Desloratadine Normon 0.5 mg/ml oral solution EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Desloratadine Normon 0.5 mg/ml oral solution EFG

desloratadine

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 only, and you should not give it to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents:

1. What Desloratadine Normon is and what it is used for
2. What you need to know before taking Desloratadine Normon
3. How to take Desloratadine Normon
4. Possible side effects
5. How to store Desloratadine Normon
6. Contents of the pack and other information

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

Desloratadine Normon oral solution is a non-sedating antihistamine medicine. It 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, itching of the palate, and itchy, red or watery eyes.

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

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

2. What you need to know before starting Desloratadina Normon

Do not take Desloratadina Normon

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

Warnings and precautions

Consult your doctor or pharmacist before starting Desloratadina Normon:

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

Use in children and adolescents Do not administer this medicine to children under 1 year of age.

Taking Desloratadina Normon with other medicines

There are no known interactions between Desloratadina Normon and other medicines.

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

Taking Desloratadina Normon with food and drinks

Desloratadina Normon can be taken regardless of meals.

Exercise caution when taking desloratadine with alcohol.

Pregnancy, breastfeeding and fertility

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

If you are pregnant or breastfeeding a baby, it is not recommended to take Desloratadina Normon.

Fertility

There are no available data on male and female fertility.

Driving and using machines

At the recommended dose, this medicine is not expected to affect your ability to drive or operate machinery. Although most people do not experience drowsiness, it is recommended not to perform activities requiring mental alertness, such as driving a car or operating machinery, until you have determined your individual response to the medicine.

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

This medicine contains 0.56 mg of sodium benzoate per millilitre.

This medicine contains 100 mg of propylene glycol per millilitre.

This medicine contains 150 mg of sorbitol per millilitre.

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

This medicine contains less than 23 mg of sodium (1 mmol) per millilitre; hence, it is essentially "sodium-free".

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

3. How to take Desloratadine Normon

Follow exactly the administration instructions for this medicine 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 using the oral dosing cup once daily.

Children from 6 to 11 years of age:

The recommended dose is 5 ml using the oral dosing cup once daily.

Adults and adolescents aged 12 years and older

The recommended dose is 10 ml using the oral dosing cup once daily.

This medicine is for oral use.

Swallow the oral solution dose, 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 Normon oral solution. If your allergic rhinitis is intermittent (symptoms present for fewer than 4 days per week or for fewer 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 Normon than you should

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

In case of overdose or accidental ingestion, consult your doctor or pharmacist or call the Toxicology Information Service at telephone number 915620420, indicating the medicine 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 your usual dosing schedule. Do not take a double dose to make up for missed doses.

If you stop treatment with Desloratadine Normon

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

4. Possible adverse effects

Like all medicines, Desloratadine Normon oral solution may cause adverse effects, although not everyone experiences them.

During the marketing of desloratadine, very rare cases of serious allergic reactions (difficulty breathing, wheezing, itching, hives, and swelling) have been reported. If you experience any of these serious adverse effects, stop taking this medicine immediately and consult your doctor without delay.

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

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

Children

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

• Diarrhoea
• 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 adverse effects have been reported as:

Adults

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

• Serious allergic reactions
• Fast heartbeat
• Vomiting
• Dizziness
• Muscle pain
• Restlessness with increased body movement
• Skin rash
• Stomach pain
• Upset stomach
• Somnolence
• Hallucinations
• Liver inflammation
• Strong or irregular heartbeat
• Nausea
• Diarrhoea
• Difficulty sleeping
• Seizures
• Abnormal liver function tests

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

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

Reporting of adverse effects

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

5. Storage of Desloratadine Normon

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

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

Do not freeze.

No special storage conditions are required.

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

Medicines must not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE point in your pharmacy. If you are unsure, ask your pharmacist how to dispose of containers and unused medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Desloratadine

• The active substance is desloratadine 0.5 mg/ml.
• The other components of the oral solution are sodium benzoate (E-211), sodium saccharin, sorbitol (E-420), propylene glycol (E-1520), anhydrous citric acid, anhydrous sodium citrate, hydroxyethylcellulose, orange flavour (contains 94% m/m), and purified water.

Appearance of the product and contents of the pack

Desloratadine Normon oral solution is supplied in a polyethylene terephthalate (PET) bottle with an aluminium screw cap, containing 120 ml of oral solution and a dosing cup with markings 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 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 Medical Devices (AEMPS) http://www.aemps.gob.es/”

You can access detailed and up-to-date information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the package leaflet and outer packaging. You may also access this information at the following internet address:

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