Desloratadine Tecnigen 5 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Desloratadine TecniGen 5 mg film-coated tablets EFG

Read the entire package leaflet carefully before starting to take this medicine, 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 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.

Package leaflet contents

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

2. What you need to know before taking Desloratadine TecniGen

3. How to take Desloratadine TecniGen

4. Possible side effects

5. Storage of Desloratadine TecniGen

6. Contents of the pack and other information

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

Desloratadine TecniGen is a non-sedating antihistamine medicine. It 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 dust). These symptoms include sneezing, runny or itchy nose, itching of the palate, and eye itching, redness, or tearing.

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

Relief from these symptoms lasts for a full day, helping you continue your daily activities and maintain normal sleep periods.

2. What you need to know before taking Desloratadine TecniGen

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

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

Warnings and precautions

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

• if you have impaired renal function

• if you have a personal or family history of seizures

Taking Desloratadine TecniGen with other medicines

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

There are no known interactions of Desloratadine TecniGen with other medicines.

Desloratadine TecniGen with food, drinks and alcohol

Desloratadine TecniGen may be taken regardless of meals.

Pregnancy, lactation and fertility

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

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

Driving and operating machinery

At the recommended dose, Desloratadine TecniGen is not expected to cause drowsiness or impair your attention. However, very rarely, some individuals may experience drowsiness, which could affect their ability to drive or operate machinery.

Desloratadine TecniGen contains sorbitol, glycerol, and sodium

This medicine contains sorbitol. If your doctor has informed you of an intolerance to certain sugars, consult with them before taking this medicine.

This medicine may cause headache, stomach discomfort, and diarrhea because it contains glycerol.

Patients on low-sodium diets should be aware that this medicine 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 daily. 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 you have intermittent allergic rhinitis (symptoms present for fewer than 4 days per week or for fewer than 4 weeks), your doctor will recommend a treatment regimen based on an assessment of your medical history.

If you have persistent allergic rhinitis (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 TecniGen than you should

Take Desloratadine TecniGen only as your doctor has instructed. Serious problems are not expected from accidental overdose.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately, or call the Toxicology Information Service at telephone number 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, then continue with your regular dosing schedule. Do not take a double dose to make up for the missed dose.

4. Possible adverse effects

Like all medicines, Desloratadina TecniGen may cause adverse effects, although not everyone experiences them.

Adults:

In adults, adverse effects were approximately the same as with a tablet containing no active substance. However, fatigue, dry mouth, and headache were reported more frequently than with a tablet containing no active substance.

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

Children and adolescents:

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

Frequency not known: frequency cannot be estimated from the available data; slow heartbeat, change in the way the heart beats, abnormal behaviour, aggression.

During the marketing of Desloratadina TecniGen, very rare cases of serious allergic reactions (difficulty breathing, wheezing, itching, skin rash, and swelling) and skin rash have been reported. Very rare cases of palpitations, rapid heartbeat, stomach pain, nausea (feeling sick), vomiting, upset stomach, diarrhoea, dizziness, drowsiness, difficulty sleeping, muscle pain, hallucinations, seizures, restlessness with increased body movement, liver inflammation, and changes in liver function tests have also been reported.

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

If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this 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 expiry date stated on the packaging and blister. The expiry date refers to the last day of the month indicated.

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

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at a SIGRE point in your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Desloratadine TecniGen

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

Coating: hypromellose, hydroxypropylcellulose, titanium dioxide, indigo carmine aluminum lake.

Appearance of the product and contents of the container

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

Marketing Authorization Holder and Manufacturing Responsible Party

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

or

Atlantic Pharma - Produções Farmacêuticas, S.A.
Rua da Tapada Grande, n.º 2,
Abrunheira, 2710-089 Sintra, Portugal

Date of the most recent review of this leaflet: December 2017

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