Delortan

Package Leaflet: Information for the User

Delortan, 5 mg, Film-Coated Tablets

Desloratadine

Read the package 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 you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• 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 is an anti-allergic medicine that does not cause drowsiness. It helps control allergic reactions and their symptoms.

When to use Delortan

Delortan relieves the symptoms associated with allergic rhinitis (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 watery eyes. Delortan is also used to relieve the symptoms of urticaria (a skin condition caused by an allergy). Symptoms of this condition include: itchy skin 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 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 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.

Delortan with 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 any you plan to take.

Delortan with food, drink, and alcohol

Delortan can be taken with or without food. Be careful when taking Delortan 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 Delortan during pregnancy or breastfeeding.

Fertility

There are no available data on the effect on fertility in men and women.

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 this medicine affects you.

Delortan contains isomalt

Delortan contains isomalt. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

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.

Adults and adolescents (12 years and older)

The recommended dose is one tablet once daily, taken with water, with or without food. This medicine is for oral use only. Swallow the tablet whole. The duration of treatment with Delortan 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. For urticaria, the duration of treatment may vary from patient to patient. Therefore, you should follow your doctor's advice.

Taking a higher dose of Delortan than recommended

Delortan should be taken only as directed. In case of accidental overdose, no serious problems are expected. 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 product, 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 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 attention immediately. In clinical studies, the side effects in adults were almost the same as with a placebo. However, fatigue, dry mouth, and headache were reported more often than with a placebo. In adolescents, the most commonly reported side effect was headache. The following side effects have been reported in clinical studies with desloratadine:

• fatigue,
• dry mouth,
• headache.

After desloratadine was made available, the following side effects have been reported:

• severe allergic reactions, rash,
• palpitations, irregular heartbeat, rapid heartbeat,
• abdominal pain, nausea, vomiting, dyspepsia, diarrhea,
• dizziness, somnolence, insomnia,
• muscle pain,
• hallucinations, seizures, restlessness with increased physical 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 skin and/or eyes,
• increased sensitivity of the skin to the sun, even in cloudy weather and to UV (ultraviolet) radiation, e.g., to UV radiation in a solarium,
• 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, change 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 Monitoring 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

Do not store above 30°C. Store in the original package to protect from moisture. Keep the medicine out of the sight and reach of children. Do not use this medicine after the expiry date stated on the carton and blister after EXP. The expiry date refers to the last day of the month. The notation on the packaging after the abbreviation "EXP" refers to the expiry date, and after the abbreviation "Lot" refers to the batch number. Do not use this medicine if you notice any change in the appearance of the tablets. 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 tablet contains 5 mg of desloratadine.
• The other ingredients are:

Core: isomalt (E 953); maize starch; microcrystalline cellulose; heavy magnesium oxide; hydroxypropylcellulose; crospovidone (type A); magnesium stearate. Coating: polyvinyl alcohol; titanium dioxide (E 171); macrogol 3350; talc; indigo carmine, lake (E 132).

What Delortan looks like and contents of the pack

Delortan 5 mg film-coated tablets are blue, round, biconvex, film-coated tablets with a diameter of about 6.5 mm. Delortan 5 mg film-coated tablets are packaged in PCTFE/PVC/Aluminum blisters in a cardboard box. Pack sizes: 7, 10, 15, 20, 21, 28, 30, 50, 90, or 100 tablets. 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: PharmaPath S.A., 28is Oktovriou 1, Agia Varvara, 123 51, Greece. Date of last revision of the leaflet:December 2024.