DESLORATADINE SANDOZ 0.5 mg/1 ml ORAL SOLUTION

Introduction

Package Leaflet: Information for the Patient

Desloratadine Sandoz 0.5 mg/ml Oral Solution EFG

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What is Desloratadine Sandoz and what is it 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. Package Contents and Additional Information

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

What is Desloratadine Sandoz

Desloratadine Sandoz contains desloratadine, which is an antihistamine.

How Desloratadine Sandoz works

Desloratadine Sandoz oral solution is an anti-allergic medication that does not cause drowsiness. It helps control the allergic reaction and its symptoms.

When to use Desloratadine Sandoz

Desloratadine 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 from 1 year of age. These symptoms include sneezing, runny or itchy nose, itchy palate, and itchy, red, or watery eyes.

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

Relief from these symptoms lasts a full day and helps you continue your daily activities and normal sleep periods.

2. What you need to know before taking Desloratadine Sandoz

Do not take Desloratadine Sandoz

• if you are allergic to desloratadine or any of the other ingredients of this medication (listed in section 6) or to loratadine.

Warnings and Precautions

Consult your doctor, pharmacist, or nurse before starting to take Desloratadine Sandoz:

• if you have a medical history or family history of seizures,
• if you have altered kidney function.

Use in Children and Adolescents

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

Taking Desloratadine Sandoz with Other Medications

There are no known interactions between desloratadine and other medications.

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

Taking Desloratadine Sandoz with Food, Drinks, and Alcohol

Desloratadine can be taken with or without food.

Be careful when taking desloratadine 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.

It is not recommended to take desloratadine if you are pregnant or breastfeeding.

Fertility

There is no available data on male and female fertility.

Driving and Using Machines

At the recommended dose, this medication 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 that require a state of mental alertness, such as driving a car or using machines, until you have determined your own response to the medication.

Desloratadine Sandoz contains Sorbitol, Propylene Glycol, and Sodium

This medication contains up to 97.5 mg of sorbitol per 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 you have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disease in which the patient cannot break down fructose, consult your doctor 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/cooking salt) per ml of oral solution. This is equivalent to 0.19% of the maximum recommended daily sodium intake for an adult.

3. How to Take Desloratadine Sandoz

Follow the administration instructions for this medication exactly as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Children

Children from 1 to 5 years of age:

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

Children from 6 to 11 years of age:

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

Adults and Adolescents (from 12 years of age and older):

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

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

This medication is for oral use.

Swallow the dose of oral solution, 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 measuring spoon marked at doses of 2.5 ml and 5 ml or a 5 ml dosing syringe marked every 0.5 ml. To measure the dose of medication, use the syringe:

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

If you see air bubbles in the dosing syringe after removing the necessary dose of oral solution, turn the syringe upside down with the tip facing up. This will move the air to the tip of the syringe. Pull the plunger back and then gently push it forward to eliminate the bubbles. Do not worry if small bubbles remain.

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

Administering the Medication Using the Syringe

• Make sure the child is in an upright position.
• Place the tip of the syringe carefully in the child's mouth. Direct the tip of the syringe inside the cheek.
• Slowly push the syringe plunger: do not let the medication come out quickly in a stream. The medication should enter the child's mouth like a thread of solution.
• Give the child time to swallow the medication.

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

• if your allergic rhinitis is intermittent (presence of symptoms for less than 4 days a week or for less than 4 weeks), your doctor will recommend a treatment schedule based on the evaluation of your medical history,
• if your allergic rhinitis is persistent (presence of symptoms for 4 or more days a week and for more than 4 weeks), your doctor may recommend long-term treatment,
• for urticaria, the duration of treatment may vary from patient to patient, and therefore, you should follow your doctor's instructions.

If you take more Desloratadine Sandoz than you should

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

If you forget to take Desloratadine Sandoz

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

Do not take a double dose to make up for forgotten doses.

If you interrupt treatment with Desloratadine Sandoz

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

4. Possible Side Effects

Like all medications, this medication can cause side effects, although not everyone experiences them.

During the marketing of desloratadine, very rare cases of severe allergic reactions(difficulty breathing, wheezing, itching, rashes, and swelling) have been reported. If you experience any of these serious side effects, stop taking this medication and seek medical attention immediately.

In clinical trials in most children and adults, the side effects with desloratadine were approximately the same as with a solution or tablet that does not contain the 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 the active ingredient.

In 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:

Adults

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

• Severe allergic reactions,
• Skin rash,
• Strong or irregular heartbeats,
• Rapid heartbeat,
• Stomach pain,
• Nausea,
• Vomiting,
• Upset stomach,
• Diarrhea,
• Dizziness,
• Drowsiness,
• Difficulty sleeping,
• Muscle pain,
• Hallucinations,
• Seizures,
• Agitation with increased body movement,
• Liver inflammation,
• Abnormal liver function tests.

Frequency not known: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 sunbed,
• Change in heart rhythm,
• Weight gain,
• Increased appetite.

Children

Frequency not known:the frequency cannot be estimated from the available data.

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

Reporting Side Effects

If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: https:///www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Desloratadine Sandoz

Keep this medication out of sight and reach of children.

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

No special storage conditions are required.

Shelf life after first opening of 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 wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE collection point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Desloratadine Sandoz

• The active ingredient is desloratadine.

Each ml of oral solution contains 0.5 mg of desloratadine.

• The other ingredients 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 Package Contents

Clear, colorless solution.

The oral solution is packaged in type III amber glass bottles, closed with a child-resistant polypropylene cap with a screw cap, which has multiple layers of polyethylene included in a carton box.

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

Package sizes

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

Not all package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

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 medication is authorized in the Member States of the European Economic Area under 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

Date of the last revision of this package leaflet:July 2022

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/