Deslodina

Package Leaflet: Information for the Patient

Deslodyna, 2.5 mg, Oral Disintegrating Tablets

Desloratadine

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• 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, including any not listed in this leaflet, please tell your doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Leaflet

• 1. What is Deslodyna and what is it used for
• 2. Important information before taking Deslodyna
• 3. How to take Deslodyna
• 4. Possible side effects
• 5. How to store Deslodyna
• 6. Contents of the pack and other information

1. What is Deslodyna and what is it used for

What is Deslodyna

Deslodyna, an oral disintegrating tablet, contains desloratadine, which is an antihistamine.

How Deslodyna works

Deslodyna is an anti-allergic medicine that does not cause drowsiness. It helps control allergic reactions and their symptoms.

When to use Deslodyna

Deslodyna relieves symptoms associated with allergic rhinitis (inflammation of the nasal mucosa caused by an allergy, such as hay fever or allergy to dust mites) in adults, adolescents, and children aged 6 years and older. The symptoms include: sneezing, runny or itchy nose, itchy palate, and itchy, red, or watery eyes.
Deslodyna is also used to relieve symptoms associated with urticaria (a skin condition caused by an allergy). The symptoms of this condition include: skin itching and urticaria.
The relief of these symptoms persists throughout the day, making it easier to return to normal daily activities and normal sleep.

2. Important information before taking Deslodyna

When not to take Deslodyna

Warnings and precautions

Before taking Deslodyna, discuss with your doctor, pharmacist, or nurse:

Children and adolescents

Do not give this medicine to children under 6 years of age.

Deslodyna and other medicines

Tell your doctor or pharmacist about all medicines you are taking, or have recently taken, and about any medicines you plan to take.
No interactions with other medicines are known.

Deslodyna with food, drink, and alcohol

It is not necessary to take Deslodyna with water or any other liquid. Additionally, Deslodyna can be taken with or without food. Caution should be exercised when taking Deslodyna 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. It is not recommended to take Deslodyna during pregnancy or breastfeeding.
Fertility
There are no available data on the effect on fertility in males and females.

Driving and using machines

It is not expected that this medicine, when taken as recommended, will affect your ability to drive or use machines. Although most people do not experience drowsiness, it is recommended to refrain from performing tasks that require attention, such as driving or operating machinery, until it is known how you react to this medicine.

Deslodyna contains mannitol, aspartame (E 951), propylene glycol, benzyl alcohol, and sodium

The medicine contains 1.5 mg of aspartame in each oral disintegrating tablet. Aspartame is a source of phenylalanine. It may be harmful to patients with phenylketonuria. This is a rare genetic disorder in which phenylalanine accumulates in the body due to its improper excretion.
The medicine contains 0.00281 mg of benzyl alcohol in each oral disintegrating tablet. Benzyl alcohol may cause allergic reactions. Pregnant or breastfeeding women should consult their doctor before taking the medicine, as a large amount of benzyl alcohol may accumulate in their body and cause side effects (so-called metabolic acidosis).
Patients with liver or kidney disease should consult their doctor before taking the medicine, as a large amount of benzyl alcohol may accumulate in their body and cause side effects (so-called metabolic acidosis).
The medicine contains less than 1 mmol (23 mg) of sodium per oral disintegrating tablet, which means that the medicine is considered "sodium-free".

3. How to take Deslodyna

This medicine should always be taken exactly as advised by your doctor or pharmacist. If you are unsure, ask your doctor or pharmacist.
The medicine is intended for oral use.
Before taking, carefully open the blister by tearing it. Remove the oral disintegrating tablet without crushing it. Place it in your mouth, where it will immediately disintegrate. Water or any other liquid is not needed to swallow the dose. Take the dose immediately after opening the blister.

Adults and adolescents over 12 years of age

The recommended dose is two tablets once a day, taken with or without food.

Children from 6 to 11 years of age

The recommended dose is one tablet once a day, taken with or without food.
The duration of treatment with Deslodyna oral disintegrating tablets will be determined by your doctor, depending on the type of allergic rhinitis you have.
If you have intermittent allergic rhinitis (symptoms that occur for less than 4 days a week or for less than 4 weeks), your doctor will recommend a treatment schedule based on your medical history. If you have persistent allergic rhinitis (symptoms that occur for 4 or more days a week and for more than 4 weeks), your doctor may recommend longer treatment with the medicine.
In urticaria, the duration of treatment may vary from patient to patient. Therefore, you should follow your doctor's advice.

Taking a higher dose of Deslodyna than recommended

Deslodyna should only be taken as prescribed. In case of accidental overdose, no serious disorders should occur. However, if you take more Deslodyna than recommended, tell your doctor, pharmacist, or nurse immediately.

Missing a dose of Deslodyna

If you miss a dose, take it as soon as possible, and then continue with your regular dosing schedule. Do not take a double dose to make up for a missed dose.

Stopping treatment with Deslodyna

If you have any further questions about taking this medicine, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, Deslodyna can cause side effects, although not everybody gets them.
After the marketing of desloratadine, very rare cases of severe allergic reactions (difficulty breathing, wheezing, itching, urticaria, and swelling) have been reported. If you experience any of these severe side effects, stop taking the medicine and seek medical attention immediately.
In clinical trials in adult patients, side effects were almost the same as with a placebo. However, fatigue, dry mouth, and headache were reported more frequently than with a placebo. In adolescents, the most commonly reported side effect was headache.
The following side effects have been reported in clinical trials with desloratadine:
Frequent(may occur in less than 1 in 10 patients):

• fatigue
• dry mouth
• headache

After the marketing of desloratadine, the following side effects have been reported:
Very rare(may occur in less than 1 in 10,000 patients):

• severe allergic reactions
• rash
• palpitations and irregular heartbeat
• rapid heartbeat
• abdominal pain
• nausea
• vomiting
• gastrointestinal upset
• diarrhea
• dizziness
• drowsiness
• insomnia
• muscle pain
• hallucinations
• seizures
• restlessness with excessive motor activity
• hepatitis
• abnormal liver function tests

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

• unusual weakness
• yellowing of the skin and/or eyes
• increased sensitivity of the skin to the sun,
• changes in heart rhythm
• unusual behavior
• aggressive behavior
• weight gain, increased appetite
• low mood
• dry eyes

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

• slow heartbeat
• change in heart rhythm, even in the case of cloudiness, and UV radiation (ultraviolet), for example, UV radiation in a solarium
• unusual behavior
• aggressive behavior

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw
tel.: +48 22 49 21 301, fax: +48 22 49 21 309,
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Deslodyna

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
There are no special precautions for storage.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Deslodyna contains

• The active substance is desloratadine. One oral disintegrating tablet contains 2.5 mg of desloratadine.
• The other ingredients (excipients) are: polacrilin potassium, citric acid monohydrate (for pH adjustment), potassium hydroxide 50% (for pH adjustment), mannitol, microcrystalline cellulose, sodium croscarmellose, aspartame (E 951), iron oxide red (E 172), Tutti-Frutti SD 0272 flavor (contains, among others, propylene glycol, benzyl alcohol, citral, geraniol, farnesol, linalool, d-limonene), magnesium stearate.

What Deslodyna looks like and contents of the pack

Deslodyna is a pink oral disintegrating tablet with red-pink speckles, round, smooth, biconvex, with a beveled edge, without engraving, approximately 6 mm in diameter.
One pack of the medicine contains 30 oral disintegrating tablets in OPA/Aluminum/PVC/Aluminum blisters in a cardboard box.

Marketing authorization holder and manufacturer

"PRZEDSIĘBIORSTWO PRODUKCJI FARMACEUTYCZNEJ HASCO-LEK" S.A.
51-131 Wrocław, ul. Żmigrodzka 242 E

Medicine information

tel.: (22) 742 00 22
email: [email protected]

Date of last revision of the leaflet: