DESLORATADINE NORMON 0.5 mg/ml ORAL SOLUTION

Introduction

Package Leaflet: Information for the Patient

Desloratadine Normon 0.5 mg/ml Oral Solution EFG

desloratadine

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 or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult 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 Normon and what is it used for
2. What you need to know before taking Desloratadine Normon
3. How to take Desloratadine Normon
4. Possible side effects
5. Storage of Desloratadine Normon
6. Package Contents and Additional Information

1. What is Desloratadine Normon and what is it used for

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

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

Desloratadine Normon oral solution 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 normal sleep periods.

2. What you need to know before taking Desloratadine Normon

Do not take Desloratadine Normon

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

Warnings and Precautions

Consult your doctor or pharmacist before starting to take Desloratadine Normon:

-if you have impaired kidney function

-if you have a personal or family history of seizures

Use in Children and AdolescentsDo not administer this medication to children under 1 year of age.

Taking Desloratadine Normon with Other Medications

There are no known interactions between Desloratadine Normon and other medications.

Tell your doctor or pharmacist if you are using, have recently used, or may need to use any other medication.

Taking Desloratadine Normon with Food and Drinks

Desloratadine Normon can be taken with or without food.

Be careful when taking desloratadine with alcohol.

Pregnancy, Breastfeeding, and Fertility

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

If you are pregnant or breastfeeding, it is not recommended to take Desloratadine Normon.

Fertility

No data are available on male and female fertility.

Driving and Using Machines

At the recommended dose, this medication is not expected to affect your ability to drive or use machines. Although most people do not experience drowsiness, it is recommended not to engage in activities that require a state of mental alertness, such as driving a car or using machines, until you have determined your own response to the medication.

Desloratadine Normon contains sodium benzoate (E-211), propylene glycol (E-1520), sorbitol (E-420), sodium, and ethanol.

This medication contains 0.56 mg of sodium benzoate per milliliter.

This medication contains 100 mg of propylene glycol per milliliter.

This medication contains 150 mg of sorbitol per milliliter.

Sorbitol is a source of fructose. If your doctor has told you that you (or your child) have an intolerance to certain sugars, or have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which the patient cannot break down fructose, consult your doctor before taking this medication.

This medication contains less than 23 mg of sodium (1 mmol) per milliliter; it is essentially "sodium-free".

This medication contains 9.3 mg of alcohol (ethanol) per 10 ml dose, which is equivalent to 0.93 mg/ml (0.093 p/v). The amount in each 10 ml dose of this medication is equivalent to less than 1 ml of beer or 1 ml of wine. The small amount of alcohol in this medication does not produce any noticeable effect.

3. How to Take Desloratadine Normon

Follow the administration instructions for this medication exactly as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Children

Children from 1 to 5 years of age:

The recommended dose is 2.5 ml with the measuring cup of oral solution once a day.

Children from 6 to 11 years of age:

The recommended dose is 5 ml with the measuring cup of oral solution once a day.

Adults and Adolescents from 12 years of age

The recommended dose is 10 ml with the measuring cup of oral solution once a day.

This medication is for oral use.

Swallow the dose of oral solution, and then drink a little water. You can take this medication 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 Normon 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 Normon than you should

Take Desloratadine Normon only as your doctor has indicated. An accidental overdose is not expected to cause serious problems. However, if you take more Desloratadine Normon than you should, tell your doctor, pharmacist, or nurse immediately.

In case of overdose or accidental ingestion, consult your doctor or pharmacist or call the Toxicology Information Service, phone 915620420, indicating the medication and the amount ingested.

If you forget to take Desloratadine Normon

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 forgotten doses.

If you stop taking Desloratadine Normon

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

4. Possible Side Effects

Like all medications, Desloratadine Normon oral solution can cause side effects, although not everyone experiences them.

During the marketing of desloratadine, very rare cases of severe allergic reactions (difficulty breathing, wheezing, itching, hives, and swelling) have been reported. If you experience any of these serious side effects, stop taking this medication and seek medical attention immediately.

In clinical trials in most children and adults, the side effects with desloratadine 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.

In clinical trials with desloratadine, the following side effects were reported:

Children

Frequent in children under 2 years of age: the following may affect up to 1 in 10 children

• Diarrhea
• Fever
• Insomnia

Adults

Frequent: the following may affect up to 1 in 10 people

• Fatigue
• Dry mouth
• Headache

During the marketing of desloratadine, the following side effects were reported:

Adults

Very rare: the following may affect up to 1 in 10,000 people

• Severe allergic reactions
• Rapid heartbeats
• Vomiting
• Dizziness
• Muscle pain
• Agitation with increased body movement
• Skin rash
• Stomach pain
• Upset stomach
• Drowsiness
• Hallucinations
• Liver inflammation
• Strong or irregular heartbeats
• Feeling sick (nausea)
• Diarrhea
• Difficulty sleeping
• Seizures
• Changes in liver function tests

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

• Unusual weakness
• Yellowing of the skin and/or eyes
• Increased sensitivity of the skin to the sun, even on cloudy days, and to ultraviolet light, for example, to the ultraviolet light of a sunbed
• Change in heart rhythm
• 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 heart rhythm
• Abnormal behavior
• Aggression

Reporting Side Effects

If you experience any side effects, consult your doctor, pharmacist, or nurse, 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: https://www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Desloratadine Normon

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

Do not use Desloratadine Normon after the expiration date stated on the carton and bottle after EXP. The expiration date is the last day of the month indicated.

Do not freeze.

No special storage conditions are required.

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

Medications should not be disposed of through wastewater or household waste. Dispose of the packaging and any unused medication in the pharmacy's SIGRE collection point. If in doubt, consult your pharmacist on how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Desloratadine

• The active ingredient is desloratadine 0.5 mg/ml.
• The other ingredients of the oral solution are sodium benzoate (E-211), sodium saccharin, sorbitol (E-420), propylene glycol (E-1520), anhydrous citric acid, anhydrous sodium citrate, hydroxyethyl cellulose, orange flavor (contains 94% w/w), and purified water.

Appearance of the Product and Package Contents

Desloratadine Normon oral solution is presented in a polyethylene terephthalate bottle with a screw cap, containing 120 ml of oral solution and a measuring cup with marks for 2.5 ml and 5 ml doses.

Marketing Authorization Holder and Manufacturer

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (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 Healthcare Products (AEMPS) http://www.aemps.gob.es/"

You can access detailed and updated information on this medication by scanning the QR code included in the package leaflet and carton with your smartphone. You can also access this information at the following internet address:

https://cima.aemps.es/cima/dochtml/p/75842/P_75842.html