DESLORATADINE KERN PHARMA 0.5 mg/ml ORAL SOLUTION

Introduction

Package Leaflet: Information for the User

Desloratadine Kern Pharma 0.5 mg/ml Oral Solution EFG

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

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you, do not pass it on to others, even if their symptoms are the same as yours, as it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What is Desloratadine Kern Pharma and what is it 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
6. Contents of the pack and further information

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

Desloratadine oral solution is a non-sedating antihistamine that helps control allergic reactions and their symptoms.

Desloratadine oral solution relieves the symptoms associated with allergic rhinitis (inflammation of the nasal passages caused by an allergy, for example, hay fever or allergy to dust mites). These symptoms include sneezing, runny or itchy nose, itchy palate, and itchy, red, or watery eyes.

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

Relief from 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 Kern Pharma

Do not take Desloratadine Kern Pharma

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

Desloratadine Kern Pharma is indicated for children from 1 to 11 years of age, adolescents (from 12 years of age), and adults, including the elderly.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before taking Desloratadine Kern Pharma:

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

Using Desloratadine Kern Pharma with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

There are no known interactions between desloratadine and other medicines.

Using Desloratadine Kern Pharma with food, drinks, and alcohol

Desloratadine can be taken with or without food.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

If you are pregnant or breastfeeding, it is not recommended to take desloratadine oral solution.

Driving and using machines

At the recommended dose, desloratadine is not expected to cause drowsiness or affect your ability to concentrate. However, very rarely, some people may experience drowsiness, which may affect their ability to drive or use machines.

Desloratadine Kern Pharma oral solution contains sorbitol.

If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

Desloratadine Kern Pharma oral solution contains propylene glycol.

This medicine contains 200 mg of propylene glycol in each ml of product.

Concomitant administration with any substrate for alcohol dehydrogenase, such as ethanol, may cause severe adverse reactions in newborns.

3. How to take Desloratadine Kern Pharma

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

The recommended dose is:

Children from 1 to 5 years of age: take 2.5 ml of oral solution once a day.

Children from 6 to 11 years of age: take 5 ml of oral solution once a day.

Adults and adolescents (from 12 years of age): take 10 ml of oral solution once a day.

Plastic bottle with dosing syringe: Use the dosing syringe provided with the pack containing the bottle of oral solution to take the correct amount of oral solution.

Glass bottle with measuring cup: Use the measuring cup provided with the pack containing the bottle of oral solution to take the correct amount of oral solution.

Swallow the dose of oral solution, and then drink a little water. You can take this medicine 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 oral solution.

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 Kern Pharma than you should

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 medicine and the amount ingested.

If you forget to take Desloratadine Kern Pharma

Do not take a double dose to make up for forgotten doses.

If you stop taking Desloratadine Kern Pharma

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

4. Possible side effects

Like all medicines, Desloratadine Kern Pharma can cause side effects, although not everybody gets them.

In most children and adults, the side effects with desloratadine oral solution were approximately the same as with a solution or tablet that does not contain the active ingredient. However, the common side effects in children under 2 years of age were diarrhea, fever, and insomnia, while in adults, fatigue, dry mouth, and headache were reported more frequently than with a tablet that does not contain the active ingredient.

During the marketing of desloratadine in oral solution, very rare cases of severe allergic reactions (difficulty breathing, wheezing, itching, skin rashes, and swelling) and skin rash have been reported. Also, very rare cases of 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 changes in liver function tests have been reported.

Adults

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

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

Children

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

• Slow heartbeat - Changes in the way the heart beats
• Abnormal behavior - aggression

• Depressed mood
• Dry eyes

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency's website: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Desloratadine Kern Pharma

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

Do not freeze. Store in the original packaging.

Once opened, the contents of the bottle should be used within 6 months.

Do not use this medicine after the expiry date which is stated on the packaging after "CAD". The expiry date is the last day of the month indicated.

Do not use this medicine if you notice any change in the appearance of the oral solution.

Medicines should not be disposed of via wastewater or household waste. Dispose of the packaging and any unused medicine in the pharmacy's SIGRE collection point. If you are unsure, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Contents of the pack and further information

Composition of Desloratadine Kern Pharma

• The active ingredient is desloratadine. Each ml of oral solution contains 0.5 mg of desloratadine.
• The other ingredients of the oral solution are: sorbitol (E420), propylene glycol (E1520), sodium saccharin (E954), sodium citrate (E331), citric acid (E330), raspberry flavor, and purified water.

Appearance of the product and pack contents

Desloratadine Kern Pharma is presented in an amber-colored plastic bottle containing 120 ml of oral solution, accompanied by a dosing syringe and closed with a child-resistant polypropylene cap.

Desloratadine Kern Pharma is presented in an amber-colored glass bottle containing 120 ml of oral solution, accompanied by a measuring cup and closed with a metal cap.

Marketing authorization holder and manufacturer

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa - Barcelona

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

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS) http://www.aemps.gob.es/