Desloratadine Qualigen 5 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Desloratadine Qualigen 5 mg film-coated tablets EFG

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 may harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet.

Leaflet contents:

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

2. What you need to know before taking Desloratadine Qualigen

3. How to take Desloratadine Qualigen

4. Possible adverse effects

5. How to store Desloratadine Qualigen

6. Contents of the container and other information

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

What Desloratadina Qualigen is

Desloratadina Qualigen is a medicine that contains desloratadine, which is an antihistamine.

How Desloratadina Qualigen works

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

Desloratadina Qualigen tablets are also used to relieve symptoms associated with urticaria (a skin condition caused by an allergy). These symptoms include itching and skin rashes.

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

2. What you need to know before starting to take Desloratadine Qualigen

Do not take Desloratadine Qualigen

• If you are allergic to desloratadine or to any of the other ingredients of this medicine (listed in section 6) or to loratadine.
• Desloratadine Qualigen contains soya lecithin (E-322). It must not be used if you are allergic to peanuts or soya.

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 medicine to children under 12 years of age.

Taking Desloratadine Qualigen with other medicines

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

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

Taking Desloratadine Qualigen with food, drinks, and alcohol

Desloratadine Qualigen can be taken regardless of meals.

Be cautious when taking Desloratadine Qualigen with alcohol.

Pregnancy, breastfeeding, and fertility

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

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

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 advised not to engage in activities requiring mental alertness, such as driving a car or operating machinery, until you have determined how the medicine affects you.

Desloratadine Qualigen contains lactose and sodium

This medicine contains lactose. If your doctor has informed you of an intolerance to certain sugars, consult him before taking this medicine.

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

3. How to take Desloratadine Qualigen

Follow exactly the instructions for administering this medicine as given by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist again.

Adults and adolescents aged 12 years and older

The recommended dose is one tablet once daily.

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

This medicine 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 you have intermittent allergic rhinitis (symptoms present for less than 4 days per week or for less than 4 weeks), your doctor will recommend a treatment regimen based on the assessment of your medical history.

If you have persistent allergic rhinitis (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 Qualigen than you should

Take Desloratadine Qualigen tablets only as directed by your doctor. Accidental overdose is not expected to cause serious problems. However, if you take more Desloratadine Qualigen than prescribed, inform 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, then continue with your usual dosing schedule. Do not take a double dose to make up for a missed dose.

If you stop taking Desloratadine Qualigen

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

4. Possible adverse effects

Like all medicines, Desloratadina Qualigen tablets may cause adverse effects, although not everybody gets them.

During the marketing of Desloratadina Qualigen, 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 and contact your doctor immediately.

In clinical trials in adults, adverse effects were approximately the same as with a tablet containing no active ingredient. However, fatigue, dry mouth, and headache were reported more frequently than with a tablet containing no active ingredient. In adolescents, headache was the most frequently reported adverse reaction.

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

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

• fatigue
• dry mouth
• headache

Adults

During the marketing of Desloratadina Qualigen, the following adverse effects were reported as:

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

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 the way the heart beats
• weight gain, increased appetite
• abnormal behavior
• aggression
• changes in the way the heart beats
• depressed mood
• dry eyes

Children

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

• slow heartbeat
• change in the way the heart beats

Reporting of adverse reactions

If you experience any type of adverse reaction, consult your doctor or pharmacist, even if it is a possible adverse reaction not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. Storage of DESLORATADINE QUALIGEN TABLETS

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

Store in the original packaging.

Do not use Desloratadine Qualigen after the expiry date stated on the packaging and blister after "EXP". The expiry date refers to the last day of the month indicated.

Do not use this medicine if you notice any changes in the appearance of the tablets.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE Point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. PACKAGE CONTENTS AND ADDITIONAL INFORMATION

Composition of Desloratadine Qualigen

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

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

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

• Tablet coating: polyvinyl alcohol, titanium dioxide (E-171), talc (E-553b), soya lecithin (E-322), xanthan gum (E-415), indigo carmine (E-132).

Appearance of the medicinal product and pack contents

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

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

Only certain 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 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.es/.