Desloratadine Stada 5 mg film-coated tablets EFG

Package Leaflet: Information for the User

Introduction

Package Leaflet: Information for the Patient

Desloratadina Stada 5 mg Film-coated Tablets EFG

Read the entire leaflet carefully before you start taking 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, 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 may harm them.

• If you experience any adverse effects, consult your doctor or pharmacist, even if these effects are not listed in this leaflet. See section 4.

Leaflet Contents

1. What Desloratadina Stada is and what it is used for

2. What you need to know before taking Desloratadina Stada

3. How to take Desloratadina Stada

4. Possible adverse effects

5. How to store Desloratadina Stada

6. Contents of the pack and other information

1. What Desloratadina Stada is and what it is used for

What Desloratadina Stada is

Desloratadina Stada contains desloratadine, which is an antihistamine.

How Desloratadina Stada works

Desloratadina Stada is an antiallergy medicine that does not cause drowsiness. It helps control the allergic reaction and its symptoms.

When Desloratadina Stada should be used

Desloratadine relieves symptoms associated with allergic rhinitis (inflammation of the nasal passages caused by an allergy, such as hay fever or dust mite allergy) in adults and adolescents aged 12 years and older. These symptoms include sneezing, runny or itchy nose, itching of the palate, and itchy, red or watery eyes.

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

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 Desloratadina Stada

Do NOT take Desloratadina Stada

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

Warnings and precautions

Talk to your doctor or pharmacist before taking Desloratadina Stada

• if you have impaired kidney function.
• if you or a family member has a history of seizures.

Use in children and adolescents

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

Other medicines and Desloratadina Stada

There are no known interactions of desloratadine with other medicines.

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

Desloratadina Stada with food, drinks and alcohol

Desloratadine can be taken regardless of meals.

Be cautious when taking desloratadine with alcohol.

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

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

Fertility

There is no available data on male and female fertility.

Driving and using machines

At the recommended dose, this medicine is not expected to affect your ability to drive or operate machinery.

Although most people do not experience drowsiness, it is recommended not to perform activities requiring mental alertness, such as driving a car or operating machinery, until you have determined how the medicine affects you.

Desloratadina Stada contains isomalt (E953)

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

3. How to take Desloratadine Stada

Follow exactly the instructions for use of this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Adults and adolescents aged 12 years and older

The recommended dose is one tablet once daily with water, with or without food.

Method of administration

This medicine is for oral use.

Swallow the tablet whole.

Duration of treatment

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

If you have intermittent allergic rhinitis (symptoms present for less than 4 days per week or for less 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 Stada than you should

Take desloratadine only as directed by your doctor. 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 Toxicology Information Service at telephone number: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Desloratadine Stada

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 missed doses.

If you stop taking Desloratadine Stada

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

4. Possible adverse effects

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

During the marketing of desloratadine, very rare cases of serious allergic reactions (difficulty breathing, wheezing, itching, skin rash, and swelling) and skin rash have been reported. If you experience any of these serious adverse effects, stop taking this medicine and seek immediate medical attention.

In clinical trials in adults, adverse effects were approximately the same as with a tablet containing no active ingredient. However, fatigue, dry mouth, and headache were reported more frequently than with a tablet containing no active ingredient. In adolescents, headache was the most frequently reported adverse reaction.

In clinical trials with desloratadine, the following adverse effects were reported as:

Frequent: the following may affect up to 1 in 10 people

• fatigue
• dry mouth
• headache

Adults

During the marketing of desloratadine, the following adverse effects were reported as:

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

Frequency not known: frequency cannot be estimated from the available data

• unusual weakness
• yellowish discoloration of the skin and/or eyes
• increased sensitivity of the skin to sunlight, even on cloudy days, and to ultraviolet light, for example ultraviolet light from a solarium
• change in the way the heart beats
• abnormal behavior
• aggression
• weight gain, increased appetite
• depressed mood
• dry eyes

Children

Frequency not known: frequency cannot be estimated from the available data

• slow heartbeat
• change in the way the heart beats
• abnormal behavior
• aggression
• weight gain, increased appetite

Reporting of adverse reactions

If you experience any type of adverse reaction, consult your doctor or pharmacist, even if it is an adverse reaction not listed in this leaflet. You may also report them directly through the national reporting system included in the Spanish System of Pharmacovigilance of Human Medicines: https://www.notificaram.es. By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. Storage of Desloratadine Stada

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging and blister after EXP. The expiry date refers to the last day of the month indicated.

Do not store above 30°C.

Keep in the original packaging to protect from moisture.

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 containers at the SIGRE Point in your pharmacy. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Desloratadine Stada

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

The other components of the tablet are:

Tablet core:

Isomalt (E953)

Starch, pregelatinized (from maize)

Microcrystalline cellulose

Magnesium oxide, heavy

Hydroxypropylcellulose

Crospovidone (type A)

Magnesium stearate

Tablet coating:

Polyvinyl alcohol

Titanium dioxide (E171)

Macrogol / PEG 3350

Talc

FD&C Blue No. 2 / Indigo carmine aluminum lake (E132)

Appearance of the medicinal product and contents of the pack

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

Desloratadine Stada 5 mg film-coated tablets are packed in blisters made of Polychlorotrifluoroethylene (PCTFE) / polyvinyl chloride (PVC) / aluminum.

Desloratadine Stada 5 mg film-coated tablets are available in unit dose blisters in pack sizes of 7, 10, 15, 20, 30, 50, 60, 90, 100, 120, 150, 180 film-coated tablets.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

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 European Economic Area (EEA) Member States under the following names:

Austria Desloratadin Stada 5 mg Filmtabletten

Belgium Desloratadine EG 5mg filmomhulde tabletten

Denmark Desloratadin Stada

Finland Desloratadin Stada

France DESLORATADINE EG 5 mg, comprimé pelliculé

Germany Desloratadin Stada 5 mg Filmtabletten

Hungary Desloratadine Stada

Italy Desloratadina EG 5 mg compresse rivestite con film

Luxembourg Desloratadine EG 5mg comprimés pelliculés

Netherlands Desloratadine CF 5 mg, filmomhulde tabletten

Portugal Desloratadina Ciclum

Spain Desloratadina Stada 5 mg comprimidos recubiertos con película EFG

Sweden Desloratadin Stada filmdragerade tabletter

Date of the most recent revision of this leaflet: October 2022

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