Desloratadine Cinfa 5 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

desloratadine cinfa 5 mg film-coated tablets EFG

Read the entire leaflet carefully before you start taking this medicine because 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 and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents

1. What desloratadine cinfa is and what it is used for
2. What you need to know before taking desloratadine cinfa
3. How to take desloratadine cinfa
4. Possible adverse effects
5. How to store desloratadine cinfa
6. Contents of the pack and other information

1. What desloratadine cinfa is and what it is used for

What is desloratadine cinfa

desloratadine cinfa contains desloratadine, which is an antihistamine.

How desloratadine cinfa works

Desloratadine is an antiallergic medicine that does not cause drowsiness. It helps control the allergic reaction and its symptoms.

When to use desloratadine cinfa

Desloratadine 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 aged 12 years and older. These symptoms include sneezing, runny or itchy nose, itching of the palate, and itchy, red or watery eyes.

Desloratadine is also used to relieve symptoms associated with urticaria (a skin condition caused by an allergy). These symptoms include itching and skin rashes.

Relief of these symptoms lasts for a full day and helps you continue your daily activities and maintain normal sleep periods.

2. What you need to know before taking desloratadine cinfa

Do not take desloratadine cinfa

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

Warnings and precautions

Talk to your doctor or pharmacist before taking desloratadine cinfa.

• If you have impaired kidney function.
• If you have a personal or family history of seizures.

Children and adolescents

Do not give this medicine to children under 12 years of age.

Taking desloratadine cinfa with other medicines

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

There are no known interactions between desloratadine and other medicines.

Taking desloratadine cinfa with food, drinks and alcohol

Desloratadine can be taken regardless of meals. Be cautious when taking desloratadine with alcohol.

Pregnancy, breastfeeding and fertility

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

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

Fertility

There are no data available regarding male and female fertility.

Driving and using machines

At the recommended dose, this medicine is not expected to affect your ability to drive or operate machinery. Although most people do not experience drowsiness, it is recommended not to perform activities requiring mental alertness, such as driving a car or operating machinery, until you have determined how you react to the medicine.

desloratadine cinfa contains sodium

This medicine contains 26 mg of sodium (main component of table/cooking salt) per tablet. This corresponds to 1.3% of the maximum daily sodium intake recommended for an adult.

3. How to take desloratadine cinfa

Follow exactly the instructions for use of this medicine as given 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 daily with water, with or without food.

This medicine 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.

If your allergic rhinitis is intermittent (symptoms present for less than 4 days per week or for less than 4 weeks), your doctor will recommend a treatment regimen based on an assessment of your medical history.

If your allergic rhinitis is persistent (symptoms present for 4 or more days per 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 desloratadine cinfa than you should

Take desloratadine only as directed by your doctor. Accidental overdose is not expected to cause serious problems. However, if you take more desloratadine than prescribed, inform your doctor, pharmacist, or nurse immediately.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take desloratadine cinfa

If you forget to take your dose at the scheduled 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 a missed dose.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse 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 adverse effects, stop taking this medicine immediately and contact your doctor without delay.

In clinical trials in adults, adverse effects were approximately the same as with a tablet containing no active ingredient. However, fatigue, dry mouth, and headache were reported more frequently than with a tablet containing no active ingredient. In adolescents, headache was the most frequently reported adverse reaction.

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

Very rare (may affect up to 1 in 10,000 people):

Frequency not known (cannot be estimated from the available data):

Children

Frequency not known (cannot be estimated from the available data):

Reporting of side effects

If you experience any type of adverse reaction, consult your doctor or pharmacist, even if it is a possible adverse reaction not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. Storage of desloratadine cinfa

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

This medicine does not require any special storage temperature conditions.

Store in the original packaging.

Medicines must not be disposed of via wastewater or household waste. Dispose of containers and any unused medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of desloratadine cinfa

• The active substance is desloratadine. Each film-coated tablet contains 5 mg of desloratadine.

• The other components of the tablet are:

Core: anhydrous sodium carbonate, microcrystalline cellulose (E-460i), corn starch, talc, sodium croscarmellose, and magnesium stearate.

Coating: Opadry II White (polyvinyl alcohol, titanium dioxide (E-171), talc, polyethylene glycol, macrogol) and indigo carmine (E-132).

Appearance of the product and contents of the pack

desloratadine cinfa 5 mg film-coated tablets EFG are cylindrical, biconvex, film-coated blue tablets marked with the code “DL”.

They are supplied in aluminium/aluminium blisters. Each pack contains 20 or 100 tablets (clinical pack).

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) - Spain

Date of the most recent revision of this leaflet: August 2022

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) www.aemps.gob.es/

You can access detailed and up-to-date information about this medicine by scanning the QR code included in the package leaflet and packaging with your mobile phone (smartphone). You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/75335/P_75335.html

QR code to: https://cima.aemps.es/cima/dochtml/p/75335/P_75335.html