DESLORATADINE TARBIS 0.5 mg/ml ORAL SOLUTION

Introduction

Package Leaflet: Information for the Patient

Desloratadine Tarbis0.5 mg/ml Oral Solution EFG

Read this entire leaflet carefully before starting to take this medicine, as 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 or pharmacist.
• This medicine 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 or pharmacist, even if they are not listed in this leaflet.

Contents of the Package Leaflet

1. What is Desloratadine Tarbis and what is it used for
2. What you need to know before taking Desloratadine Tarbis
3. How to take Desloratadine Tarbis
4. Possible side effects
5. Storage of Desloratadine Tarbis
6. Package Contents and Additional Information

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

Desloratadine Tarbis oral solution is a non-drowsy antiallergic medicine that helps control allergic reactions and their symptoms.

Desloratadine Tarbis 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). These symptoms include sneezing, runny or itchy nose, itchy palate, and itchy, red, or watery eyes.

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

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

Desloratadine Tarbis oral solution is indicated for children from 1 to 11 years of age, adolescents (from 12 years of age), and adults, including the elderly.

2. What you need to know before taking Desloratadine Tarbis

Do not takeDesloratadine Tarbis

• if you are allergic (hypersensitive) to desloratadine, loratadine, or any of the other ingredients of Desloratadine Tarbis (listed in section 6)

Warnings and Precautions

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

If this happens to you, or if you are unsure, consult your doctor before taking Desloratadine Tarbis.

TakingDesloratadine Tarbiswith other medicines

Tell your doctor or pharmacist if you are using, have recently used, or may need to use any other medicine.

There are no known interactions between Desloratadine Tarbis and other medicines.

TakingDesloratadine Tarbiswith food and drinks

Desloratadine Tarbis can be taken with or without food.

Pregnancy and Breastfeeding

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

Driving and Using Machines

The influence of desloratadine on the ability to drive and use machines is negligible. At the recommended dose, Desloratadine Tarbis is not expected to cause drowsiness or affect your attention. However, very rarely, some people may experience drowsiness, which may affect their ability to drive or use machines.

Desloratadine Tarbiscontains sorbitol

Desloratadine Tarbis contains sorbitol. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medicine.

3. How to take Desloratadine Tarbis

Follow the instructions for administration of this medicine indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Children from 1 to 5 years of age: take 2.5 ml of oral solution once a day.

Children from 6 to 11 years of age: take 5 ml of oral solution once a day.

Adults and adolescents: take 10 ml (two 5 ml spoonfuls) of oral solution once a day.

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

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

If your allergic rhinitis is intermittent (symptoms present 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 (symptoms present 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 you should follow your doctor's instructions.

If you take moreDesloratadine Tarbisthan you should

Take Desloratadine Tarbis only as your doctor has indicated. An accidental overdose is not expected to cause serious problems.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount taken.

If you forget to takeDesloratadine Tarbis

If you forget to take your dose at the scheduled time, take it as soon as possible, and then continue with your regular dosing schedule. Do not take a double dose to make up for missed doses.

If you have any other questions about the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Desloratadine Tarbis can cause side effects, although not everyone gets them.

In adults, side effects were approximately the same as with a placebo. However, fatigue, dry mouth, and headache were reported more frequently than with a placebo. In adolescents, headache was the most commonly reported adverse reaction.

During the marketing of Desloratadine Tarbis, very rare cases of severe allergic reactions (difficulty breathing, wheezing, itching, skin hives, and swelling) and skin rash have been reported. Palpitations, rapid heartbeats, stomach pain, nausea (vomiting), vomiting, upset stomach, diarrhea, dizziness, drowsiness, difficulty sleeping, muscle pain, hallucinations, seizures, agitation with increased body movement, liver inflammation, and changes in liver function tests have also been reported very rarely.

The following side effects have been reported, but their frequency cannot be estimated from the available data (Frequency not known): abnormal behavior, aggression, changes in heart rhythm, depressed mood, dry eyes, weight gain, and increased appetite.

If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet.

5. Storage of Desloratadine Tarbis

Keep out of sight and reach of children.

Do not freeze.

No special storage conditions are required

The solution is stable for 48 days after first opening. Do not store above 25°C.

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

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicines in the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Desloratadine Tarbis

• The active ingredient is desloratadine 0.5 mg/ml
• The other ingredients of the oral solution are sodium benzoate, sodium saccharin, sorbitol, propylene glycol, anhydrous citric acid, hydroxyethylcellulose, orange flavor, and purified water.

Appearance of the Product and Package Contents

The oral solution is transparent, practically colorless, and has an orange flavor.

Desloratadine Tarbis oral solution is available in a 60 ml, 100 ml, 120 ml, and 150 ml amber polyethylene terephthalate (PET) bottle with a child-resistant screw cap and a dosing cup with marks for 2.5 ml, 5 ml, and 10 ml doses.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Tarbis Farma, S.L.

Gran Vía Carlos III, 94

08028 Barcelona

Spain

Manufacturer:

Laboratorios NORMON, S.A.

Ronda de Valdecarrizo, 6

ES – 28760 Tres Cantos, Madrid

Spain

You can request more information about this medicine from the local representative of the Marketing Authorization Holder

Date of the last revision of this leaflet: December 2022

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