DESLORATADINE STADA 5 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Desloratadine Stada 5 mg film-coated tablets EFG

Read the entire package leaflet carefully before starting to take this medication because it contains important information for you.

• Keep this package leaflet, as you may need to read it again.

• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are side effects not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

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

1. Possible side effects
2. Storage of Desloratadine Stada

1. Package Contents and Additional Information

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

What is Desloratadine Stada

Desloratadine Stada contains desloratadine, which is an antihistamine.

How Desloratadine Stada works

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

When to use Desloratadine Stada

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

Desloratadine 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 Stada

Do not take Desloratadine Stada

• if you are allergic to desloratadine or 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 Desloratadine 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 Desloratadine Stada

There are no known interactions between desloratadine and other medications.

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

Desloratadine Stada with Food, Drinks, and Alcohol

Desloratadine can be taken with or without food.

Be careful when taking desloratadine with alcohol.

Pregnancy, Breastfeeding, and Fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan 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

There are no available data on male and female fertility.

Driving and Using Machines

At the recommended dose, this medication is not expected to affect your ability to drive or use machines.

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

Desloratadine Stada contains isomalt (E953)

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

3. How to take Desloratadine Stada

Follow the administration instructions of this medication exactly as indicated 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 a day with water, with or without food.

Method of Administration

This medication 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 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 disease 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 Stada than you should

Take desloratadine 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 Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Desloratadine Stada

If you forgot to take your dose at the scheduled time, take it as soon as possible and then continue with the 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 other questions about the use of this medication, ask your doctor or pharmacist.

4. Possible Side Effects

Like all medications, this medication can cause side effects, although not everyone experiences them.

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

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 commonly 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:

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

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

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

Children

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

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

Reporting Side Effects

If you experience any side effects, consult your doctor or pharmacist, even if they are side effects not listed in this package leaflet. You can also report them directly through the national reporting system included in the Spanish Medicines Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Desloratadine Stada

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

Do not use this medication after the expiration date stated on the package and blister after EXP. The expiration date is 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 change in the appearance of the tablets, inform your pharmacist.

Medications should not be disposed of through wastewater or household waste. Dispose of the packaging and any unused medication in the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Desloratadine Stada

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

The other ingredients of the tablet are:

Tablet core:

Isomalt (E953)

Pregelatinized starch (from corn)

Microcrystalline cellulose

Heavy magnesium oxide

Hydroxypropylcellulose

Crospovidone (type A)

Magnesium stearate

Tablet coating:

Polyvinyl alcohol

Titanium dioxide (E171) Macrogol / PEG 3350

Talc

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

Appearance of the Product and Package Contents

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

Desloratadine Stada 5 mg film-coated tablets are packaged in PCTFE/PVC/Aluminum blisters.

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

Not all 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 Vienna

Austria

This medication is authorized in the Member States of the European Economic Area under the following names:

Austria Desloratadine Stada 5 mg film-coated tablets

Belgium Desloratadine EG 5mg film-coated tablets

Denmark Desloratadine Stada

Finland Desloratadine Stada

France DESLORATADINE EG 5 mg, film-coated tablet

Germany Desloratadine Stada 5 mg film-coated tablets

Hungary Desloratadine Stada

Italy Desloratadina EG 5 mg film-coated tablets

Luxembourg Desloratadine EG 5mg film-coated tablets

Netherlands Desloratadine CF 5 mg, film-coated tablets

Portugal Desloratadina Ciclum

Spain Desloratadina Stada 5 mg film-coated tablets EFG

Sweden Desloratadine Stada film-coated tablets

Date of the last revision of this package leaflet:October 2022

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