Desloratadine Sandoz

Package leaflet: Information for the patient

Desloratadine Sandoz 5 mg film-coated tablets

Generic medicine
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 adverse reactions, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.

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

1. What Desloratadine Sandoz is and what it is used for

What Desloratadine Sandoz is
Desloratadine Sandoz contains desloratadine, which is an antihistamine.
How Desloratadine Sandoz works
Desloratadine Sandoz is an antiallergic medicine that does not cause drowsiness. It helps control your allergic reaction and its symptoms.
When Desloratadine Sandoz should be used
Desloratadine Sandoz relieves symptoms associated with allergic rhinitis (inflammation of the nasal passages caused by an allergy, such as hay fever or dust mite allergy) in adults and adolescents aged 12 years and older. These symptoms include sneezing, itching and runny nose, itching of the palate, redness, itching and watering of the eyes.
Desloratadine Sandoz 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 for a full day and helps restore normal daily activities and sleep.

2. What you need to know before taking Desloratadina Sandoz

Do not take Desloratadina Sandoz

• 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 Desloratadina Sandoz:

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

Children and adolescents
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Do not give this medicine to children under 12 years of age.
Other medicines and Desloratadina Sandoz
There are no known interactions between Desloratadina Sandoz and other medicines.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Desloratadina Sandoz with food, drinks and alcohol
Desloratadina Sandoz can be taken with or without food.
Use caution when taking Desloratadina Sandoz with alcohol.
Pregnancy, breastfeeding and fertility
If you are pregnant, think you might be pregnant or are planning to become pregnant, or if you are breastfeeding,
ask your doctor or pharmacist for advice before taking this medicine.
The use of Desloratadina Sandoz is not recommended during pregnancy or while breastfeeding.
Fertility
There are no data available on male/female fertility.
Driving and using machines
At the recommended dose, this medicine is not expected to impair your ability to drive or use machinery. However, since some people may experience drowsiness, it is recommended not to engage in activities requiring mental alertness, such as driving a car or operating machinery, until you know how this medicine affects you.

3. How to take Desloratadina Sandoz

Take this medicine exactly as prescribed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
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 Desloratadina Sandoz.

• If you have intermittent allergic rhinitis (symptoms present for less than 4 days per week or for less than 4 weeks), your doctor will prescribe a dosing regimen based on the assessment of your medical history.
• If you have persistent allergic rhinitis (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 Desloratadina Sandoz than you should
Take Desloratadina Sandoz only in the amount prescribed for you. Serious problems are not expected following accidental overdose. However, if you take more Desloratadina Sandoz than prescribed, inform your doctor, pharmacist, or nurse immediately.
If you forget to take Desloratadina Sandoz
If you forget to take your dose at the scheduled time, take it as soon as possible, then continue your treatment as usual. Do not take a double dose to make up for the missed dose.
If you stop taking Desloratadina Sandoz
FI_DESLORATADINA_SANDOZ fct-sol or 2510-06
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 will experience them.
During post-marketing experience with desloratadine, very rare cases of serious 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 seek immediate medical help.

In clinical studies in adults, side effects were similar to those with placebo (an inactive tablet). However, fatigue, dry mouth, and headache occurred more frequently than with placebo.
In adolescents, the most commonly reported side effect was headache.

The following side effects have been reported in clinical trials with desloratadine:
Common: may affect up to 1 in 10 people

• Fatigue
• Dry mouth
• Headache

Adults
During post-marketing use of desloratadine, the following side effects have been reported:
Very rare: may affect up to 1 in 10,000 people

• Severe allergic reactions
• Rash
• Pounding or irregular heartbeat
• Fast heartbeat
• Stomach discomfort
• Feeling unwell (nausea)
• Vomiting
• Stomach problems
• Diarrhoea
• Dizziness
• Drowsiness
• Insomnia
• Muscle pain
• Hallucinations
• Seizures
• Restlessness with increased body movements
• Liver inflammation
• Changes in liver function tests

Not known: frequency cannot be estimated from the available data

• Abnormal behaviour
• Aggressiveness
• Depressed mood
• Dry eyes
• Unusual weakness
• Yellowing of the skin and/or eyes (jaundice)

FI_DESLORATADINA_SANDOZ fct-sol or 2510-06

• Increased sensitivity of the skin to sunlight, even on cloudy days, and to UV rays, for example from sunbeds
• Changes in heart rhythm
• Weight gain
• Increased appetite

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

• Abnormal behaviour
• Aggressiveness
• Slowed heartbeat
• Changes in heart rhythm
• Weight gain
• Increased appetite

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. Side effects can also be reported directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. Reporting side effects helps provide more information on the safety of this medicine.

5. How to store Desloratadine Sandoz

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 on the blister after EXP. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
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 you no longer use. This will help protect the environment.

6. Package contents and other information

What Desloratadine Sandoz contains

• The active substance is desloratadine. Each film-coated tablet contains 5 mg of desloratadine.
• The other components are:
  Tablet core: Maize starch, microcrystalline cellulose, hypromellose, anhydrous colloidal silica, hydrogenated vegetable oil (type 1)
  Tablet coating: Blue Opadry® 03B50689 (hypromellose E464, titanium dioxide E171, Macrogol 400 E1521, indigo carmine aluminium lake E132)

Description of the appearance of Desloratadine Sandoz and contents of the pack
Desloratadine Sandoz is presented as blue, round, biconvex, film-coated tablets,
with the imprint “5” on one side. Diameter 6.50 ± 0.10 mm.
Desloratadine Sandoz is available in blister packs made of OPA/ALU/PVC/ALU and in blister packs made of
PVC/Aclar/ALU
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Pack sizes (unit doses):
1x1, 2x1, 3x1, 5x1, 7x1, 10x1, 14x1, 15x1, 20x1, 21x1, 30x1, 50x1, 90x1 and 100x1 film-coated tablets
Not all pack sizes may be marketed.
Pack sizes (non-unit doses):
1, 2, 3, 5, 7, 10, 14, 15, 20, 21, 30, 50, 90 and 100 film-coated tablets
Not all pack sizes may be marketed.

Marketing Authorization Holder
Sandoz S.p.A.
Viale Luigi Sturzo 43
20154 Milan
Italy

Manufacturer
Lek Pharmaceuticals d.d.
Verovškova 57, 1526 Ljubljana
Slovenia
Salutas Pharma GmbH
Otto-von-Guericke-Allee 1, 39179 Barleben
Germany
LEK S.A.
Administrative site
ul. Podlipie 16, 95-010 Stryków
Poland
Production site
ul. Domaniewska 50 C, 02-672 Warszawa
Poland
Lek Pharmaceuticals d.d.
Trimlini 2 D, 9220 Lendava
Slovenia

This medicinal product is authorized in the Member States of the European Economic Area under the following names:
Austria Desloratadin Sandoz 5 mg Filmtabletten
Belgium Desloratadin Sandoz 5 mg filmomhulde tabletten
Cyprus Desloratadine Sandoz
Denmark Desloratadine “Sandoz”
Finland Desloratadine Sandoz 5 mg kalvopäällystein en tabletti
France DESLORATADINE SANDOZ 5 mg comprimé pelliculé
Iceland Desloratadine Sandoz 5 mg filmuhùŏaŏar
Italy Desloratadina Sandoz
Luxembourg Desloratadine Sandoz 5 mg comprimés pelliculés
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Netherlands Desloratadine Sandoz 5 mg filmomhulde tabletten
Portugal Desloratadina Sandoz
Spain Desloratadina Sandoz 5 mg comprimidos recubiertos EFG
Sweden Desloratadine Sandoz 5 mg filmdragerade tabletter
FI_DESLORATADINA_SANDOZ fct-sol or 2510-06

Package leaflet: information for the patient

Desloratadine Sandoz 0.5 mg/ml oral solution

Generic medicine
Please read this entire leaflet carefully before taking this medicine, as 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 could be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

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

1. What Desloratadina Sandoz is and what it is used for

What Desloratadina Sandoz is
Desloratadina Sandoz contains desloratadine, which is an antihistamine.
How Desloratadina Sandoz works
Desloratadina Sandoz oral solution is an antiallergic medicine that does not cause drowsiness. It helps control your allergic reaction and its symptoms.
When Desloratadina Sandoz should be used
Desloratadina Sandoz oral solution relieves symptoms associated with allergic rhinitis (inflammation of the nasal passages caused by an allergy, such as hay fever or dust mite allergy) in adults, adolescents, and children aged 1 year and older. These symptoms include sneezing, itching and runny nose, itching of the palate, redness, itching and watering of the eyes.
Desloratadina Sandoz oral solution is also used to relieve symptoms associated with urticaria (a skin condition caused by an allergy). These symptoms include itching and hives.
Relief from these symptoms lasts for a full day, helping you resume normal daily activities and sleep.

2. What you need to know before taking Desloratadine Sandoz

Do not take Desloratadine Sandoz

• 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 Desloratadine Sandoz:

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

Use in children and adolescents
FI_DESLORATADINE_SANDOZ fct-sol or 2510-06
Do not give this medicine to children under 1 year of age.
Other medicines and Desloratadine Sandoz
There are no known interactions between Desloratadine Sandoz and other medicines.
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Desloratadine Sandoz with food, drinks, and alcohol
Desloratadine Sandoz may be taken with or without food.
Use caution when taking Desloratadine Sandoz with alcohol.
Pregnancy, breastfeeding, and fertility
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
The use of Desloratadine Sandoz oral solution is not recommended during pregnancy or while breastfeeding.
Fertility
There are no data available on male/female fertility.
Driving and using machines
At the recommended dose, this medicine is not expected to impair your 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 car or operating machinery, until you know how this medicine affects you.
Desloratadine Sandoz oral solution contains sorbitol, propylene glycol, and sodium
This medicine contains up to 97.5 mg of sorbitol 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 certain sugars, or if you have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which patients cannot metabolize fructose, speak with your doctor before you (or your child) take or receive this medicine.
This medicine contains 102.3 mg of propylene glycol per each ml of oral solution.
This medicine contains 38.5 mg of sodium (the main component of table salt) per ml of oral solution. This is equivalent to 0.19% of the maximum daily sodium intake for an adult.

3. How to take Desloratadina Sandoz

Take this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Children
Children from 1 to 5 years of age:
The recommended dose is 2.5 ml (½ measuring spoon of 5 ml) of oral solution once daily.
Children from 6 to 11 years of age:
The recommended dose is 5 ml (one 5 ml measuring spoon) of oral solution once daily.
Adults and adolescents aged 12 years and older
The recommended dose is 10 ml (two 5 ml measuring spoons) of oral solution once daily.
If the oral solution bottle is equipped with an oral dosing syringe, you may use it instead to measure the
appropriate amount of oral solution.
This medicine is for oral use.
FI_DESLORATADINA_SANDOZ fct-sol or 2510-06
Swallow the dose of oral solution, then drink some water. You may take this medicine with or without
food.
How to measure the dose
This medicine comes with a dosing spoon marked for 2.5 ml and 5 ml doses, or with a 5 ml dosing syringe
marked every 0.5 ml. To measure the medicine using the syringe:

• remove the cap from the bottle and place it in a safe place
• insert the tip of the syringe into the solution
• pull the plunger back to draw up the prescribed dose
• remove the syringe from the bottle and close the bottle.

If, after drawing up the solution, you notice air bubbles in the syringe, rotate it into an upright position with the tip pointing upwards. The air will rise to the top of the syringe. Pull the plunger back again, then gently push it to eliminate the bubbles. Do not be concerned if a few tiny bubbles remain.
If you need advice on how to measure the correct amount of medicine, consult your doctor or pharmacist.
How to administer the medicine using the syringe:

• ensure the child is held in an upright position
• gently insert the tip of the syringe into the child's mouth, directing it towards the inside of the cheek
• slowly press the syringe plunger: do not spray the medicine rapidly. The solution will flow slowly into the child's mouth
• allow the child time to swallow the medicine.

Regarding the duration of treatment, your doctor will determine the type of allergic rhinitis you have and
how long you should take Desloratadina Sandoz 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 dosing regimen based on an evaluation 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 Desloratadina Sandoz than you should
Take Desloratadina Sandoz oral solution only in the amount prescribed for you. Serious problems are not expected
following accidental overdose. However, if you take more Desloratadina Sandoz
oral solution than prescribed, inform your doctor, pharmacist or nurse immediately.
If you forget to take Desloratadina Sandoz
If you forget to take your dose at the prescribed time, take it as soon as you remember, then continue your
treatment as usual. Do not take a double dose to make up for a missed dose.
If you stop taking Desloratadina Sandoz
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 everyone will experience them.
During post-marketing surveillance of desloratadine, 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 seek immediate medical attention.
In clinical studies involving most children and adults, side effects with Desloratadina Sandoz were similar to those observed with placebo (a solution or tablet without active ingredient). 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 placebo.
The following side effects have been reported in clinical studies with desloratadine:

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

• Diarrhoea
• Fever
• Insomnia

Adults
Common: may affect up to 1 in 10 people

• Fatigue
• Dry mouth
• Headache

The following side effects have been reported during post-marketing experience with desloratadine:

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

• Severe allergic reactions
• Skin rash
• Pounding or irregular heartbeat
• Fast heartbeat
• Stomach discomfort
• Feeling unwell (nausea)
• Vomiting
• Stomach disturbances
• Diarrhoea
• Dizziness
• Drowsiness
• Insomnia
• Muscle pain
• Hallucinations
• Seizures
• Restlessness with increased body movements
• Liver inflammation
• Changes in liver function tests

Not known: frequency cannot be estimated from the available data

• Abnormal behaviour
• Aggressiveness
• Unusual weakness
• Depressed mood
• Dry eyes
• Yellowing of the skin and/or eyes (jaundice)
• Increased sensitivity of the skin to sunlight, even on cloudy days, and to UV rays, for example from UV lamps in sunbeds
• Changes in heart rhythm
• Weight gain
• Increased appetite

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

• Abnormal behaviour
• Aggressiveness
• Slowed heartbeat
• Changes in heart rhythm
• Weight gain
• Increased appetite

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please inform your doctor or pharmacist. Side effects can also be reported directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse
Reporting side effects helps provide more information on the safety of this medicine.

5. How to store Desloratadine Sandoz

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 and outer carton after the word “EXP”. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Validity after first opening of the bottle: 2 months.
Do not use this medicine if you notice any changes in the appearance of the oral solution.
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. Package contents and other information

What Desloratadina Sandoz contains

• The active substance is desloratadine. Each ml of oral solution contains 0.5 mg of desloratadine.
• The other components of the oral solution are non-crystallizing liquid sorbitol (E420), propylene glycol, citric acid monohydrate, sodium citrate, hypromellose 2910, sucralose, disodium edetate, tutti frutti flavoring, purified water.

Description of the appearance of Desloratadina Sandoz and package contents
Clear, colourless solution.
The oral solution is packaged in amber Type III glass bottles closed with a child-resistant cap made of polypropylene, fitted with a multi-layer liner, the outer layer being polyethylene, and placed in a cardboard box.
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All packages are supplied with a CE-marked dosing spoon 0373, marked for 2.5 ml and 5 ml doses, or an oral dosing syringe CE 0373 with a total volume of 5 ml, marked every 0.5 ml.
Pack sizes:
50, 60, 100, 120 and 150 ml oral solution.
It is possible that not all pack sizes are marketed.

Marketing Authorization Holder
Sandoz S.p.A.
Viale Luigi Sturzo 43
20154 Milan
Italy

Manufacturer
Lek Pharmaceuticals d.d.
Verovškova 57, 1526 Ljubljana
Slovenia
Salutas Pharma GmbH
Otto-von-Guericke-Allee 1, 39179 Barleben
Germany
LEK S.A.
Administrative site
ul. Podlipie 16, 95-010 Stryków
Poland
Production site
ul. Domaniewska 50 C, 02-672 Warsaw
Poland
Balkanpharma Troyan AD
1 Krayrechna Str.
Troyan 5600
Bulgaria

This medicinal product is authorized in the European Economic Area countries under the following names:
Belgium Desloratadin Sandoz 0.5 mg/ml drink
Cyprus Desloratadine Sandoz
Denmark Desloratadine “Sandoz”
France DESLORATADINE SANDOZ 0.5 mg/ml solution buvable
Italy Desloratadina Sandoz
Netherlands Desloratadine Sandoz 0.5 mg/ml, drink
Portugal Desloratadina Sandoz
Romania DESLORATADINA SANDOZ 0.5 mg solutie oralã
Spain Desloratadina Sandoz 0.5 mg/ml solución oral EFG
FI_DESLORATADINA_SANDOZ fct-sol or 2510-06