DESLORATADINE AUROVITAS 5 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Desloratadine Aurovitas 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, pharmacist, or nurse.
• 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, pharmacist, or nurse, even if they are side effects not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What is Desloratadine Aurovitas and what is it used for
2. What you need to know before taking Desloratadine Aurovitas
3. How to take Desloratadine Aurovitas
4. Possible side effects
5. Storage of Desloratadine Aurovitas
6. Package Contents and Additional Information

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

What isDesloratadine Aurovitas

Desloratadine is a type of antihistamine.

How it worksDesloratadine Aurovitas

Desloratadine is an anti-allergic medication that does not cause drowsiness. It helps control the allergic reaction and its symptoms.

When to useDesloratadine Aurovitas

Desloratadine relieves the 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.

Desloratadine is also used to relieve the symptoms associated with urticaria (a 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.

2. What you need to know before taking Desloratadine Aurovitas

Do not take Desloratadine Aurovitas

• if you are allergic 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 Aurovitas:

• if you have impaired kidney 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 Desloratadine Aurovitas

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

There are no known interactions between desloratadine and other medications.

Taking Desloratadine 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 plan 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

There are no available data on male/female fertility.

Driving and Using Machines

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

3. How to Take Desloratadine Aurovitas

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

Adults and Adolescents Aged 12 Years 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 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 assessment of your disease 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 one patient to another, and therefore, you should follow your doctor's instructions.

If You Take More Desloratadine Aurovitas 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 immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If You Forget to Take Desloratadine Aurovitas

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

If You Stop Taking Desloratadine Aurovitas

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

4. Possible Side Effects

Like all medications, this medication can cause side effects, although not everyone gets them.

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

In clinical trials in adults, side effects were approximately the same as with a tablet that does not contain the active ingredient. However, fatigue, dry mouth, and headache were reported more frequently than with a tablet that does not contain the active ingredient. In adolescents, headache was the most commonly reported adverse reaction.

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

Frequent: may affect up to 1 in 10 people

• Fatigue.
• Dry mouth.
• Headache.

Adults

During the marketing of desloratadine, the following side effects have been 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.
• Liver inflammation.
• Abnormal liver function tests.
• Agitation with increased body movement.

Frequency Not Known: frequency 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.
• Abnormal behavior.
• Aggression.
• Change in heart rhythm.
• Weight gain, increased appetite.
• Depressed mood.
• Dry eyes.

Children

Frequency Not Known: frequency cannot be estimated from available data

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

Reporting Side Effects

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

5. Storage of Desloratadine Aurovitas

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

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

Keep in the original packaging to protect from moisture.

Blister: Do not store 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 notice any change in the appearance of the tablets.

Medications should not be disposed of via wastewater or household waste. Return the packaging and any unused medication to the pharmacy's SIGRE collection point. If in doubt, ask your pharmacist how to dispose of the packaging and medication you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition ofDesloratadine Aurovitas

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

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

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

Appearance of the Product and Package Contents

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

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

Package sizes:

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

PEAD Bottles: 250 tablets.

Not all package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Manufacturer:

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

Or

Generis Farmacêutica, S.A.

Rua João de Deus, 19

Amadora 2700-487

Portugal

This medication is authorized in the Member States of the European Economic Area under 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

Date of Last Revision of this Package Leaflet:January 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).