Patient Information Leaflet: Summary of Product Characteristics

Desloratadine Stada 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 pass it on to others even if their symptoms are the same. It may harm them.
• If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

1. Side effects
2. Storage of Desloratadine Stada

1. Contents of the pack and other information

What is Desloratadina Stada

Desloratadina Stada contains desloratadine, which is an antihistamine.

How Desloratadina Stada works

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

When to use Desloratadina Stada

Desloratadine 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 12 years of age and older. These symptoms include sneezing, runny nose or nasal itching, palate itching, eye redness or tearing.

Desloratadine 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 Stada

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Desloratadina Stada

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

Use in children and adolescents

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

Other medications and Desloratadina Stada

No known interactions of desloratadine with other medications have been reported.

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

Desloratadina Stada 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 medication.

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

Fertility

No data is available on male and female fertility.

Driving and operating machinery

At the recommended dose, it is not expected that this medication will affect your ability to drive or operate machinery.

Although most people do not experience drowsiness, it is recommended not to perform activities that require a state of alertness, such as driving a car or operating machinery, until you have determined your own response to the medication.

Desloratadina Stada contains isomalta (E953)

This medication contains isomalta (E953). If your doctor has indicated that you have an intolerance to certain sugars, consult with them before taking this medication.

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.

Administration Form

This medication is for oral use.

Swallow the tablet whole.

Treatment Duration

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

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 treatment duration may vary from patient to patient, and you should follow your doctor's instructions.

If you take more Desloratadina Stada than you should

Take desloratadina only as your doctor has indicated. An accidental overdose is not expected to cause serious problems. However, 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 Stada

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

If you interrupt treatment with Desloratadina Stada

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

During the marketing of desloratadine, very rarely reported cases of severe allergic reactions (difficulty breathing, wheezing, itching, skin rashes, and swelling) and skin rash 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: the following may affect up to 1 in 10 people

• fatigue
• dry mouth
• headache

Adults

During the marketing of desloratadine, the following side effects were reported:

Rare: the following may affect up to 1 in 10,000 people

Unknown frequency: the frequency cannot be estimated from the available data

• unusual weakness
• yellowing of the skin and/or eyes
• increased sensitivity of the skin to the sun, even on cloudy days, and to ultraviolet light, for example, ultraviolet light from a sunbed
• change in heart rhythm
• abnormal behavior
• aggression
• weight gain, increased appetite
• depressed mood
• dry eyes

Children

Unknown frequency: the frequency cannot be estimated from the available data

• slow heart rate
• change in heart rhythm
• abnormal behavior
• aggression
• weight gain, increased appetite

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a side effect that does not appear in this leaflet. You can also report them directly through the national notification system included in the Spanish System of 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 and blister after CAD. The expiration date is the last day of the month indicated.

Do not store at a temperature above 30°C.

Store in the original packaging to protect it from moisture.

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

Medications should not be disposed of through drains or in the trash. Deposit the packaging and medications you no longer need at the SIGRE collection point of the pharmacy. Ask your pharmacist how to dispose of the packaging and medications you no longer need. In this way, you will help protect the environment.

Composition of Desloratadina Stada

The active ingredient is desloratadine. Each tablet contains 5 mg of desloratadine.

The other components of the tablet are:

Tablet core:

Isomalta (E953)

Pregelatinized corn starch

Microcrystalline cellulose

Heavy magnesium oxide

Hydroxypropyl cellulose

Crospovidone (type A)

Magnesium stearate

Tablet coating:

Polvinyl alcohol

Titanium dioxide (E171) Macrogol / PEG 3350

Talc

FD&C Blue No. 2 / Aluminum lake indigo carmine (E132)

Appearance of the product and contents of the package

Desloratadina Stada 5 mg film-coated tablets are blue, round, biconvex tablets with a diameter of approximately 6.5 mm.

Desloratadina Stada 5 mg film-coated tablets are packaged in blisters of Polychlorotrifluoroethylene (PCTFE) / Polyvinyl chloride (PVC) / Aluminum.

Desloratadina Stada 5 mg film-coated tablets are packaged in unit dose blisters in containers of 7, 10, 15, 20, 30, 50, 60, 90, 100, 120, 150, 180 film-coated tablets.

Only some package sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Responsible manufacturer

STADA Arzneimittel AG

Stadastrasse 2-18

61118 Bad Vilbel

Germany

or

PharmaPath S.A.

28is Oktovriou 1,

Agia Varvara, 123 51,

Greece

or

STADA Arzneimittel GmbH

Muthgasse 36/2

1190 Wien

Austria

This medicinal product is authorized in the Member States of the European Economic Area with the following names:

AustriaDesloratadin Stada 5 mg Filmtabletten

BelgiumDesloratadine EG 5mg filmomhulde tabletten

DenmarkDesloratadin Stada

FinlandDesloratadin Stada

FranceDESLORATADINE EG 5 mg, comprimé pelliculé

GermanyDesloratadinStada5mgFilmtabletten

HungaryDesloratadine Stada

ItalyDesloratadina EG5 mgcompresse rivestite con film

LuxembourgDesloratadine EG 5mgcomprimés pelliculés

NetherlandsDesloratadine CF 5 mg, filmomhulde tabletten

PortugalDesloratadina Ciclum

SpainDesloratadina Stada5 mg comprimidos recubiertos con película EFG

SwedenDesloratadin Stadafilmdragerade tabletter

Last review date of this leaflet:October 2022

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