DESLORATADINE NORMON 5 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Desloratadine Normon 5 mg Film-Coated Tablets 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 side effects 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 tablets are a non-sedating antihistamine medication that helps control allergic reactions and their symptoms.

Desloratadine Normon tablets relieve 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 tablets are 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 or any of the other components of this medication (listed in section 6) or to loratadine.

Desloratadine Normon is indicated for adults and adolescents (12 years of age and older).

Warnings and Precautions

Consult your doctor or pharmacist before starting to take Desloratadine 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 12 years of age.

Taking Desloratadine Normon with Other Medications

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

Inform 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

There are no available data on male and female fertility.

Driving and Using Machines

At the recommended dose, it is not expected that this medication will 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 Lactose

This medication contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

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.

Adults and Adolescents 12 Years of Age and Older:

The recommended dose is one tablet once a day with water, with or without food.

This medication is for oral use.

Swallow the tablet whole.

Regarding the duration of treatment, your doctor will determine the type of allergic rhinitis you have and how long you should take Desloratadine Normon.

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. It is not expected that an accidental overdose will 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 the missed doses.

If You Interrupt Treatment with Desloratadine Normon

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

4. Possible Side Effects

Like all medications, Desloratadine Normon can cause side effects, although not everyone will experience 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 adults, side effects were approximately the same as with a placebo tablet. However, fatigue, dry mouth, and headache were reported more frequently than with a placebo tablet. In adolescents, headache was the most frequently reported adverse reaction.

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

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

• Fatigue
• Dry mouth
• Headache

Adults

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

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 or pharmacist, even if they are side effects not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for human use, https://www.notificaRAM.es. By reporting side effects, you can contribute to providing 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 shown on the packaging and blister after CAD. The expiration date is the last day of the month indicated.

Store in the original packaging to protect it from light and moisture.

Do not use this medication if you notice any change in the appearance of the tablets.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE collection point in your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Desloratadine Normon

• The active ingredient is desloratadine 5 mg.
• The other components of the tablet are: lactose, microcrystalline cellulose, calcium hydrogen phosphate, low-substituted hydroxypropylcellulose, magnesium stearate, colloidal silica, hypromellose, macrogol 6000, talc, titanium dioxide (E-171), and indigo carmine lake (E132).

Appearance of the Product and Package Contents

Film-coated tablets are round, biconvex, blue, and engraved with a "D" on one side.

They are available in packages of 20 tablets.

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 Health Products (AEMPS) http://www.aemps.gob.es/"

You can access detailed and updated information about this medication by scanning the QR code included in the package leaflet and packaging with your mobile phone (smartphone). You can also access this information at the following internet address:

https://cima.aemps.es/cima/dochtml/p/75840/P_75840.html