Patient Information Leaflet

Deslodyna, 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 them even if their symptoms are the same as yours.
If you experience any side effects, including any not listed in this leaflet, please inform your doctor, pharmacist, or nurse. See section 4.

Table of Contents

What Deslodyna is and what it is used for
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 tablets contain desloratadine, which is an antihistamine medicine.
How Deslodyna works
Deslodyna is an antiallergy medicine that does not cause drowsiness. It helps control allergic reactions and their symptoms.
When Deslodyna should be used
Deslodyna relieves symptoms of allergic rhinitis (inflammation of the nasal mucosa caused by allergy, such as hay fever or dust mite allergy) in adults and adolescents aged 12 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 of this condition include: itchy skin and hives.
Relief from these symptoms lasts throughout the day, helping you return to normal daily activities and sleep.

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 taking Deslodyna, talk to your doctor, pharmacist, or nurse:

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

Children and adolescents
This medicine should not be given to children under 12 years of age.
Deslodyna and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to use.
No interactions between Deslodyna and other medicines are known.
Deslodyna with 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 her doctor or pharmacist before using this medicine. 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 drowsiness does not occur in most people, it is recommended to refrain from activities requiring mental alertness, such as driving or operating machinery, until the patient's response to the medicine is known.
Deslodyna contains mannitol, aspartame (E 951), propylene glycol, benzyl alcohol, and sodium
The medicine contains 3 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 0.00562 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 use Deslodyna

This medicine should always be used as directed by a physician or pharmacist. In case of doubt,
consult a doctor or pharmacist.
Adults and adolescents aged 12 years and older
The recommended dose is one tablet once daily, taken with or without food.
This medicine is intended for oral administration.
Before use, the blister should be carefully opened by tearing it open. Remove the orally disintegrating 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.
The duration of treatment with Deslodyna orally disintegrating tablet will be determined by the attending physician after establishing the type of allergic rhinitis present in the patient.
If the patient has intermittent allergic rhinitis (symptoms occur for less than 4 days per week or for less than 4 weeks), the attending physician will recommend a treatment regimen taking into account 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 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.
Use of a higher than recommended dose of Deslodyna
Deslodyna should be taken only as prescribed. Serious adverse effects are not expected after accidental overdose. However, in case of ingestion of a higher than recommended dose of Deslodyna, inform a doctor, pharmacist, or nurse immediately.
Missed dose of Deslodyna
If a dose of Deslodyna is missed, it should be taken as soon as possible, and then the regular dosing schedule should be resumed. Do not take a double dose to make up for the missed dose.
Stopping Deslodyna
If you have any further questions about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Very rarely, severe allergic reactions (difficulty breathing, wheezing, itching, hives, and swelling) have been reported after desloratadine became available on the market. If any of these severe adverse reactions occur, treatment should be discontinued immediately and medical advice should be sought without delay.

In clinical trials in adult patients, adverse reactions were almost the same as with placebo (a tablet without active ingredient). However, fatigue, dry mouth, and headache were reported more frequently than with placebo. 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 fewer than 1 in 10 patients):

fatigue
dry mouth
headache

After desloratadine became available on the market, the following adverse reactions have been reported:
Very rare (may occur in fewer than 1 in 10,000 patients):

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

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

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

Children
Frequency not known (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 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions contributes to providing more information on the safety of the medicine.

5. How to store Deslodyna

Keep this 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 stated month.
No special storage conditions are required for this medicine.
Medicines must 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. Each orodispersible tablet contains 5 mg of desloratadine.
The other ingredients (excipients) are: potassium polacrilin, 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 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 and embossed with the letter "D" on one side, approximately 8 mm in diameter.
One pack contains 30 or 90 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
Medicines Information
tel.: (22) 742 00 22
email: [email protected]