DESLORATADINE QUALIGEN 5 mg FILM-COATED TABLETS

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Desloratadine Qualigen 5 mg film-coated tablets EFG

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.

Contents of the package leaflet:

1. What is Desloratadine Qualigen and what is it used for
2. What you need to know before taking Desloratadine Qualigen
3. How to take Desloratadine Qualigen
4. Possible side effects
5. Storage of Desloratadine Qualigen

1. Contents of the pack and further information

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

What is Desloratadine Qualigen

It is a medication that contains desloratadine, which is an antihistamine.

How Desloratadine Qualigen works

Desloratadine Qualigen tablets relieve the symptoms associated with allergic rhinitis (inflammation of the nasal passages caused by an allergy, for example, hay fever or allergy to dust mites) in adults and adolescents from 12 years of age. These symptoms include sneezing, runny or itchy nose, itchy palate, and itchy, red, or watery eyes.

Desloratadine Qualigen tablets are also used to relieve the 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 Qualigen

Do not take Desloratadine Qualigen

• If you are allergic to desloratadine or any of the other components of this medication (listed in section 6) or to loratadine.
• Desloratadine Qualigen contains soy lecithin (E-322). It should not be used in case of peanut or soy allergy.

Warnings and precautions

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

• 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 Qualigen with other medications

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

Tell your doctor or pharmacist if you are taking or have recently taken or may need to take any other medication.

Taking Desloratadine Qualigen with food, drinks, and alcohol

Desloratadine Qualigen can be taken with or without food.

Be careful when taking Desloratadine Qualigen 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.

It is not recommended to take Desloratadine Qualigen tablets if you are pregnant or breastfeeding.

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 Qualigen contains lactose and sodium

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.

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

3. How to take Desloratadine Qualigen

Follow the administration instructions of this medication exactly as indicated by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist again.

Adults and adolescents from 12 years of age

The recommended dose is one tablet once a day.

Swallow the tablet whole with water, with or without food.

This medication is for oral use.

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

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 Qualigen than you should

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

If you forget to take Desloratadine Qualigen

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 stop taking Desloratadine Qualigen

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

4. Possible side effects

Like all medications, Desloratadine Qualigen tablets can cause side effects, although not everyone gets them.

During the marketing of Desloratadine Qualigen, 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 tablet that does not contain the active ingredient. However, fatigue, dry mouth, and headache were reported more frequently than with a tablet that does not contain the active ingredient. In adolescents, headache was the most frequently reported adverse reaction.

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

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

• fatigue
• dry mouth
• headache

Adults

During the marketing of Desloratadine Qualigen, the following side effects were reported:

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

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 sunlight, even on cloudy days, and to ultraviolet light, for example, to the ultraviolet light of a sunlamp
• change in heart rhythm
• weight gain, increased appetite
• abnormal behavior
• aggression
• changes in heart rhythm
• depressed mood
• dry eyes

Children

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

• slow heartbeat
• change in heart rhythm

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Pharmacovigilance System for human use medications: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Desloratadine Qualigen

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

Store in the original package.

Do not use Desloratadine Qualigen after the expiration date stated on the package and blister after "EXP". The expiration date is the last day of the month indicated.

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 packages and medications you no longer need at the SIGRE collection point in your pharmacy. If you have any doubts, ask your pharmacist how to dispose of the packages and medications you no longer need. This will help protect the environment.

6. CONTENTS OF THE PACKAGE AND FURTHER INFORMATION

Composition of Desloratadine Qualigen

• The active ingredient is desloratadine. Each tablet contains 5 mg of desloratadine.

• The other components of the tablets (excipients) are:

Core of the tablet: disodium hydrogen phosphate, corn starch, microcrystalline cellulose (E-460i), lactose monohydrate, pregelatinized corn starch, anhydrous colloidal silica (E-551), hydrogenated cottonseed oil, magnesium stearate (E-470b).

• Coating of the tablet: polyvinyl alcohol, titanium dioxide (E-171), talc (E-553b), soy lecithin (E-322), xanthan gum (E-415), carmine indigo (E-132).

Appearance of the product and contents of the package

Desloratadine Qualigen 5 mg is presented in the form of film-coated tablets. The tablets are round, biconvex, and blue in color.

Desloratadine Qualigen 5 mg film-coated tablets are presented in packages of 1, 2, 3, 5, 7, 10, 14, 15, 20, 21, 30, 50, 90, or 100 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

Neuraxpharm Spain, S.L.U.

Avda. Barcelona 69

08970 SANT JOAN DESPÍ (Barcelona) Spain

Manufacturer

Neuraxpharm Pharmaceuticals, S.L.

Avda. Barcelona 69

08970 SANT JOAN DESPÍ (Barcelona) Spain

Date of the last revision of this package leaflet:June 2022

Detailed and updated information about this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.es/.