DESLORATADINE TECNIGEN 5 mg FILM-COATED TABLETS

Contents of the Package Leaflet

1. What is Desloratadine TecniGen and what is it used for.
2. What you need to know before taking Desloratadine TecniGen
3. How to take Desloratadine TecniGen

1. Possible side effects.
2. Storage of Desloratadine TecniGen 6. Package Contents and Additional Information.

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

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

Desloratadine TecniGen relieves symptoms associated with allergic rhinitis (inflammation of the nasal passages caused by an allergy, such as hay fever or allergy to dust mites and pollen). These symptoms include sneezing, runny or itchy nose, itchy palate, and itchy, red, or watery eyes.

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

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 TecniGen

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

Desloratadine TecniGen is indicated for adults and adolescents (12 years of age and older).

Warnings and Precautions

Consult your doctor or pharmacist before starting to take Desloratadine TecniGen:

• if you have impaired kidney function

• if you have a personal or family history of seizures

Taking Desloratadine TecniGen with Other Medications

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

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

Desloratadine TecniGen with Food, Beverages, and Alcohol

Desloratadine TecniGen can be taken with or without food.

Pregnancy, Breastfeeding, and Fertility

Consult your doctor or pharmacist before using any medication during pregnancy or breastfeeding.

If you are pregnant or breastfeeding, it is not recommended that you take Desloratadine TecniGen.

Driving and Using Machines

At the recommended dose, Desloratadine TecniGen is not expected to cause drowsiness or affect your ability to concentrate. However, very rarely, some people may experience drowsiness, which may affect their ability to drive or use machines.

Desloratadine TecniGen Contains Sorbitol, Glycerol, and Sodium

This medication contains sorbitol. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

This medication may cause headache, stomach upset, and diarrhea because it contains glycerol.

Patients on low-sodium diets should note that this medication contains 23 mg (1 mmol) of sodium per 10 ml of solution.

3. How to Take Desloratadine TecniGen

Adults and adolescents (12 years of age and older): take one tablet once a day. Swallow the tablet whole with water, with or without food.

Regarding the duration of treatment, your doctor will determine the type of allergic rhinitis you have and how long you should take Desloratadine TecniGen.

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 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 TecniGen Than You Should

Take Desloratadine TecniGen 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, phone 91 562 04 20, indicating the medication and the amount ingested.

If You Forget to Take Desloratadine TecniGen

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 the missed dose.

4. Possible Side Effects

Like all medications, Desloratadine TecniGen can cause side effects, although not everyone experiences them.

Adults:

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.

Frequency not known: the frequency cannot be estimated from the available data; abnormal behavior and aggression.

Children and Adolescents:

In adolescents, headache was the most commonly reported adverse reaction.

Frequency not known: the frequency cannot be estimated from the available data; slow heart rate, change in heart rhythm, abnormal behavior, aggression.

During the marketing of Desloratadine TecniGen, very rare cases of severe allergic reactions (difficulty breathing, wheezing, itching, skin hives, and swelling) and skin rash have been reported. Palpitations, rapid heart rate, stomach pain, nausea (vomiting), vomiting, upset stomach, diarrhea, dizziness, drowsiness, difficulty sleeping, muscle pain, hallucinations, seizures, agitation with increased body movement, liver inflammation, and altered liver function tests have also been reported very rarely.

Frequency not known: weight gain, increased appetite, depressed mood, dry eyes.

If you experience side effects, consult your doctor or pharmacist, even if they are side effects not listed in this package leaflet.

5. Storage of Desloratadine TecniGen

Keep out of sight and reach of children.

No special storage conditions are required.

Do not use Desloratadine TecniGen after the expiration date stated on the packaging and blister. The expiration date is the last day of the month indicated.

If you notice any change in the appearance of the tablets, inform your pharmacist.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and any unused medications at the SIGRE collection point in your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medications. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Desloratadine TecniGen

• The active ingredient is Desloratadine. Each tablet contains 5 mg of Desloratadine.
• The other ingredients are: Core: microcrystalline cellulose, mannitol, magnesium stearate.

Coating: Hypromellose, hydroxypropylcellulose, titanium dioxide, aluminum lake indigo carmine

Appearance of the product and package contents

Desloratadine TecniGen 5 mg film-coated tablets are presented in blisters. The tablets are light blue, round, and biconvex. Each package contains 20 tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Tecnimede España Industria Farmaceutica, S.A.

Avda. de Bruselas, 13, 3º D. Edificio América. Polígono Arroyo de la Vega

28108 Alcobendas (Madrid)

Manufacturer

Iberfar – Indústria Farmacêutica, S.A.

Estrada Consigliery Pedroso, 123 Queluz de Baixo

Barcarena, Portugal

O

Atlantic Pharma - Produções Farmacêuticas, S.A.

Rua da Tapada Grande, n.º 2,

Abrunheira. 2710-089 Sintra, Portugal

Date of the Last Revision of this Package Leaflet: December 2017

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