Azomyr - patient leaflet, side effects, dosage

B. PACKAGE LEAFLET

Package leaflet: Information for the patient

Azomyr 5 mg film-coated tablets desloratadine

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

• – Keep this leaflet. You may need to read it again.

• – If you have any further questions, ask your doctor, pharmacist or nurse.

• – This medicine has been prescribed for you only. Do not pass it on to others. It may harm them,

even if their signs of illness are the same as yours.

• – If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible

side effects not listed in this leaflet. See section 4.

What is in this leaflet

• 1. What Azomyr is and what it is used for

• 2. What you need to know before you take Azomyr

• 3. How to take Azomyr

• 4. Possible side effects

• 5. How to store Azomyr

• 6. Contents of the pack and other information

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 make you drowsy. It helps control your allergic reaction and its symptoms.

When Azomyr should be used

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

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

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

2. What you need to know before you take Azomyr

Do not take Azomyr

• – if you are allergic to desloratadine, or any of the other ingredients of this medicine (listed in

section 6) or to loratadine.

Warnings and precautions

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

• – if you have poor kidney function.

• – if you have medical or familial history of seizures.

Children and adolescents

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

Other medicines and Azomyr

There are no known interactions of Azomyr with other medicines.

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Azomyr with food, drink and alcohol

Azomyr may be taken with or without a meal.

Use caution when taking Azomyr with alcohol.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Taking Azomyr is not recommended if you are pregnant or nursing a baby.

There is no data available on male/female fertility.

Driving and using machines

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

Azomyr tablet contains lactose

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

3. How to take Azomyr

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

Use in adults and adolescents 12 years of age and over

The recommended dose is one tablet once a day with water, with or without food.

This medicine is for oral use.

Swallow the tablet whole.

Regarding the duration of treatment, your physician will determine the type of allergic rhinitis you are suffering from and will determine for how long you should take Azomyr.

If your allergic rhinitis is intermittent (presence of symptoms for less than 4 days per week or for less than 4 weeks), your physician will recommend you a treatment schedule that will depend on the evaluation of the history of your disease.

If your allergic rhinitis is persistent (presence of symptoms for 4 days or more per week and for more than 4 weeks), your physician may recommend you a longer term treatment.

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

If you take more Azomyr than you should

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

If you forget to take Azomyr

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

If you stop taking Azomyr

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

4. Possible side effects

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

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

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

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

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

• fatigue
• dry mouth
• headache

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

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

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

Not known: frequency cannot be estimated from the available data

• unusual weakness
• yellowing of the skin and/or eyes
• increased sensitivity of the skin to the sun, even in case of hazy sun, and to UV light, for instance

to UV lights of a solarium

• changes in the way the heart beats

abnormal behaviour

• aggression
• weight increased, increased appetite

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 inBy 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 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 Azomyr contains

• – The active substance is desloratadine 5 mg

• – The other ingredients of the tablet are calcium hydrogen phosphate dihydrate, microcrystalline

cellulose, maize starch, talc. Tablet coating contains film coat (containing lactose monohydrate (see section 2 “Azomyr tablet contains lactose”), hypromellose, titanium dioxide, macrogol 400, indigotin (E132)), clear coat (containing hypromellose, macrogol 400), carnauba wax, white wax.

What Azomyr looks like and contents of the pack

Azomyr 5 mg film-coated tablet is light blue, round and embossed with elongated letters “S” and “P” on one side and plain on the other.

Azomyr 5 mg film-coated tablets are packed in blisters in packs of 1, 2, 3, 5, 7, 10, 14, 15, 20, 21, 30, 50 or 100 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

N.V. Organon

Kloosterstraat 6

5349 AB Oss

The Netherlands

Manufacturer: SP Labo N.V., Industriepark 30, B-2220 Heist-op-den-Berg, Belgium.

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

Ireland Organon Pharma (Ireland) Limited Tel: +353 15828260	Slovenija Organon Pharma B.V., Oss, podružnica Ljubljana Tel: +386 1 300 10 80
Island Vistor hf. Simi: +354 535 7000	Slovenská republika Organon Slovakia s. r. o. Tel: +421 2 44 88 98 88
Italia Organon Italia S.r.l. Tel: +39 06 3336407	Suomi/Finland Organon Finland Oy Puh/Tel: +358 (0) 29 170 3520
Knnpog Organon Pharma B.V., Cyprus branch Tql: +357 22866730	Sverige Organon Sweden AB Tel: +46 8 502 597 00
Latvija Ärvalsts komersanta “Organon Pharma B.V.” pärstävnieciba Tel: +371 66968876	United Kingdom (Northern Ireland) Organon Pharma (Ireland) Limited Tel: +353 15828260

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

Detailed information on this medicine is available on the European Medicines Agency website

Package leaflet: Information for the patient

Azomyr 2.5 mg orodispersible tablets desloratadine

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

• – Keep this leaflet. You may need to read it again.

• – If you have any further questions, ask your doctor, pharmacist or nurse.

• – This medicine has been prescribed for you only. Do not pass it on to others. It may harm them,

even if their signs of illness are the same as yours.

• – If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible

side effects not listed in this leaflet. See section 4.

What is in this leaflet

• 1. What Azomyr orodispersible tablet is and what it is used for

• 2. What you need to know before you take Azomyr orodispersible ta­blet

• 3. How to take Azomyr orodispersible tablet

• 4. Possible side effects

• 5. How to store Azomyr orodispersible tablet

• 6. Contents of the pack and other information

1. What Azomyr orodispersible tablet is and what it is used for

What Azomyr is

Azomyr contains desloratadine which is an antihistamine.

How Azomyr works

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

When Azomyr should be used

Azomyr orodispersible tablet 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 6 years of age and older. These symptoms include sneezing, runny or itchy nose, itchy palate, and itchy, red or watery eyes.

Azomyr orodispersible tablet 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 Azomyr orodispersible tablet

Do not take Azomyr orodispersible tablet

• – if you are allergic to desloratadine, or any of the other ingredients of this medicine (listed in

section 6) or to loratadine.

Warnings and precautions

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

• – if you have poor kidney function.

• – if you have medical or familial history of seizures.

Children and adolescents

Do not give this medicine to children less than 6 years of age.

Other medicines and Azomyr

There are no known interactions of Azomyr with other medicines.

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Azomyr orodispersible tablet with food, drink and alcohol

Azomyr orodispersible tablet does not need to be taken with water or liquid. Additionally, Azomyr orodispersible tablet may be taken with or without a meal. Use caution when taking Azomyr with alcohol.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Taking Azomyr is not recommended if you are pregnant or nursing a baby.

There is no data available on male/female fertility.

Driving and using machines

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

Azomyr orodispersible tablet contains aspartame (E951)

This medicine contains 2.55 mg aspartame (E951) per dose of an orodispersible tablet. Aspartame (E951) is a source of phenylalanine. It may be harmful if you have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine builds up because the body cannot remove it properly.

Azomyr orodispersible tablet contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.

3. How to take Azomyr orodispersible tablet

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 two tablets once a day with or without food.

This medicine is for oral use.

Before using, carefully peel open the blister and remove the dose of orodispersible tablet without crushing it. Place it in your mouth and it will disperse immediately. Water or other liquid is not needed to swallow the dose. Take the dose immediately after removal from the blister.

Use in children from 6 to 11 years of age

The recommended dose is one tablet once a day 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 Azomyr orodispersible tablets.

If your allergic rhinitis is intermittent (presence of symptoms for less than 4 days per week or for less than 4 weeks), your physician will recommend you a treatment schedule that will depend on the evaluation of the history of your disease.

If your allergic rhinitis is persistent (presence of symptoms for 4 days or more per week and for more than 4 weeks), your physician may recommend you a longer term treatment.

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

If you take more Azomyr orodispersible tablet than you should

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

If you forget to take Azomyr orodispersible tablet

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 forgotten individual doses.

If you stop taking Azomyr orodispersible tablet

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

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

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

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

• fatigue
• dry mouth
• headache

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

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

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

Not known: frequency cannot be estimated from the available data

• unusual weakness
• yellowing of the skin and/or eyes
• increased sensitivity of the skin to the sun, even in case of hazy sun, and to UV light, for instance

to UV lights of a solarium

• changes in the way the heart beats
• abnormal behaviour
• aggression
• weight increased, increased appetite

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 inBy reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Azomyr orodispersible tablet

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.

Store in the original package.

Do not use this medicine if you notice any change in the appearance of Azomyr orodispersible tablet.

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 Azomyr orodispersible tablet contains

• – The active substance is desloratadine 2.5 mg

• – The other ingredients are microcrystalline cellulose, pregelatinized starch, sodium starch

glycolate, magnesium stearate, butylated methacrylate copolymer, crospovidone, sodium hydrogen carbonate, citric acid, colloidal silicon dioxide, ferric oxide, mannitol, aspartame (E951) (see section 2 “Azomyr orodispersible tablet contains aspartame (E951)”) and flavour Tutti-Frutti.

What Azomyr orodispersible tablet looks like and contents of the pack

Azomyr 2.5 mg orodispersible tablet is light red, speckled, and round with “K” branded on one side.

Azomyr orodispersible tablet is packed in unit dose blisters in packs of

5, 6, 10, 12, 15, 18, 20, 30, 50, 60, 90 and 100 doses of orodispersible tablet. 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: SP Labo N.V., Industriepark 30, B-2220 Heist-op-den-Berg, Belgium.

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

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

Detailed information on this medicine is available on the European Medicines Agency website

Package leaflet: Information for the patient

Azomyr 5 mg orodispersible tablets desloratadine

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

• – Keep this leaflet. You may need to read it again.

• – If you have any further questions, ask your doctor, pharmacist or nurse.

• – This medicine has been prescribed for you only. Do not pass it on to others. It may harm them,

even if their signs of illness are the same as yours.

• – If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible

side effects not listed in this leaflet. See section 4.

What is in this leaflet

• 1. What Azomyr orodispersible tablet is and what it is used for

• 2. What you need to know before you take Azomyr orodispersible ta­blet

• 3. How to take Azomyr orodispersible tablet

• 4. Possible side effects

• 5. How to store Azomyr orodispersible tablet

• 6. Contents of the pack and other information

1. What Azomyr orodispersible tablet is and what it is used for

What Azomyr is

Azomyr contains desloratadine which is an antihistamine.

How Azomyr works

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

When Azomyr should be used

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

Azomyr orodispersible tablet 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 Azomyr orodispersible tablet

Do not take Azomyr orodispersible tablet

• – if you are allergic to desloratadine, or any of the other ingredients of, this medicine (listed in

section 6) or to loratadine.

Warnings and precautions

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

• – if you have poor kidney function.

• – if you have medical or familial history of seizures.

Children and adolescents

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

Other medicines and Azomyr

There are no known interactions of Azomyr with other medicines.

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Azomyr orodispersible tablet with food, drink and alcohol

Azomyr orodispersible tablet does not need to be taken with water or liquid. Additionally, Azomyr orodispersible tablet may be taken with or without a meal. Use caution when taking Azomyr with alcohol.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Taking Azomyr is not recommended if you are pregnant or nursing a baby.

There is no data available on male/female fertility.

Driving and using machines

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

Azomyr orodispersible tablet contains aspartame (E951)

This medicine contains 5.10 mg aspartame (E951) per dose of an orodispersible tablet. Aspartame (E951) is a source of phenylalanine. It may be harmful if you have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine builds up because the body cannot remove it properly.

Azomyr orodispersible tablet contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.

3. How to take Azomyr orodispersible tablet

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 or without food.

This medicine is for oral use.

Before using, carefully peel open the blister and remove the dose of orodispersible tablet without crushing it. Place it in your mouth and it will disperse immediately. Water or other liquid is not needed to swallow the dose. Take the dose immediately after removal from the blister.

Regarding the duration of treatment, your physician will determine the type of allergic rhinitis you are suffering from and will determine for how long you should take Azomyr orodispersible tablets.

If your allergic rhinitis is intermittent (presence of symptoms for less than 4 days per week or for less than 4 weeks), your physician will recommend you a treatment schedule that will depend on the evaluation of the history of your disease.

If your allergic rhinitis is persistent (presence of symptoms for 4 days or more per week and for more than 4 weeks), your physician may recommend you a longer term treatment.

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

If you take more Azomyr orodispersible tablet than you should

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

If you forget to take Azomyr orodispersible tablet

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 forgotten individual doses.

If you stop taking Azomyr orodispersible tablet

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

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

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

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

• fatigue
• dry mouth
• headache

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

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

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

Not known: frequency cannot be estimated from the available data

• unusual weakness
• yellowing of the skin and/or eyes
• increased sensitivity of the skin to the sun, even in case of hazy sun, and to UV light, for instance

to UV lights of a solarium

• changes in the way the heart beats
• abnormal behaviour
• aggression
• weight increased, increased appetite

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 inBy reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Azomyr orodispersible tablet

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.

Store in the original package.

Do not use this medicine if you notice any change in the appearance of Azomyr orodispersible tablet.

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 Azomyr orodispersible tablet contains

• – The active substance is desloratadine 5 mg

• – The other ingredients are microcrystalline cellulose, pregelatinized starch, sodium starch

glycolate, magnesium stearate, butylated methacrylate copolymer, crospovidone, sodium hydrogen carbonate, citric acid, colloidal silicon dioxide, ferric oxide, mannitol, aspartame (E951) (see section 2 “Azomyr orodispersible tablet contains aspartame (E951)”) and flavour Tutti-Frutti.

What Azomyr orodispersible tablet looks like and contents of the pack

Azomyr 5 mg orodispersible tablet is light red, speckled, and round with “A” branded on one side. Azomyr orodispersible tablet is packed in unit dose blisters in packs of

5, 6, 10, 12, 15, 18, 20, 30, 50, 60, 90 and 100 doses of orodispersible tablet.

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: SP Labo N.V., Industriepark 30, B-2220 Heist-op-den-Berg, Belgium.

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

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

Detailed information on this medicine is available on the European Medicines Agency website

Package leaflet: Information for the patient

Azomyr 0.5 mg/ml oral solution desloratadine

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

• – Keep this leaflet. You may need to read it again.

• – If you have any further questions, ask your doctor, pharmacist or nurse.

• – This medicine has been prescribed for you only. Do not pass it on to others. It may harm them,

even if their signs of illness are the same as yours.

• – If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible

side effects not listed in this leaflet. See section 4.

What is in this leaflet

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

• 2. What you need to know before you take 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 antiallergy medicine that does not make you drowsy. 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 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.

Azomyr 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 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 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 Azomyr

There are no known interactions of Azomyr with other medicines.

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Azomyr oral solution with food, drink and alcohol

Azomyr may be taken with or without a meal.

Use caution when taking Azomyr with alcohol.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Taking Azomyr oral solution is not recommended if you are pregnant or nursing a baby.

There is no data available on male/female fertility.

Driving and using machines

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

Azomyr 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.

Azomyr oral solution contains propylene glycol (E1520)

This medicine contains 100.75 mg propylene glycol (E1520) in each ml of oral solution.

Azomyr oral solution contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium-free’.

Azomyr oral solution contains benzyl alcohol

This medicine contains 0.75 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 Azomyr 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 (^ 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 Azomyr 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 Azomyr oral solution than you should

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

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

In clinical studies in most children and adults, side effects with Azomyr 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 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 less than 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 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

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 inBy reporting side effects you can 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 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 Azomyr 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

What Azomyr oral solution looks like 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 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.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

N.V. Organon

Kloosterstraat 6

5349 AB Oss

The Netherlands

Manufacturer: SP Labo N.V., Industriepark 30, B-2220 Heist-op-den-Berg, Belgium.

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

Belgie/Belgiqu­e/Belgien

Organon Belgium

Tél/Tel: 0080066550123 (+32 2 2418100)

Efc^rapufl

OpraHOH (H.A.) E.B. – k.toh Etnrapua

Tea.: +359 2 806 3030

Česká republika

Organon Czech Republic s.r.o.

Tel.: +420 233 010 300

Danmark

Organon Denmark ApS

Tlf: +45 4484 6800

Deutschland

Organon Healthcare GmbH

Tel: 0800 3384 726 (+49 (0) 89 2040022 10)

Eesti

Organon Pharma B.V. Estonian RO

Tel: +372 66 61 300

EXXáSa

N.V. Organon

Tql: +30–216 6008607

España

Organon Salud, S.L.

Tel: +34 91 591 12 79

France

Organon France

Tél: +33 (0) 1 57 77 32 00

Hrvatska

Organon Pharma d.o.o.

Tel: +385 1 638 4530

Ireland

Organon Pharma (Ireland) Limited

Tel: +353 15828260

Lietuva

Organon Pharma B.V. Lithuania atstovybe

Tel.: +370 52041693

Luxembourg/Lu­xemburg

Organon Belgium

Tel/Tel: 0080066550123 (+32 2 2418100)

Magyarorszag

Organon Hungary Kft.

Tel.: +36 1 766 1963

Malta

Organon Pharma B.V., Cyprus branch

Tel: +356 2277 8116

Nederland

N.V. Organon

Tel.: 00800 66550123

(+32 2 2418100)

Norge

Organon Norway AS

Tlf: +47 24 14 56 60

Österreich

Organon Austria GmbH

Tel: +43 (0) 1 263 28 65

Polska

Organon Polska Sp. z o.o.

Tel.: +48 22 105 50 01

Portugal

Organon Portugal, Sociedade Unipessoal Lda.

Tel: +351 218705500

Romania

Organon Biosciences S.R.L.

Tel: +40 21 527 29 90

Slovenija

Organon Pharma B.V., Oss, podruznica

Ljubljana

Tel: +386 1 300 10 80

Ísland

Vistor hf.

Sími: +354 535 7000

Italia

Organon Italia S.r.l.

Tel: +39 06 3336407

Kvnpog

Organon Pharma B.V., Cyprus branch

Tql: +357 22866730

Latvija

Arvalsts komersanta “Organon Pharma B.V.”” parstavnieciba

Tel: +371 66968876

Slovenská republika

Organon Slovakia s. r. o.

Tel: +421 2 44 88 98 88

Suomi/Finland

Organon Finland Oy

Puh/Tel: +358 (0) 29 170 3520

Sverige

Organon Sweden AB

Tel: +46 8 502 597 00

United Kingdom (Northern Ireland)

Organon Pharma (Ireland) Limited

Tel: +353 15828260

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

Detailed information on this medicine is available on the European Medicines Agency website

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