DASERGIN 5 mg FILM-COATED TABLETS

Introduction

Patient Information Leaflet

Dasergin 5 mg film-coated tablets EFG

Read all of this leaflet carefully before you start taking this medicine.It contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.

• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What Dasergin is and what it is used for
2. What you need to know before you take Dasergin
3. How to take Dasergin
4. Possible side effects
5. Storage of 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 a non-sedating antiallergic medicine that helps to control allergic reactions and their symptoms.

When to use Dasergin

Dasergin relieves the symptoms associated with allergic rhinitis (inflammation of the nasal passages caused by an allergy, such as 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.

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

The relief of these symptoms lasts a full day and helps you to continue your daily activities and normal sleep periods.

2. What you need to know before you take Dasergin

Do not take Dasergin

• if you are allergic to desloratadine or any of the other ingredients 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 kidney problems.
• if you have a medical 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 take any other medicines.

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 are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Dasergin is not recommended if you are pregnant or breastfeeding.

Fertility

There is no available data on 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 engage in activities that require a state of alertness, such as driving a car or using machines, until you have determined your own response to the medicine.

Dasergin contains lactose and sodium

If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

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

3. How to take Dasergin

Follow exactly the administration instructions of the medicine contained in this leaflet or as directed by your doctor or pharmacist. If you are unsure, ask your doctor or pharmacist.

Adults and adolescents from 12 years of age

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 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 you should follow your doctor's instructions.

If you take more Dasergin than you should

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

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

If you forget to take Dasergin

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

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

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 have been reported:

Very rare (may affect up to 1 in 10,000 people):

• severe allergic reactions,
• skin rash,
• strong or irregular heartbeats,
• rapid heart rate,
• 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: 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: frequency cannot be estimated from the available data

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

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Spanish Medicines and Healthcare Products Agency (AEMPS) at https://www.notificaram.es. By reporting side 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 which is stated on the carton and blister after EXP. The expiry date refers to the last day of the month shown.

Store in the original package to protect from moisture.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to your pharmacist. This will help to 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 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 "Dasergin contains lactose and sodium".

Appearance and packaging

Round, light blue, film-coated tablets with beveled 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.

Not all pack sizes may be marketed.

Marketing authorisation 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 obtain further information about this medicine from the representative of the marketing authorisation holder:

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

This medicine is authorised in the Member States of the European Economic Area under the following names:

Date of last revision of this leaflet:February 2023

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