Desloratadine Mabo 5 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Desloratadine MABO 5 mg film-coated tablets EFG

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet. 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. Do 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 effects, consult your doctor or pharmacist, even if such effects are not listed in this leaflet.

Contents of this leaflet:

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

2. What you need to know before taking Desloratadine MABO

3. How to take Desloratadine MABO

4. Possible side effects

5. How to store Desloratadine MABO

6. Contents of the pack and other information

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

What Desloratadine MABO is

Desloratadine MABO is a medicine that contains desloratadine, which is an antihistamine.

How Desloratadine 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 aged 12 years and older. These symptoms include sneezing, runny or itchy nose, itching of the palate, and itching, redness, or watering of the eyes.

Desloratadine is 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 continue your normal daily activities and sleep periods.

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

Do not take Desloratadine

• If you are allergic to desloratadine or to any of the other components of this medicine (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 medicine.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Desloratadine:

• if you have impaired kidney 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 with other medicines

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

Desloratadine may be taken regardless of meals.

Be cautious when taking Desloratadine with alcohol.

Pregnancy, breastfeeding, and fertility

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

Desloratadine tablets are not recommended if you are pregnant or breastfeeding. There are no available data regarding male and female fertility.

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 recommended not to perform activities requiring mental alertness, such as driving a car or operating machinery, until you have determined your individual response to the medicine.

Desloratadine MABO contains lactose

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

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

3. How to take Desloratadine MABO

Follow exactly the instructions for use of this medicine as given by your doctor or pharmacist. If you are unsure, 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 tablets.

If your allergic rhinitis is intermittent (symptoms present for fewer than 4 days per week or for fewer than 4 weeks), your doctor will recommend a treatment regimen based on an assessment of your medical history.

If your allergic rhinitis is persistent (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 than you should

Take desloratadine tablets only as your doctor has instructed. Accidental overdose is not expected to cause serious problems. However, if you take more desloratadine than prescribed, inform your doctor, pharmacist, or nurse immediately, or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medicine and the amount ingested.

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 your usual dosing schedule. Do not take a double dose to make up for forgotten doses.

If you stop treatment with desloratadine

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

4. Possible adverse effects

Like all medicines, Desloratadine tablets may cause adverse effects, although not everyone experiences them.

During the marketing of Desloratadine, 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 immediately and contact your doctor without delay.

In clinical trials in adults, adverse 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 adverse effects were reported as:

Frequent: these may affect up to 1 in 10 people

• fatigue
• dry mouth
• headache

Adults

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

Very rare: these 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
• abnormal behavior
• aggression
• weight gain, increased appetite
• 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
• abnormal behavior
• aggression

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 Medicines: https://www.notificaram.es. By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. Storage of Desloratadine MABO

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

Store in the original packaging.

Do not use Desloratadine 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 containers at a SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and containers you no longer need. This helps protect the environment.

6. Contents of the pack and other information

Composition of Desloratadine MABO

• The active substance 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, soybean lecithin (E-322), xanthan gum (E-415), Indigo carmine (E-132).

Appearance of the product and contents of the container

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

Desloratadine MABO 5 mg film-coated tablets are available in blisters in packs 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 most recent review of this leaflet: May 2023

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.es/ http://www.aemps.es/.