DESLORATADINE ALTER 5 mg ORALLY DISINTEGRATING TABLETS

Introduction

Patient Information Leaflet

Desloratadine Alter 5 mg Oral Disintegrating Tablets EFG

Read the entire leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this 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 leaflet. See section 4.

Contents of the Leaflet:

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

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

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

Desloratadine 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 and above. These symptoms include sneezing, runny nose or nasal itching, itching of the palate, and itching, redness, or tearing of the eyes.

Desloratadine 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 a full day and helps you continue your daily activities and normal sleep periods.

2. What you need to know before taking Desloratadine Alter

Do not take Desloratadine Alter

• if you are allergic (hypersensitive) to desloratadine 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 starting to take Desloratadine 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 Desloratadine Alter

There are no known interactions between Desloratadine and other medications.

Inform your doctor or pharmacist if you are using, have recently used, or may need to use any other medication.

Taking Desloratadine Alter with food, drinks, and alcohol

It is not necessary to take Desloratadine Alter with food and drinks.

Additionally, it can be taken independently of meals. Be careful when taking Desloratadine 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 Desloratadine Alter.

No data are available on male and female fertility.

Driving and using machines

At the recommended dose, it is not expected that Desloratadine Alter will 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 Alter contains aspartame

This medication may be harmful to people with phenylketonuria because it contains aspartame, which is a source of phenylalanine.

3. How to take Desloratadine Alter

Follow the administration instructions for this medication exactly as indicated by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

Use in adults and adolescents aged 12 and above

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

This medication is for oral use.

Before use, carefully open the blister pack and remove the oral disintegrating tablet without breaking it. Place it in your mouth, and it will dissolve immediately. No water or other liquid is needed to swallow the dose.

Take the tablet immediately after removing it from the blister pack.

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

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 Desloratadine Alter than you should

Take desloratadine only as your doctor has indicated. An accidental overdose is not expected to cause serious problems. However, if you take more desloratadine than you have been told, inform 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 Desloratadine 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 further questions about the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medications, Desloratadine Alter can cause side effects, although not everyone will experience them.

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

Common: may affect up to 1 in 10 people

• fatigue
• dry mouth
• headache

During the marketing of Desloratadine, 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 heartbeats
• rapid heartbeats
• 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

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency (AEMPS) website: www.notificaRAM.es By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Desloratadine Alter

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

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

Store in the original packaging.

Do not store above 30°C.

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. Dispose of the packaging and any unused medication in the pharmacy's SIGRE collection point. If you are unsure, 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 Desloratadine Alter

• The active ingredient is desloratadine 5 mg
• The other ingredients are microcrystalline cellulose, pregelatinized corn starch, copolymer of polyvinyl alcohol and polyethylene glycol, butyl methacrylate copolymer, red iron oxide, talc, mannitol, crospovidone, aspartame (E951), calcium stearate, and strawberry flavor.

Appearance of the product and package contents

Desloratadine Alter 5 mg is presented in oral disintegrating tablets, which dissolve in the mouth. They are light red, speckled, flat, and round tablets.

They are packaged in a Poliamide/Aluminum/PVC blister pack and an Aluminum blister pack.

Each package contains 20 tablets.

Marketing authorization holder and manufacturer

Laboratorios Alter

C/ Mateo Inurria, 30

28036 Madrid

Date of the last revision of this leaflet: October 2023

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