DESLORATADINE ALTER 5 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Desloratadine Alter 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. See section 4.

Contents of the Package Leaflet

1. What is Desloratadina Alter and what is it used for
2. What you need to know before taking Desloratadina Alter
3. How to take Desloratadina Alter
4. Possible side effects
5. Storage of Desloratadina Alter
6. Package contents and additional information

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

Desloratadina Alter is a non-sedating antihistamine medication that helps control allergic reactions and their symptoms.

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

Desloratadina is also used to relieve symptoms associated with urticaria (a skin disease caused by an allergy). These symptoms include itching and skin rashes.

Relief from these symptoms lasts for a full day and helps you continue your daily activities and normal sleep periods.

2. What you need to know before taking Desloratadina Alter

Do not take Desloratadina Alter

• if you are allergic (hypersensitive) to desloratadina or any of the other ingredients of this medication (listed in section 6) or to loratadine.

Warnings and precautions

Consult your doctor or pharmacist before taking Desloratadina Alter:

• if you have impaired kidney function.
• if you have a personal or family history of seizures.

Children and adolescents

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

Other medications and Desloratadina Alter

There are no known interactions between Desloratadina Alter and other medications.

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medication.

Taking Desloratadina Alter with food, drinks, and alcohol

Desloratadina Alter can be taken with or without food.

Be careful when taking Desloratadina Alter 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. If you are pregnant or breastfeeding, it is not recommended to take Desloratadina Alter.

No data are available on male and female fertility.

Driving and using machines

At the recommended dose, Desloratadina Alter 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 alertness, such as driving a car or using machines, until you have determined your own response to the medication.

Desloratadina Alter contains Orange Yellow S

This medication may cause allergic reactions because it contains Orange Yellow S. It can cause asthma, especially in patients allergic to acetylsalicylic acid.

3. How to take Desloratadina Alter

Follow the exact instructions for administration of this medication as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Adults and adolescents (12 years of age and older):

The recommended dose is one tablet once a day, with or without food.

Swallow the tablet whole with water.

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

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 you should follow your doctor's instructions.

If you take more Desloratadina Alter than you should

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

In case of overdose or accidental ingestion, consult your doctor or pharmacist or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Desloratadina Alter

If you forget to take your dose at the scheduled time, take it as soon as possible, and then continue with your regular dosing schedule. Do not take a double dose to make up for missed doses.

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

4. Possible side effects

Like all medications, Desloratadina Alter can cause side effects, although not everyone experiences them. 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 commonly reported adverse reaction.

During the marketing of Desloratadina Alter, very rare cases of severe allergic reactions (difficulty breathing, wheezing, itching, skin rashes, and swelling) and skin rash have been reported. If you experience any of these serious side effects, stop taking this medication and seek medical attention immediately.

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

Common: may affect up to 1 in 10 people

• fatigue
• dry mouth
• headache

During the marketing of Desloratadina, the following side effects were reported:

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

• severe allergic reactions
• skin rash
• strong or irregular heartbeat
• rapid heartbeat
• stomach pain
• nausea
• vomiting
• upset stomach
• diarrhea
• dizziness
• drowsiness
• difficulty sleeping
• muscle pain
• hallucinations
• seizures
• agitation with increased body movement
• liver inflammation
• abnormal liver function tests

Frequency not known: cannot be estimated from 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, such as that from a sunlamp
• changes in heart rhythm
• abnormal behavior
• aggression
• weight gain, increased appetite
• depressed mood
• dry eyes

Children

Frequency not known: cannot be estimated from available data

If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet.

5. Storage of Desloratadina Alter

Keep out of sight and reach of children.

Do not use this medication after the expiration date stated on the package and blister after CAD. The expiration date is the last day of the month indicated.

Store in the original packaging.

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

Medications should not be disposed of via wastewater or household waste. Deposit the packaging and any unused medication in the pharmacy's SIGRE point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Package contents and additional information

Composition of Desloratadina Alter

• The active ingredient is desloratadina 5 mg
• The other ingredients of the tablet are: calcium phosphate dihydrate, pregelatinized corn starch, corn starch, microcrystalline cellulose, talc, calcium stearate, Opadry II blue (partially hydrolyzed polyvinyl alcohol, titanium dioxide (E171), macrogol, talc, indigo carmine (E132), and orange yellow S (E110)).

Appearance of the product and package contents

Blue, round, biconvex film-coated tablets. Available in packages of 20 tablets.

Marketing authorization holder and manufacturer

Laboratorios Alter, S.A.

C/Mateo Inurria, 30

28036 Madrid

Spain

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

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