Package leaflet: Information for the user

Desloratadine Genoptim, 5 mg, film-coated tablets
Desloratadinum
Please read the entire leaflet carefully before taking this medicine, as it contains
important information for the patient.

Keep this leaflet, as you may need to read it again.
Consult your doctor or pharmacist if you have any further questions.
This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm other people, even if their symptoms are the same.
If any of the adverse reactions worsens or if any adverse reactions occur, including those not listed in this leaflet, inform your doctor or pharmacist.

Leaflet contents:

What Desloratadine Genoptim is and what it is used for
Important information before taking Desloratadine Genoptim
How to take Desloratadine Genoptim
Possible side effects
How to store Desloratadine Genoptim
Contents of the pack and other information

1. What Desloratadine Genoptim is and what it is used for

Desloratadine Genoptim is an antiallergic medicine that does not cause drowsiness. It helps control allergic reactions and their symptoms.
Desloratadine Genoptim relieves symptoms associated with allergic rhinitis (inflammation of the nasal mucosa caused by allergy, for example, hay fever or dust mite allergy). These symptoms include: sneezing, itching or runny nose, itching of the palate, and itching, redness or watering of the eyes.
Desloratadine Genoptim is also used to relieve symptoms associated with urticaria (skin condition caused by allergy). Symptoms of this condition include: skin itching and hives.
Relief from these symptoms lasts throughout the day, helping patients return to normal daily activities and achieve normal sleep.
Desloratadine Genoptim is indicated for use in adults and adolescents (aged 12 years and older).

2. Important information before using Desloratadine Genoptim

When not to use Desloratadine Genoptim

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

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

If this applies to the patient or if the patient has any doubts, they should consult a doctor before using Desloratadine Genoptim.
Other medicines and Desloratadine Genoptim
Tell your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take.
No interactions between Desloratadine Genoptim and other medicines are known.
Desloratadine Genoptim with food and drink
Desloratadine Genoptim can be taken on an empty stomach or with food.
Pregnancy and breastfeeding
During pregnancy or breastfeeding, or if the patient suspects she may be pregnant or is planning a pregnancy, she should consult a doctor or pharmacist before using this medicine.
Driving and using machines
Desloratadine has no effect on the ability to drive or operate machinery, or the effect is negligible.
It is not expected that Desloratadine Genoptim, when used at the recommended dose, would cause drowsiness or impair attention. However, very rarely, some individuals may experience drowsiness, which could affect their ability to drive or operate machinery.
Desloratadine Genoptim contains lactose
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.

3. How to use Desloratadine Genoptim

This medicine should always be taken as directed by the physician. In case of doubts, consult
your doctor or pharmacist.
The usual dose is:
Use in children: The efficacy and safety of Desloratadine Genoptim in children under 12 years of age have not been established. There is no data available.
Adults and adolescents (12 years and older): one tablet once daily. The tablet should be swallowed whole with water, with or without food.
The duration of treatment with Desloratadine Genoptim 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 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 will recommend long-term use of the medicine.
In the case of urticaria, the duration of treatment may vary among individual patients. Therefore, the patient should follow the recommendations of the attending physician.
Taking more Desloratadine Genoptim than prescribed
Desloratadine Genoptim should be taken only as prescribed. Serious adverse effects are not expected after accidental overdose. However, if a dose higher than recommended is taken, consult your doctor or pharmacist.
Missing a dose of Desloratadine Genoptim
If a dose is missed, take it as soon as possible, then return to the prescribed 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 any medicine, this medicine can cause adverse reactions, although not everyone will
experience them.
In adult patients, adverse reactions were almost the same as those observed after taking a
placebo tablet (a tablet without active ingredient). However, fatigue, dry mouth and headache
were reported more frequently than after taking a placebo tablet. In adolescents, the most
commonly reported adverse reaction was headache.
Very rarely, following the introduction of Desloratadine Genoptim to the market, severe
allergic reactions (difficulty breathing, wheezing, itching, hives, swelling) and rash have been
reported. Very rarely, palpitations, rapid heartbeat, abdominal pain, nausea (feeling of
sickness), vomiting, stomach upset, dizziness, somnolence, insomnia, muscle pain,
hallucinations, convulsions, restlessness with increased motor activity, hepatitis and
abnormalities in liver function tests have also been reported.
The following adverse reactions have been reported, but their frequency cannot be estimated
from the available data (frequency unknown): unusual behaviour, aggressive behaviour and
changes in heartbeat, weight gain, increased appetite, low mood and dry eyes.
If any adverse reactions occur, including any possible adverse reactions not listed in this
leaflet, consult a doctor or pharmacist.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform
a 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, PL-02 222 Warsaw,
Tel.: + 48 22 49 21 301, Fax: + 48 22 49 21 309, website:
https://smz.ezdrowie.gov.pl
Reporting adverse reactions helps to provide more information on the safety of this medicine.

5. How to store Desloratadine Genoptim

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister.
The expiry date refers to the last day of that month.
Store in the original packaging to protect from light and moisture.
Do not use the medicine if any changes in the appearance of the tablets are visible.
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 Desloratadine Genoptim contains

The active substance is desloratadine 5 mg.
The other ingredients are: anhydrous lactose, microcrystalline cellulose, anhydrous calcium hydrogen phosphate, low-substituted hydroxypropylcellulose, magnesium stearate, colloidal anhydrous silica, hypromellose, titanium dioxide (E 171), talc, indigo carmine (E 132), lake, and macrogol 6000.

What Desloratadine Genoptim looks like and contents of the pack
Blue, round, biconvex film-coated tablets with an embossed "D" on one side.
Desloratadine Genoptim 5 mg film-coated tablets are packed in blisters containing 10,
20, 30, 50 or 100 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Synoptis Pharma Sp. z o.o.
ul. Krakowiaków 65
02-255 Warsaw, Poland

Manufacturer:
Laboratorios NORMON, S.A.
Ronda de Valdecarrizo, 6
ES – 28760 Tres Cantos, Madrid
Spain

This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Portugal: Desloratadina NORMON 5 mg comprimidos revestidos por película
Bulgaria: Desloratadine IBERMEDGEN 5 mg филмирани таблетки
Germany: Desloratadin IBERMEDGEN 5 mg Filmtabletten
Poland: Desloratadine Genoptim
Romania: Desloratadină IBERMEDGEN 5 mg comprimate filmate
Spain: Desloratadina TARBIS 5 mg comprimidos recubiertos con película EFG