Desloratadine Kern Pharma 0.5 mg/ml oral solution EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Desloratadine Kern Pharma 0.5 mg/ml oral solution 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 or pharmacist.
• This medicine has been prescribed for you and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

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. How to store Desloratadine Kern Pharma
6. Contents of the pack and other information

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

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

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

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

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 taking Desloratadine Kern Pharma

Do not take Desloratadine Kern Pharma

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

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

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to take Desloratadine Kern Pharma:

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

Use of Desloratadine Kern Pharma with other medicines

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

There are no known interactions between desloratadine and other medicines.

Use of Desloratadine Kern Pharma with food, drinks, and alcohol

Desloratadine may be taken regardless of meals.

Pregnancy, breastfeeding, and fertility

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

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

Driving and using machines

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

Desloratadine Kern Pharma oral solution contains sorbitol.

If your doctor has informed you that you have an intolerance to certain sugars, consult with 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 given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The recommended dose is:

Children 1 to 5 years of age: take 2.5 ml of oral solution once daily.

Children 6 to 11 years of age: take 5 ml of oral solution once daily.

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

Plastic bottle with dosing syringe: Use the dosing syringe provided in the package with the bottle of oral solution to measure the correct amount of oral solution.

Glass bottle with dosing cup: Use the dosing cup provided in the package with the bottle of oral solution to measure the correct amount of oral solution.

Swallow the dose of oral solution, and then drink a little water. You may 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 per week or for less than 4 weeks), your doctor will recommend a treatment regimen based on an assessment of your medical history.

If your allergic rhinitis is persistent (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, 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, 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

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

If you stop treatment with Desloratadine Kern Pharma

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

4. Possible adverse effects

Like all medicines, Desloratadine Kern Pharma may cause adverse effects, although not everyone experiences them.

In most children and adults, adverse effects with oral desloratadine solution were approximately the same as with a solution or tablet containing no active ingredient. However, frequent adverse effects in children under 2 years of age were diarrhea, fever, and insomnia, whereas in adults, fatigue, dry mouth, and headache were reported more frequently than with a tablet containing no active ingredient.

During the marketing of oral desloratadine solution, very rare cases of severe allergic reactions (difficulty breathing, wheezing, itching, skin rash, and swelling) and skin rash have been reported. Very rare cases of palpitations, rapid heartbeat, stomach pain, nausea (feeling of vomiting), vomiting, upset stomach, diarrhea, dizziness, somnolence, difficulty sleeping, muscle pain, hallucinations, seizures, agitation with increased body movement, liver inflammation, and abnormalities 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 – Changes in the way the heart beats
• Abnormal behaviour – Aggression
• Depressed mood
• Dry eyes

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is an adverse effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: 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 this medicine out of 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 stated on the packaging after "EXP". The expiry date refers to the last day of the month indicated.

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

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at a SIGRE point located at pharmacies. If you have any doubts, ask your pharmacist how to dispose of unused containers and medicines. 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 ml of oral solution contains 0.5 mg of desloratadine.
• The other components of the oral solution are: sorbitol (E420), propylene glycol (E1520), sodium saccharin (E954), sodium citrate (E331), citric acid (E330), raspberry flavour, and purified water.

Appearance of the medicinal product and contents of the pack

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

Desloratadine Kern Pharma is presented in an amber glass bottle containing 120 ml of oral solution, supplied with a dosing 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 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) http://www.aemps.gob.es/