Desloratadine Tarbis 5 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Desloratadine Tarbis 5 mg film-coated tablets 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, ask 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 could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet.

Contents of the leaflet

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 tablets are an antihistamine medicine that does not cause drowsiness. It helps control allergic reactions and their symptoms.

Desloratadine Tarbis tablets relieve symptoms associated with allergic rhinitis (inflammation of the nasal passages caused by an allergy, for example, hay fever or dust mite allergy). These symptoms include sneezing, runny or itchy nose, itching of the palate, and itching, redness, or watery eyes.

Desloratadine Tarbis tablets are also used to relieve symptoms associated with urticaria (a skin condition caused by an allergy). These symptoms include itching and skin rash (hives).

Relief from these symptoms lasts for a full day, helping you continue your daily activities and maintain normal sleep periods.

Desloratadine Tarbis is indicated for adults and adolescents (12 years of age and older).

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

Do not take Desloratadine Tarbis

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

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 taking, have recently taken, or might need to take 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 might 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 affect your ability to drive or use machines. However, very rarely, some individuals may experience drowsiness leading to reduced alertness. If this affects you, do not drive or operate machinery.

Desloratadine Tarbis contains lactose

This medicine contains lactose. 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 for use of this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The usual dose is:

Paediatric population: The efficacy and safety of Desloratadine Tarbis have not been established in children under 12 years of age. No data are available.

Adults and adolescents (12 years of age and older): take one tablet once daily. Swallow the tablet whole with water, 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.

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 an 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. 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 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 experiences them.

In adults, adverse effects were approximately the same as with a tablet containing no active ingredient. However, fatigue, dry mouth, and headache were reported more frequently than with a tablet containing no active ingredient. 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 eruptions have been reported. Very rare cases of palpitations, rapid heartbeat, stomach pain, nausea (feeling of wanting to vomit), vomiting, upset stomach, diarrhea, dizziness, drowsiness, difficulty sleeping, muscle pain, hallucinations, seizures, restlessness with increased body movement, liver inflammation, and abnormalities 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 sight and reach of children.

Do not use Desloratadine Tarbis after the expiry date stated on the packaging and blister; after EXP. The expiry date refers to the last day of the month indicated.

Store in the original packaging to protect from light and moisture.

Do not use this medicine if you notice any changes in the appearance of the tablets.

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

6. Contents of the pack and other information

Composition of Desloratadine Tarbis

• The active substance is desloratadine 5 mg.
• The other components of the tablet are: anhydrous lactose, microcrystalline cellulose, anhydrous calcium hydrogen phosphate, low-substituted hydroxypropylcellulose, magnesium stearate, colloidal silicon dioxide, hypromellose, titanium dioxide (E-171), talc, indigo carmine lake (E-132), and macrogol 6000.

Appearance of the product and contents of the pack

Film-coated, round, biconvex blue tablets, marked with a "D" on one side.

Desloratadine Tarbis 5 mg film-coated tablets are available in blister packs containing 10, 20, 30, 50, and 100 tablets.

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 from 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 medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS): http://www.aemps.gob.es/"