Package Insert: Information for the Patient

Desloratadina Tarbis 5 mg Film-Coated Tablets

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

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others who have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert.

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

Desloratadina 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 nose or nasal itching, palate itching, eye redness or tearing.

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

The relief of these symptoms lasts a full day and helps you continue your daily activities and normal sleep periods.

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

Do not take Desloratadina Tarbis

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

Warnings and precautions

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

If this happens, or you are unsure, consult your doctor before taking Desloratadina Tarbis.

Taking Desloratadina Tarbis with other medications

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

No known interactions of Desloratadina Tarbis with other medications

Taking Desloratadina Tarbis with food and drinks

Desloratadina Tarbis can be taken regardless of meals.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

Driving and operating machinery

The influence of desloratadine on the ability to drive and operate machinery is negligible or insignificant. At the recommended dose, it is not expected that Desloratadina Tarbis will affect your ability to drive or operate machinery. However, very rarely some people may experience drowsiness that causes reduced alertness. If it affects you, do not drive or operate machinery.

Desloratadina 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.

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

The usual dose is:

Paediatric population: The efficacy and safety of Desloratadina 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 for how long you should take Desloratadina Tarbis.

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 plan based on the evaluation of your disease 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 you should follow your doctor's instructions.

If you take more Desloratadina Tarbis than you should

Take Desloratadina 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 Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Desloratadina Tarbis

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

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

Like all medications, Desloratadina Tarbis may produce adverse effects, although not all people will experience them.

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

During the marketing of Desloratadina Tarbis, very rarely reported cases of severe allergic reactions (difficulty breathing, wheezing, itching, skin rashes, and swelling) and skin eruption have been communicated. Very rarely, palpitations, rapid heartbeats, stomach pain, nausea (urge to vomit), vomiting, stomach upset, diarrhea, dizziness, somnolence, difficulty sleeping, muscle pain, hallucinations, convulsions, agitation with increased body movement, liver inflammation, and alteration in liver function tests have also been communicated.

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

If you experience adverse effects, consult your doctor or pharmacist, even if they do not appear in this prospectus.

Keep out of sight and reach of children.

Do not use Desloratadina Tarbis after the expiration date that appears on the packaging and blister, after CAD. The expiration date is the last day of the month indicated.

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

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

Medicines should not be disposed of through drains or in the trash. Dispose of the containers and medicines you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medicines you no longer need. In this way, you will help protect the environment.

Composition of Desloratadina Tarbis

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

Appearance of the product and contents of the packaging

Coated tablets, round, biconvex, blue in color, and engraved with a "D" on one side.

Desloratadina Tarbis 5 mg coated tablets are packaged in blisters with 10, 20, 30, 50, and 100 tablets.

Only some package sizes may be commercially marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

TARBIS FARMA, S.L.

Gran Vía Carlos III, 94 - 08028 Barcelona (SPAIN)

Responsible for manufacturing:

Laboratorios NORMON, S.A.

Ronda de Valdecarrizo, 6

ES – 28760 Tres Cantos, Madrid

Spain

For more information about this medication, please contact the local representative of the holder of the marketing authorization.

Last review date of this prospectus December 2022

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