Delortan

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

• Keep this leaflet for future reference.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not give it to others. This medicine may harm others, even if their symptoms are similar.
• If you experience any adverse reactions, including those not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents:

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

1. What Delortan is and what it is used for

What Delortan is
Delortan contains desloratadine, which is an antihistamine medicine.
How Delortan works
Delortan oral solution is an antiallergic medicine that does not cause drowsiness. It helps control allergic reactions and their symptoms.
When Delortan should be used
Delortan oral solution relieves symptoms associated with allergic rhinitis (inflammation of the nasal mucosa caused by allergy, such as hay fever or allergy to house dust mites) in adults, adolescents, and children above 1 year of age. Symptoms include: sneezing, watery or itchy nose, itching of the palate, and itchy, red, or watery eyes.
Delortan oral solution is also used to relieve symptoms associated with urticaria (a skin condition caused by allergy). Symptoms of this condition include: skin itching and rash.
Relief from these symptoms lasts throughout the day, helping patients return to normal daily activities and achieve normal sleep.

2. Information before using Delortan

When not to use Delortan:

• if the patient is allergic to desloratadine or to any of the other ingredients of this medicine (listed in section 6), or to loratadine.

Warnings and precautions
Before starting treatment with Delortan, please consult your doctor, pharmacist, or nurse:

• if the patient has renal function impairment.
• if the patient has a personal or family history of seizures.

Children and adolescents
This medicine should not be given to children under 1 year of age.
Interaction of Delortan with other medicines
No interactions between Delortan and other medicines are known.
Please inform your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient intends to take.
Taking Delortan with food, drink and alcohol
Delortan may be taken with or without food.
Caution is advised when taking Delortan with alcohol.
Pregnancy, breastfeeding and fertility
If the patient is pregnant, breastfeeding, thinks she may be pregnant, or is planning to have a baby, she should consult a doctor or pharmacist before using this medicine.
The use of Delortan is not recommended during pregnancy or breastfeeding.
Fertility
There are no available data on the effects on fertility in men and women.
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 to refrain from activities requiring mental alertness, such as driving or operating machinery, until the patient's response to this medicine is known.
Delortan contains sorbitol (E420), propylene glycol (E1520), sodium, and flavouring substances
The medicine contains 106 mg of sorbitol in each ml of oral solution.
Sorbitol is a source of fructose. If the patient (or the patient's child) has previously been diagnosed with intolerance to certain sugars or hereditary fructose intolerance, a rare genetic disorder in which the body cannot break down fructose, the patient should consult a doctor before taking this medicine or giving it to the child.
The medicine contains 102.30 mg of propylene glycol in each ml of oral solution.
The medicine contains 38.5 mg of sodium (the main component of table salt) in each 10 ml. This corresponds to 1.9% of the maximum recommended daily dietary intake of sodium for adults.
The medicine contains flavouring substances: citral, geraniol, linalool, limonene, citronellol. Citral, geraniol, linalool, limonene, and citronellol may cause allergic reactions.

3. How to use Delortan

This medicine should always be used exactly as directed by your doctor or pharmacist. If in doubt,
consult your doctor or pharmacist.
Children
Children aged 1 to 5 years:
The recommended dose is 2.5 ml (½ measuring spoon of 5 ml capacity) of oral solution once daily.
Children aged 6 to 11 years:
The recommended dose is 5 ml (1 measuring spoon of 5 ml capacity) of oral solution once daily.
Adults and adolescents aged 12 years and older
The recommended dose is 10 ml (2 measuring spoons of 5 ml capacity) of oral solution once daily.
If an oral syringe is provided with the bottle of oral solution, it may be used interchangeably
to measure the appropriate amount of oral solution.
This medicine is intended for oral use.
The dose of oral solution should be swallowed and followed with water. The medicine may be taken
with or without food.
The duration of treatment with Delortan oral solution will be determined by the attending physician
after establishing the type of allergic rhinitis present in the patient.
If the patient has intermittent allergic rhinitis (symptoms occur for fewer than 4 days per week or
for less than 4 weeks), the attending physician will recommend a treatment regimen based on
the previous course of the disease.
If the patient has persistent allergic rhinitis (symptoms occur for 4 or more days per week and for
longer than 4 weeks), the attending physician may recommend prolonged use of the medicine.
In cases of urticaria, the duration of treatment may vary among individual patients. Therefore,
the patient should follow the attending physician's instructions.
Use of a higher than recommended dose of Delortan
Delortan oral solution should only be taken as prescribed. After accidental overdose, severe
adverse effects are not expected. However, if a higher than recommended dose of Delortan is taken,
inform your doctor, pharmacist, or nurse immediately.
Missed dose of Delortan
If a dose is missed, take it as soon as possible, then return to the regular dosing schedule.
Do not take a double dose to make up for a missed dose.
Stopping Delortan
If you have any further questions about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Since desloratadine has been marketed, very rare cases of severe allergic reactions (difficulty breathing, wheezing, itching, hives, and swelling) have been reported. If any of these severe adverse reactions occur, the medicine should be discontinued immediately and medical advice should be sought without delay.

In clinical trials, adverse reactions in most children and adults were almost the same as those observed after administration of a solution or tablet without active ingredient. However, in children under 2 years of age, common adverse reactions included diarrhoea, fever, and insomnia. In adult patients, fatigue, dry mouth, and headache were reported more frequently than with placebo tablets.

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

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

• diarrhoea,
• fever,
• insomnia.

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

• fatigue,
• dry mouth,
• headache.

After the introduction of desloratadine to the market, the following adverse reactions have been reported:

Very rare (may occur in up to 1 in 10,000 patients):

• severe allergic reactions, rash,
• palpitations, irregular heartbeat, rapid heartbeat,
• abdominal pain, nausea, vomiting, indigestion, diarrhoea,
• dizziness, somnolence, insomnia,
• muscle pain,
• hallucinations, convulsions, restlessness with excessive motor activity,
• hepatitis, abnormal liver function test results.

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

• unusual weakness,
• yellowing of the skin and/or eyes (jaundice),
• increased sensitivity of the skin to sunlight, even on cloudy days, and to UV (ultraviolet) radiation, e.g. UV radiation from sunbeds,
• changes in heart rhythm,
• unusual behaviour,
• aggressive behaviour,
• weight gain, increased appetite,
• low mood,
• dry eyes.

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

• slow heartbeat, change in heart rhythm,
• unusual behaviour,
• aggressive behaviour,
• weight gain, increased appetite.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department for Monitoring Adverse Drug Reactions 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Delortan

There are no special requirements for storing this medicine.
The medicine should be stored in a place invisible and inaccessible to children.
Do not use this medicine after the expiry date stated on the bottle and the cardboard box following the abbreviation EXP. The expiry date refers to the last day of the stated month.
The label on the packaging following the abbreviation "EXP" indicates the expiry date, and following the abbreviation "Lot" indicates the batch number.
Delortan should be used within 2 months after first opening the bottle.
Do not use this medicine if you notice any change in the appearance of the oral solution.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the package and other information

What Delortan contains

• The active substance is desloratadine. Each ml of oral solution contains 0.5 mg of desloratadine.
• The other ingredients are: sorbitol liquid, non-crystallizing (E 420); propylene glycol; citric acid monohydrate; sodium citrate; hypromellose 2910; sucralose; disodium edetate; Tutti frutti flavour (contains glyceryl trioctanoate; flavouring substances – citral, geraniol, linalool, limonene, citronellol; alpha-tocopherol); purified water.

What Delortan looks like and contents of the pack
Delortan oral solution is a clear, colourless liquid free from impurities.
Delortan 0.5 mg/ml oral solution is available in six different pack sizes:
50, 60, 100, 120, 150 and 300 ml. The packaging consists of:

• Amber glass type III bottles closed with a cap featuring a multilayer polyethylene insert and child-resistant closure. The 50 ml and 60 ml solutions are filled into 60 ml capacity bottles, 100 ml into 100 ml bottles, 120 ml into 125 ml bottles, 150 ml into 150 ml bottles, and 300 ml into 300 ml bottles. The bottles are then packed into cardboard boxes. Each package includes a measuring spoon allowing measurement of 2.5 ml and 5 ml of oral solution and/or a 5 ml graduated oral syringe with 0.5 ml graduations.
• Amber glass type III bottles closed with a cap composed of outer polypropylene and inner polyethylene layers and child-resistant closure. The 50 ml and 60 ml solutions are filled into 60 ml capacity bottles, 100 ml into 115 ml bottles, 120 ml into 125 ml bottles, 150 ml into 150 ml bottles, and 300 ml into 300 ml bottles. The bottles are then packed into cardboard boxes. Each package includes a 5 ml graduated oral syringe with 0.5 ml graduations.

Pack sizes:
50 ml, 60 ml, 100 ml, 120 ml, 150 ml and 300 ml of oral solution.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański
tel. +48 22 364 61 01

Manufacturer
Balkanpharma Troyan AD
1 Krayrechna Str.
Troyan 5600
Bulgaria