Package Leaflet: Information for the Patient

Desloratadine Krka 5 mg Film-Coated Tablets

Read this 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, ask your doctor or pharmacist.

-This medicine has been prescribed for you only. Do not give it to others even if they have the same symptoms as you, as it may harm them.

-If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1.What is Desloratadine Krka and what it is 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.Contents of the pack and additional information

What is Desloratadina Krka

Desloratadina Krka contains desloratadine, which is an antihistamine.

How Desloratadina Krka works

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

When to use Desloratadina Krka

Desloratadina Krka 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 aged 12 years and above. These symptoms include sneezing, runny nose or nasal itching, palate itching, eye redness or tearing.

Desloratadina Krka 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 Krka

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Desloratadina Krka:

-if you have impaired renal function.

-if you have a medical 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 Krka

No known interactions of Desloratadina Krka with other medications.

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

Taking Desloratadina Krka with food, drinks, and alcohol

Desloratadina Krka can be taken with or without food.

Be careful when taking Desloratadina Krka 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.

Do not take Desloratadina Krka if you are pregnant or breastfeeding.

Fertility

No data 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 Krka contains lactose and sodium

If your doctor has told you that you have a certain sugar intolerance, consult with him before taking this medication.

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

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. If in 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.

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 for how long you should take Desloratadina Krka.

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 Krka than you should

Take Desloratadina Krka only as your doctor has instructed. 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 Toxicological Information Service, phone 915620420, indicating the medication and the amount ingested.

If you forgot to take Desloratadina Krka

If you forgot to take your dose at the usual 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.

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

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

During the marketing of desloratadine, very rarely reported cases of severe allergic reactions (difficulty breathing, hissing, itching, rashes, and swelling) have been reported. If you experience any of these severe side effects, stop taking this medicine and seek immediate medical attention.

In clinical studies in adults, the side effects were approximately the same as those with an inactive tablet. However, fatigue, dry mouth, and headache were reported more frequently than with an inactive tablet. In adolescents, headache was the most frequent 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 (urge to vomit),
• vomiting,
• upset stomach,
• diarrhea,
• dizziness,
• drowsiness,
• difficulty sleeping,
• muscle pain,
• hallucinations,
• seizures,
• agitation with increased body movement,
• inflammation of the liver,
• alteration in liver function tests.

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

• abnormal weakness,
• yellowing of the skin and eyes,
• increased sensitivity of the skin to the sun, even on cloudy days, and to ultraviolet light, for example, to the ultraviolet light of a tanning bed,
• change in the way the heart beats,
• alteration in behavior,
• aggression,
• increased appetite,
• weight gain,
• depressed mood,
• dry eyes.

Children

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

• slow heart rate,
• change in the way the heart beats,
• alteration in behavior,
• aggression.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information about 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 box and on the blister pack after CAD. The expiration date is the last day of the month indicated.

Store in the original packaging to protect it from moisture.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Desloratadina Krka

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

Appearance of the product and contents of the packaging

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

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

Only some package sizes may be marketed.

Marketing Authorization Holder

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

Responsible for manufacturing

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

For further information about this medicinal product, please contact 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 medicinal product is authorized in the member states of the European Economic Area with the following names:

Last review date of this leaflet:February 2023

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