Delortan

Patient Information Leaflet: User Information

Delortan, 0.5 mg/ml, Oral Solution

Desloratadine

Read the leaflet carefully before taking 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 a specific person. Do not pass it on to others. The medicine may harm them, even if their symptoms are the same.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Leaflet:

• 1. What is Delortan and what is it 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 is Delortan and what is it used for

What is Delortan

Delortan contains desloratadine, which is an antihistamine.

How Delortan works

Delortan oral solution is an anti-allergic medicine that does not cause drowsiness. It helps control allergic reactions and their symptoms.

When to use Delortan

Delortan oral solution relieves symptoms associated with allergic rhinitis (hay fever or allergy to dust mites) in adults, adolescents, and children over 1 year of age. Symptoms include: sneezing, runny or itchy nose, itchy palate, and itchy, red, or teary eyes. Delortan oral solution is also used to relieve symptoms associated with urticaria (hives). Symptoms of this condition include: itchy skin and rash. 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 Delortan

When not to take Delortan:

• 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 Delortan, discuss it 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 1 year of age.

Delortan and other medicines

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

Taking Delortan with food, drink, and alcohol

Delortan can be taken with or without food. Be cautious when taking Delortan with alcohol.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, ask your doctor or pharmacist for advice before taking this medicine. It is not recommended to take Delortan 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 will affect your 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 you know how you react to this medicine.

Delortan contains sorbitol (E420), propylene glycol (E1520), sodium, flavorings

The medicine contains 106 mg of sorbitol in each ml of oral solution. Sorbitol is a source of fructose. If you (or your child) have been diagnosed with intolerance to some sugars or have a rare genetic disorder, fructose intolerance, where your body does not break down fructose, you should talk to your doctor before taking this medicine. The medicine contains 102.30 mg of propylene glycol in each ml of oral solution. The medicine contains 38.5 mg of sodium (a major component of common salt) in each 10 ml. This corresponds to 1.9% of the maximum recommended daily intake of sodium in the diet for adults. The medicine contains flavorings - citral, geraniol, linalool, limonene, citronellol. Citral, geraniol, linalool, limonene, citronellol may cause allergic reactions.

3. How to take Delortan

Always take 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 (½ measuring spoon of 5 ml) of oral solution once a day. Children from 6 to 11 years: The recommended dose is 5 ml (1 measuring spoon of 5 ml) of oral solution once a day.

Adults and adolescents over 12 years

The recommended dose is 10 ml (2 measuring spoons of 5 ml) of oral solution once a day. If a measuring spoon is provided with the oral solution bottle, it can be used to measure the correct dose. This medicine is for oral use only. The dose of oral solution should be swallowed and then followed by water. Delortan can be taken with or without food. The duration of treatment with Delortan oral solution 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. In urticaria, the duration of treatment may vary from patient to patient. Therefore, you should follow your doctor's advice.

Taking too much Delortan

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

Missing a dose of Delortan

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.

Stopping treatment with Delortan

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, Delortan 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 you experience any of these severe side effects, stop taking the medicine and seek medical help immediately. In clinical studies, most children and adults experienced side effects that were almost the same as those experienced with a placebo. However, in children under 2 years of age, common side effects were diarrhea, fever, and insomnia, while in adult patients, fatigue, dry mouth, and headache were reported more frequently than with a placebo. The following side effects have been reported in clinical studies with desloratadine: Children Common (may affect up to 1 in 10 children under 2 years):

• diarrhea,
• fever,
• insomnia.

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

• 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 patients):

• severe allergic reactions, rash,
• heart palpitations, irregular heartbeat, rapid heartbeat,
• abdominal pain, nausea, vomiting, indigestion, diarrhea,
• dizziness, drowsiness, insomnia,
• muscle pain,
• hallucinations, seizures, restlessness with hyperactivity,
• 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, even when cloudy, and to UV (ultraviolet) radiation, e.g., from sunlamps,
• changes in heart rhythm,
• abnormal 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,
• abnormal 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 Drug Safety, 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, you can help provide more information on the safety of this medicine.

5. How to store Delortan

There are no special precautions for storage. 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 bottle and carton after EXP. The expiry date refers to the last day of that month. The packaging is labeled with the expiry date and batch number after the EXP and Lot abbreviations, respectively. Delortan should be used within 2 months after opening the bottle. 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 Delortan contains

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

What Delortan looks like and contents of the pack

Delortan oral solution is a clear, colorless liquid without impurities. Delortan, 0.5 mg/ml, oral solution, is available in six different pack sizes: 50, 60, 100, 120, 150, and 300 ml. The pack consists of: orange glass type III bottles, closed with a cap with a multi-layered polyethylene plug and a child-resistant closure. The 50 ml and 60 ml oral solution is filled in 60 ml bottles, 100 ml in 100 ml bottles, 120 ml in 125 ml bottles, 150 ml in 150 ml bottles, and 300 ml in 300 ml bottles. The bottles are then packed in cardboard boxes. Each pack includes a measuring spoon that allows measuring 2.5 ml and 5 ml of oral solution and/or a measuring syringe with a capacity of 5 ml and graduations every 0.5 ml.

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

Marketing authorization holder and manufacturer

Marketing authorization 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 Date of last revision of the leaflet:December 2024