Desloratadine Genepharm

Patient Information Leaflet: User Information

Desloratadine Peseri, 2.5 mg, Oral Disintegrating Tablets

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 or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Table of Contents of the Leaflet:

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

Desloratadine Peseri is an antiallergic medicine that does not cause drowsiness. It helps control allergic reactions and their symptoms.
Desloratadine Peseri relieves the symptoms associated with allergic rhinitis (inflammation of the nasal mucosa caused by an allergy, such as hay fever or dust mite allergy). The symptoms of this condition include: sneezing, itching or discharge from the nose, itching of the palate, and itching, redness or tearing of the eyes.
Desloratadine Peseri oral disintegrating tablets are also used to relieve the symptoms associated with urticaria (a skin condition caused by an allergy). The symptoms of this condition include: skin itching and urticaria.
The relief of these symptoms persists throughout the day, making it easier to return to normal daily activities and normal sleep.
If there is no improvement or the patient feels worse, they should consult a doctor.

2. Important information before taking Desloratadine Peseri

When not to take Desloratadine Peseri

Warnings and precautions

Before taking Desloratadine Peseri, consult your doctor or pharmacist:

Desloratadine Peseri with other medicines

No interactions with other medicines are known for Desloratadine Peseri.

Desloratadine Peseri with food and drink

Taking Desloratadine Peseri does not require drinking water or any other liquid. Additionally, Desloratadine Peseri can be taken with or without food.

Pregnancy, breastfeeding, and fertility

In pregnancy, during breastfeeding, or if you 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 Desloratadine Peseri during pregnancy or breastfeeding.

Driving and using machines

It is unlikely that Desloratadine Peseri, when taken as recommended, will cause drowsiness or affect the ability to concentrate.
However, very rarely, some people may experience drowsiness, which may 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 Peseri

Take this medicine always as directed by your doctor. If you are not sure, consult your doctor or pharmacist.
Before taking, carefully open the blister by tearing it. Take out the oral disintegrating tablet without crushing it. Place it in the mouth, where it will dissolve immediately. Water or any other liquid is not needed to swallow the dose.

• Children aged 6 to 11 years: one 2.5 mg dose of Desloratadine Peseri once daily. Take the dose immediately after opening the blister.
• Adults and adolescents (aged 12 years and older): two 2.5 mg doses of Desloratadine Peseri once daily. Take the dose immediately after opening the blister. The duration of treatment with Desloratadine Peseri will be determined by your doctor after establishing 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 previous 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 long-term use of the medicine.

In the case of urticaria, the duration of treatment may vary from patient to patient. Therefore, the patient should follow the doctor's recommendations.

Taking a higher dose of Desloratadine Peseri than recommended

Desloratadine Peseri should be taken only as prescribed. No serious disorders are expected after accidental overdose of the medicine.
However, if a higher dose of Desloratadine Peseri than recommended is taken, consult a doctor or pharmacist.

Missing a dose of Desloratadine Peseri

If a dose is missed, take it as soon as possible, and 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 taking this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Desloratadine Peseri can cause side effects, although not everybody gets them.
In adult patients, side effects were almost the same as after taking a placebo tablet. However, fatigue, dry mouth, and headache were reported more frequently than after taking a placebo tablet.
In adolescents, the most commonly reported side effect was headache.
After the marketing of Desloratadine Peseri, very rare cases of severe allergic reactions (difficulty breathing, wheezing, itching, urticaria, swelling) and rash have been reported. Very rare cases of: palpitations, rapid heartbeat, abdominal pain, nausea (vomiting), vomiting, stomach upset, diarrhea, dizziness, drowsiness, insomnia, muscle pain, convulsions, restlessness with excessive motor activity, hepatitis, and liver function test abnormalities have also been reported.
If you experience any side effects, including any possible side effects not listed in this leaflet, please consult your doctor or pharmacist.

5. How to store Desloratadine Peseri

Keep the medicine out of the sight and reach of children.
Do not take Desloratadine Peseri after the expiry date stated on the carton and blister. The expiry date refers to the last day of that month.
There are no special storage precautions.
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 Desloratadine Peseri contains

• The active substance is desloratadine in a dose of 2.5 mg.
• The other ingredients are: polacrilin potassium, citric acid monohydrate, iron oxide red (E 172), magnesium stearate, croscarmellose sodium, Tutti Frutti flavor (also contains propylene glycol), aspartame (E 951), microcrystalline cellulose, mannitol (spray-dried), potassium hydroxide (to adjust pH).

What Desloratadine Peseri looks like and contents of the pack

Desloratadine Peseri 2.5 mg oral disintegrating tablets are reddish-brown, round, flat tablets with beveled edges, marked with "2.5".
Desloratadine Peseri is packaged in blisters in packs containing 5, 6, 10, 12, 15, 18, 20, 30, 50, 60, 90, and 100 oral disintegrating tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder:

Genepharm S.A.,
18th Km Marathonos Avenue, 15351 Pallini, Greece
Phone: 0030 210 60 39 336
Fax: 0030 210 60 39 402

Manufacturer:

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

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Portugal Desloratadine Peseri

Poland Desloratadine Peseri

Date of last revision of the leaflet: 07/2016