DESLORATADINE KERN PHARMA 5 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Desloratadina Kern Pharma 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 questions, consult your doctor, pharmacist, or nurse.
• This medication has been prescribed to you and should not be given to others, even if they have the same symptoms of the disease, 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 Desloratadina Kern Pharma and what is it used for
2. What you need to know before taking Desloratadina Kern Pharma
3. How to take Desloratadina Kern Pharma
4. Possible side effects

5 Conservation of Desloratadina Kern Pharma

1. Package contents and additional information

1. What is Desloratadina Kern Pharma and what is it used for

Desloratadina Kern Pharma is a non-sedating antiallergic medication that helps control the allergic reaction and its symptoms.

Desloratadina Kern Pharma relieves symptoms associated with different types of allergic rhinitis (inflammation of the nasal passages due to an allergy, such as hay fever, dust mite allergy). These symptoms include sneezing, runny or itchy nose, itchy palate, red eyes, or tearing.

Desloratadina Kern Pharma is also used to relieve symptoms associated with urticaria (a skin disease caused by an allergy). These symptoms include itching and skin hives.

Relief from these symptoms lasts a full day and helps you continue your daily activities and have normal sleep periods.

2. What you need to know before taking Desloratadina Kern Pharma

Do not take Desloratadina Kern Pharma

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

Warnings and precautions

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

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

If this happens to you, or you are not sure, consult your doctor before taking Desloratadina Kern Pharma.

Children and adolescents

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

Interaction of Desloratadina Kern Pharma with other medications

There are no known interactions between Desloratadina Kern Pharma and other medications.

Inform your doctor or pharmacist if you are using or have recently used other medications, including those purchased without a prescription.

Interaction of Desloratadina Kern Pharma with food, drink, and alcohol

Desloratadina Kern Pharma can be taken independently 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 Kern Pharma.

Driving and using machines

At the recommended dose, it is not expected that Desloratadina Kern Pharma will cause drowsiness or reduce your attention. However, very rarely, some people may experience drowsiness, which may affect their ability to drive or use machines.

3. How to take Desloratadina Kern Pharma

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 determine how long you should take Desloratadina Kern Pharma.

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 schedule based on the evaluation of your medical 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 more Desloratadina Kern Pharma than you should

Take Desloratadina Kern Pharma only as your doctor has indicated. It is not expected that an accidental overdose will cause serious problems. However, if you take more Desloratadina Kern Pharma than you should, contact your doctor or pharmacist.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Desloratadina Kern Pharma

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 missed doses.

4. Possible side effects

Like all medications, Desloratadina Kern Pharma can cause side effects, although not everyone will experience them. In adults, the side effects were approximately the same as with a tablet that does not contain the active ingredient. However, fatigue, dry mouth, and headache were reported more frequently than with a tablet that does not contain the active ingredient. In adolescents, headache was the most commonly reported adverse reaction.

During the marketing of desloratadine, very rare cases of severe allergic reactions (difficulty breathing, wheezing, itching, hives, and swelling) and skin rash have been reported. Palpitations, rapid heartbeat, stomach pain, nausea (vomiting), vomiting, upset stomach, diarrhea, dizziness, drowsiness, difficulty sleeping, muscle pain, hallucinations, seizures, agitation with increased body movement, liver inflammation, and altered liver function tests have also been reported very rarely.

Adults:

Frequency not known: the frequency cannot be estimated from the available data

• Abnormal behavior
• Aggression
• Weight gain
• Increased appetite
• Depressed mood
• Dry eyes

Children

Frequency not known: the frequency cannot be estimated from the available data

• Slow heartbeat - change in heartbeat
• Abnormal behavior - aggression, depressed mood
• Dry eyes

If you consider that any of the side effects you are experiencing is serious or if you notice any side effect not mentioned in this package leaflet, inform your doctor or pharmacist.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for human use: www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Conservation of Desloratadina Kern Pharma

Keep out of sight and reach of children.

Do not store above 30°C.

Do not use Desloratadina Kern Pharma after the expiration date stated on the packaging and on the blister pack after "CAD". The expiration date is the last day of the month indicated.

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

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

6. Package contents and additional information

Composition of Desloratadina Kern Pharma

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

Core: anhydrous sodium carbonate, microcrystalline cellulose (E-460i), cornstarch, talc, sodium croscarmellose, magnesium stearate.

Coating: polyvinyl alcohol, titanium dioxide (E-171), talc, polyethylene glycol, Opadry Blue.

Appearance of the product and package contents

Desloratadina Kern Pharma 5 mg are cylindrical, biconvex, film-coated, and blue tablets. They are available in packages of 20 tablets and 100 tablets (clinical packaging).

Marketing authorization holder

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa – Barcelona

Spain

Manufacturer

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa – Barcelona

Spain

or

Laboratorios Cinfa, S.A.

C/ Olaz-Chipi, 10 - Polígono Industrial Areta.

31620 Huarte - Pamplona (Navarra)-Spain

Date of the last revision of this package leaflet: June 2022

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