Package Insert: Information for the Patient

Desloratadina Aurovitas 5 mg Film-Coated Tablets EFG

Read this package insert carefully before starting to take this medicine, as it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed only for you, 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 any adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this package insert. See section 4.

1. What isDesloratadina Aurovitasand for what it is used

2. What you need to know before starting to takeDesloratadina Aurovitas

3. How to takeDesloratadina Aurovitas

4. Possible adverse effects

5. Storage ofDesloratadina Aurovitas

6. Contents of the package and additional information

What isDesloratadina Aurovitas

Desloratadina is a type of antihistamine.

How it worksDesloratadina Aurovitas

Desloratadina is an antiallergic medication that does not produce drowsiness. It helps to control the allergic reaction and its symptoms.

When it should be usedDesloratadina Aurovitas

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 to continue your daily activities and normal sleep periods.

Do not take Desloratadina Aurovitas

• if you are allergic to desloratadine or to 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 Desloratadina Aurovitas:

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

Use in children and adolescents

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

Other medications and Desloratadina Aurovitas

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

No known interactions of desloratadine with other medications.

Taking Desloratadina Aurovitas with food, drinks, and alcohol

Desloratadine can be taken with or without food.

Be careful when taking desloratadine with alcohol.

Pregnancy, breastfeeding, and fertility

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

It is not recommended to take desloratadine if you are pregnant or breastfeeding.

Fertility

No data available on male/female fertility.

Driving and operating machinery

At the recommended dose, it is not expected that this medication 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 alert mental state, such as driving a car or operating machinery, until you have determined your own response to the medication.

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.

Adults and adolescents 12 years of age and older

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

This medication is taken orally.

Swallow the tablet whole.

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 you should follow your doctor's instructions.

If you take more Desloratadina Aurovitas 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 were told, inform your doctor, pharmacist, or nurse immediately.

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

If you forget to take Desloratadina Aurovitas

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

If you interrupt treatment with Desloratadina Aurovitas

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

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

During the marketing of desloratadine, very rarely reported cases of severe allergic reactions (difficulty breathing, hissing, itching, rashes, and swelling) have been reported. If you experience any of these severe side effects, stop taking this medicine and seek immediate medical attention.

In clinical trials 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.

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

Frequent: may affect up to 1 in 10 people

• Fatigue.
• Dry mouth.
• Headache.

Adults

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.
• Fast heartbeats.
• Stomach pain.
• Nausea (urge to vomit).
• Vomiting.
• Disturbed stomach.
• Diarrhea.
• Dizziness.
• Somnolence.
• Difficulty sleeping.
• Muscle pain.
• Hallucinations.
• Seizures.
• Hepatic inflammation.
• Alteration in liver function tests.
• Restlessness with increased body movement.

Unknown frequency: the frequency cannot be estimated from the available data

• Unusual weakness.
• Yellowish discoloration of the skin and/or eyes.
• Increased skin sensitivity to the sun, even on cloudy days, and to ultraviolet light, for example, to the ultraviolet light of a tanning bed.
• Abnormal behavior.
• Aggression.
• Change in heart rhythm.
• Weight gain, increased appetite.
• Depressed mood.
• Dry eyes.

Children

Unknown frequency: the frequency cannot be estimated from the available data

• Slow heart rate.
• Abnormal behavior.
• Aggression.
• Change in heart rhythm.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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 after CAD. The expiration date is the last day of the month indicated.

Keep in the original packaging to protect it from moisture.

Blister: Do not store at a temperature above 30°C.

PEAD Bottle: This medication does not require any special storage temperature. Once the bottle is opened, the tablets should be used within 18 months.

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 trash. Dispose of the containers and medications you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. By doing so, you will help protect the environment.

Composition ofDesloratadina Aurovitas

• The active ingredient is desloratadine. Each film-coated tablet contains 5 mg of desloratadine.
• The other components are:

Tablet core:microcrystalline cellulose (PH 102), pregelatinized maize starch, anhydrous colloidal silica, and magnesium stearate.

Film coating:hypromellose 2910 (6 cp), titanium dioxide (E171), microcrystalline cellulose, stearic acid, and aluminium lake of indigo carmine (E132).

Appearance of the product and contents of the package

Film-coated tablets, light blue in color, round, biconvex, marked with “D” on one face and “5” on the other face.

Desloratadina Aurovitas film-coated tablets are available in blisters and in high-density polyethylene (PEAD) bottles.

Package sizes:

Blisters: 20, 28, 30, 50, 60, 90, and 100 tablets.

PEAD bottles: 250 tablets.

Only some package sizes may be marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Responsible for manufacturing:

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

O

Generis Farmacêutica, S.A.

Rua João de Deus, 19

Amadora 2700-487

Portugal

This medicine is authorized in the member states of the European Economic Area with the following names:

Germany:Desloratadin PUREN 5 mg Filmtabletten

Belgium:Desloratadine AB 5 mg filmomhulde tabletten

Spain:Desloratadina Aurovitas 5 mg comprimidos recubiertos con película EFG

Italy:Desloratadina Aurobindo Italia

Netherlands:Desloratadine Aurobindo 5 mg, filmomhulde tabletten

Poland:Desloratadine Aurovitas

Portugal:Desloratadina Generis

Czech Republic:Desloratadin Aurovitas

Romania:Desloratadina Aurobindo 5 mg comprimate filmate

Last review date of this leaflet:January 2023

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