Package leaflet: Information for the patient

DESLODYNA, 0.5 mg/ml, oral solution
Desloratadine
Please read all of this leaflet carefully before taking this medicine, because it contains information important for you.

Keep this leaflet, so that you can read it again if necessary.
If you have any further questions, please ask your doctor, pharmacist, or nurse.
This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Table of contents

What Deslodyna is and what it is used for
What you need to know before taking Deslodyna
How to take Deslodyna
Possible side effects
How to store Deslodyna
Contents of the pack and other information

1. What Deslodyna is and what it is used for

Deslodyna contains desloratadine, which is an antihistamine medicine.
Deslodyna oral solution is an antiallergy medicine that does not cause drowsiness. It helps control allergic reactions and their symptoms.
Deslodyna oral solution relieves symptoms associated with allergic rhinitis (inflammation of the nasal mucosa caused by allergy, such as hay fever or allergy to house dust mites) in adults, adolescents, and children above 1 year of age. These symptoms include: sneezing, watery or itchy nose, itching of the palate, as well as itchy, red, or watery eyes.
Deslodyna oral solution is also used to relieve symptoms associated with urticaria (skin reactions caused by allergy). Symptoms of this condition include: itchy skin and hives.
Relief from these symptoms lasts throughout the day, helping you carry out normal daily activities and enabling a normal night's sleep.

2. Important information before using Deslodyna

When not to use Deslodyna:

if the patient is allergic to desloratadine or to any of the other ingredients of this medicine (listed in section 6), or to loratadine.

Warnings and precautions
Before starting treatment with Deslodyna, discuss with your doctor or pharmacist:

if the patient has impaired kidney function,
if the patient has a history or family history of seizures.

Children and adolescents
This medicine should not be given to children under 1 year of age.
Deslodyna with other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines planned for use.
No interactions between Deslodyna and other medicines are known.
Deslodyna with food, drink and alcohol
Deslodyna may be taken with or without food.
Caution should be exercised when taking Deslodyna with alcohol.
Pregnancy, breastfeeding and fertility
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before using this medicine.
The use of Deslodyna oral solution is not recommended during pregnancy or breastfeeding.
There are no available data on the effect on fertility in men and women.
Driving and operating machinery
It is not expected that this medicine, when used at the recommended dose, affects the ability to drive or operate machinery. Although most people do not experience drowsiness, it is recommended to refrain from activities requiring mental concentration, such as driving or operating machinery, until the patient's response to this medicine is known.
Deslodyna oral solution contains sorbitol
If the patient has been previously diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.

3. How to take Deslodyna

This medicine should always be taken exactly as directed by a doctor or pharmacist. If in doubt,
consult a doctor or pharmacist.
Children
Children aged 1 to 5 years: the recommended dose is 2.5 ml of oral solution once daily.
Children aged 6 to 11 years: the recommended dose is 5 ml of oral solution once daily.
Adults and adolescents aged 12 years and older
The recommended dose is 10 ml of oral solution once daily.
This medicine is intended for oral use.
An oral syringe is provided with the bottle of oral solution to measure the correct volume of the solution.
The dose of oral solution should be swallowed and followed with water. The medicine may be taken with or without food.
The duration of treatment with Deslodyna will be determined by the attending physician based on the type of allergic
rhinitis present in the patient.
If the patient has intermittent allergic rhinitis (symptoms occur fewer than 4 days per week or for less than 4 weeks),
the attending physician will recommend a treatment regimen considering the previous course of the disease.
If the patient has persistent allergic rhinitis (symptoms occur for 4 or more days per week and for more than 4 weeks),
the attending physician may recommend long-term use of the medicine.
In the case of urticaria, the duration of treatment may vary among individual patients. Therefore, follow the
recommendations of the attending physician.
Taking more Deslodyna than prescribed
Deslodyna oral solution should be taken as directed by a doctor. After accidental overdose, severe adverse effects
are not expected. However, if more than the prescribed dose of Deslodyna oral solution has been taken,
inform a doctor, pharmacist, or nurse immediately.
Missing a dose of Deslodyna
If a dose of Deslodyna is missed at the scheduled time, take it as soon as possible, then return to the regular
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, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although they do not occur in everyone.
Since the introduction of desloratadine into the market, very rare cases of severe allergic reactions (difficulty breathing, wheezing, itching, hives and swelling) and skin rash have been reported. If any of these severe adverse reactions occur, you should stop taking the medicine immediately and consult a doctor without delay.

In clinical trials, adverse reactions in most children and adults were almost the same as those observed after administration of placebo solution or tablets (without active ingredient). However, in children younger than 2 years of age, common adverse reactions included: diarrhoea, fever and insomnia. In adult patients, fatigue, dry mouth and headache were reported more frequently than with placebo tablets.

The following adverse reactions have been reported in clinical trials with desloratadine:

Children
Common in children under 2 years of age (may occur in up to 1 in 10 children):

diarrhoea
fever
insomnia

Adults
Common (may occur in up to 1 in 10 patients):

fatigue
dry mouth
headache

After the introduction of desloratadine into the market, the following adverse reactions have been reported:

Adults
Very rare (may occur in up to 1 in 10,000 patients):

severe allergic reactions – rash – palpitations and irregular
rapid heartbeat – abdominal pain – vomiting
stomach discomfort – nausea
dizziness – somnolence – diarrhoea
muscle pain – hallucinations – insomnia
restlessness with excessive motor activity – hepatitis – convulsions
abnormal liver function test results

Frequency unknown (frequency cannot be estimated from available data):

unusual weakness – yellowing of the skin and (or) eyes
increased sensitivity of the skin to sunlight, even on cloudy days, and to UV (ultraviolet) radiation, for example UV radiation in sunbeds
changes in heart rhythm – aggressive behaviour
unusual behaviour

Children
Frequency unknown (frequency cannot be estimated from available data):

slow heartbeat – changes in heart rhythm
unusual behaviour – aggressive behaviour

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can also be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: 22 49 21 301, fax: 22 49 21 309, e-mail: [email protected].
Adverse reactions may also be reported to the marketing authorization holder.

Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Deslodyna

Keep this medicine out of sight and reach of children.
No special storage conditions are required for this medicinal product.
Shelf life after first opening the bottle: 2 months.
Do not use this medicine after the expiry date stated on the bottle. The expiry date refers to the last day of the stated month.
Do not use this medicine if a change in the appearance of the oral solution is observed.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Deslodyna contains

The active substance is desloratadine. 1 ml of oral solution contains 0.5 mg of desloratadine.
The other ingredients (excipients) are: sorbitol liquid, non-crystallising (E420), propylene glycol, citric acid monohydrate, sodium citrate, Hypromellose 2910, sucralose, disodium edetate, Tutti Frutti flavour, purified water.

What Deslodyna looks like and contents of the pack
Deslodyna oral solution is a clear, colourless solution free from foreign particles.
Deslodyna oral solution is available in bottles containing 60 ml or 150 ml of solution, closed with a child-resistant cap. The bottles are packed in cardboard boxes. Each package includes a 5 ml oral syringe with graduations every 0.5 ml.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
„PRZEDSIĘBIORSTWO PRODUKCJI FARMACEUTYCZNEJ HASCO-LEK” S.A
ul. Żmigrodzka 242 E, 51-131 Wrocław
Medicinal product information
tel.: (22) 742 00 22
e-mail: [email protected]