Dasergin 5 mg film-coated tablets EFG

Package Leaflet: Information for the User

Introduction

Package Leaflet: Information for the Patient

Dasergin 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 need advice or more information, consult your doctor or pharmacist.

• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it could harm them.

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

Leaflet Contents

1. What Dasergin is and what it is used for
2. What you need to know before taking Dasergin
3. How to take Dasergin
4. Possible adverse effects
5. How to store Dasergin
6. Contents of the pack and other information

1. What Dasergin is and what it is used for

What Dasergin is

Dasergin contains desloratadine, which is an antihistamine.

How Dasergin works

Dasergin is an antiallergic medicine that does not cause drowsiness. It helps control the allergic reaction and its symptoms.

When Dasergin should be used

Dasergin 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 or itchy nose, itchy palate, and itchy, red or watery eyes.

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

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 Dasergin

Do not take Dasergin

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

Warnings and precautions

Talk to your doctor or pharmacist before taking Dasergin:

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

Use in children and adolescents

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

Other medicines and Dasergin

There are no known interactions between Dasergin and other medicines.

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

Taking Dasergin with food, drinks and alcohol

Dasergin can be taken with or without food.

Be cautious when taking Dasergin 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 to take Dasergin if you are pregnant or breastfeeding.

Fertility

There are no data available regarding male and female fertility.

Driving and using machines

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

Dasergin contains lactose and sodium

If your doctor has informed you that you have an intolerance to certain sugars, consult him before taking this medicine.

This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e., essentially "sodium-free".

3. How to take Dasergin

Follow exactly the instructions for use provided in this leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

Adults and adolescents aged 12 years and older

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

This medicine 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 Dasergin.

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 evaluation 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 Dasergin than you should

Take Dasergin only as directed by your doctor. 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 at telephone number 915620420, indicating the medicine and the amount ingested.

If you forget to take Dasergin

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

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 experiences them.

During the marketing of desloratadine, very rare cases of severe allergic reactions (difficulty breathing, wheezing, itching, hives, and swelling) have been reported. If you experience any of these serious adverse effects, stop taking this medicine immediately and consult your doctor without delay.

In clinical studies in adults, side effects were approximately the same as with placebo tablets. However, fatigue, dry mouth, and headache were reported more frequently than with placebo tablets. In adolescents, headache was the most frequent side effect.

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

Common (may affect up to 1 in 10 people):

• fatigue,
• dry mouth,
• headache.

Adults

During the marketing of desloratadine, the following adverse 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,
• somnolence,
• difficulty sleeping,
• muscle pain,
• hallucinations,
• seizures,
• agitation with increased body movements,
• liver inflammation,
• abnormalities in liver function tests.

Frequency not known: 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, for example, ultraviolet light from a sunbed,
• change in heart rhythm,
• behavioural changes,
• aggression,
• increased appetite,
• weight gain,
• depressed mood,
• dry eyes.

Children

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

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

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Dasergin

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

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

Store in the original packaging to protect it from moisture.

Medicines must not be disposed of via wastewater drains or household waste. Dispose of unused medicines and their packaging at a SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Dasergin

• The active substance 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), corn starch, 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 pack

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

Dasergin is available in packs of 10, 30 and 100 film-coated tablets in blisters.

Only some 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

For more 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 under the following names:

Date of the latest review of this leaflet: February 2023

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