Package Insert: Information for the Patient

Desloratadine Alter 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 only for you, and you should not give it to others who may 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. See section 4.

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 (including those 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 Desloratadina Alter with other medications.

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

Taking Desloratadina Alter with food, drinks, and alcohol

Desloratadina Alter can be taken regardless of meals.

Be careful when taking Desloratadina Alter with alcohol.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication. If you are pregnant or breastfeeding, it is not recommended that you take Desloratadina Alter.

No data is 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 using machinery, until you have determined your own response to the medication.

Desloratadina Alter contains Yellow Iron Oxide S

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

Follow exactly the administration instructions for 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 for how long you should take desloratadina.

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

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.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:

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:

Very 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

If you experience side effects, consult your doctor or pharmacist, even if they do not appear in this prospectus.

Keep 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 use this medication if you observe any change in the appearance of the tablets.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and unused medicines at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medicines. By doing so, you will help protect the environment.

Composition of Desloratadina Alter

• The active ingredient is desloratadine 5 mg
• The other components of the tablet are: calcium dihydrogen phosphate monohydrate, pregelatinized cornstarch, cornstarch, microcrystalline cellulose, talc, calcium stearate, Opadry II blue(partially hydrolyzed polyvinyl alcohol, titanium dioxide (E171), macrogol, talc, indigotin (E132) and yellow-orange S (E110)).

Appearance of the product and contents of the packaging

Blue-coated, round, biconvex tablets. It is presented in packs of 20 tablets.

Holder of the marketing authorization and responsible for manufacturing

Laboratorios Alter, S.A.

C/Mateo Inurria, 30

28036 Madrid

Spain

Last review date of this leaflet:October 2023

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