Leaflet: information for the user

desloratadine cinfa 5 mg film-coated tablets

Read this leaflet carefully before you start to take 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. Do not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

What is desloratadina cinfa

desloratadina cinfa contains desloratadina, which is an antihistamine.

How desloratadina cinfa works

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

When to use desloratadina cinfa

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 aged 12 years 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 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 starting to take desloratadina cinfa.

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

Children and adolescents

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

Desloratadine cinfa with other medicines

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

No known interactions of desloratadine with other medicines.

Desloratadine cinfa with food, drinks and alcohol

Desloratadine can be taken regardless of meals. 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 medicine.

Do not take desloratadine if you are pregnant or breastfeeding a baby.

Fertility

No data available on male and female fertility.

Driving and operating 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 perform activities that require a state of alert mental, 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 (main component of table salt/for cooking) in each tablet. This is equivalent to 1.3% of the maximum daily sodium intake recommended for an adult.

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 for oral use. 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 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 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 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 cinfa than you should

Take desloratadine only as your doctor has instructed. An accidental overdose is not expected to cause serious problems. However, if you take more desloratadine than you were told, tell 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 forgot to take desloratadine cinfa

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

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

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:

Frequent (may affect up to 1 in 10 patients):

• 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 patients):

Unknown frequency (cannot be estimated from available data):

Children

Unknown frequency (cannot be estimated from available data):

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:https://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.

This medication does not require any special storage temperature.

Store in the original packaging.

Medications should not be thrown down the drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of desloratadine cinfa

• The active ingredient 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), cornstarch, talc, sodium croscarmellose, and magnesium stearate.

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

Appearance of the product and contents of the packaging

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

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

Only some package sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Cinfa Laboratories, S.A.

Carretera Olaz-Chipi, 10. Industrial Estate Areta

31620 Huarte (Navarra) - Spain

Last review date of this leaflet:August 2022

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

You can access detailed and updated information about this medicine by scanning with your smartphone the QR code included in the leaflet and packaging. 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