Prospect: Information for the user

Desloratadine Kern Pharma 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 for you and should not be given to others, even if they present the same symptoms of the disease, as it may harm them.

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

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

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

3.How to take Desloratadine Kern Pharma

4.Possible adverse effects

5Storage of Desloratadine Kern Pharma

6.Contents of the package and additional information

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

Desloratadina 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, palate itching, eye redness, 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.

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

Do not take Desloratadina Kern Pharma

• 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:

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

If this happens, or you are unsure, 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

No known interactions of Desloratadina Kern Pharma with 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 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 Kern Pharma.

Driving and operating machinery

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

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 will determine for 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 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 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 instructed. An accidental overdose is not expected to cause serious problems. However, if you take more Desloratadina Kern Pharma than you have been told, contact your doctor or pharmacist.

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 Kern Pharma

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 compensate for the missed doses.

Like all medications, Desloratadina Kern Pharma may produce adverse effects, although not all people may 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, very rarely reported cases of severe allergic reactions (difficulty breathing, wheezing, itching, skin rashes, and swelling) and skin eruptions 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 alterations in liver function tests have also been reported.

Adults:

Unknown frequency: the frequency cannot be estimated from available data

- Abnormal behavior

- Aggression

- Weight gain

- Increased appetite

- Depressed mood

- Dry eyes

Children:

Unknown frequency: the frequency cannot be estimated from available data

• Slow heart rate - Change in heart rhythm
• Abnormal behavior - Aggression/depressed mood
• Dry eyes

If you consider that any of the adverse effects you are experiencing are severe or if you notice any adverse effect not mentioned in this prospectus, inform your doctor or pharmacist.

Reporting 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 prospectus. You can also report them directly through the Spanish System of Pharmacovigilance of Medicines for human use: www.notificaRAM.es . By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

Keep out of the sight and reach of children.

Do not store above 30°C.

Do not use Desloratadina Kern Pharma after the expiration date that appears on the packaging and in the blister after “CAD”. The expiration date is the last day of the month indicated.

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

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

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 content of the packaging

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

Holder of the marketing authorization

Kern Pharma, S.L.

Venus, 72 - Pol. Ind.Colón II

08228 Terrassa – Barcelona

Spain

Responsible for manufacturing

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

Last review date of this leaflet: June 2022

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