Package leaflet: information for the patient

Desloratadine Sopharma, 5 mg, film-coated tablets
Desloratadinum
Please read the entire leaflet carefully before taking this medicine, as it contains important
information for you.
Always use this medicine exactly as described in this patient leaflet or as directed by your doctor or pharmacist.

Keep this leaflet, as you may need to read it again.
If you need advice or further information, consult your pharmacist.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.
If there is no improvement after 3 days or if your condition worsens, contact your doctor.

Table of contents

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

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

What Desloratadine Sopharma is
Desloratadine Sopharma contains desloratadine — an antihistamine substance.
How Desloratadine Sopharma works
Desloratadine is an antiallergic medicine that does not cause drowsiness. It helps control allergic reactions and their symptoms.
When to use Desloratadine Sopharma
Desloratadine 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. These symptoms include sneezing, watery nasal discharge or nasal itching, itching of the palate, as well as itchy, red or watery eyes.
Desloratadine is also used to relieve symptoms of urticaria (an allergic skin condition). These symptoms include itching and hives.
Relief from these symptoms lasts throughout the day, helping patients return to normal daily activities and sleep normally.
If there is no improvement after 3 days or if your condition worsens, consult your doctor.

2. Information before using Desloratadine Sopharma

When not to use Desloratadine Sopharma:

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 Desloratadine Sopharma, discuss with your doctor or
pharmacist:

if the patient has been diagnosed with kidney function disorders;
if the patient has a personal or family history of seizures.

Children and adolescents
This medicine should not be given to children under 12 years of age.
Desloratadine Sopharma with other medicines
No interactions between desloratadine and other medicines are known.
Tell your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take.
Desloratadine Sopharma with food, drink and alcohol
Desloratadine tablets may be taken with or without food.
Caution is advised when taking the medicine together with alcohol.
Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor or pharmacist before using this medicine.
The use of desloratadine is not recommended during pregnancy or breastfeeding.
There are no available data on the effect of Desloratadine Sopharma on fertility in women and men.
Driving and operating machinery
This medicine, when used at the recommended dose, is not expected to affect the ability to drive or operate machinery. Although most people do not experience drowsiness, it is recommended that patients refrain from activities requiring mental alertness, such as driving or operating machinery, until it has been established how they react to this medicine.
Desloratadine Sopharma contains lactose
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult their doctor before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to take Desloratadine Sopharma

This medicine should always be taken exactly as described in this patient information leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Dosage for adults and adolescents aged 12 years and older:
The recommended dose is one tablet once daily, taken with water, with or without food.
This medicine is intended for oral use.
The tablet should be swallowed whole.
The duration of treatment with Desloratadine Sopharma will be determined by your doctor after assessing the type of allergic rhinitis affecting the patient.
If the patient has intermittent allergic rhinitis (symptoms occurring for less than four days per week or for less than four weeks), the treating doctor will recommend a treatment regimen based on the previous course of the disease.
If the patient has persistent allergic rhinitis (symptoms occurring for four or more days per week and for more than four weeks), the treating doctor may recommend prolonged use of the medicine.
In the case of urticaria, the duration of treatment may vary among individual patients. Therefore, the patient should follow the instructions provided by the treating doctor.
If there is no improvement after 3 days, or if the patient feels worse, medical advice should be sought immediately.
Do not use Desloratadine Sopharma for longer than 10 days without consulting a doctor.
Taking more Desloratadine Sopharma than recommended
Desloratadine Sopharma should only be taken as prescribed. Accidental overdose is unlikely to cause serious problems. However, if an overdose of Desloratadine Sopharma is taken, inform your doctor, pharmacist, or nurse immediately.
If you miss a dose of Desloratadine Sopharma
If a dose is missed, take it as soon as possible, then continue with 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.
Since desloratadine has been marketed, severe allergic reactions (difficulty breathing, wheezing, itching, hives, swelling) have been reported very rarely. If any of these serious adverse reactions occur, you should stop taking the medicine immediately and consult your doctor without delay.

In clinical trials, adverse reactions in adults were almost the same as those observed with placebo tablets (tablets containing no active substance). However, fatigue, dryness of the oral mucosa, and headache were reported more frequently than with placebo. In adolescents, the most commonly reported adverse reaction was headache.

The following adverse reactions have been reported in clinical trials with desloratadine:
Common (may affect up to 1 in 10 people):

fatigue
dryness of the oral mucous membranes
headache

Adults
After desloratadine was introduced to the market, the following adverse reactions have been reported:
Very rare (may affect up to 1 in 10,000 people):

severe allergic reactions • rash • palpitations or irregular heartbeat
rapid heartbeat • abdominal pain • vomiting
gastrointestinal discomfort • nausea • dizziness
drowsiness • diarrhoea • muscle pain
hallucinations • insomnia
restlessness with excessive motor activity • hepatitis • convulsions • abnormal liver function test results

Frequency not known (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 in a solarium
changes in heart rhythm
unusual behaviour
aggressive behaviour
weight gain
increased appetite
low mood
dry eyes

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

slow heartbeat
changes in heart rhythm
aggressive behaviour
unusual behaviour

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions, 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 this medicine.

5. How to store Desloratadine Sopharma

Keep the medicine out of the sight and reach of children.
Store below 25°C.
Do not use this medicine after the expiry date stated on the carton and blister after "EXP".
The expiry date refers to the last day of the stated month.
Medicines should 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 Sopharma contains

The active substance is desloratadine. One coated tablet contains 5 mg of desloratadine.
The other ingredients are:
Tablet core: microcrystalline cellulose, calcium hydrogen phosphate dihydrate, maize starch, hypromellose 15 cP, talc, sodium stearyl fumarate, colloidal anhydrous silica.
Tablet coating: hypromellose 6 cP, lactose monohydrate, titanium dioxide (E171), macrogol 3350,
indigo carmine (E132), lac dye and quinoline yellow (E104), lac.

What Desloratadine Sopharma looks like and contents of the pack
Desloratadine Sopharma 5 mg are light blue, round, biconvex coated tablets with a diameter of 6 mm.
Desloratadine Sopharma 5 mg, coated tablets, are supplied in blisters made of PVC/PCTFE/Aluminium, in packs containing 10 tablets.

Marketing Authorisation Holder
Sopharma Warszawa Sp. z o.o.
Al. Jerozolimskie 136, 02-305 Warsaw
e-mail: [email protected]

Manufacturer
Sopharma AD
16 Iliensko Shosse Str.
1220 Sofia
Bulgaria

This medicinal product is authorised in the European Economic Area countries under the following names:
Bulgaria: Десл 5 mg филмирани таблетки
Estonia: Desloratadine Sopharma
Latvia: Desloratadine Sopharma 5 mg apvalkotās tabletes
Lithuania: Desloratadine Sopharma 5 mg plėvele dengtos tabletės
Poland: Desloratadine Sopharma