius
Aerius contains desloratadine, which is an antihistamine.
How Aerius works
Aerius is an antiallergic medicine that does not cause drowsiness. 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 allergy, such as hay fever or dust mite allergy) in adults and adolescents aged 12 years and older. These symptoms include sneezing, runny or itchy nose, itchy palate, and itchy, red or watery eyes.
Aerius is also used to relieve symptoms associated with urticaria (a skin condition caused by an allergy). These symptoms include itching and hives (wheals).
Relief from these symptoms lasts throughout the day, helping you resume your normal daily activities and improve your sleep.

2. What you need to know before taking Aerius

Do not take Aerius

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 reduced kidney function.
if you or your family have a history of seizures.

Children and adolescents
Do not give this medicine to children under 12 years of age.
Other medicines and Aerius
No interactions between Aerius and other medicines are known.
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Aerius with food, drinks and alcohol
Aerius can be taken with or without food.
Use caution when taking Aerius with alcohol.
Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
The use of Aerius is not recommended during pregnancy or while breastfeeding.
There are no available data 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 machinery. Although most people do not experience drowsiness, it is recommended not to engage in activities requiring mental alertness, such as driving a vehicle or operating machinery, until you know how this medicine affects you.
Aerius tablets contain lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.

3. How to take Aerius

Take this medicine exactly as directed by your doctor or pharmacist. If
you have any doubts, consult your doctor or pharmacist.
Use in adults and adolescents aged 12 years and older
The recommended dose is one tablet once daily with water, with or without food.
This medicine is for oral use.
Swallow the tablet whole.
Regarding the duration of treatment, your doctor will determine the type of allergic rhinitis you have
and how long you should take Aerius.
If your allergic rhinitis is intermittent (symptoms present for less than 4 days per week or for less than
4 weeks), your doctor will prescribe a treatment regimen based on an assessment of your medical
history.
If your allergic rhinitis is persistent (symptoms present for 4 or more days per week and for more than
4 weeks), your doctor may prescribe long-term treatment.
In the case of urticaria, the duration of treatment may vary from patient to patient, so you must follow
your doctor’s instructions.
If you take more Aerius than you should
Take Aerius only if it has been prescribed for you. No serious problems are expected following
accidental overdose. However, if you take more Aerius than prescribed, inform your doctor,
pharmacist, or nurse immediately.
If you forget to take Aerius
If you forget to take your dose at the prescribed time, take it as soon as possible and then continue
your treatment as usual. Do not take a double dose to make up for the missed dose.
If you stop taking Aerius
If you have any doubts about using this medicine, consult your doctor, pharmacist, or
nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will get them.
During the marketing of Aerius, very rare cases of serious allergic reactions (difficulty breathing, wheezing, itching, hives, and swelling) have been reported. If you notice any of these serious side effects, stop taking the medicine and contact a doctor immediately.

In clinical studies in adults, side effects with Aerius were similar to those observed with a tablet without active ingredient (placebo). However, fatigue, dry mouth, and headache were reported more frequently than with a placebo tablet. In adolescents, headache was the most commonly reported side effect.

In clinical studies with Aerius, the following side effects have been 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 have been reported as:
Very rare: the following may affect up to 1 in 10,000 people

serious allergic reactions
skin rash
pounding or irregular heartbeat
rapid heartbeat
stomach ache
feeling unwell (nausea)
vomiting
stomach discomfort
diarrhoea
dizziness
drowsiness
difficulty sleeping (insomnia)
muscle pain
hallucinations
seizures
restlessness with increased body movement
liver inflammation
changes in 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 sunlight, even on cloudy days, and to UV (ultraviolet) light, for example from UV lamps in a solarium
changes in heart rhythm
abnormal behaviour
aggression
weight gain, increased appetite
depressed mood
dry eyes

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

slow heartbeat
changes in heart rhythm
abnormal behaviour
aggression

Reporting of side effects
If you get any side effects, including any not listed in this leaflet, talk to your doctor, pharmacist, or nurse. You can also report side effects directly via the national reporting system referred to in Annex 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. or EXP. The expiry date refers to the last day of that month.
Do not store above 30°C. Store in the original packaging.
Do not use this medicine if you notice any changes in the appearance of Aerius tablets.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This 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, corn starch, and talc. The tablet coating contains a film (containing lactose monohydrate (see section 2 “Aerius tablets contain lactose”), hypromellose, titanium dioxide, macrogol 400, indigotine (E132)), a transparent coating (containing hypromellose, macrogol 400), carnauba wax, and white wax.

Description of the appearance of Aerius and contents of the pack
Aerius 5 mg film-coated tablets are round, light blue tablets, with “C5” engraved on one side and smooth on the other.
Aerius 5 mg film-coated tablets are packed in blisters in pack sizes 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 further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien Lietuva
Organon Belgium Organon Pharma B.V. Lithuania atstovybė
Tél/Tel: 0080066550123 (+32 2 2418100) Tel.: +370 52041693
[email protected] [email protected]

България Luxembourg/Luxemburg
Органон (И.А.) Б.В. - клон България Organon Belgium
Тел.: +359 2 806 3030 Tél/Tel: 0080066550123 (+32 2 2418100)
[email protected] [email protected]

Česká republika Magyarország
Organon Czech Republic s.r.o. Organon Hungary Kft.
Tel.: +420 233 010 300 Tel.: +36 1 766 1963
[email protected] [email protected]

Danmark Malta
Organon Denmark ApS Organon Pharma B.V., Cyprus branch
Tlf: +45 4484 6800 Tel: +356 2277 8116
[email protected] [email protected]

Deutschland Nederland
Organon Healthcare GmbH N.V. Organon
Tel: 0800 3384 726 (+49 (0) 89 2040022 10) Tel.: 00800 66550123
[email protected] (+32 2 2418100)
[email protected]

Eesti Norge
Organon Pharma B.V. Estonian RO Organon Norway AS
Tel: +372 66 61 300 Tlf: +47 24 14 56 60
[email protected] [email protected]

Ελλάδα Österreich
BIANEΞ Α.Ε. Organon Healthcare GmbH
Τηλ: +30 210 80091 11 Tel: +49 (0) 89 2040022 10
[email protected] [email protected]

España Polska
Organon Salud, S.L. Organon Polska Sp. z o.o.
Tel: +34 91 591 12 79 Tel.: +48 22 105 50 01
[email protected] [email protected]

France Portugal
Organon France Organon Portugal, Sociedade Unipessoal Lda.
Tél: +33 (0) 1 57 77 32 00 Tel: +351 218705500
[email protected]

Hrvatska România
Organon Pharma d.o.o. Organon Biosciences S.R.L.
Tel: +385 1 638 4530 Tel: +40 21 527 29 90
[email protected] [email protected]

Ireland Slovenija
Organon Pharma (Ireland) Limited Organon Pharma B.V., Oss, podružnica Ljubljana
Tel: +353 15828260 Tel: +386 1 300 10 80
[email protected] [email protected]

Ísland Slovenská republika
Vistor hf. Organon Slovakia s. r. o.
Sími: +354 535 70 00 Tel: +421 2 44 88 98 88
[email protected]

Italia Suomi/Finland
Organon Italia S.r.l. Organon Finland Oy
Tel: +39 06 90259059 Puh/Tel: +358 (0) 29 170 3520
[email protected] [email protected]

Κύπρος Sverige
Organon Pharma B.V., Cyprus branch Organon Sweden AB
Τηλ: +357 22866730 Tel: +46 8 502 597 00
[email protected] [email protected]

Latvija United Kingdom (Northern Ireland)
Ārvalsts komersanta “Organon Pharma B.V.” Organon Pharma (UK) Limited
pārstāvniecība Tel: +44 (0) 208 159 359
Tel: +371 66968876 [email protected]
[email protected]

More detailed information on this medicinal product 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
Please read this leaflet carefully before taking this medicine because it contains
important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor, pharmacist, or nurse.
This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as you, because it may be harmful.
If you experience any side effects, including those not listed in this leaflet, consult your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet

What Aerius oral solution is and what it is used for
What you need to know before taking Aerius oral solution
How to take Aerius oral solution
Possible side effects
How to store Aerius oral solution
Contents of the pack and other information

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

What is Aerius
Aerius contains desloratadine, which is an antihistamine.
How Aerius works
Aerius oral solution is an antiallergic medicine that does not cause drowsiness. 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 due to allergy, for example, hay fever or dust mite allergy) in adults, adolescents, and children aged 1 year and older. These symptoms include sneezing, runny nose, nasal itching, itching of the palate, and itchy, red, or watery eyes.
Aerius oral solution is also used to relieve symptoms associated with urticaria (a skin condition caused by an allergy). These symptoms include itching and hives (wheals).
Relief from these symptoms lasts throughout the day, helping you resume your normal daily activities and improve your sleep.

2. What you need to know before taking Aerius oral solution

Do not take Aerius oral solution

if you are allergic to desloratadine, 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 reduced kidney function.
if you have a personal or family history of seizures.

Children and adolescents
Do not give this medicine to children under 1 year of age.
Other medicines and Aerius
No interactions between Aerius and other medicines are known.
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Aerius oral solution with food, drinks, and alcohol
Aerius may be taken with or without food.
Use caution when taking Aerius with alcohol.
Pregnancy, breastfeeding, and fertility
If you are pregnant, think you might be pregnant, planning to become pregnant, or breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
The use of Aerius oral solution is not recommended during pregnancy or while breastfeeding.
There are no available data on male/female fertility.
Driving and using machines
At the recommended dose, this medicine is not expected to affect the ability to drive or use machinery. Although most people do not experience drowsiness, it is recommended not to undertake activities requiring mental alertness, such as driving a vehicle or operating machinery, until you know how this medicine affects you.
Aerius oral solution contains sorbitol (E420)
This medicine contains 150 mg of sorbitol (E420) in each ml of oral solution.
Sorbitol is a source of fructose. If your doctor has told you that you (or the child) have an intolerance to certain sugars or if you have been diagnosed with hereditary fructose intolerance, a rare genetic disorder in which patients cannot metabolize fructose, speak with your doctor before you (or the child) take or receive this medicine.
Aerius oral solution contains propylene glycol (E1520)
This medicine contains 100.19 mg of propylene glycol (E1520) in each ml of oral solution.
Aerius oral solution contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e., essentially "sodium-free".
Aerius oral solution contains benzyl alcohol
This medicine contains 0.375 mg of benzyl alcohol in each ml of oral solution.
Benzyl alcohol may cause allergic reactions.
Do not use for more than one week in young children (under 3 years of age) unless otherwise recommended by a doctor or pharmacist.
Consult your doctor or pharmacist if you have liver or kidney disease. This is because large amounts of benzyl alcohol may accumulate in the body and cause undesirable effects (such as metabolic acidosis).
Consult your doctor or pharmacist if you are pregnant or breastfeeding. This is because large amounts of benzyl alcohol may accumulate in the body and cause undesirable effects (such as metabolic acidosis).

3. How to take Aerius oral solution

Take this medicine exactly as directed by your doctor or pharmacist. If
you have any doubts, consult your doctor or pharmacist.
Use in children
Children aged 1 to 5 years:
The recommended dose is 2.5 ml (½ of a 5 ml spoon) of oral solution once daily.
Children aged 6 to 11 years:
The recommended dose is 5 ml (one 5 ml spoon) of oral solution once daily.
Use in adults and adolescents aged 12 years and older
The recommended dose is 10 ml (two 5 ml spoons) of oral solution once daily.
If an oral dosing syringe is provided with the bottle of oral solution, it may be used as an alternative to measure the correct amount of oral solution.
This medicine is for oral use.
Swallow the dose of oral solution and then drink some water. You may take this medicine with or
without food.
Regarding the duration of treatment, your doctor will determine the type of allergic rhinitis you have and how long you should take Aerius oral solution.
If your allergic rhinitis is intermittent (symptoms present for less than 4 days per week or for less than 4 weeks), your doctor will prescribe a treatment regimen based on an assessment of your medical history.
If your allergic rhinitis is persistent (symptoms present for 4 or more days per week and for more than 4 weeks), your doctor may prescribe long-term treatment.
In the case of urticaria, the duration of treatment may vary from patient to patient, so you must follow your doctor's instructions.
If you take more Aerius oral solution than you should
Take Aerius oral solution only if it has been prescribed for you. No serious problems are expected following accidental ingestion of excess doses. However, if you take more Aerius oral solution than prescribed, inform your doctor, pharmacist or nurse immediately.
If you forget to take Aerius oral solution
If you forget to take your dose at the prescribed time, take it as soon as possible and then continue your treatment as usual. Do not take a double dose to make up for the missed dose.
If you stop taking Aerius oral solution
If you have any doubts about how to use this medicine, consult 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, very rare cases of severe allergic reactions (difficulty breathing, wheezing, itching, hives, and swelling) have been reported. If you experience any of these serious side effects, stop taking the medicine and contact a doctor immediately.
In clinical studies, in most children and adults, side effects with Aerius were similar to those observed with a tablet or solution without active ingredient (placebo). However, common side effects in children under 2 years of age were diarrhoea, fever, and insomnia, whereas in adults, fatigue, dry mouth, and headache were reported more frequently than with a placebo tablet.
In clinical studies with Aerius, the following side effects were reported as:
Common: these may affect up to 1 in 10 people

fatigue
dry mouth
headache

Children
Common in children under 2 years of age: these may affect up to 1 in 10 children

diarrhoea
fever
insomnia

During the marketing of Aerius, the following side effects have been reported as:
Very rare: these may affect up to 1 in 10,000 people

severe allergic reactions
skin rash
pounding or irregular heartbeat
rapid heartbeat
stomach ache
feeling unwell (nausea)
vomiting
stomach discomfort
diarrhoea
dizziness
drowsiness
difficulty sleeping (insomnia)
muscle pain
hallucinations
seizures
restlessness with increased body movement
liver inflammation
changes in 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 sunlight, even on overcast days, and to UV light, for example from UV lamps in sunbeds
changes in heart rhythm
abnormal behaviour
aggression
weight gain, increased appetite
depressed mood
dry eyes

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

slow heartbeat
changes in heart rhythm
abnormal behaviour
aggression

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. You can also report side effects directly via the national reporting system detailed in Annex 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 stated on the bottle after "Exp". The expiry date refers to the last day of that month.
Do not freeze. Store in the original packaging.
Do not use this medicine if you notice any changes in the appearance of Aerius oral solution.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Aerius oral solution contains

The active substance is desloratadine 0.5 mg/ml.
The other components 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 dihydrate citrate, natural and artificial flavour (chewing gum flavour containing propylene glycol (E1520) and benzyl alcohol (see section 2 “Aerius oral solution contains benzyl alcohol”) ), anhydrous citric acid, disodium edetate and purified water.

Description of the appearance of Aerius oral solution and package contents
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 child-resistant cap. All pack sizes except the 150 ml pack are supplied with a dosing spoon graduated with markings for 2.5 ml and 5 ml doses. For the 150 ml pack, a dosing spoon and an oral dosing syringe graduated with markings for 2.5 ml and 5 ml doses are supplied.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
N.V. Organon
Kloosterstraat 6
5349 AB Oss
The Netherlands

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

For further information on this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien Lietuva
Organon Belgium Organon Pharma B.V. Lithuania atstovybė
Tél/Tel: 0080066550123 (+32 2 2418100) Tel.: +370 52041693
[email protected] [email protected]

Česká republika Magyarország
Organon Czech Republic s.r.o. Organon Hungary Kft.
Tel.: +420 233 010 300 Tel.: +36 1 766 1963
[email protected] [email protected]

Danmark Malta
Organon Denmark ApS Organon Pharma B.V., Cyprus branch
Tlf: +45 4484 6800 Tel: +356 2277 8116
[email protected] [email protected]

Deutschland Nederland
Organon Healthcare GmbH N.V. Organon
Tel: 0800 3384 726 (+49 (0) 89 2040022 10) Tel.: 00800 66550123 (+32 2 2418100)
[email protected] [email protected]

Eesti Norge
Organon Pharma B.V. Estonian RO Organon Norway AS
Tel: +372 66 61 300 Tlf: +47 24 14 56 60
[email protected] [email protected]

Ελλάδα Österreich
BIANEΞ Α.Ε. Organon Healthcare GmbH
Τηλ: +30 210 80091 11 Tel: +49 (0) 89 2040022 10
[email protected] [email protected]

España Polska
Organon Salud, S.L. Organon Polska Sp. z o.o.
Tel: +34 91 591 12 79 Tel.: +48 22 105 50 01
[email protected] [email protected]

France Portugal
Organon France Organon Portugal, Sociedade Unipessoal Lda.
Tél: +33 (0) 1 57 77 32 00 Tel: +351 218705500
[email protected]

Hrvatska România
Organon Pharma d.o.o. Organon Biosciences S.R.L.
Tel: +385 1 638 4530 Tel: +40 21 527 29 90
[email protected] [email protected]

Ireland Slovenija
Organon Pharma (Ireland) Limited Organon Pharma B.V., Oss, podružnica Ljubljana
Tel: +353 15828260 Tel: +386 1 300 10 80
[email protected] [email protected]

Ísland Slovenská republika
Vistor hf. Organon Slovakia s.r.o.
Sími: +354 535 70 00 Tel: +421 2 44 88 98 88
[email protected]

Italia Suomi/Finland
Organon Italia S.r.l. Organon Finland Oy
Tel: +39 06 90259059 Puh/Tel: +358 (0) 29 170 3520
[email protected] [email protected]

Κύπρος Sverige
Organon Pharma B.V., Cyprus branch Organon Sweden AB
Τηλ: +357 22866730 Tel: +46 8 502 597 00
[email protected] [email protected]

Latvija United Kingdom (Northern Ireland)
Ārvalsts komersanta “Organon Pharma B.V.” Organon Pharma (UK) Limited
pārstāvniecība Tel: +44 (0) 208 159 3593
Tel: +371 66968876 [email protected]
[email protected]

More detailed information on this medicinal product is available on the European Medicines Agency website: https://www.ema.europa.eu.