Package Insert: Information for the User

Desloratadina MABO 5 mg Film-Coated Tablets

Read this package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed for you only and should not be given to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert.

6. Contents of the pack and additional information

What is Desloratadina MABO

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

How Desloratadina works

Desloratadine relieves 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 12 years of age and older. These symptoms include sneezing, runny nose or nasal itching, palate itching, eye redness or tearing.

Desloratadine 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

• If you are allergic to desloratadine or to any of the other ingredients of this medication (listed in section 6) or to loratadine.
• Desloratadina 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 Desloratadina :

- 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 Desloratadina with other medications

No known interactions of Desloratadina with other medications.

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

Taking Desloratadina with food, drinks, and alcohol

Desloratadina can be taken regardless of meals.

Be careful when taking Desloratadina with alcohol.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding or believe you may be pregnant or intend to become pregnant, consult your doctor or pharmacist before using this medication.

Do not recommend taking Desloratadina tablets if you are pregnant or breastfeeding. No data is available on male and female fertility.

Driving and operating machines

At the recommended dose, it is not expected that this medication will affect your ability to drive or operate machines. Although most people do not experience drowsiness, it is recommended not to perform activities that require a state of mental alertness, such as driving a car or operating machines, until you have determined your own response to the medication.

Desloratadina MABO contains lactose

This medication contains lactose. If your doctor has indicated that you have a certain sugar intolerance, consult with him before taking this medication.

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

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

Adults and adolescents 12 years of age and older

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 for how long you should take Desloratadina tablets.

If your allergic rhinitis is intermittent (presence of symptoms for less than 4 days a week or 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 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 than you should

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

If you forget to take Desloratadina

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

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

Like all medicines, Desloratadina tablets may cause side effects, 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 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 desloratadina, the following side effects were reported as:

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

• fatigue
• dry mouth
• headache

Adults

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

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

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 or pharmacist, 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 for the Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es.By reporting side effects, you can contribute to providing more information about the safety of this medication.

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

Store in the original packaging.

Do not use Desloratadine after the expiration date that appears on the packaging and blister after “CAD”. The expiration date is the last day of the month indicated.

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

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Desloratadina 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, cornstarch, microcrystalline cellulose (E-460), lactose monohydrate, pregelatinized cornstarch, 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 carmin (E-132) .

Appearance of the product and content of the packaging

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

Desloratadina MABO 5 mg film-coated tablets are presented in a blister pack, in containers of 20 tablets.

Marketing Authorization Holder

MABO-FARMA, S.A.

Calle Vía de los Poblados, 3, Edificio 6

28033 Madrid,

Spain.

Responsible for manufacturing

Neuraxpharm Pharmaceuticals, S.L.

Avda. Barcelona, 69

08970 Sant Joan Despí (Barcelona)

Spain

Last review date of this leaflet: May 2023

The 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.es/ http://www.aemps.es/ .