DESLORATADINE CINFA 5 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

desloratadine cinfa 5 mg film-coated tablets EFG

Read this package leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. See section 4.

Contents of the package leaflet

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

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

What is desloratadine cinfa

desloratadine cinfa contains desloratadine, which is an antihistamine.

How desloratadine cinfa works

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

When to use desloratadine cinfa

Desloratadine relieves the symptoms associated with allergic rhinitis (inflammation of the nasal passages caused by an allergy, for example, hay fever or house 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 rashes.

The relief of these symptoms lasts a full day and helps you to continue your daily activities and normal sleep periods.

2. What you need to know before you take desloratadine cinfa

Do not take desloratadine cinfa

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

Warnings and precautions

Consult 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 take any other medicines.

There are no known interactions of desloratadine with other medicines.

Taking desloratadine cinfa 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 are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

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

Fertility

There are no data available on male and female fertility.

Driving and using machines

At the recommended dose, it is not expected that this medicine will 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 medicine.

desloratadine cinfa contains sodium

This medicine contains 26 mg of sodium (a major component of cooking/table salt) in each tablet. This is equivalent to 1.3% of the maximum recommended daily intake of sodium for an adult.

3. How to take desloratadine cinfa

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

Adults and adolescents from 12 years of age

The recommended dose is one tablet once a day 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 (presence of symptoms for less than 4 days a week or for less than 4 weeks), your doctor will recommend a treatment schedule that depends on the evaluation of your medical 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 one patient to another and therefore you should follow your doctor's instructions.

If you take more desloratadine cinfa than you should

Take desloratadine only as your doctor has told you. An accidental overdose is not expected to cause serious problems. However, if you take more desloratadine than you should, tell 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, telephone 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take desloratadine cinfa

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

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

In clinical trials in adults, the side effects were approximately the same as with a tablet that does not contain active ingredients. However, fatigue, dry mouth and headache were reported more frequently than with a tablet that does not contain active ingredients. 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 patients):

• 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 patients):

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 side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. You can also report side effects directly to the Spanish Medicines and Healthcare Products Agency (AEMPS) via the website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of desloratadine cinfa

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

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of the month shown.

This medicine does not require any special storage conditions.

Store in the original package.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and further information

Composition of desloratadine cinfa

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

• The other ingredients 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 tablets, blue in color and marked with the code “DL”.

They are presented in aluminum/aluminum blisters. Each pack contains 20 or 100 (clinical pack) film-coated tablets.

Not all 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 last revision of this package leaflet:August 2022

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Healthcare 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 carton with your 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