Prospect: information for the patient

Desloratadine Sandoz 5 mg film-coated tablets EFG

Read this prospect carefully before starting to take this medicine, as it contains important information for you.

-Keep this prospect, as you may need to read it again.

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

-This medicine has been prescribed only for you, and you must not give it to other people even if they have the same symptoms as you, as it may harm them.

-If you experience any adverse effects, consult your doctor, pharmacist or nurse, even if they are not listed in this prospect. See section 4.

1.What is Desloratadine Sandoz and what is it used for

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

3.How to take Desloratadine Sandoz

4.Possible adverse effects

5.Storage of Desloratadine Sandoz

6.Contents of the package and additional information

What is Desloratadina Sandoz

Desloratadina Sandoz contains desloratadine, which is an antihistamine.

How Desloratadina Sandoz works

Desloratadine is an antiallergic medication that does not cause drowsiness. It helps to control the allergic reaction and its symptoms.

When to use Desloratadina Sandoz

Desloratadine relieves symptoms associated with allergic rhinitis (inflammation of the nasal passages caused by an allergy, e.g., hay fever or dust mite allergy) in adults and adolescents aged 12 years and older. These symptoms include sneezing, runny nose or nasal itching, palate itching, eye redness or tearing.

Desloratadine 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 to continue your daily activities and normal sleep periods.

Do not take Desloratadina Sandoz

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

Warnings and precautions

Consult your doctor, pharmacist or nurse before starting to take Desloratadina Sandoz:

- if you have impaired renal function.

- if you have a medical history or family history of seizures,

Children and adolescents

Do not administer this medication to children under 12 years of age.

Other medications and Desloratadina Sandoz

No known interactions of desloratadine with other medications.

Inform your doctor if you are taking, have taken recently or may have to take any other medication.

Taking Desloratadina Sandoz with food, drinks and alcohol

Desloratadina Sandoz can be taken with or without food.

Be careful when taking Desloratadina Sandoz with alcohol.

Pregnancy, breastfeeding and fertility

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

Desloratadine is not recommended for use during pregnancy or breastfeeding.

Fertility

No data available on male and female fertility.

Driving and operating machinery

At the recommended dose, it is not expected that this medication will affect your ability to drive or operate machinery. Although most people do not experience drowsiness, it is recommended not to perform activities that require a state of mental alertness, such as driving a car or operating machinery, until you have determined your own response to the 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.

Adults and adolescents 12 years of age and older

The recommended dose is one tablet once a day with water, with or without food.

This medication is for oral use.

Swallow the tablet whole.

Regarding theduration of treatment, your doctor will determine the type of allergic rhinitis you have and for how long you should take Desloratadina Sandoz film-coated tablets.

-ifyour allergic rhinitis is intermittent(presence of symptoms for less than 4 days a week or less than 4 weeks), your doctor will recommend a treatment schedule that will depend on the evaluation of your disease history,

-if yourallergic rhinitis is persistent(presence of symptoms for 4 or more days a week and more than 4 weeks), your doctor may recommend long-term treatment,

-forurticaria, 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 Sandoz than you should

Take desloratadine only as your doctor has instructed. A accidental overdose is not expected to cause serious problems.

In case of overdose or accidental ingestion, consult your doctor or pharmacist or call the Toxicological Information Service, phone 915620420, indicating the medication and the amount ingested.

If you forget to take Desloratadina Sandoz

If you forget 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 interrupt treatment with Desloratadina Sandoz

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

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

During the marketing of desloratadine, very rarely reported cases ofsevere allergic reactions(difficulty breathing, hissing, itching, rashes, and swelling) have been communicated. If you experience any of these severe side effects,stop taking this medicine and seek immediate medical attention.

In clinical trials in adults, side effects were approximately the same as with a placebo tablet. However, fatigue, dry mouth, and headachewere reported more frequently than with a placebo tablet. In adolescents, headache was the most frequent side effect.

During clinical trials with desloratadine, the following side effects were reported as:

Frequent:may affect up to 1 in 10 people

• fatigue,
• dry mouth,
• headache.

Adults

During the marketing of desloratadine, the following side effects were reported as:

Rare:may affect up to 1 in 10,000 people

• severe allergic reactions,
• skin rash,
• strong or irregular heartbeats,
• rapid heartbeats,
• stomach pain,
• nausea (gag reflex),
• vomiting,
• upset stomach,
• diarrhea,
• dizziness,
• drowsiness,
• difficulty sleeping,
• muscle pain,
• hallucinations,
• seizures,
• agitation with increased body movement,
• inflammation of the liver,
• alteration in liver function tests.

Unknown frequency:the frequency cannot be estimated from the available data.

• alteration of behavior,
• aggression,
• depressed mood
• dry eyes,
• unusual weakness,
• yellowing of the skin and eyes,
• increased sensitivity of the skin to the sun, even on cloudy days, and to ultraviolet light, for example, to the ultraviolet light of a tanning bed,
• change in the way the heart beats
• weight gain,
• increased appetite.

Children

Unknown frequency:the frequency cannot be estimated from the available data

• alteration of behavior,
• aggression,
• slow heart rate,
• change in the way the heart beats
• weight gain,
• increased appetite.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the National System of Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

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

This medication does not require special storage conditions.

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

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

Composition of Desloratadina Sandoz

-The active ingredient is desloratadine. Each tablet contains 5 mg of desloratadine.

-The other components are:

Core: maize starch, microcrystalline cellulose, hypromellose, anhydrous colloidal silica, hydrogenated vegetable oil (type 1).

Coating:Opadry blue 03B50689 containing: hypromellose (E464), titanium dioxide (E171), macrogol 400 (E1521), aluminium lake of indigo carmine (E132)

Appearance of the product and contents of the package

Desloratadina Sandoz 5 mg film-coated tablets are blue-coloured, round, biconvex tablets with the mark of the number “5” on one face. Diameter: 6.50 ± 0.10 mm.

Desloratadina Sandoz 5 mg film-coated tablets are packaged in OPA/ALU/PVC/ALU or PVC/Aclar/ALU blisters.

Unit packs:

Desloratadina Sandoz 5 mg is available in 1x1, 2x1, 3x1, 5x1, 7x1, 10x1, 14x1, 15x1, 20x1, 21x1, 30x1, 50x1, 90x1 and 100x1 film-coated tablets.

Non-unit packs:

Desloratadina Sandoz 5 mg is available in 1, 2, 3, 5, 7, 10, 14, 15, 20, 21, 30, 50, 90 and 100 film-coated tablets.

Only some pack sizes may be marketed.

Marketing authorisation holder and manufacturer responsible

Marketing authorisation holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer responsible

Lek Pharmaceuticals d.d.

Verovskova 57, SI-1526,

Ljubljana, Slovenia

or

Salutas Pharma GmbH

Otto-von-Guericke-Alle 5,

39179, Barleben

Germany

or

Lek S.A.

Ul. Domaniewska 50C

02-672 Warsaw

Poland

or

Lek Pharmaceuticals d.d

Trimlini 2 D

9220 Lendava

Slovenia

This medicinal product is authorised in the Member States of the European Economic Area with the following names:

Austria:Desloratadin Sandoz 5 mg filmtabletten

Belgium:Desloratadin Sandoz 5 mg filmomhulde tabletten

Denmark:Desloratadine Sandoz

Finland:Desloratadine Sandoz 5 mg kalvopäällysteinen tabletti

France:Desloratadine Sandoz 5 mg comprimé pelliculé

Italy:DESLORATADINA SANDOZ 5 mg compresse rivestite con film

Netherlands:Desloratadine Sandoz 5 mg filmomhulde tabletten

Portugal:Desloratadina Sandoz 5 mg comprimido revestido por película

Sweden:Desloratadine Sandoz 5 mg filmdragerade tabletter

Last date of revision of this leaflet:July 2022

The detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es.