DESLORATADINE PENSA 5 mg FILM-COATED TABLETS

Introduction

Patient Information Leaflet

Desloratadine Pensa 5 mg film-coated 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, 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 or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the Leaflet

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

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

What is Desloratadine Pensa

Desloratadine Pensa contains desloratadine, which is an antihistamine.

How Desloratadine Pensa works

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

When to use Desloratadine Pensa

Desloratadine Pensa 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 years and older. These symptoms include sneezing, runny or itchy nose, itchy palate, and itchy, red, or watery eyes.

Desloratadine Pensa 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 Pensa

Do not take Desloratadine Pensa

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

Warnings and precautions

Consult your doctor, pharmacist, or nurse before taking Desloratadine Pensa:

? 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.

Taking Desloratadine Pensa with other medications

There are no known interactions between Desloratadine Pensa and other medications.

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

Taking Desloratadine Pensa with food, drinks, and alcohol

Desloratadine Pensa can be taken with or without food.

Be careful when taking Desloratadine Pensa with alcohol.

Pregnancy, breastfeeding, and fertility

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

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

Fertility

There are no available data on male and 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 alertness, such as driving a car or using machines, until you have determined your own response to the medication.

3. How to take Desloratadine Pensa

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.

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 for oral use.

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 Pensa.

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 plan 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 Pensa than you should

Take Desloratadine Pensa only as your doctor has indicated. An accidental overdose is not expected to cause serious problems.

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

If you forget to take Desloratadine Pensa

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 stop taking Desloratadine Pensa

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 experiences them.

During the marketing of Desloratadine Pensa, very rare cases of severe allergic reactions (difficulty breathing, wheezing, itching, rashes, and swelling) have been reported.

If you experience any of these serious side effects, stop taking this medication and seek medical attention immediately.

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 commonly reported adverse reaction.

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

Common: may affect up to 1 in 10 people

? fatigue

? dry mouth

? headache

Adults

During the marketing of Desloratadine Pensa, 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 heartbeat

? rapid heartbeat

? stomach pain

? nausea

? vomiting

? upset stomach

? diarrhea

? dizziness

? drowsiness

? difficulty sleeping

? muscle pain

? hallucinations

? seizures

? agitation with increased body movement

? liver inflammation

? changes in 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

? slow heartbeat

? changes in heart rhythm

? abnormal behavior

? aggression

Reporting side effects

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

5. Storage of Desloratadine Pensa

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

Do not use this medication after the expiration date stated on the packaging after "EXP". The expiration date is the last day of the month indicated.

This medication does not require any special storage temperature; keep it in the original packaging to protect it from light.

Medications should not be disposed of via wastewater or household waste. Dispose of the packaging and any unused medication at 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

• The active ingredient is desloratadine. Each tablet contains 5 mg of desloratadine.
• The other ingredients are: microcrystalline cellulose, pregelatinized corn starch, magnesium stearate, and anhydrous colloidal silica.

Coating: Opadry blue 03A30735, which consists of: hypromellose 6cP, titanium dioxide (E171), microcrystalline cellulose, stearic acid, indigo carmine (E132), and brilliant blue FCF (E133).

Appearance of the product and package contents

Blue, round, biconvex film-coated tablets with a diameter of 6.5 mm and a thickness of 3.2 mm.

Desloratadine Pensa 5 mg film-coated tablets are available in PVC/PE/PVDC-Aluminum or PVC/PCTFE (Aclar)-Aluminum blister packs of 20 tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder

Towa Pharmaceutical, S.A.

C/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

Manufacturer

Date of the last revision of this leaflet:May 2022

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