Deslodina

Package Leaflet: Information for the Patient

Deslodyna, 5 mg, Oral Disintegrating Tablets

Desloratadine

Read the Leaflet Carefully Before Taking the Medication, 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 get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Table of Contents of the Leaflet

• 1. What is Deslodyna and what is it used for
• 2. Important information before taking Deslodyna
• 3. How to take 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

What is Deslodyna

Deslodyna, an oral disintegrating tablet, contains desloratadine, which is an antihistamine.

How Deslodyna works

Deslodyna is an anti-allergic medication that does not cause drowsiness. It helps control allergic reactions and their symptoms.

When to use Deslodyna

Deslodyna relieves symptoms associated with allergic rhinitis (inflammation of the nasal mucosa caused by an allergy, such as hay fever or allergy to dust mites) in adults and adolescents aged 12 years and older. Symptoms include: sneezing, runny or itchy nose, itchy palate, and itchy, red, or teary eyes. Deslodyna is also used to relieve symptoms associated with hives (a skin condition caused by an allergy). Symptoms of this condition include: skin itching and hives. Relief of these symptoms persists throughout the day, making it easier to return to normal daily activities and normal sleep.

2. Important information before taking Deslodyna

When not to take 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, discuss with your doctor, pharmacist, or nurse:

• 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 12 years of age.

Deslodyna and other medicines

Tell your doctor or pharmacist about all medicines you are taking, or have recently taken, and about any medicines you plan to take. No interactions with other medicines are known.

Deslodyna with food, drink, and alcohol

It is not necessary to take Deslodyna with water or any other liquid. Additionally, Deslodyna can be taken with or without food. Caution should be exercised 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. It is not recommended to take Deslodyna during pregnancy or breastfeeding. Fertility: There are no available data on the effect on fertility in males and females.

Driving and using machines

It is unlikely that this medicine, when taken as recommended, will affect your ability to drive or use machines. Although most people do not experience drowsiness, it is recommended to refrain from performing tasks that require concentration, such as driving or operating machinery, until you know how you react to this medicine.

Deslodyna contains mannitol, aspartame (E 951), propylene glycol, benzyl alcohol, and sodium

The medicine contains 3 mg of aspartame in each oral disintegrating tablet. Aspartame is a source of phenylalanine. It may be harmful to patients with phenylketonuria. This is a rare genetic disorder in which phenylalanine accumulates in the body due to its improper excretion. The medicine contains 0.00562 mg of benzyl alcohol in each oral disintegrating tablet. Benzyl alcohol may cause allergic reactions. Pregnant or breastfeeding women should consult their doctor before taking the medicine, as a large amount of benzyl alcohol may accumulate in their body and cause side effects (such as metabolic acidosis). Patients with liver or kidney disease should consult their doctor before taking the medicine, as a large amount of benzyl alcohol may accumulate in their body and cause side effects (such as metabolic acidosis). The medicine contains less than 1 mmol (23 mg) of sodium in each oral disintegrating tablet, which means the medicine is considered "sodium-free".

3. How to take Deslodyna

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.

Adults and adolescents aged 12 years and older

The recommended dose is one tablet once a day, taken with or without food. The medicine is intended for oral use. Before taking, carefully open the blister by tearing it. Remove the oral disintegrating tablet without crushing it. Place it in your mouth, where it will dissolve immediately. Water or any other liquid is not needed to swallow the dose. Take the dose immediately after opening the blister. The duration of treatment with Deslodyna oral disintegrating tablets will be determined by your doctor, depending on the type of allergic rhinitis you have. If you have intermittent 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 medical history. If you have persistent allergic rhinitis (symptoms that occur for 4 or more days a week and for more than 4 weeks), your doctor may recommend longer treatment with the medicine. In the case of hives, the duration of treatment may vary from patient to patient. Therefore, you should follow your doctor's recommendations.

Take more Deslodyna than recommended

Deslodyna should only be taken as prescribed. In case of accidental overdose, severe disorders should not occur. However, if you take more Deslodyna than recommended, tell your doctor, pharmacist, or nurse immediately.

Miss a dose of Deslodyna

If you miss a dose, take it as soon as possible, and then return to your regular dosing schedule. Do not take a double dose to make up for a missed dose.

Stop taking Deslodyna

If you have any further questions on the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine 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) have been reported. If you experience any of these severe side effects, stop taking the medicine and seek medical help immediately. In clinical studies in adult patients, side effects were almost the same as after taking a placebo tablet. However, fatigue, dry mouth, and headache were reported more often than after taking a placebo tablet. In adolescents, the most commonly reported side effect was headache. In clinical studies of desloratadine, the following side effects were reported:

• Frequently(may affect up to 1 in 10 people):
• fatigue
• dry mouth
• headache

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

• Very rarely(may affect up to 1 in 10,000 people):
• severe allergic reactions
• rash
• palpitations and irregular heartbeat
• rapid heartbeat
• abdominal pain
• nausea
• vomiting
• gastrointestinal upset
• diarrhea
• dizziness
• drowsiness
• insomnia
• muscle pain
• hallucinations
• seizures
• restlessness with excessive motor activity
• hepatitis
• 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,
• changes in heart rhythm
• unusual behavior
• aggressive behavior
• weight gain, increased appetite
• low mood
• dry eyes

Children

• Frequency not known(frequency cannot be estimated from the available data):
• slow heart rate
• changes in heart rhythm, even in the case of clouded sun and UV radiation, e.g., UV radiation in a solarium
• unusual behavior
• aggressive behavior

Reporting side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Department of Monitoring of Adverse Reactions to Medicinal Products 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. You can also report side effects 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. Do not use this medicine after the expiry date which is stated on the carton. The expiry date refers to the last day of that month. There are no special storage instructions for this medicine. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Deslodyna contains

• The active substance is desloratadine. One oral disintegrating tablet contains 5 mg of desloratadine.
• The other ingredients (excipients) are: polacrilin potassium, citric acid monohydrate (for pH adjustment), potassium hydroxide 50% (for pH adjustment), mannitol, microcrystalline cellulose, sodium croscarmellose, aspartame (E 951), red iron oxide (E 172), Tutti-Frutti SD 0272 flavor (contains, among others, propylene glycol, benzyl alcohol, citral, geraniol, farnesol, linalool, d-limonene), magnesium stearate.

What Deslodyna looks like and contents of the pack

Deslodyna is a pink oral disintegrating tablet with red-pink speckles, round, smooth, biconvex, with a beveled edge and embossing "D" on one side, with a diameter of about 8 mm. One pack of the medicine contains 30 or 90 oral disintegrating tablets in OPA/Aluminum/PVC/Aluminum blisters in a cardboard box.

Marketing authorization holder and manufacturer

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

Medicine information

tel.: (22) 742 00 22, email: [email protected]

Date of last revision of the leaflet: