DESLORATADINE TARBIS 5 mg FILM-COATED TABLETS

2. What you need to know before taking Desloratadine Tarbis

Do not take Desloratadine Tarbis

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

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 you are unsure, consult your doctor before taking Desloratadine Tarbis.

Taking Desloratadine Tarbis with other medications

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

There are no known interactions between Desloratadine Tarbis and other medications

Taking Desloratadine Tarbis with food and beverages

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 medication.

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 affect your ability to drive or use machines. However, very rarely, some people may experience drowsiness that causes a lower state of alertness. If this affects you, do not drive or use machines.

Desloratadine Tarbis contains lactose

This medication contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

3. How to take Desloratadine Tarbis

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

The usual dose is:

Pediatric 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 a day. 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 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 one patient to another, 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 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 medication 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, and then continue with the usual 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 medications, Desloratadine Tarbis can cause side effects, although not everyone will experience them.

In adults, side effects were approximately the same as with a tablet that does not contain the active ingredient. However, fatigue, dry mouth, and headache were reported more frequently than with a tablet that does not contain the active ingredient. In adolescents, headache was the most commonly reported adverse reaction.

During the marketing of Desloratadine Tarbis, very rare cases of serious allergic reactions (difficulty breathing, wheezing, itching, hives, and swelling) and skin rash have been reported. Palpitations, rapid heartbeat, stomach pain, nausea (vomiting), vomiting, upset stomach, diarrhea, dizziness, drowsiness, difficulty sleeping, muscle pain, hallucinations, seizures, agitation with increased body movement, liver inflammation, and altered 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 side effects not listed in this package leaflet.

5. Storage of Desloratadine Tarbis

Keep out of sight and reach of children.

Do not use Desloratadine Tarbis after the expiration date stated on the packaging and blister, after EXP. The expiration date is the last day of the month indicated.

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

Do not use this medication if you notice any change in the appearance of the tablets.

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 your pharmacy. If you have any questions, 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 Tarbis

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

Appearance of the Product and Package Contents

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

Desloratadine Tarbis 5 mg film-coated tablets are packaged in blisters of 10, 20, 30, 50, and 100 tablets.

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 medication by contacting the local representative of the Marketing Authorization Holder

Date of the last revision of this package leaflet December 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/"