Desloratadine doppelherz

Desloratadyna Doppelherz, 5 mg, orally disintegrating tablets
Desloratadinum
Please read the entire leaflet carefully before using the medicine, as it contains
important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as directed by
the doctor, pharmacist, or nurse.

• Keep this leaflet for future reference.
• If you need advice or further information, consult your pharmacist.
• If any adverse reactions occur, including any possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement after 3 days or if the patient feels worse, contact a doctor.

Table of contents:

1. What Desloratadyna Doppelherz is and what it is used for
2. What you need to know before taking Desloratadyna Doppelherz
3. How to take Desloratadyna Doppelherz
4. Possible side effects
5. How to store Desloratadyna Doppelherz
6. Contents of the pack and other information

1. What Desloratadyna Doppelherz is and what it is used for

What is Desloratadyna Doppelherz
Desloratadyna Doppelherz contains desloratadine, which is an antihistamine medicine.
How Desloratadyna Doppelherz works
Desloratadyna Doppelherz is an antiallergic medicine that does not cause drowsiness. It helps control allergic reactions and their symptoms.
When to use Desloratadyna Doppelherz
Desloratadyna Doppelherz relieves symptoms associated with allergic rhinitis (inflammation of the nasal mucosa caused by allergy, such as hay fever or allergy to house dust mites) in adults and adolescents aged 12 years and older. Symptoms include:
sneezing, watery or runny nose, nasal itching, itching of the palate, as well as itching, redness, or watering of the eyes.
Desloratadyna Doppelherz in the form of orally disintegrating tablets is also used to relieve symptoms associated with 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 the patient return to normal daily activities and achieve normal sleep.
If there is no improvement after 3 days or if the patient feels worse, consult a doctor.

2. Important information before using Desloratadyna Doppelherz

When not to use Desloratadyna Doppelherz

• 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 Desloratadyna Doppelherz, consult your doctor,
pharmacist, or nurse:

• if the patient has kidney function disorders.
• if the patient has a personal or family history of seizures.

Children and adolescents
This medicine should not be given to children under 12 years of age.
Desloratadyna Doppelherz and other medicines
No interactions between Desloratadyna Doppelherz and other medicines are known.
You should inform your doctor or pharmacist about all medicines the patient is currently taking
or has recently taken, as well as any medicines the patient plans to take.
Desloratadyna Doppelherz with food, drink and alcohol
It is not necessary to take Desloratadyna Doppelherz with water or other liquid. Moreover, Desloratadyna Doppelherz may be taken with or without food. Caution should be exercised when taking Desloratadyna Doppelherz with alcohol.
Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.
Use of Desloratadyna Doppelherz is not recommended during pregnancy or breastfeeding.
Fertility
There are no available data regarding 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 drowsiness does not occur in most people, it is recommended to refrain from performing tasks requiring mental alertness, such as driving or operating machinery, until the individual's response to the medicine is known.
Desloratadyna Doppelherz contains aspartame.
The medicine contains 3 mg of aspartame in each orodispersible tablet.
Aspartame is a source of phenylalanine. It may be harmful for patients with phenylketonuria. This is a rare genetic disorder in which phenylalanine accumulates in the body due to impaired excretion.

3. How to use Desloratadyna Doppelherz

This medicine should always be taken exactly as described in this patient information leaflet or as directed by a physician or pharmacist. If in doubt, consult a physician or pharmacist.
Adults and adolescents aged 12 years and older
The recommended dose is one tablet once daily, taken with or without food.
This medicine is intended for oral use.
Before administration, carefully open the blister pack by tearing it open. Remove the orodispersible tablet without crushing it. Place the tablet in the mouth, where it will disintegrate immediately. Water or any other liquid is not required to swallow the dose. The dose should be taken immediately after opening the blister.
Duration of treatment
Do not use the medicine for longer than 10 days without consulting a physician. If there is no improvement after 3 days, or if symptoms worsen, consult a physician.
Taking more than the recommended dose of Desloratadyna Doppelherz
Desloratadyna Doppelherz should only be taken as described in the patient information leaflet or as directed by a physician or pharmacist. Severe adverse effects are not expected after accidental overdose. However, if more than the recommended dose of Desloratadyna Doppelherz has been taken, contact a physician or pharmacist.
Missed dose of Desloratadyna Doppelherz
If a dose is missed at the scheduled time, 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 individual dose.
Stopping Desloratadyna Doppelherz
If you have any further questions about the use of this medicine, consult a physician, pharmacist, or nurse.

4. Possible adverse reactions

Like any medicine, 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 should stop taking the medicine and consult a doctor immediately.

In clinical trials in adult patients, adverse reactions were almost the same as with placebo (tablet without active substance). 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 (may affect up to 1 in 10 patients):

• fatigue
• dry mouth
• headache

The following adverse reactions have been reported since desloratadine has been marketed:

Very rare (may affect up to 1 in 10,000 patients):

• severe allergic reactions ● rash ● palpitations and irregular heartbeat
• fast heartbeat ● abdominal pain ● nausea
• vomiting ● stomach discomfort ● diarrhoea
• dizziness ● drowsiness ● insomnia
• muscle pain ● hallucinations ● seizures
• restlessness with excessive motor activity ● hepatitis ● abnormal liver function test results

Frequency not known (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, for example UV radiation in sunbeds
• changes in heart rhythm
• unusual behaviour
• aggressive behaviour
• weight gain
• increased appetite
• low mood
• dry eyes

Additional adverse reactions in children:

Frequency not known (frequency cannot be estimated from available data):

• slow heartbeat ● change in heart rhythm
• unusual behaviour ● aggressive behaviour

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

5. How to store Desloratadyna Doppelherz

Keep the medicine out of sight and reach of children.
Do not use Desloratadyna Doppelherz after the expiry date stated on the carton and blister after: EXP. The expiry date refers to the last day of the stated month.
No special storage conditions apply for this medicine.
Do not use this medicine if you notice any changes 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. This will help protect the environment.

6. Contents of the package and other information

What Desloratadyna Doppelherz contains

• The active substance is desloratadine in a dose of 5 mg.
• The other ingredients are: potassium polycrylate, 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 Desloratadyna Doppelherz looks like and contents of the pack
Desloratadyna Doppelherz 5 mg orodispersible tablets are brick-red, round, flat tablets with bevelled edges, marked with the number "5".
Desloratadyna Doppelherz is packed in blisters in packages containing 5, 6, or 10 orodispersible tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder:
Doppelherz Pharma GmbH
Schleswiger Strasse 74
24941 Flensburg
Germany

Manufacturer:
Genepharm S.A.
18 Km Marathon Avenue
15351 Pallini, Greece
Pharmapath S.A.
28is Oktovriou 1
Agia Varvara, 123 51
Greece

For further information, please contact the local representative of the Marketing Authorisation Holder:
Queisser Pharma Poland Sp. z o.o.
ul. Domaniewska 39
02-672 Warszawa
Poland
Tel.: (22) 487 52 54
E-mail: [email protected]

This medicinal product is authorised in the European Economic Area countries under the following names:
Poland Desloratadyna Doppelherz