Patient Information Leaflet

Desloratadine Alter 5 mg Buccal Tablets EFG

Read this leaflet carefully before you start taking this medicine. It contains important information for you.

• Keep this leaflet, as 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 others, even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet.

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

2.What you need to know before you start taking Desloratadine Alter

3.How to take Desloratadine Alter

4.Possible side effects

5.Storage of Desloratadine Alter

6.Contents of the pack and additional information

Desloratadina Alter is an antihistamine medication that does not cause drowsiness. It helps control allergic reactions and their symptoms.

Desloratadina 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.

Desloratadina 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 Alter

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Desloratadina Alter:

- if you have impaired renal 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

No known interactions of Desloratadinawith other medications.

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

Taking Desloratadina Alter with food, drinks, and alcohol

No need to take Desloratadina Alter with food and drinks.

You can take it independently of meals.Be careful when taking Desloratadina Alter with alcohol.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or think you might be 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 available on male and female fertility.

Driving and operating machinery

At the recommended dose, it is not expected that Desloratadina Alter will affect your ability to drive or operate machinery.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 machinery, until you have determined your own response to the medication.

Desloratadina Alter contains aspartame

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

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

Use in adults and adolescents 12 years of age and older

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 and remove the buccal 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.

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

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 therefore you should follow your doctor's instructions.

If you take more Desloratadina Alter than you should

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

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

If you forgot to take Desloratadina Alter

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

Like all medications, Desloratadina Alter may cause side effects, although not everyone will experience them.

During the marketing of Desloratadina Alter, very rarely reported 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 severe side effects, stop taking this medication and seek immediate medical attention.

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

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

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

• severe allergic reactions
• skin rash
• strong or irregular heartbeats
• rapid heartbeats
• stomach pain
• nausea (urge to vomit)
• vomiting
• upset stomach
• diarrhea
• dizziness
• drowsiness
• difficulty sleeping
• muscle pain
• hallucinations
• seizures
• agitation with increased body movement
• inflammation of the liver
• alteration in liver function tests

Unknown frequency: the frequency cannot be estimated from 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 ultraviolet light from a tanning bed
• changes in heart rhythm
• abnormal behavior
• aggression
• weight gain, increased appetite
• depressed mood

dry eyes

Children

Unknown frequency: the frequency cannot be estimated from available data

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Vigilance of Medicines for Human Use: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.

Do not use this medication after the expiration date that appears 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 at a temperature above 30°C.

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 Alter

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

Appearance of the product and content of the packaging

Desloratadina Alter 5 mg is presented in buccal dispersible tablets, which dissolve in the mouth. They are red clear speckled tablets, flat on top, round.

It is presented in a Poliamida/Aluminio/PVC blister and another of Aluminio.

Each package contains 20 tablets.

Holder of the marketing authorization and responsible for manufacturing

Laboratorios Alter

C/ Mateo Inurria, 30

28036 Madrid

Date of the last review of this leaflet: October 2023

The detailed information of this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/