DESLORATADINE KRKA 5 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Desloratadine Krka 5 mg Film-Coated Tablets EFG

Read the entire package leaflet carefully before starting to take this medication, as 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 you, 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 Krka and what is it used for
2. What you need to know before taking Desloratadine Krka
3. How to take Desloratadine Krka
4. Possible side effects
5. Storage of Desloratadine Krka
6. Package Contents and Additional Information

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

What is Desloratadine Krka

Desloratadine Krka contains desloratadine, which is an antihistamine.

How Desloratadine Krka works

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

When to use Desloratadine Krka

Desloratadine Krka 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, itchy palate, and itchy, red, or watery eyes.

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

The relief of 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 Krka

Do not take Desloratadine Krka

• 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 Krka:

• if you have impaired kidney function.
• if you have a medical history or family history of seizures,

Use in Children and Adolescents

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

Other Medications and Desloratadine Krka

There are no known interactions between Desloratadine Krka and other medications.

Tell your doctor or pharmacist if you are using, have recently used, or may need to use any other medication.

Taking Desloratadine Krka with Food, Drinks, and Alcohol

Desloratadine Krka can be taken with or without food.

Be careful when taking Desloratadine Krka 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 Krka 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 Krka contains Lactose and Sodium

If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

This medication contains less than 1 mmol of sodium (23 mg) per tablet; this is essentially "sodium-free".

3. How to take Desloratadine Krka

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.

This medication is for oral use.

Swallow the tablet whole.

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

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 medical 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 one patient to another, and therefore, you should follow your doctor's instructions.

If you take more Desloratadine Krka than you should

Take Desloratadine Krka only as your doctor has indicated. An accidental overdose is not expected to cause serious problems.

If you have taken more desloratadine than you should, consult your doctor, pharmacist, or call the Toxicology Information Service, phone 915620420, indicating the medication and the amount ingested.

If you forget to take Desloratadine Krka

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

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, rashes, and swelling) have been reported. If you experience any of these serious side effects, stop taking this medication and seek immediate medical attention.

In clinical studies 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 common side effect.

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

Frequent (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 (may affect up to 1 in 10,000 people)

• severe allergic reactions,
• skin rash,
• strong or irregular heartbeats,
• rapid heartbeats,
• stomach pain,
• nausea,
• vomiting,
• upset stomach,
• diarrhea,
• dizziness,
• drowsiness,
• difficulty sleeping,
• muscle pain,
• hallucinations,
• seizures,
• agitation with increased body movement,
• liver inflammation,
• abnormal liver function tests.

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

• unusual weakness,
• yellowing of the skin and eyes,
• increased sensitivity of the skin to sunlight, even on cloudy days, and to ultraviolet light, such as that from a sunlamp,
• change in heart rhythm,
• behavioral changes,
• aggression,
• increased appetite,
• weight gain,
• depressed mood,
• dry eyes.

Children

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

• slow heartbeat,
• change in heart rhythm,
• behavioral changes,
• aggression.

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 Spanish Medicines Agency's website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Desloratadine Krka

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

Do not use this medication after the expiration date stated on the carton and blister after EXP. The expiration date is the last day of the month indicated.

Store in the original packaging to protect from moisture.

Medications should not be disposed of via wastewater or household waste. Return the packaging and any unused medication to a pharmacy for proper disposal. If in doubt, consult your pharmacist on 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 Krka

• The active ingredient is desloratadine. Each film-coated tablet contains 5 mg of desloratadine.
• The other ingredients are: microcrystalline cellulose, hypromellose, hydrochloric acid (for pH adjustment), sodium hydroxide (for pH adjustment), corn starch, lactose monohydrate, and talc in the tablet core, and hypromellose, macrogol 400, lactose monohydrate, titanium dioxide (E171), and carmine indigo (E132) in the film coating. See section 2 "Desloratadine Krka contains lactose and sodium".

Appearance of the Product and Package Contents

Round, light blue, film-coated tablets with beveled edges (diameter: 6.5 mm, thickness: 2.3-3.5 mm).

Desloratadine Krka is available in packs of 10, 20, 30, 50, and 100 film-coated tablets in blisters.

Not all pack sizes may be marketed.

Marketing Authorization Holder

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Manufacturer

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

You can request more information about this medication from the local representative of the Marketing Authorization Holder:

KRKA Farmacéutica, S.L., C/ Anabel Segura 10, Pta. Baja, Oficina 1, 28108 Alcobendas, Madrid, Spain.

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

Date of the last revision of this package leaflet:February 2023

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/