Patient Information Leaflet

Desloratadine Sopharma, 0.5 mg/ml, oral solution
Desloratadinum
Please read the entire leaflet before using this medicine, as it contains important information for the patient.

Keep this leaflet for future reference.
Consult your doctor, pharmacist, or nurse if you have any questions or doubts.
This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm other people, even if their symptoms are similar.
If any adverse reactions occur, inform your doctor, pharmacist, or nurse. This includes any possible adverse reactions not listed in this leaflet. See section 4.

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 is Desloratadine Sopharma
Desloratadine Sopharma contains desloratadine – an antihistamine substance.
How Desloratadine Sopharma works
Desloratadine Sopharma is an antiallergic medicine that does not cause drowsiness. It helps control allergic reactions and their symptoms.
When to use Desloratadine Sopharma
Desloratadine Sopharma relieves symptoms associated with allergic rhinitis (inflammation of the nasal mucosa caused by allergy, such as hay fever or dust mite allergy) in adults, adolescents, and children after completion of 1 year of age. These symptoms include: sneezing, watery or itchy nose, itchy palate, and itchy, red, or watery eyes.
Desloratadine Sopharma is also used to relieve symptoms associated with urticaria (a skin condition caused by allergy). These symptoms include itching and hives.
Relief from these symptoms lasts throughout the day, helping patients return to normal daily activities and achieve normal sleep.

2. Important 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 starting to use Desloratadine Sopharma, consult a doctor, pharmacist, or nurse:

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

Use in children and adolescents
This medicine should not be given to children under 1 year of age.
Desloratadine Sopharma and other medicines
No interactions between Desloratadine Sopharma 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 Sopharma can be taken with or without food.
Caution is advised when using Desloratadine Sopharma with alcohol.
Pregnancy, breastfeeding and fertility
If the patient is pregnant, suspects she may be pregnant, is planning to become pregnant, or is breastfeeding, she should consult a doctor or pharmacist before using this medicine.
Use of Desloratadine Sopharma is not recommended if the patient is pregnant or breastfeeding.
Fertility
There are no available data on fertility in women and men.
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 that patients avoid activities requiring mental alertness, such as driving or operating machinery, until it is known how they react to this medicinal product.
Desloratadine Sopharma contains sorbitol and propylene glycol
This medicine contains 375 mg of sorbitol per 2.5 ml, equivalent to 150 mg/ml. Patients with hereditary fructose intolerance should not take/receive this medicinal product.
Sorbitol is a source of fructose. If the doctor has informed the patient (or their child) that they have an intolerance to certain sugars, or if the patient has been diagnosed with hereditary fructose intolerance, a rare genetic disorder in which a person cannot break down fructose, speak to the doctor before the patient (or child) takes or receives this medicine.
This medicine contains approximately 127 mg of propylene glycol per 2.5 ml, equivalent to 50.67 mg/ml.

3. How to take Desloratadine Sopharma

This medicine should always be taken as directed by a doctor or pharmacist. If in doubt,
consult a doctor or pharmacist.
Use in children
Children aged 1 year to 5 years:
The recommended dose is 2.5 ml of oral solution once daily.
Children aged 6 to 11 years:
The recommended dose is 5 ml of oral solution once daily.
To administer the correct volume of oral solution, use the dosing syringe provided in the package.
Adults and adolescents aged 12 years and above:
The recommended dose is 10 ml of oral solution once daily.
To administer the correct volume of oral solution, use the dosing device (measuring cup or syringe) provided in the package.
This medicine is intended for oral use.
The dose of oral solution should be swallowed with water. The medicine may be taken with or without food.
The duration of treatment with Desloratadine Sopharma will be determined by the physician based on 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 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 physician may recommend longer-term treatment.
In the case of urticaria, the duration of treatment may vary among individual patients. Therefore, the patient should follow the physician's instructions.
Taking more than the recommended dose of Desloratadine Sopharma
Desloratadine Sopharma should only be taken as prescribed. Serious problems are not expected after accidental overdose. However, if a higher than recommended dose of Desloratadine Sopharma has been taken, inform a doctor, pharmacist, or nurse immediately.
Missing 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.
Stopping Desloratadine Sopharma
If you have any further questions about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although they do not occur in everyone.
Very rarely, severe allergic reactions (difficulty breathing, wheezing, itching, hives, swelling) have been reported after desloratadine became available on the market. If any of these serious adverse reactions occur, you must stop taking the medicine and contact your doctor immediately.

In clinical trials, adverse reactions to desloratadine in most children and adults were almost the same as those observed with placebo (solution or tablet without active ingredient). However, in children under 2 years of age, common adverse reactions included diarrhoea, fever, and insomnia, whereas in adult patients, fatigue, dryness of the oral mucous membranes, and headache were observed more frequently than with placebo.

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

Children
Common (may occur in up to 1 in 10 children under 2 years of age):

diarrhoea
fever
insomnia

Adults
Common (may occur in up to 1 in 10 people):

fatigue
dryness of the oral mucous membranes
headache

After desloratadine was placed on the market, the following adverse reactions have been reported:

Adults
Very rare (may occur in 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 increased motor activity – hepatitis – seizures – abnormal liver function test results

Unknown frequency (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
aggression
weight gain
increased appetite
low mood
dry eyes

Children
Unknown frequency (frequency cannot be estimated from available data):

slow heartbeat
changes in heart rhythm
unusual behaviour
aggression

Reporting of adverse reactions
If you experience any adverse reactions, tell your doctor, pharmacist, or nurse. This includes any possible adverse reactions not listed in this leaflet. Adverse reactions can also be reported directly to the Department of Monitoring Adverse Reactions to Medicinal Products 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, e-mail: [email protected]. Adverse reactions can also be reported directly to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Desloratadine Sopharma

Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and bottle (after EXP).
The expiry date refers to the last day of the stated month.
Store in the original packaging to protect from light.
This medicine does not require any special storage temperature conditions.
Store in the original packaging to protect from light.
Shelf life after first opening of the bottle: 6 months.
Do not use this medicine if you notice any changes in the appearance of the solution.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the packaging and other information

What Desloratadine Sopharma contains

The active substance is desloratadine. 1 ml of oral solution contains 0.5 mg of desloratadine.
The other ingredients are: sorbitol liquid, non-crystallizing (E420), propylene glycol (E1520), sucralose (E955), hypromellose 15 cP, sodium citrate, sour cherry flavour (D-limonene, benzaldehyde, alpha-terpineol, 2-phenylethanol, triacetin, propylene glycol), citric acid monohydrate, disodium edetate, and purified water.

What Desloratadine Sopharma looks like and contents of the pack
Desloratadine Sopharma is a clear, colourless liquid with a cherry flavour.
Desloratadine Sopharma 120 ml is supplied in:
125 ml bottles made of dark brown glass (type III) or PET, equipped with a tamper-evident ring and an LDPE liner, with a child-resistant closure.
The pack includes a measuring cup (capable of measuring 2.5 ml, 5 ml, 10 ml, 15 ml, and 20 ml or 2.5 ml, 3 ml, 5 ml, 7.5 ml, 10 ml, 12.5 ml, 15 ml, and 20 ml) and an oral dosing syringe (capable of measuring 0.5 ml, 1 ml, 1.5 ml, 2 ml, 2.5 ml, 3 ml, 3.5 ml, 4 ml, 4.5 ml, and 5 ml) for administering the medicinal product.

Marketing Authorisation Holder
Sopharma Warszawa Sp. z o.o.
Al. Jerozolimskie 136, 02-305 Warsaw
Poland

Manufacturer
Sopharma AD
16, Iliensko Shosse Str.
1220 Sofia
Bulgaria