DESLORATADINE GENEPHARM

Desloratadine Peseri, 2.5 mg, orodispersible tablets
Desloratadine

Read the entire leaflet carefully before using this medicine, because it contains important information for the patient.

• Keep this leaflet for future reference.
• Consult your doctor or pharmacist if you have any further questions.
• This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm others, even if their symptoms are the same.
• If any side effects worsen or if any side effects occur, including those not listed in this leaflet, inform your doctor or pharmacist.

Leaflet contents:

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

1. What Desloratadine Peseri is and what it is used for

Desloratadine Peseri is an antihistamine medicine that does not cause drowsiness. It helps control allergic reactions and their symptoms.

Desloratadine Peseri relieves symptoms associated with allergic rhinitis (inflammation of the nasal mucosa caused by allergy, such as hay fever or dust mite allergy). Symptoms of this condition include: sneezing, runny or itchy nose, itching of the palate, and itchy, red, watery eyes.

Desloratadine Peseri orodispersible tablets are also used to relieve symptoms of urticaria (a skin condition caused by allergy). Symptoms of this condition include: skin itching and hives.

Relief from these symptoms lasts throughout the day, helping patients return to normal daily activities and sleep.

If there is no improvement or if the patient feels worse, consult a doctor.

2. Important information before using Desloratadine Peseri

When not to use Desloratadine Peseri

• if the patient is allergic (hypersensitive) to desloratadine or to any of the other ingredients of the medicine (listed in section 6), or to loratadine. Desloratadine Peseri is intended for adults and children (aged 6 years or older).

Warnings and precautions

Before starting to use Desloratadine Peseri, consult a doctor or pharmacist:

• if the patient has impaired kidney function.

Desloratadine Peseri with other medicines

No interactions between Desloratadine Peseri and other medicines are known.

Desloratadine Peseri with food and drink

Desloratadine Peseri does not need to be taken with water or any other liquid. Additionally, Desloratadine Peseri may be taken with or without food.

Pregnancy, breastfeeding, and fertility

During pregnancy or breastfeeding, or if the patient suspects she may be pregnant or is planning a pregnancy, she should consult a doctor or pharmacist before using this medicine.
Use of Desloratadine Peseri is not recommended during pregnancy or breastfeeding.

Driving and operating machinery

Desloratadine Peseri, when used at the recommended dose, is not expected to cause drowsiness or impair attention. However, very rarely, some individuals may experience drowsiness, which could affect their ability to drive or operate machinery.

This product contains aspartame. Aspartame is a source of phenylalanine and may be harmful to people with phenylketonuria.

3. How to take Desloratadine Genepharm

This medicine should always be taken as prescribed by your doctor. If in doubt, consult your doctor or pharmacist.
Before taking, carefully open the blister pack by tearing it. Remove the orally disintegrating tablet without crushing it. Place the tablet in the mouth, where it will disintegrate immediately. Water or any other liquid is not needed to swallow the dose.
The recommended dose is:

• Children aged 6 to 11 years: one 2.5 mg dose of Desloratadine Genepharm once daily. The dose should be taken immediately after opening the blister pack.
• Adults and adolescents (aged 12 years and older): two 2.5 mg doses of Desloratadine Genepharm once daily. The dose should be taken immediately after opening the blister pack.

The duration of treatment with Desloratadine Genepharm will be determined by the attending physician based on the type of allergic rhinitis present in the patient. If the patient has intermittent allergic rhinitis (symptoms lasting fewer than 4 days per week or less than 4 weeks), the attending physician will recommend a treatment regimen considering the previous course of the disease. If the patient has persistent allergic rhinitis (symptoms occurring for 4 or more days per week and for more than 4 weeks), the attending physician may recommend long-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 instructions of the attending physician.

Taking more than the recommended dose of Desloratadine Genepharm
Desloratadine Genepharm should be taken only as prescribed. Severe adverse effects are unlikely after accidental overdose.
However, if a dose higher than recommended is taken, contact your doctor or pharmacist.

Missing a dose of Desloratadine Genepharm
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.

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

4. Possible adverse reactions

Like all medicines, Desloratadine Genepharm may cause adverse reactions, although not everyone experiences them.
In adult patients, adverse reactions were almost the same as those observed with placebo tablet (a tablet without active ingredient). However, fatigue, dry mouth, and headache were reported more frequently than with placebo.
In adolescents, the most commonly reported adverse reaction was headache.
Since the marketing of Desloratadine Genepharm, very rare cases of severe allergic reactions (difficulty in breathing, wheezing, itching, urticaria, swelling) and rash have been reported. Very rare cases of the following have also been reported: palpitations, rapid heartbeat, abdominal pain, nausea, vomiting, stomach discomfort, diarrhoea, dizziness, somnolence, insomnia, muscle pain, hallucinations, convulsions, restlessness with excessive motor activity, hepatitis, and abnormalities in liver function tests.
If any adverse reactions occur, including any possible adverse reactions not listed in this leaflet, consult a doctor or pharmacist.

5. How to store Desloratadine Peseri

Keep the medicine out of the reach and sight of children.
Do not use Desloratadine Peseri after the expiry date stated on the carton and blister pack. The expiry date refers to the last day of the specified month.
No special storage conditions apply.
Medicines must 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 Desloratadine Peseri contains

• The active substance is desloratadine 2.5 mg.
• The other ingredients are: potassium polyacrylate, citric acid monohydrate, iron oxide red (E 172), magnesium stearate, sodium croscarmellose, Tutti Frutti flavour (also contains propylene glycol), aspartame (E 951), microcrystalline cellulose, mannitol (spray dried), potassium hydroxide (for pH adjustment).

What Desloratadine Peseri looks like and contents of the pack
Desloratadine Peseri 2.5 mg orodispersible tablets are brick-red, round, flat tablets with bevelled edges, marked with "2.5".
Desloratadine Peseri is packed in blisters in pack sizes containing 5, 6, 10, 12, 15, 18, 20, 30, 50, 60, 90 and 100 orodispersible tablets. Not all pack sizes may be marketed.

Marketing Authorisation Holder:
Genepharm S.A., 18th Km Marathonos Avenue, 15351 Pallini, Greece
Telephone: 0030 210 60 39 336
Telefax: 0030 210 60 39 402

Manufacturer:
Genapharm S.A.
18 Km Marathon Avenue
15351 Pallini, Greece

This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Portugal
Desloratadine Peseri
Poland
Desloratadine Peseri