DESLORATADINE MABO 5 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Desloratadine MABO 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 side effects not listed in this package leaflet.

Contents of the package leaflet:

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

1. Package contents and additional information

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

What is Desloratadine MABO

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

How Desloratadine works

Desloratadine relieves 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 is 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 MABO

Do not take Desloratadine

• If you are allergic to desloratadine or any of the other components of this medication (listed in section 6) or to loratadine.
• Desloratadine MABO contains soy lecithin (E-322). If you are allergic to peanuts or soy, do not take this medication.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Desloratadine:

Use in children and adolescents

Do not administer this medication to children under 12 years of age.

Taking Desloratadine with other medications

There are no known interactions between Desloratadine 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 with food, drinks, and alcohol

Desloratadine can be taken independently of meals.

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.

It is not recommended to take Desloratadine tablets if you are pregnant or breastfeeding. There is no available data on male and female fertility.

Driving and using machines

At the recommended dose, this medication is not expected to 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 MABO 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.

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

3. How to take Desloratadine MABO

Follow the administration instructions for 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 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 than you should

Take Desloratadine tablets only as your doctor has indicated. An accidental overdose is not expected to cause serious problems. However, if you take more Desloratadine than you should, tell your doctor, pharmacist, or nurse immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount taken.

If you forget to take Desloratadine

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 forgotten doses.

If you stop taking Desloratadine

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

4. Possible side effects

Like all medications, Desloratadine tablets can cause side effects, although not everyone experiences 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 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, 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 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 possible side effects 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 contribute to providing more information on the safety of this medication.

5. Storage of Desloratadine MABO

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

Store in the original package.

Do not use Desloratadine 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 point in the pharmacy. If in doubt, ask your pharmacist how to dispose of packages and medications you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Desloratadine MABO

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

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

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

• Tablet coating: polyvinyl alcohol, titanium dioxide (E-171), talc, soy lecithin (E-322), xanthan gum (E-415), Indigo carmine (E-132).

Appearance of the product and package contents

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

Desloratadine MABO 5 mg film-coated tablets are presented in blisters, in packages of 20 tablets.

Marketing authorization holder

MABO-FARMA, S.A.

Calle Vía de los Poblados, 3, Edificio 6

28033 Madrid,

Spain.

Manufacturer

Neuraxpharm Pharmaceuticals, S.L.

Avda. Barcelona, 69

08970 Sant Joan Despí (Barcelona)

Spain

Date of the last revision of this package leaflet:May 2023

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.es/.