Leaflet: information for the user

Desloratadine Vir 5 mg film-coated tablets EFG

Read the entire leaflet carefully before starting to take the medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.

• If you have any doubts, consult your doctor or pharmacist.

• This medicine has been prescribed for you and should not be given to others even if they have the same symptoms as you, as it may harm them.

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

1. What you need to know before starting to take Desloratadine Vir
2. How to take Desloratadine Vir

1. Possible side effects
2. Storage of Desloratadine Vir
3. Contents of the pack and additional information

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

Desloratadina Vir 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 Vir is also used to relieve symptoms associated with urticaria (a 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.

N Do not take Desloratadina Vir:

- If you are allergic to desloratadine, loratadine, or any of the other components of this medication (listed in section 6).

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Desloratadina Vir:

- If you have impaired renal function.

- If you have a personal or family history of seizures.

Taking Desloratadina Vir with other medications

No known interactions have been reported with Desloratadina Vir and other medications.

Taking Desloratadina Vir with food and beverages

Desloratadina Vir can be taken regardless of meals.

Pregnancy, breastfeeding, and fertility

Consult your doctor or pharmacist before using any medication during pregnancy or breastfeeding.

If you are pregnant or breastfeeding a baby, it is not recommended to take Desloratadina Vir.

Driving and operating machinery

At the recommended dose, Desloratadina Vir is not expected to cause drowsiness or impair your ability to pay attention. However, very rarely, some people may experience drowsiness, which can affect your ability to drive or operate machinery.

Desloratadina Vir contains lactose

If your doctor has told you that you have a certain sugar intolerance, consult with them before taking this medication.

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

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 Vir.

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 one patient to another, and therefore you should follow your doctor's instructions.

If you take more Desloratadina Vir than you should

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

If you forgot to take Desloratadina Vir

If you forgot to take your dose at the scheduled 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.

Like all medications, Desloratadina Vir may produce adverse effects, although not all people 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 Vir, 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.

Unknown frequency: abnormal behavior and aggression, weight gain, increased appetite, depressed mood, and dry eyes.

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

Keep this medication out of the sight and reach of children.

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

Store below 30°C. Store in the original packaging.

If you observe any change in the appearance of the tablets, inform your pharmacist.

Medications should not be disposed of through drains or in the trash. Deposit the packaging and medications you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Desloratadina VIR

• The active ingredient is desloratadine 5 mg.

• The other components of the tablet are anhydrous lactose, microcrystalline cellulose, cornstarch, magnesium stearate, and magnesium oxide. The tablet coating contains a pellicular coating (containing hypromellose, titanium dioxide, polyethylene glycol/macrogol, indigotin (E132).

Appearance of the product and contents of the packaging

The tablets are packaged in PVC/Aclar/aluminum blisters and in monodose paperboard cartons.

Packaging with 100 tablets in PVC/Aclar/aluminum blisters.

Packaging with monodose paperboard cartons containing 10, 20, 30, 50, or 90 tablets.

Monodose paperboard carton.

Only some package sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder:

Industria Química y Farmacéutica VIR, S.A.

C/ Laguna 66-70, Polígono Industrial URTINSA II

28923 Alcorcón (Madrid) - España

Manufacturers:

Industria Química y Farmacéutica VIR, S.A.

C/ Laguna 66-70, Polígono Industrial URTINSA II

28923 Alcorcón (Madrid) - España

Pharmaceutical Works POLPHARMA S.A.

Production Department in Nowa Deba

1 Szypowskiego Str. 39-460 Nowa Deba, Poland

Last review date of this leaflet:May 2022

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