Package leaflet: Information for the user

Delortan, 5 mg, coated tablets
Desloratadinum
Please read all of this leaflet carefully before taking this medicine because it contains
important information for you.

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 individual. 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.

Contents of the leaflet

What Delortan is and what it is used for
What you need to know before taking Delortan
How to take Delortan
Possible side effects
How to store Delortan
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 is an antiallergy medicine that does not cause drowsiness. It helps control allergic reactions and their symptoms.
When Delortan should be used
Delortan relieves symptoms of allergic rhinitis (inflammation of the nasal mucosa caused by allergy, such as hay fever or dust mite allergy) in adults and adolescents aged 12 years and older. Symptoms include: sneezing, watery or itchy nose, itchy palate, and itchy, red, or watery eyes.
Delortan is also used to relieve symptoms of urticaria (a skin condition caused by allergy). Symptoms of this condition include: itchy skin and rash.
Relief from these symptoms lasts throughout the day, helping you return to normal daily activities and sleep normally.

2. Important information before using Delortan

When not to use Delortan:

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 starting treatment with Delortan, consult your doctor, pharmacist, or nurse:

if the patient has impaired kidney function.
if the patient has a history or family history of seizures.

Children and adolescents
This medicine should not be given to children under 12 years of age.
Delortan and other medicines
No interactions between Delortan and other medicines are known.
Tell your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take.
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 or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before using this medicine.
Use of Delortan is not recommended during pregnancy or breastfeeding.
Fertility
There are no available data on the effect 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 individual's response to the medicine is known.
Delortan contains isomalt
Delortan contains isomalt. If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult their doctor before taking this medicine.

3. How to use Delortan

This medicine should always be taken exactly as directed by your doctor or pharmacist. If you have any doubts,
consult your doctor or pharmacist.

Adults and adolescents (aged 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.
The tablet should be swallowed whole.

The duration of treatment with Delortan will be determined by your doctor after establishing the type of allergic
rhinitis affecting the patient.

If the patient suffers from intermittent allergic rhinitis (symptoms occurring for less than 4 days per week or for less than 4 weeks),
your doctor will recommend a treatment regimen based on the previous course of the disease.

If the patient suffers from persistent allergic rhinitis (symptoms occurring for 4 or more days per week and for more than 4 weeks),
your doctor may recommend longer-term use of the medicine.

In the case of urticaria, the duration of treatment may vary among individual patients. Therefore, the patient should follow
the doctor's instructions.

Taking more Delortan than recommended
Delortan should only be taken as prescribed. Serious adverse effects are not expected after accidental overdose.
However, if you take more Delortan than recommended, inform your doctor, pharmacist, or nurse immediately.

If you forget to take Delortan
If you miss a dose, take it as soon as possible, then return to your regular dosing schedule.
Do not take a double dose to make up for a missed dose.

Stopping Delortan
If you have any further doubts about using 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, you must stop taking the medicine and contact your doctor immediately.

In clinical trials in adult patients, adverse reactions were almost the same as with placebo (a tablet containing no active ingredient). However, fatigue, dry mouth, and headache were reported more frequently than with placebo. In adolescents, headache was the most commonly reported adverse reaction.

The following adverse reactions have been reported in clinical trials with desloratadine:
Common (less frequent than in 1 in 10 patients):

fatigue,
dry mouth,
headache.

After the marketing of desloratadine, the following adverse reactions have been reported:
Very rare (less frequent than in 1 in 10,000 patients):

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

Frequency unknown (frequency cannot be estimated from available data):

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

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

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

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, tell your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +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.
By reporting adverse reactions, additional information on the safety of the medicine can be collected.

5. How to store Delortan

Do not store above 30°C.
Keep in the original packaging to protect from moisture.
Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the cardboard box and blister pack following "EXP". The expiry date refers to the last day of the specified month.
The marking on the packaging following the abbreviation "EXP" indicates the expiry date, and following the abbreviation "Lot" indicates the batch number.
Do not use this medicine if you notice any change in the appearance of the tablets.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the packaging and other information

What Delortan contains

The active substance is desloratadine. Each tablet contains 5 mg of desloratadine.
The other ingredients are:

Tablet core: isomalt (E 953); pregelatinized corn starch; microcrystalline cellulose;
heavy magnesium oxide; hydroxypropylcellulose; crospovidone (type A); magnesium stearate.
Tablet 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 coated tablets are blue, round, biconvex coated tablets with a diameter of approximately 6.5 mm.
Delortan 5 mg coated tablets are packed in PCTFE/PVC/Aluminium 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 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:
PharmaPath S.A.
28is Oktovriou 1,
Agia Varvara, 123 51,
Greece