Product Information for the Patient

Desloratadina Tarbis0.5 mg/ml Oral Solution

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

• Keep this product information, as you may need to read it again.
  If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only to 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 product information.

1. What isDesloratadina Tarbisand how is it used

2. What you need to know before starting to takeDesloratadina Tarbis

3. How to takeDesloratadina Tarbis

4. Possible adverse effects

5. Storage ofDesloratadina Tarbis

6. Contents of the package and additional information

Desloratadina Tarbisoral solution is an antihistamine medication that does not cause drowsiness. It helps control allergic reactions and their symptoms.

Desloratadina Tarbisoral solution relieves 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 Tarbisoral solution is 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 Tarbisoral solution is indicated for children aged1 to11 years, adolescents (from 12 years of age), and adults, including the elderly.

Do not takeDesloratadina Tarbis

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

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 takingDesloratadina Tarbis.

TakingDesloratadina Tarbiswith other medicines

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

No known interactions exist betweenDesloratadina Tarbisand other medicines.

TakingDesloratadina Tarbiswith food and drinks

Desloratadina Tarbiscan 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 medicine.

Driving and operating machines

The influenceof desloratadine on the ability todrive and usemachines is negligible orinsignificant.At the recommended dose, it is not expected thatDesloratadina Tarbiswill cause drowsiness or impair your ability to pay attention. However, very rarely some people experience drowsiness, which may affect your ability to drive or use machines.

Desloratadina Tarbiscontains sorbitol

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

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.

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

Children aged 6 to 11 years: 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 oral dose, and then drink a little water. You can take this medication 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 takeDesloratadina Tarbisoral solution.

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 that will depend 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 therefore you should follow your doctor's instructions.

If you take moreDesloratadina Tarbisthan you should

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

If you forgot to takeDesloratadina 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 may 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 freeze.

No special storage conditions are required.

The solution is stable for 48 days after its first opening.Do not store at a temperature above25°C.

Do not use this medication after the expiration date that appears on the box and on the bottle after CAD. The expiration date is the last day of the month indicated.

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 pointofthe pharmacy. Incase of doubt, ask your pharmacist how to dispose of the containers and medicines you no longer need. By doing so, you will help protect the environment.

Composition of Desloratadina Tarbis

• The active ingredient 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 packaging

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

Desloratadina Tarbis oral solution is presented in amber-colored polyethylene terephthalate (PET) bottles closed with aluminum screw caps, child-resistant, containing 60 ml, 100 ml, 120 ml, and 150 ml of oral solution and a dosing cup with markings for 2.5 ml, 5 ml, and 10 ml doses.

Only some sizes of packaging may be commercially available.

Holder of the marketing authorization and responsible manufacturer

Holder of the marketing authorization:

Tarbis Farma, S.L.

Gran Vía Carlos III, 94

08028 Barcelona

Spain

Responsible 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 holder of the marketing authorization.

Last review date of this leaflet 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/”