Prospect: information for the patient

Desloratadina TecniGen 5 mg film-coated tablets

Read this prospect carefully before starting to take this medicine, as it contains important information for you

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only for you and should not be given to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they do not appear in this prospect.

Content of the prospect

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

1. Possible adverse effects.
2. Storage of Desloratadina TecniGen 6.Contents of the package and additional information.

Desloratadina TecniGen is an antihistamine medication that does not cause drowsiness. It helps control allergic reactions and their symptoms.

Desloratadina TecniGen relieves symptoms associated with allergic rhinitis (inflammation of the nasal passages caused by an allergy, for example, hay fever or allergy to dust mites and dust). These symptoms include sneezing, runny nose or nasal itching, palate itching, eye redness or tearing.

Desloratadina TecniGen is also used to relieve symptoms associated with urticaria (a 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 continue your daily activities and normal sleep periods.

• If you are allergic to desloratadina or to any of the other components of this medication (including those listed in section 6) or to loratadina.

Desloratadina 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 Desloratadina TecniGen:

• If you have impaired renal function

• If you have a personal or family history of seizures

Taking Desloratadina TecniGen with other medications

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

No known interactions of Desloratadina TecniGen with other medications.

Desloratadina TecniGen with food, drinks, and alcohol

Desloratadina TecniGen can be taken regardless of meals.

Pregnancy, breastfeeding, and fertility

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

If you are pregnant or breastfeeding a baby, it is not recommended to take Desloratadina TecniGen.

Driving and operating machines

At the recommended dose, it is not expected that Desloratadina TecniGen will cause drowsiness or impair your ability to pay attention. However, very rarely some people may experience drowsiness, which may affect your ability to drive or operate machines.

Desloratadina 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 headaches, stomach discomfort, 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.

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 for how long you should take Desloratadina TecniGen.

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 Desloratadina TecniGen Than You Should

Take Desloratadina TecniGen only as your doctor has instructed. 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 Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If You Forget to Take Desloratadina TecniGen

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 the missed dose.

Like all medications, Desloratadina TecniGen may produce adverse effects, although not all people will experience them.

Adults:

In adults, adverse effects were approximately the same as with an inactive ingredient tablet. However, fatigue, dry mouth, and headache were reported more frequently than with an inactive ingredient tablet.

Unknown frequency: the frequency cannot be estimated from available data; abnormal behavior and aggression.

Children and adolescents:

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

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

During the marketing of Desloratadina TecniGen, very rarely reported cases of severe allergic reactions (difficulty breathing, wheezing, itching, skin rashes, and swelling) and skin eruption have been reported. Very rarely, palpitations, rapid heart rate, stomach pain, nausea (urge to vomit), vomiting, stomach upset, diarrhea, dizziness, somnolence, difficulty sleeping, muscle pain, hallucinations, seizures, agitation with increased bodily movement, liver inflammation, and liver function test alterations have also been reported.

Unknown frequency: weight gain, increased appetite, depressed mood, dry eyes.

If you experience adverse effects, consult your doctor or pharmacist, even if they do not appear in this prospectus.

Keep out of the sight and reach of children.

No special storage conditions are required.

Do not use Desloratadina TecniGen after the expiration date that appears 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.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and unused medicines at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and unused medicines. By doing so, you will help protect the environment.

Composition of Desloratadina TecniGen

- The active ingredient is Desloratadina. Each tablet contains 5 mg of Desloratadina.

- The other components are: Core: microcrystalline cellulose, mannitol, magnesium stearate.

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

Appearance of the product and content of the packaging

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

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Tecnimede España Industria Farmaceutica, S.A

Avda. de Bruselas, 13, 3rd floor. Edificio América. Polígono Arroyo de la Vega

28108 Alcobendas (Madrid)

Responsible for manufacturing

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

Last review date of this leaflet: December 2017

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/