Patient Information Leaflet

Deslodyna, 2.5 mg, orodispersible tablets
Desloratadine
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.

Keep this leaflet, as you may need to read it again.
If you have any further questions, please ask your doctor, pharmacist or nurse.
This medicine has been prescribed for you personally. Do not pass it on to others. It may harm someone else even if their symptoms are the same as yours.
If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of the leaflet

What Deslodyna is and what it is used for
What you need to know before you take 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

What Deslodyna is
Deslodyna orodispersible tablet contains desloratadine, which is an antihistamine medicine.
How Deslodyna works
Deslodyna is an antiallergic medicine that does not cause drowsiness. It helps control allergic reactions and their symptoms.
When to use Deslodyna
Deslodyna relieves symptoms of allergic rhinitis (inflammation of the nasal mucosa caused by allergy, such as hay fever or dust mite allergy) in adults, adolescents and children aged 6 years and older. Symptoms include: sneezing, watery or itchy nose, itchy palate, and itchy, red or watery eyes.
Deslodyna is also used to relieve symptoms of urticaria (a skin condition caused by allergy). Symptoms include: itchy skin and hives.
Relief of these symptoms lasts throughout the day, helping you return to normal daily activities and sleep normally.

2. Important information before using Deslodyna

When not to use Deslodyna

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

Warnings and precautions
Before starting to use Deslodyna, discuss this with your doctor, pharmacist, or nurse:

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

Children and adolescents
This medicine must not be given to children under 6 years of age.
Deslodyna and other medicines
Tell your doctor or pharmacist about any medicines the patient is currently taking, has recently taken, or plans to take.
No interactions between Deslodyna and other medicines are known.
Deslodyna, food, drink, and alcohol
It is not necessary to take Deslodyna with water or any other liquid. 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 or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult a doctor or pharmacist before using this medicine. Use of Deslodyna is not recommended during pregnancy or breastfeeding.
Fertility
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 concentration, such as driving or operating machinery, until the patient's response to this medicine is known.
Deslodyna contains mannitol, aspartame (E 951), propylene glycol, benzyl alcohol, and sodium
The medicine contains 1.5 mg of aspartame in each orodispersible 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 impaired excretion.
The medicine contains 0.00281 mg of benzyl alcohol in each orodispersible tablet. Benzyl alcohol may cause allergic reactions. Pregnant or breastfeeding women should consult a doctor before using the medicine, as a large amount of benzyl alcohol may accumulate in their bodies and cause adverse effects (so-called metabolic acidosis).
Patients with liver or kidney disease should consult a doctor before using the medicine, as a large amount of benzyl alcohol may accumulate in their bodies and cause adverse effects (so-called metabolic acidosis).
The medicine contains less than 1 mmol (23 mg) of sodium in each orodispersible tablet, meaning the medicine is considered "sodium-free".

3. How to take Deslodyna

This medicine should always be taken as directed by a doctor or pharmacist. If in doubt,
consult a doctor or pharmacist.
This medicine is for oral use.
Before use, carefully open the blister pack by tearing it apart. Remove the orodispersible tablet without crushing it. Place the tablet in the mouth, where it will disintegrate immediately. Water or other liquids are not required to swallow the dose. The dose should be taken immediately after opening the blister pack.
Adults and adolescents aged 12 years and older
The recommended dose is two tablets once daily, taken with or without food.
Children aged 6 to 11 years
The recommended dose is one tablet once daily, taken with or without food.
The duration of treatment with Deslodyna orodispersible tablets will be determined by the attending physician after identifying the type of allergic rhinitis present in the patient.
If the patient has intermittent allergic rhinitis (symptoms occurring for less than 4 days per week or for less than 4 weeks), the attending physician will recommend a treatment regimen based on the previous course of the disease. If the patient has persistent allergic rhinitis (symptoms occurring for 4 or more days per week and for more than 4 weeks), the attending physician may recommend prolonged use of the medicine.
In urticaria, the duration of treatment may vary among individual patients. Therefore, the patient should follow the instructions of the attending physician.
Taking more than the recommended dose of Deslodyna
Deslodyna should be taken only as prescribed. Accidental overdose is unlikely to cause severe adverse effects. However, if a higher than recommended dose of Deslodyna is taken, inform a doctor, pharmacist, or nurse immediately.
Missing a dose of Deslodyna
If a dose is missed, 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.
Stopping Deslodyna treatment
If there are any further doubts regarding the use of this medicine, consult a doctor, pharmacist, or nurse.

4. Possible adverse reactions

Like any medicine, 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) 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 in adult patients, adverse reactions were almost the same as those observed with placebo tablets (tablets without active ingredient). However, fatigue, dry mouth, and headache were reported more frequently than with placebo tablets. In adolescents, headache was the most commonly reported adverse reaction.

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

Common (may occur in less than 1 in 10 people):

fatigue
dry mouth
headache

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

Very rare (may occur in less than 1 in 10,000 people):

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

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

unusual weakness – changes in heart rhythm
yellowing of the skin and/or eyes – unusual behaviour
increased sensitivity of the skin to sunlight, even on cloudy days, and – weight gain, increased appetite for UV (ultraviolet) radiation, for example in solariums – dry eyes – depressed mood – dry eyes

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

slow heartbeat
change in heart rhythm
unusual behaviour
aggressive behaviour

Reporting of adverse reactions
If any adverse reactions occur, including any possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at 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
Adverse reactions can also be reported directly 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.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
No special storage instructions apply.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This helps protect the environment.

6. Contents of the pack and other information

What Deslodyna contains

The active substance is desloratadine. Each orodispersible tablet contains 2.5 mg of desloratadine.
Other ingredients (excipients) are: potassium polyacrylate, monohydrate citric acid (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 flavour (containing, 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 orodispersible tablet with red-pink specks, round, smooth, biconvex, with a bevelled edge, without engraving, approximately 6 mm in diameter.
One pack of the medicinal product contains 30 orodispersible tablets in blisters OPA/Aluminium/PVC/Aluminium, packed in a cardboard box.

Marketing Authorisation Holder and Manufacturer
"PRZEDSIĘBIORSTWO PRODUKCJI FARMACEUTYCZNEJ HASCO-LEK" S.A.
51-131 Wrocław, ul. Żmigrodzka 242 E

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