Deslodina fast

Leaflet attached to the packaging: patient information

Deslodyna fast, 5 mg, orally disintegrating tablets

Desloratadine

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

This medicine should always be taken exactly as described in this patient leaflet or as directed by a doctor, pharmacist, or nurse.

• Keep this leaflet, you may need to read it again.
• If you need advice or additional information, consult a pharmacist.
• If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.
• If there is no improvement or the patient feels worse after 3 days, they should contact a doctor.

Table of contents of the leaflet

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

1. What is Deslodyna fast and what is it used for

What is Deslodyna fast

Deslodyna fast, an orally disintegrating tablet, contains desloratadine, which is an antihistamine.

How Deslodyna fast works

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

When to use Deslodyna fast

Deslodyna fast relieves symptoms associated with allergic rhinitis (hay fever or allergy to dust mites) in adults and adolescents 12 years and older. Symptoms include: sneezing, runny or itchy nose, itchy palate, and itchy, red, or watery eyes.
Deslodyna fast is also used to relieve symptoms associated with urticaria (a skin condition caused by an allergy). Symptoms include: itchy skin and hives.
The relief of these symptoms persists throughout the day, making it easier to return to normal daily activities and normal sleep.
If there is no improvement or the patient feels worse after 3 days, they should contact a doctor.

2. Important information before taking Deslodyna fast

When not to take Deslodyna fast

• 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 Deslodyna fast, the patient should discuss it with their doctor, pharmacist, or nurse:

• if the patient has kidney problems,
• if the patient has a history of seizures or a family history of seizures.

Children and adolescents

This medicine should not be given to children under 12 years of age.

Deslodyna fast and other medicines

The patient should tell their doctor or pharmacist about all medicines they are taking, have recently taken, or might take.
No interactions with other medicines are known.

Deslodyna fast with food, drink, and alcohol

It is not necessary to take Deslodyna fast with water or any other liquid. Additionally, Deslodyna fast can be taken with or without food. The patient should be cautious when taking Deslodyna fast with alcohol.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a baby, they should consult their doctor or pharmacist before taking this medicine. It is not recommended to take Deslodyna fast during pregnancy or breastfeeding.
Fertility
There is no available data on the effect on fertility in males and females.

Driving and using machines

It is unlikely that this medicine will affect the ability to drive or use machines. Although most people do not experience drowsiness, it is recommended to avoid activities that require concentration, such as driving or using machines, until it is known how the medicine affects them.

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

The medicine contains 3 mg of aspartame in each orally 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 elimination.
The medicine contains 0.00562 mg of benzyl alcohol in each orally 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 (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 (metabolic acidosis).
The medicine contains less than 1 mmol (23 mg) of sodium in each orally disintegrating tablet, which means the medicine is considered "sodium-free".

3. How to take Deslodyna fast

This medicine should always be taken exactly as described in this patient leaflet or as directed by a doctor or pharmacist. If in doubt, the patient should consult their doctor or pharmacist.
The medicine is intended for oral use.
Before taking, the blister should be carefully opened by tearing it. The orally disintegrating tablet should be removed without crushing. It should be placed in the mouth, where it will immediately disintegrate. Water or any other liquid is not needed to swallow the dose. The dose should be taken immediately after opening the blister.
Without consulting a doctor, the medicine should not be taken for more than 10 days.
If there is no improvement or the patient feels worse after 3 days, they should contact a doctor.

Adults and adolescents 12 years and older

The recommended dose is one tablet once a day, taken with or without food.

Taking a higher dose of Deslodyna fast than recommended

Deslodyna fast should only be taken as described in this leaflet or as directed by a doctor or pharmacist. In case of accidental overdose, no serious disorders should occur. However, if a higher dose of Deslodyna fast is taken, the patient should immediately inform their doctor, pharmacist, or nurse.

Missing a dose of Deslodyna fast

If a dose is missed, it should be taken as soon as possible, and then the patient should return to their regular dosing schedule. A double dose should not be taken to make up for a missed dose.

Stopping Deslodyna fast

If the patient has any further questions about taking this medicine, they should consult their doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, Deslodyna fast can cause side effects, although not everybody gets them.
After desloratadine was made available, very rare cases of severe allergic reactions (difficulty breathing, wheezing, itching, hives, and swelling) have been reported. If any of these severe side effects occur, the patient should stop taking the medicine and immediately consult their doctor.
In clinical studies in adult patients, side effects were almost the same as after taking a placebo. However, fatigue, dry mouth, and headache were reported more often than after taking a placebo. In adolescents, the most commonly reported side effect was headache.
The following side effects have been reported in clinical studies of desloratadine:
Frequent(may affect up to 1 in 10 people):

• fatigue
• dry mouth
• headache

After desloratadine was made available, the following side effects have been reported:
Very rare(may affect up to 1 in 10,000 people):

• severe allergic reactions
• rash
• palpitations and irregular heartbeat
• rapid heartbeat
• abdominal pain
• nausea
• vomiting
• gastrointestinal disorders
• 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
• jaundice and/or yellowing of the 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 heartbeat
• changes in heart rhythm even in the case of clouded sun and UV radiation, for example, in a solarium
• unusual behavior
• aggressive behavior

Reporting side effects

If the patient experiences any side effects, including those not listed in the leaflet, they should inform their doctor or pharmacist. Side effects can be reported 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
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Deslodyna fast

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
There are no special precautions for storage.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Deslodyna fast contains

• The active substance is desloratadine. One orally 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 fast looks like and contents of the pack

Deslodyna fast is a pink, orally disintegrating tablet with red-pink speckles, round, smooth, biconvex, with a beveled edge and embossing "D" on one side, approximately 8 mm in diameter.
One pack of the medicine contains 10 orally disintegrating tablets in OPA/Aluminum/PVC/Aluminum blisters in a cardboard box.

Marketing authorization holder and manufacturer

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

Medicine information

tel.: (22) 742 00 22
email: informacjaoleku@hasco-lek.pl

Date of last revision of the leaflet: