DESLORATADINE SANDOZ 5 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Desloratadine Sandoz 5 mg film-coated tablets EFG

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

• Keep this package leaflet, as you may need to read it again.
• If you have any doubts, consult your doctor, pharmacist, or nurse.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor, pharmacist, or nurse, even if they are side effects not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What is Desloratadine Sandoz and what is it used for
2. What you need to know before taking Desloratadine Sandoz
3. How to take Desloratadine Sandoz
4. Possible side effects
5. Storage of Desloratadine Sandoz
6. Package Contents and Additional Information

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

What is Desloratadine Sandoz

Desloratadine Sandoz contains desloratadine, which is an antihistamine.

How Desloratadine Sandoz works

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

When to use Desloratadine Sandoz

Desloratadine relieves the 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 from 12 years of age. These symptoms include sneezing, runny or itchy nose, itchy palate, and itchy, red, or watery eyes.

Desloratadine is also used to relieve the symptoms associated with urticaria (a skin disease caused by an allergy). These symptoms include itching and skin rashes.

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

2. What you need to know before taking Desloratadine Sandoz

Do not take Desloratadine Sandoz

• if you are allergic to desloratadine or 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 Desloratadine Sandoz:

• if you have impaired kidney function.
• if you have a medical history or family history of seizures,

Children and Adolescents

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

Other Medications and Desloratadine Sandoz

There are no known interactions between desloratadine and other medications.

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

Taking Desloratadine Sandoz with Food, Drinks, and Alcohol

Desloratadine Sandoz can be taken with or without food.

Be careful when taking Desloratadine Sandoz with alcohol.

Pregnancy, Breastfeeding, and Fertility

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

It is not recommended to take desloratadine if you are pregnant or breastfeeding.

Fertility

There is no available data on male and female fertility.

Driving and Using Machines

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

3. How to take Desloratadine Sandoz

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

Adults and Adolescents from 12 years of age

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

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

If you take more Desloratadine Sandoz than you should

Take desloratadine 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 or call the Toxicology Information Service, phone 915620420, indicating the medication and the amount ingested.

If you forget to take Desloratadine Sandoz

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 the missed doses.

If you stop taking Desloratadine Sandoz

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

4. Possible Side Effects

Like all medications, this medication can cause side effects, although not everyone experiences them.

During the marketing of desloratadine, very rare cases of severe allergic reactions(difficulty breathing, wheezing, itching, rashes, and swelling) have been reported. If you experience any of these serious side effects, stop taking this medication and seek medical attention immediately.

In clinical trials in adults, side 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 common side effect.

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

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:

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

• severe allergic reactions,
• skin rash,
• strong or irregular heartbeats,
• rapid heartbeats,
• stomach pain,
• nausea,
• vomiting,
• upset stomach,
• diarrhea,
• dizziness,
• drowsiness,
• difficulty sleeping,
• muscle pain,
• hallucinations,
• seizures,
• agitation with increased body movement,
• liver inflammation,
• abnormal liver function tests.

Frequency Not Known:the frequency cannot be estimated from the available data.

• behavioral changes,
• aggression,
• depressed mood
• dry eyes,
• unusual weakness,
• yellowing of the skin and eyes,
• increased sensitivity of the skin to sunlight, even on cloudy days, and to ultraviolet light, for example, to the ultraviolet light of a sunbed,
• change in heart rhythm
• weight gain,
• increased appetite.

Children

Frequency Not Known:the frequency cannot be estimated from the available data

• behavioral changes,
• aggression,
• slow heartbeat,
• change in heart rhythm
• weight gain,
• increased appetite.

Reporting Side Effects

If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are side effects not listed in this package leaflet. You can also report them directly through the National Medication Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Desloratadine Sandoz

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

Do not use this medication after the expiration date stated on the carton and blister after 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 wastewater or household waste. Place the packaging and any unused medication in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Desloratadine Sandoz

• The active ingredient is desloratadine. Each tablet contains 5 mg of desloratadine.
• The other ingredients are:

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

Coating: Opadry blue 03B50689, which contains: hypromellose (E464), titanium dioxide (E171), macrogol 400 (E1521), aluminum indigo carmine lake (E132)

Appearance of the Product and Package Contents

Desloratadine Sandoz 5 mg film-coated tablets are light blue, round, biconvex tablets with the number "5" marked on one side. Diameter: 6.50 ± 0.10 mm.

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

Single-dose packaging:

Desloratadine 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-single-dose packaging:

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

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer

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 Warsawa

Poland

or

Lek Pharmaceuticals d.d

Trimlini 2 D

9220 Lendava

Slovenia

This medication is authorized in the Member States of the European Economic Area under 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

Date of the Last Revision of this Package Leaflet:July 2022

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