Desloratadina normon 0,5 mg/ml solucion oral efg

Patient Information Leaflet

Desloratadine Normon 0.5 mg/ml Oral Solution EFG

desloratadine

Read this 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. Do not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

DesloratadinaNormon oral solution is an antihistamine medication that does not cause drowsiness. It helps control allergic reactions and their symptoms.

Desloratadina Normon 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 nose or nasal itching, palate itching, eye redness or tearing.

Desloratadina Normon oral solution is also used to relieve symptoms associated with urticaria (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 normal sleep periods.

Do not take Desloratadina Normon

-if you are allergic (hypersensitive) to desloratadina, loratadina, or any of the other components of Desloratadina Normon (listed in section 6) or loratadina.

Warnings and precautions

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

-if you have impaired renal function

-if you have a personal or family history of seizures

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

Taking Desloratadina Normon with other medications

No known interactions have been reported with Desloratadina Normon and other medications.

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

Taking Desloratadina Normon with food and beverages

Desloratadina Normon can be taken regardless of meals.

Be cautious when taking desloratadina with alcohol.

Pregnancy, breastfeeding, and fertility

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

It is not recommended to take Desloratadina Normon if you are pregnant or breastfeeding.

Fertility

No data is available on male and female fertility.

Driving and operating machinery

At the recommended dose, this medication 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 that require mental alertness, such as driving a car or operating machinery, until you have determined your own response to the medication.

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

This medication contains 0.56 mg of benzoate of sodium per milliliter.

This medication contains 100 mg of propylene glycol per milliliter..

This medication contains 150 mg of sorbitol per milliliter.

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

This medication contains less than 23 mg of sodium (1 mmol) per milliliter; this 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 contained in this medication does not produce any noticeable effect.

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

Children

Children aged 1 to 5 years:

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

Children aged 6 to 11 years:

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

Adults and adolescents 12 years of age and older

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

This medication is for oral use.

Swallow the oral solution dose, 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 for how long you should take Desloratadina Normon oral solution. 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 based 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 you should follow your doctor's instructions.

If you take more Desloratadina Normon than you should

Take Desloratadina Normon only as your doctor has instructed.No serious problems are expected from an accidental overdose.However, if you take more Desloratadina Normon than you were told, 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 Desloratadina Normon

If you forget to take your dose at the usual 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 the missed dose.

If you interrupt treatment with Desloratadina Normon

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

Although all medications can cause side effects, Desloratadina Normon oral solution may produce them, although not everyone will experience them.

During the marketing of desloratadina, very rarely reported cases of severe allergic reactions (difficulty breathing, hissing, itching, rashes, and swelling) have been communicated. If you experience any of these severe side effects, stop taking this medication and seek immediate medical attention.

In clinical trials in most children and adults, the side effects of desloratadina were approximately the same as those of a solution or a tablet without an active ingredient. However, frequent 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 without an active ingredient.

During clinical trials with desloratadina, 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

• Diarhea
• Fever
• Insomnia

Adults

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

• Fatigue
• Dry mouth
• Headache

During the marketing of desloratadina, the following side effects were reported as:

Adults

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

• Severe allergic reactions
• Fast heartbeats
• Vomiting
• Dizziness
• Muscle pain
• Restlessness with increased body movement
• Skin rash
• Stomach pain
• Upset stomach
• Drowsiness
• Hallucinations
• Liver inflammation
• Strong or irregular heartbeats
• Nausea (urge to vomit)
• Diarhea
• Difficulty sleeping
• Seizures
• Alteration in liver function tests

Unknown frequency: 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 tanning bed
• Change in heart rhythm
• Abnormal behavior
• Aggression
• Weight gain, increased appetite
• Depressed mood
• Dry eyes

Children

Unknown frequency: the frequency cannot be estimated from the available data

• Slow heart rate
• Change in heart rhythm
• Abnormal behavior
• Aggression

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System of Pharmacovigilance of human use medicines, https://www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

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

Do not use Desloratadina Normon after the expiration date that appears on the box and on the bottle after CAD. The expiration date is the last day of the month indicated.

Do not freeze.

No special storage conditions are required.

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

Medicines should not be disposed of through drains or in the trash. Deposit the containers and medicines you no longer need at the SIGRE point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medicines you no longer need. In this way, you will help protect the environment.

Composition of Desloratadina

• The active ingredient 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 flavor (contains 94% m/m) and purified water.

Appearance of the product and contents of the packaging

Desloratadina Normon oral solution is presented in a closed polyethylene terephthalate bottle with an aluminum cap, containing 120 ml of oral solution and a dosing cup with markings for 2.5 ml and 5 ml doses.

Holder of the marketing authorization and responsible manufacturer

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (Spain)

Date of the last review of this leaflet: June 2022

“Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/”

You can access detailed and updated information on this medicine by scanning the QR code included in the leaflet and packaging 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