Azomyr

Package leaflet: Information for the patient

Azomyr 5 mg film-coated tablets

desloratadine
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 pass it on to others, 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, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet

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

1. What Azomyr is and what it is used for

What Azomyr is
Azomyr contains desloratadine, which is an antihistamine.
How Azomyr works
Azomyr is an antiallergy medicine that does not cause drowsiness. 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 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, itching of the palate, and itchy, red or watery eyes.
Azomyr 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 for a full 24 hours, helping you resume your normal daily activities and improving your sleep.

2. What you need to know before taking Azomyr

Do not take Azomyr

• 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 Azomyr:

• 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 12 years of age.
Other medicines and Azomyr
No interactions between Azomyr and other medicines are known.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Azomyr with food, drinks and alcohol
Azomyr may be taken with or without food.
Use caution when taking Azomyr with alcohol.
Pregnancy, breast-feeding and fertility
If you are pregnant, think you may be pregnant or are planning to become pregnant, or if you are breast-feeding, ask your doctor or pharmacist for advice before taking this medicine.
The use of Azomyr is not recommended during pregnancy or while breast-feeding.
There are no data available regarding effects on male/female fertility.
Driving and using machines
At the recommended dose, this medicine is not expected to affect the ability to drive or operate 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.
Azomyr tablets contain lactose
If you have been diagnosed by your doctor with an intolerance to certain sugars, consult him/her before taking this medicine.

3. How to take Azomyr

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 Azomyr.
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, therefore you must follow your doctor's instructions.
If you take more Azomyr than you should
Take Azomyr only if it has been prescribed for you. No serious problems are expected following accidental intake of higher doses. However, if you take more Azomyr than prescribed, inform your doctor, pharmacist or nurse immediately.
If you forget to take Azomyr
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 Azomyr
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 everyone gets them.
During the marketing of Azomyr, 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 adults, side effects with Azomyr were similar to those observed with a tablet containing no active ingredient (placebo). However, fatigue, dry mouth and headache were reported more frequently than with a tablet containing no active ingredient (placebo). In adolescents, headache was the most commonly reported side effect.
In clinical studies with Azomyr, the following side effects were reported as:
Common: these may affect up to 1 in 10 people

• fatigue
• dry mouth
• headache

During the marketing of Azomyr, 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 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

• slowing of the heartbeat
• changes in heart rhythm
• abnormal behaviour
• aggression

Reporting of side effects
If you get any side effects, 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 listed in Annex V.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Azomyr

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after Scad. 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 the tablets.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Azomyr contains

• The active substance is desloratadine 5 mg.
• The other components of the tablet are calcium hydrogen phosphate dihydrate, microcrystalline cellulose, maize starch, talc. The tablet coating contains a film (containing lactose monohydrate (see section 2 “Azomyr tablets contain lactose”), hypromellose, titanium dioxide, macrogol 400, indigotine (E132)), a transparent coating (containing hypromellose, macrogol 400), carnauba wax, white wax.

Description of the appearance of Azomyr and contents of the pack
Azomyr 5 mg film-coated tablets are round, light blue tablets with “C5” marked on one side and smooth on the other.
Azomyr 5 mg film-coated tablets are packed in blisters containing 1, 2, 3, 5, 7, 10, 14, 15, 20, 21, 30, 50 or 100 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization 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 Authorization 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
N.V. Organon Organon Healthcare GmbH
Τηλ: +30-216 6008607 Tel: +49 (0) 89 2040022 10
[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.

Package leaflet: information for the patient

Azomyr 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 others, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet

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

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

What Azomyr is
Azomyr contains desloratadine, which is an antihistamine.
How Azomyr works
Azomyr oral solution is an antiallergic medicine that does not cause drowsiness. It helps control your allergic reaction and its symptoms.
When Azomyr should be used
Azomyr 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 or itchy nose, itching of the palate, and itchy, red or watery eyes.
Azomyr oral solution is also used to relieve symptoms associated with urticaria (a skin condition caused by an allergy). These symptoms include itching and wheals (hives).
Relief from these symptoms lasts throughout the day, helping you resume your normal daily activities and improving your sleep.

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

Do not take Azomyr 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 Azomyr:

• 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 Azomyr
No interactions between Azomyr and other medicines are known.
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Azomyr oral solution with food, drinks, and alcohol
Azomyr oral solution can be taken with or without food.
Use caution when taking Azomyr with alcohol.
Pregnancy, breastfeeding, and fertility
If you are pregnant, think you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
The use of Azomyr 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 engage in activities requiring mental alertness, such as driving a vehicle or operating machinery, until you know how this medicine affects you.
Azomyr 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 (or the child) 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.
Azomyr oral solution contains propylene glycol (E1520)
This medicine contains 100.19 mg of propylene glycol (E1520) in each ml of oral solution.
Azomyr oral solution contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e., essentially “sodium-free”.
Azomyr 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 (less than 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 Azomyr oral solution

Take this medicine exactly as your doctor or pharmacist has told you. 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 instead to administer 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 Azomyr 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 the 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 a long-term treatment.
In the case of urticaria, the duration of treatment may vary from patient to patient; therefore, you must
follow your doctor's instructions.
If you take more Azomyr oral solution than you should
Take Azomyr oral solution only if it has been prescribed for you. No serious problems are expected
following accidental intake of higher doses. However, if you take more Azomyr oral solution than
prescribed, inform your doctor, pharmacist or nurse immediately.
If you forget to take Azomyr 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 Azomyr oral solution
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 gets them.
During the marketing of Azomyr, 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 immediately and contact a doctor straight away.
In clinical studies, in most children and adults, side effects with Azomyr 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 occurred more frequently than with a tablet without active ingredient (placebo).
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

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

• diarrhoea
• fever
• insomnia

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

• severe allergic reactions
• 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 with overcast sun, and to UV (ultraviolet) light, for example UV lamps in a sunbed
• changes in the way the heart beats
• 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 the way the heart beats
• abnormal behaviour, aggression

Reporting of side effects
If you get 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 referred to in Annex V. Reporting side effects may help provide more information on the safety of this medicine.

5. How to store Azomyr 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 the 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 Azomyr 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 “Azomyr oral solution contains sorbitol (E420) and propylene glycol (E1520)”), sucralose (E955), hypromellose 2910, sodium citrate dihydrate, natural and artificial flavour (chewing gum flavour containing propylene glycol (E1520) and benzyl alcohol (see section 2 “Azomyr oral solution contains benzyl alcohol”)), anhydrous citric acid, disodium edetate and purified water.

Description of the appearance of Azomyr oral solution and contents of the pack
Azomyr oral solution is a clear, colourless solution.
Azomyr 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 graduated dosing spoon marked with 2.5 ml and 5 ml graduations. For the 150 ml pack, a dosing spoon and an oral dosing syringe graduated with 2.5 ml and 5 ml markings are supplied.
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 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]

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
N.V. Organon Organon Healthcare GmbH
Τηλ: +30-216 6008607 Tel: +49 (0) 89 2040022 10
[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 21 8705500
[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 website of the European Medicines Agency: https://www.ema.europa.eu.