Desetax

Package Leaflet: Information for the Patient

Desetax, 0.5 mg/ml, Oral Solution

Desloratadine

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

This medicine should always be taken exactly as described in the package leaflet or as directed by your doctor, pharmacist, or nurse.

• Keep this leaflet, you may need to read it again.
• If you need advice or further information, ask your pharmacist.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.
• If after 3 days there is no improvement or you feel worse, you should contact your doctor.

Table of Contents of the Leaflet

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

1. What is Desetax and what is it used for

Desetax oral solution contains desloratadine, which is an antihistamine.
Desetax oral solution is an anti-allergic medicine that does not cause drowsiness. It helps
control allergic reactions and their symptoms.

When to use Desetax

Desetax relieves symptoms associated with allergic rhinitis (inflammation of the nasal mucosa caused by an allergy, such as hay fever or dust mite allergy) in adults, adolescents, and children aged 6 and above.
The symptoms of this condition include: sneezing, itching or discharge from the nose, itching of the palate, and itching, redness, or tearing of the eyes.
Desetax oral solution is also used to relieve symptoms associated with hives (a skin condition caused by an allergy), such as: itching of the skin and hives.
The relief of these symptoms lasts throughout the day, making it easier to return to normal daily activities and normal sleep.
If after 3 days there is no improvement or you feel worse, you should contact your doctor.

2. Important information before taking Desetax

When not to take Desetax:

if you are allergic to the active substance (desloratadine) or any of the other ingredients of this medicine (listed in section 6),
if you are allergic to loratadine.

Warnings and precautions

Before taking Desetax, you should discuss it with your doctor, pharmacist, or nurse:

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

If the above situation applies to you or you have any questions, you should consult your doctor before taking Desetax.

Children and adolescents

This medicine should not be given to children under 6 years of age.

Desetax and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take.
No interactions with other medicines are known for Desetax.

Desetax with food, drink, and alcohol

Desetax can be taken with or without food.
Caution should be exercised when taking Desetax 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.
Desetax should not be used during pregnancy or breastfeeding.
Fertility
There are no available data on the effect on fertility in males and females.

Driving and using machines

Desetax is not expected to affect the ability to drive or use machines at the recommended dose. However, it is recommended to avoid activities that require concentration, such as driving or using machines, until you know how you react to this medicine.

Desetax contains propylene glycol

The medicine contains 100 mg of propylene glycol in each 1 ml of oral solution.

Desetax contains sorbitol

The medicine contains 150 mg of sorbitol in each 1 ml of oral solution.
Sorbitol is a source of fructose. If you have been previously diagnosed with intolerance to some sugars or previously diagnosed with hereditary fructose intolerance, a rare genetic disorder in which your body does not break down fructose, you should consult your doctor before taking this medicine or giving it to a child. Sorbitol may cause gastrointestinal discomfort and may have a mild laxative effect.
The medicine contains less than 1 mmol (23 mg) of sodium per ml of oral solution, which means it is essentially 'sodium-free'.

3. How to take Desetax

This medicine should always be taken exactly as described in the package leaflet or as directed by your doctor or pharmacist. If you are unsure, ask your doctor or pharmacist.

Children aged 6 to 11 years

The recommended dose is 5 ml (one 5 ml measuring cup) of oral solution once daily.
In case of underweight or overweight, it is recommended to consult a doctor to adjust the dose.

Adults and adolescents (12 years and above)

The recommended dose is 10 ml (two 5 ml measuring cups) of oral solution once daily.
This medicine is intended for oral use.
The dose of oral solution should be swallowed and then followed by water. The medicine can be taken with or without food.
If after 3 days there is no improvement or you feel worse, you should contact your doctor.

Do not take Desetax for more than 10 days without consulting a doctor.

Taking a higher dose of Desetax than recommended

Desetax oral solution should only be taken as described in the package leaflet or as directed by your doctor. In case of accidental overdose, no serious disorders are expected to occur. However, if you take more than the recommended dose of Desetax oral solution, you should contact your doctor or pharmacist.

Missing a dose of Desetax

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.

Stopping Desetax

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

4. Possible side effects

Like all medicines, Desetax can cause side effects, although not everybody gets them.
After desloratadine (the active substance of Desetax) was marketed, very rare cases of severe allergic reactions (difficulty breathing, wheezing, itching, hives, and swelling) were reported. If you experience any of these severe side effects, stop taking the medicine and seek medical help immediately.
In clinical trials, most children and adults experienced side effects that were almost the same as those experienced with a placebo solution (a solution that does not contain the active substance). However, in adult patients, fatigue, dry mouth, and headache were reported more often than with a placebo.
The following side effects were reported in clinical trials of desloratadine:
Adults
Frequent:may affect up to 1 in 10 people

• fatigue
• dry mouth
• headache.

After desloratadine was marketed, the following side effects were 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 upset
• diarrhea
• dizziness
• drowsiness
• insomnia
• muscle pain
• hallucinations
• seizures
• restlessness with excessive motor activity
• hepatitis
• abnormal liver function test results. Frequency not known:frequency cannot be estimated from the available data
• unusual weakness
• jaundice (yellowing of the skin and/or eyes)
• increased sensitivity of the skin to the sun, even when the sun is cloudy, and to UV (ultraviolet) radiation, such as that from a sunbed
• change in heartbeat
• 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
• change in heartbeat
• unusual behavior
• aggressive behavior
• weight gain
• increased appetite.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. 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:
Aleje Jerozolimskie 181C, 02-222 Warsaw, tel.: 22 49 21 301, fax: 22 49 21 309,
website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Desetax

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the bottle and carton after:
“EXP”. The expiry date refers to the last day of the month.
The shelf life after first opening the bottle is 3 months.
Do not store above 30°C.
Do not refrigerate or freeze.
Store in the original package to protect from light.
Do not use this medicine if you notice any 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 Desetax contains

The active substance is desloratadine.
1 ml of oral solution contains 0.5 mg of desloratadine.
The other ingredients are: liquid sorbitol, non-crystallizing, propylene glycol, sucralose (E 955),
hypromellose 3870 cPs, sodium citrate (to adjust pH), anhydrous citric acid (to adjust pH), peach flavor (contains, among others, propylene glycol, cis-3-hexenol), disodium edetate, purified water.

What Desetax looks like and contents of the pack

Desetax is a colorless, clear oral solution.
Packaging:
A 125 ml type III amber glass bottle with a child-resistant HDPE closure, a 5 ml PP measuring cup with a 2.5 ml graduation, in a cardboard box.
The pack contains 100 ml of solution.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Aristo Pharma Sp. z o.o.
Baletowa 30 Street
02-867 Warsaw

Manufacturer:

Laboratórios Basi – Indústria Farmacêutica, S.A.
Parque Industrial Manuel Lourenço Ferreira, Lotes 15 e 16
3450-232 Mortágua
Portugal
Date of last revision of the leaflet:May 2022