Desloratadine Kern Pharma 5 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Desloratadine Kern Pharma 5 mg film-coated tablets EFG

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you and you should not give it to other people, even if they have the same symptoms, as it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist or nurse, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents:

1. What Desloratadine Kern Pharma is and what it is used for
2. What you need to know before taking Desloratadine Kern Pharma
3. How to take Desloratadine Kern Pharma
4. Possible side effects

5 Storage of Desloratadine Kern Pharma

1. Contents of the pack and other information

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

Desloratadine Kern Pharma is a non-sedating antiallergic medicine. It helps control allergic reactions and their symptoms.

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

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

Relief from these symptoms lasts for a full day, helping you continue your daily activities and maintain normal sleep patterns.

2. What you need to know before starting to take Desloratadine Kern Pharma

Do not take Desloratadine Kern Pharma

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

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before taking Desloratadine:

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

If any of these apply to you, or if you are unsure, consult your doctor before taking Desloratadine Kern Pharma.

Children and adolescents

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

Interaction of Desloratadine Kern Pharma with other medicines

There are no known interactions between Desloratadine Kern Pharma and other medicines.

Tell your doctor or pharmacist if you are using or have recently used any other medicines, including those obtained without a prescription.

Interaction of Desloratadine Kern Pharma with food, drink and alcohol

Desloratadine Kern Pharma can be taken regardless of meals.

Pregnancy, breastfeeding and fertility

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

If you are pregnant or breastfeeding, Desloratadine Kern Pharma is not recommended.

Driving and using machines

At the recommended dose, Desloratadine Kern Pharma is not expected to cause drowsiness or reduce your attention. However, very rarely, some individuals may experience drowsiness, which could affect their ability to drive or operate machinery.

3. How to take Desloratadine Kern Pharma

Adults and adolescents (12 years of age and older): take one tablet once daily.

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 how long you should take Desloratadine Kern Pharma.

If you have intermittent allergic rhinitis (symptoms present for less than 4 days per week or for less than 4 weeks), your doctor will recommend a treatment regimen based on an assessment of your medical history.

If you have persistent allergic rhinitis (symptoms present for 4 or more days per 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, so you should follow your doctor's instructions.

If you take more Desloratadine Kern Pharma than you should

Take Desloratadine Kern Pharma only as directed by your doctor. Accidental overdose is not expected to cause serious problems. However, if you take more Desloratadine Kern Pharma than prescribed, contact your doctor or pharmacist.

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

If you forget to take Desloratadine Kern Pharma

If you forget 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 missed doses.

4. Possible adverse effects

Like all medicines, Desloratadine Kern Pharma may cause adverse effects, although not everyone experiences them. In adults, adverse effects were approximately the same as with a tablet containing no active ingredient. However, fatigue, dry mouth, and headache were reported more frequently than with a tablet containing no active ingredient. In adolescents, headache was the most frequently reported adverse reaction.

During the marketing of desloratadine, very rare cases of serious allergic reactions (difficulty breathing, wheezing, itching, skin rash, and swelling) and skin eruptions have been reported. Very rare cases of palpitations, rapid heartbeat, stomach pain, nausea (feeling like vomiting), vomiting, upset stomach, diarrhea, dizziness, somnolence, difficulty sleeping, muscle pain, hallucinations, seizures, restlessness with increased body movement, liver inflammation, and changes in liver function tests have also been reported.

Adults:

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

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

Children

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

• Slow heartbeat – change in the way the heart beats
• Abnormal behaviour – aggression, depressed mood
• Dry eyes

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effect not listed in this leaflet, inform your doctor or pharmacist.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Desloratadine Kern Pharma

Keep out of the sight and reach of children.

Do not store above 30°C.

Do not use Desloratadine Kern Pharma after the expiry date stated on the outer packaging and blister pack following “EXP”. The expiry date refers to the last day of the month indicated.

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

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE point located in your pharmacy. If in doubt, ask your pharmacist how to properly dispose of unused medicines and packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Desloratadine Kern Pharma

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

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

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

Appearance of the product and contents of the pack

Desloratadine Kern Pharma 5 mg are cylindrical, biconvex, film-coated blue tablets. They are available in packs of 20 tablets and 100 tablets (hospital pack).

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 most recent review of this leaflet: June 2022

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) www.aemps.gob.es