Deslodina

Package Leaflet: Information for the Patient

DESLODYNA, 0.5 mg/ml, Oral Solution

Desloratadine

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. 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 tell your doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Leaflet

• 1. What is Deslodyna and what is it used for
• 2. Important information before using Deslodyna
• 3. How to use Deslodyna
• 4. Possible side effects
• 5. How to store Deslodyna
• 6. Contents of the pack and other information

1. What is Deslodyna and what is it used for

Deslodyna contains desloratadine, which is an antihistamine.
Deslodyna oral solution is an antiallergic medicine that does not cause drowsiness. It helps
to control allergic reactions and their symptoms.
Deslodyna oral solution relieves the symptoms associated with allergic rhinitis (inflammation of the nasal passages caused by an allergy, such as hay fever or allergy to dust mites) in adults, adolescents, and children over 1 year of age. The symptoms of this condition include:
sneezing, runny or itchy nose, itchy palate, and itchy, red, or teary eyes.
Deslodyna oral solution is also used to relieve the symptoms associated with hives (skin changes caused by an allergy). The symptoms of this condition include: itchy skin and hives.
The relief of these symptoms lasts all day, making it easier to perform normal daily activities and allowing for normal sleep.

2. Important information before using Deslodyna

When not to use Deslodyna:

• if you are 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, you should discuss it with your doctor or pharmacist:

• if you have kidney problems,
• if you have a history of seizures or a family history of seizures.

Children and adolescents

Do not give this medicine to children under 1 year of age.

Deslodyna and other medicines

Tell your doctor or pharmacist about all the medicines you are taking, or have recently taken, and about any medicines you plan to take.
There are no known interactions between Deslodyna and other medicines.

Deslodyna with food, drink, and alcohol

Deslodyna can be taken with or without food.
Be careful when taking Deslodyna with alcohol.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Deslodyna oral solution should not be used during pregnancy or breastfeeding.
There is no data available on the effect of Deslodyna on fertility in men and women.

Driving and using machines

It is unlikely that this medicine will affect your ability to drive or use machines. However, you should not perform tasks that require concentration, such as driving or using machines, until you know how this medicine affects you.

Deslodyna oral solution contains sorbitol

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

3. How to use Deslodyna

Always use this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
Children
Children from 1 to 5 years: the recommended dose is 2.5 ml of oral solution once a day.
Children from 6 to 11 years: the recommended dose is 5 ml of oral solution once a day.
Adults and adolescents over 12 years
The recommended dose is 10 ml of oral solution once a day.
This medicine is for oral use only.
A measuring cup is provided with the bottle of oral solution to measure the correct dose. The dose should be swallowed and then followed by a glass of water. The medicine can be taken with or without food.
The duration of treatment with Deslodyna will be determined by your doctor, depending on the type of allergic rhinitis you have.
If you have seasonal allergic rhinitis (symptoms that occur for less than 4 days a week or for less than 4 weeks), your doctor will recommend a treatment schedule based on your previous medical history.
If you have perennial allergic rhinitis (symptoms that occur for 4 or more days a week and for more than 4 weeks), your doctor may recommend long-term use of the medicine.
The duration of treatment for hives may vary from patient to patient. Therefore, follow your doctor's advice.

Overdose of Deslodyna

Deslodyna oral solution should be taken as recommended by your doctor. If you accidentally take more than the recommended dose, it is unlikely to cause serious problems. However, if you take more than the recommended dose of Deslodyna oral solution, tell your doctor, pharmacist, or nurse immediately.

Missed dose of Deslodyna

If you miss a dose, take it as soon as you remember, and then continue with your regular dosing schedule.
Do not take a double dose to make up for a missed dose.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Deslodyna can cause side effects, although not everybody gets them.
After desloratadine has been marketed, very rare cases of severe allergic reactions (difficulty breathing, wheezing, itching, hives, and swelling) and rash have been reported. If you experience any of these severe side effects, stop taking the medicine and seek medical attention immediately.
In clinical trials, the side effects in children and adults were similar to those seen with placebo. However, in children under 2 years of age, the common side effects were: diarrhea, fever, and insomnia, while in adults, fatigue, dry mouth, and headache were reported more frequently than with placebo.
The following side effects have been reported in clinical trials with desloratadine:

• diarrhea
• fever
• insomnia

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

• fatigue
• dry mouth
• headache

After desloratadine has been marketed, the following side effects have been reported:

• severe allergic reactions
• rapid heartbeat
• vomiting
• dizziness
• muscle pain
• restlessness
• rash
• abdominal pain
• nausea
• diarrhea
• insomnia
• seizures
• abnormal liver function tests

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

• unusual weakness
• yellowing of the skin and/or eyes
• increased sensitivity of the skin to the sun, even when cloudy, and to UV (ultraviolet) radiation, such as in a solarium
• changes in heart rhythm
• abnormal behavior
• aggressive behavior

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

• slow heartbeat
• abnormal behavior
• changes in heart rhythm
• aggressive behavior

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: 22 49 21 301, fax: 22 49 21 309, e-mail: [email protected].
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Deslodyna

Keep this medicine out of the sight and reach of children.
There are no special precautions for storage.
Shelf-life after first opening of the bottle: 2 months.
Do not use this medicine after the expiry date stated on the bottle. The expiry date refers to the last day of the month.
Do not use this medicine if you notice a change in the appearance of the oral solution.
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 Deslodyna contains

• The active substance is desloratadine. 1 ml of oral solution contains 0.5 mg of desloratadine.
• The other ingredients (excipients) are: liquid sorbitol, non-crystallizing (E420), propylene glycol, citric acid monohydrate, sodium citrate, Hypromellose 2910, sucralose, disodium edetate, Tutti Frutti flavor, purified water.

What Deslodyna looks like and contents of the pack

Deslodyna oral solution is a clear, colorless solution without any foreign particles.
Deslodyna oral solution is available in bottles containing 60 ml or 150 ml of solution, closed with a child-resistant cap. The bottles are packaged in cardboard boxes. A 5 ml measuring cup with 0.5 ml graduations is provided with each pack.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

“PRZEDSIĘBIORSTWO PRODUKCJI FARMACEUTYCZNEJ HASCO-LEK” S.A
ul. Żmigrodzka 242 E, 51-131 Wrocław

Information about the medicine

tel.: (22) 742 00 22
e-mail: [email protected]
Date of last revision of the leaflet:27.07.2017