Package Leaflet: Information for the Patient

Desloratadine Sandoz 0.5 mg/ml Oral Solution

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

-Keep this leaflet, as you may need to read it again.

-If you have any questions, ask your doctor, pharmacist or nurse.

-This medicine has been prescribed for you only. Do not give it to others even if they have the same symptoms as you, as it may harm them.

-If you experience any side effects, talk to your doctor, pharmacist or nurse, even if they are not listed in this leaflet. See section 4.

1.What is Desloratadine Sandoz 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.Storage of Desloratadine Sandoz

6.Contents of the pack and additional information

What is Desloratadina Sandoz

Desloratadina Sandoz contains desloratadine, which is an antihistamine.

How Desloratadina Sandoz works

Desloratadina Sandoz oral solution is an antiallergic medication that does not cause drowsiness. It helps control allergic reactions and their symptoms.

When to use Desloratadina Sandoz

Desloratadina Sandoz oral solution relieves symptoms associated with allergic rhinitis (inflammation of the nasal passages caused by an allergy, for example, hay fever or dust mite allergy) in adults, adolescents, and children aged 1 year and older. These symptoms include sneezing, runny nose or nasal itching, palate itching, eye redness, or tearing.

Desloratadine is also used to relieve symptoms associated with urticaria (skin disease caused by an allergy). These symptoms include itching and skin hives.

The relief of these symptoms lasts a full day and helps you continue your daily activities and normal sleep periods.

Do not take Desloratadina Sandoz

-if you are allergic to desloratadina or to any of the other ingredients of this medication (listed in section 6) or to loratadina.

Warnings and precautions

Consult your pharmacist or nurse before starting to take Desloratadina Sandoz:

-if you have a medical history or family history of seizures,

-if you have altered renal function.

Use in children and adolescents

Do not administer this medication to children under 1 year of age.

Desloratadina Sandoz use with other medications

No known interactions of desloratadina with other medications have been reported.

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

Desloratadina Sandoz use with food, drinks, and alcohol

Desloratadina can be taken with or without food.

Be cautious when taking desloratadina with alcohol.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Desloratadina is not recommended for use during pregnancy or breastfeeding.

Fertility

No data is available on male and female fertility.

Driving and operating machinery

At the recommended dose, this medication is not expected to affect your ability to drive or operate machinery. Although most people do not experience drowsiness, it is recommended not to perform activities that require a state of alertness, such as driving a car or operating machinery, until you have determined your own response to the medication.

Desloratadina Sandoz contains sorbitol, propylene glycol, and sodium

This medication containsup to 97.5 mg ofsorbitol per ml of oral solution.Sorbitol is a source of fructose. If your doctor has indicated that you (or your child) suffer from an intolerance to certain sugars, or have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disease in which the patient cannot break down fructose, consult your doctor (or your child) before taking this medication.

This medication contains 102.3 mg of propylene glycol per ml of oral solution.

This medication contains 3.85 mg of sodium (main component of table salt/for cooking) per ml of oral solution. This is equivalent to 0.19% of the maximum daily sodium intake recommended for an adult.

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Children

Children aged 1 to 5 years:

The recommended dose is 2.5 ml (half a 5 ml spoonful) of oral solution once a day.

Children aged 6 to 11 years:

The recommended dose is 5 ml (a 5 ml spoonful) of oral solution once a day.

Adults and adolescents (12 years of age and older):

The recommended dose is 10 ml (two 5 ml spoonfuls) of oral solution once a day.

If the desloratadine oral solution bottle comes with a dosing syringe, you can use it alternatively to administer the appropriate amount of oral solution.

This medication is for oral use.

Swallow the oral solution dose, and then drink a little water. You can take this medication with or without food.

How to measure the dose

This medication comes with a dosing spoon marked at 2.5 ml and 5 ml or a 5 ml dosing syringe marked every 0.5 ml. To measure the medication dose, use the syringe:

• Remove the cap and leave it in a safe place.
• Insert the dosing syringe into the oral solution bottle.
• Pull the syringe plunger to measure the required dose.
• Remove the dosing syringe from the bottle and close it.

If you see air bubbles coming out of the dosing syringe after removing the required dose of oral solution, turn the syringe upside down with the tip pointing upwards. This will move the air to the tip of the syringe. Pull the plunger back and then push it forward gently to remove the air bubbles. Do not worry if small air bubbles remain.

Consult your doctor or pharmacist if you have any doubts about how to measure the amount of medication.

Administering the medication using the syringe

• Ensure the child is in an upright position.
• Place the syringe tip carefully in the child's mouth. Direct the syringe tip into the cheek.
• Gently push the syringe plunger: do not make the medication come out quickly as a jet. The medication should enter the child's mouth as a thread of solution.
• Give the child time to swallow the medication.

Regarding theduration of treatment, your doctor will determine the type of allergic rhinitis you have and for how long you should take desloratadina oral solution.

-ifyour allergic rhinitis is intermittent(presence of symptoms for less than 4 days a week or less than 4 weeks), your doctor will recommend a treatment schedule that will depend on the evaluation of your disease history,

-if yourallergic rhinitis is persistent(presence of symptoms for 4 or more days a week and more than 4 weeks), your doctor may recommend long-term treatment,

-forurticaria, the duration of treatment may vary from one patient to another and therefore you should follow your doctor's instructions.

If you take more Desloratadina Sandoz than you should

Take Desloratadina Sandoz only as your doctor has indicated. An accidental overdose is not expected to cause serious problems.If you have taken more Desloratadina Sandoz oral solution than you should, consult your doctor, pharmacist, or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount used.

If you forgot to take Desloratadina Sandoz

If you forgot to take your dose at the scheduled time, take it as soon as possible, and then continue with your usual dosing schedule.

Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Desloratadina Sandoz

If you have any other doubts about the use of this medication, ask your doctor, pharmacist, or nurse.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

During the marketing of desloratadine, very rarely reported cases ofsevere allergic reactions(difficulty breathing, wheezing, itching, hives, and swelling) have been communicated. If you experience any of these severe side effects,stop taking this medicine and seek immediate medical attention.

In clinical trials in most children and adults, the side effects of desloratadine were approximately the same as those of a solution or tablet that does not contain an active ingredient. However, the frequent side effects in children under 2 years of age were diarrhea, fever, and insomnia, while in adults, fatigue, dry mouth, and headache were reported more frequently than with a tablet that does not contain an active ingredient.

During clinical trials with desloratadine, the following side effects were reported:

Children

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

• Diarrhea,
• Fever,
• Insomnia.

Adults

Frequent:may affect up to 1 in 10 people

• Fatigue,
• Dry mouth,
• Headache.

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

Adults

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

• Severe allergic reactions,
• Skin rash,
• Strong or irregular heartbeats,
• Fast heartbeats,
• Stomach pain,
• Nausea (gag reflex),
• Vomiting,
• Upset stomach,
• Diarrhea,
• Dizziness,
• Somnolence,
• Difficulty sleeping,
• Muscle pain,
• Hallucinations,
• Seizures,
• Restlessness with increased body movement,
• Liver inflammation,
• Abnormal liver function test results.

Unknown frequency:The frequency cannot be estimated from the available data.

• Abnormal behavior,
• Aggression,
• Depressed mood,
• Dry eyes,
• Unusual weakness,
• Yellowing of the skin and/or eyes,
• Increased sensitivity of the skin to the sun, even on cloudy days, and to ultraviolet light, for example, to the ultraviolet light of a tanning bed,
• Change in heart rhythm,
• Weight gain,
• Increased appetite.

Children

Unknown frequency:The frequency cannot be estimated from the available data.

• Abnormal behavior,
• Aggression,
• Slow heart rate,
• Change in heart rhythm,
• Weight gain,
• Increased appetite.

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use: https:///www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this oral medication after the expiration date that appears on the carton packaging and on the bottle after CAD/EXP. The expiration date is the last day of the month indicated.

No special storage conditions are required.

Expiration after first opening the bottle: 2 months.

If you notice any change in the appearance of the oral solution, do not use this medication.

Medications should not be disposed of through drains or in the trash. Dispose of the containers and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. By doing so, you will help protect the environment.

Composition of Desloratadina Sandoz

-The active ingredient is desloratadine.

Each milliliter of oral solution contains 0.5 mg of desloratadine.

-The other components of the oral solution are: non-crystallizing liquid sorbitol (E-420), propylene glycol (E-1520), citric acid monohydrate, sodium citrate, hypromellose 2910, sucralose, disodium edetate, tutti-fruti flavor, and purified water.

Appearance of the product and contents of the package

Clear, colorless solution.

The oral solution is packaged in amber type III glass bottles, closed with a polypropylene cap with a child-resistant closure (C/R), which has multiple layers of polyethylene that are included in a cardboard package.

All presentations include a CE 0373 measuring spoon with marks for 2.5 ml and 5 ml doses or a CE 0373 dosing syringe with a 5 ml volume marked every 0.5 ml.

Package sizes

50, 60, 100, 120, and 150 ml of oral solution.

Only some package sizes may be commercially available.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Responsible manufacturer

Lek Pharmaceuticals d.d.

Verovskova 57,

1526 Ljubljana,

Slovenia

or

Salutas Pharma GmbH

Otto-von-Guericke-Alle 1,

39179 Barleben

Germany

or

Lek S.A.

Ul. Podlipie 16 C,

95 010 Strykow

Poland

or

S.C. Sandoz SRL

Str. Livezeni, 7A

RO-540472 Targu Mures

Romania

or

Salutas Pharma GmbH

Dieselstrasse, 5

Gerlinger-70839

Germany

or

Balkanpharma Troyan AD

1 Krayrechna Str.

Troyan 5600

Bulgaria

This medicine is authorized in the Member States of the European Economic Area with the following names:

Denmark:Desloratadine Sandoz

Belgium:Desloratadin Sandoz 0.5 mg/ml drank

Cyprus:Desloratadine Sandoz

France:Desloratadine Sandoz 0.5 mg/ml solution buvable

Italy:Desloratadina Sandoz

Netherlands:Desloratadine Sandoz 0.5mg/ml drank

Portugal:Desloratadina Sandoz

Romania:Desloratadina Sandoz 0.5mg/ml solutie orala

Last review date of this leaflet:July 2022

The detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/