Desloratadine Tarbis 0.5 mg/ml oral solution EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Desloratadine Tarbis 0.5 mg/ml oral solution EFG

Read the entire 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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet.

Leaflet contents

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

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

Desloratadine Tarbis oral solution is a non-drowsy antihistamine medicine. It 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, itching of the palate, and itchy, red, or watery eyes.

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

Relief from these symptoms lasts for a full day, helping you carry on with your daily activities and maintain normal sleep patterns.

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

2. What you need to know before starting to take Desloratadine Tarbis

Do not take Desloratadine Tarbis

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

Warnings and precautions

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

If any of these apply to you, or if you are unsure, consult your doctor before taking Desloratadine Tarbis.

Taking Desloratadine Tarbis with other medicines

Inform your doctor or pharmacist if you are using, have recently used, or might need to use any other medicines.

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

Taking Desloratadine Tarbis with food and drinks

Desloratadine Tarbis can be taken regardless of meals.

Pregnancy and breastfeeding

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

Driving and using machines

The effect of desloratadine on the ability to drive and operate machinery is none or negligible. At the recommended dose, Desloratadine Tarbis is not expected to cause drowsiness or reduce your attention. However, very rarely, some individuals may experience drowsiness, which could affect their ability to drive or operate machinery.

Desloratadine Tarbis contains sorbitol

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

3. How to take Desloratadine Tarbis

Follow exactly the instructions given by your doctor or pharmacist for taking this medicine. If in doubt, consult your doctor or pharmacist again.

Children 1 to 5 years of age: take 2.5 ml of oral solution once daily.

Children 6 to 11 years of age: take 5 ml of oral solution once daily.

Adults and adolescents: take 10 ml (two 5 ml spoons) of oral solution once daily.

Swallow the dose of oral solution, then drink a little water. You may 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 per week or for less than 4 weeks), your doctor will recommend a treatment regimen based on the assessment 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 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 Tarbis than you should

Take Desloratadine Tarbis only as your doctor has instructed. Accidental overdose is not expected to cause serious problems.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Desloratadine Tarbis

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

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

4. Possible adverse effects

Like all medicines, Desloratadine Tarbis may cause adverse effects, although not everyone will experience them.

In adults, adverse effects were approximately the same as with a tablet containing no active substance. However, fatigue, dry mouth, and headache were reported more frequently than with a tablet containing no active substance. In adolescents, headache was the most frequently reported adverse reaction.

During the marketing of Desloratadine Tarbis, very rare cases of serious allergic reactions (difficulty breathing, wheezing, itching, skin rash, and swelling) and skin rash have been reported. Very rare cases of palpitations, rapid heartbeat, stomach pain, nausea (feeling sick), vomiting, upset stomach, diarrhoea, dizziness, drowsiness, difficulty sleeping, muscle pain, hallucinations, seizures, restlessness with increased body movement, liver inflammation, and changes in liver function tests have also been reported.

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

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

5. Storage of Desloratadine Tarbis

Keep out of the 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 expiry date stated on the carton and on the bottle after EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Desloratadine Tarbis

• The active substance is desloratadine 0.5 mg/mL.
• The other components 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 contents of the container

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

Desloratadine Tarbis oral solution is available in amber-colored polyethylene terephthalate (PET) bottles with an aluminum screw cap and child-resistant closure, containing 60 mL, 100 mL, 120 mL, and 150 mL of oral solution, and supplied with a dosing cup marked for doses of 2.5 mL, 5 mL, and 10 mL.

Please note that only certain 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

Further information on this medicinal product is available upon request by contacting the local representative of the Marketing Authorization Holder.

Date of the most recent review of this leaflet: December 2022

"Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/"