Patient Information Leaflet

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

Keep this leaflet, as you may need to read it again.
If you have any questions, consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm others, even if their symptoms are the same.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of Contents

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

1. What is Desloratadine +pharma and what is it used for

Desloratadine +pharma contains desloratadine, which is an antihistamine.
Desloratadine +pharma is an antiallergic medicine that does not cause drowsiness. It helps control
allergic reactions and their symptoms.
Desloratadine +pharma 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 and adolescents aged 12 years and older. Symptoms include:
sneezing, nasal itching or discharge, itching of the palate, and itching, redness or watering of the eyes.
Desloratadine +pharma is also used to relieve symptoms associated with urticaria (a skin condition caused by allergy). Symptoms of this condition include: skin itching and hives.
Symptom relief lasts throughout the day, helping patients return to normal daily activities and sleep normally.

2. Important information before using Desloratadine +pharma

When not to use Desloratadine +pharma

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

Warnings and precautions
Before starting to use Desloratadine +pharma, discuss this with 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.
Desloratadine +pharma with other medicines
No interactions between Desloratadine +pharma and other medicines are known.
You should 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.
Desloratadine +pharma with food, drink, and alcohol
Desloratadine +pharma can be taken with or without food.
Caution should be exercised when taking Desloratadine +pharma 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.
The use of Desloratadine +pharma is not recommended during pregnancy or breastfeeding.
There are no available data on the effect on fertility in men and women.
Driving and using machines
It is not expected that Desloratadine +pharma, 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 alertness, such as
driving or operating machinery, until the patient's response to this medicine is known.

3. How to use Desloratadine +pharma

This medicine should always be taken exactly as directed by your doctor. If in doubt, consult your doctor or pharmacist.

Adults and adolescents aged 12 years and older
The recommended dose is one tablet once daily.

Method of administration
The tablet should be swallowed whole with water, with or without food.

Duration of treatment
The duration of treatment with Desloratadine +pharma 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 occurring for fewer 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 occurring 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, the patient should follow the attending physician's instructions.

Use of a higher than recommended dose of Desloratadine +pharma
Desloratadine +pharma should be taken only as prescribed.
Serious adverse effects are not expected following accidental overdose.
However, if a higher than recommended dose of Desloratadine +pharma is taken, contact your doctor, pharmacist, or nurse immediately.

Missed dose of Desloratadine +pharma
If a dose 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, pharmacist, or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
In clinical studies, adverse reactions in adult patients were almost the same as those observed
after administration of a tablet without active substance. However, fatigue, dry mouth,
and headache were reported more frequently than with the placebo tablet. In adolescents,
the most commonly reported adverse reaction was headache.
After the medicine was placed on the market, very rare cases of severe allergic reactions
(difficulty breathing, wheezing, itching, hives, and swelling) have been reported.
If any of these adverse reactions occur, discontinue use of the medicine immediately and consult a doctor without delay.
The following adverse reactions have been reported in clinical studies:
Common: may affect up to 1 in 10 patients

Fatigue
Dry mouth
Headache

Adults
After marketing authorization, the following adverse reactions have been reported:
Very rare: may affect up to 1 in 10,000 patients

Severe allergic reactions
Fast heartbeat
Vomiting
Dizziness
Muscle pain
Restlessness with excessive physical activity
Rash
Abdominal pain
Stomach discomfort
Somnolence (drowsiness)
Hallucinations
Hepatitis
Palpitations and irregular heartbeat
Nausea
Diarrhea
Insomnia
Seizures
Abnormal liver function tests

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

Unusual weakness
Increased skin sensitivity to sunlight, even on cloudy days, and to UV (ultraviolet) radiation, for example in sunbeds
Changes in heart rhythm
Yellowing of the skin and/or eyes
Unusual behaviour
Aggressive behaviour
Weight gain, increased appetite
Low mood
Dry eyes

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

Slow heartbeat
Changes in heart rhythm
Unusual behaviour
Aggressive behaviour

Reporting of adverse reactions
If any adverse reactions occur, including any 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 helps provide more information on the safety of the medicine.

5. How to store Desloratadine +pharma

Keep this medicine out of sight and reach of children.
Store in the original packaging to protect from moisture and light.
Do not use this medicine if you notice any change in the appearance of the tablets.
Do not use this medicine after the expiry date stated on the carton and blister after:
"Expiry date" or "EXP". The expiry date refers to the last day of the month indicated.
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 Desloratadine +pharma contains

The active substance is desloratadine in a dose of 5 mg.
The other ingredients are: microcrystalline cellulose, mannitol, magnesium stearate, hypromellose 6 cPs, hydroxypropyl cellulose, titanium dioxide (E 171), indigo carmine (E 132), lac.

What Desloratadine +pharma looks like and contents of the pack
Desloratadine +pharma is a light blue, round, biconvex film-coated tablet.
Desloratadine +pharma is available in blister packs containing 10, 15 or 30 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
+pharma arzneimittel gmbh
Hafnerstraβe 211
8054 Graz
Austria
Manufacturer
Iberfar - Indústria Farmacêutica, S.A.
Estrada Consiglieri Pedroso, n. 123
Queluz de Baixo
Barcarena, 2734-501
Portugal
Genericon Pharma Gesellschaft m.b.H.
Hafnerstraβe 211
8054 Graz
Austria
For detailed information about the medicinal product and its names in the Member States of the European Economic Area, please contact the representative of the Marketing Authorisation Holder:
+pharma Polska sp. z o.o.
ul. Podgórska 34
31-536 Kraków
Poland
Tel: +48 12 262 32 36