Patient Information Leaflet: Dasergin 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 need advice or more information, 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 as yours. It may harm them.
• If you experience any side effects, talk to your doctor or pharmacist. See section 4.

1.What Dasergin is and what it is used for

2.What you need to know before you start taking Dasergin

3.How to take Dasergin

4.Possible side effects

5.Storage of Dasergin

6.Contents of the pack and additional information

What is Desloratadine

Desloratadine contains desloratadine, which is an antihistamine.

How Desloratadine works

Desloratadine is an antiallergic medication that does not cause drowsiness. It helps to control allergic reactions and their symptoms.

When to use Desloratadine

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 aged 12 years 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 Dasergin

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Dasergin:

-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 Dasergin

No known interactions of Dasergin with other medications.

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

Taking Dasergin with food, drinks, and alcohol

Dasergin can be taken with or without food.

Be careful when taking Dasergin 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 Dasergin if you are pregnant or breastfeeding.

Fertility

No data available on male and female fertility.

Driving and operating machines

At the recommended dose, it is not expected that this medication will affect your ability to drive or operate machines. Although most people do not experience drowsiness, it is recommended not to perform activities that require a state of mental alertness, such as driving a car or operating machines, until you have determined your own response to the medication.

Dasergin contains lactose and sodium

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

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

Follow exactly the medication administration instructions contained in this leaflet or those indicated by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.

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 Dasergin.

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 regimen 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 therefore you should follow your doctor's instructions.

If you take more Dasergin than you should

Take Dasergin only as your doctor has instructed. An accidental overdose is not expected to cause serious problems.

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

If you forgot to take Dasergin

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

• unusual 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 ultraviolet light from a tanning bed,
• change in the way the heart beats,
• change 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.
• change 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 leaflet. 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 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 shown on the packaging (box and blister) after CAD. The expiration date is the last day of the month indicated.

Store in the original packaging to protect it from moisture.

Do not dispose of medications through drains or trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at your 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 Dasergin

• 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 “Dasergin contains lactose and sodium”.

Appearance of the product and contents of the package

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

Dasergin is available in blister packs of 10, 30, 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

Manufacturer

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

You can request more information about this medication by contacting 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 with the following names:

Last review date of this leaflet:February 2023

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