Desloratadina Doppelhezh

Patient Information Leaflet: User Information

Desloratadine Doppelherz, 5 mg, orally disintegrating tablets

Desloratadine

Read the leaflet carefully before taking the medicine, as it contains important information for you.

Always take this medicine exactly as described in this patient information leaflet or as directed by your doctor, pharmacist, or nurse.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your pharmacist.
• If you experience any side effects, including any not listed in this leaflet, please inform your doctor or pharmacist. See section 4.
• If after 3 days there is no improvement or you feel worse, you should consult a doctor.

Table of Contents of the Leaflet:

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

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

What is Desloratadine Doppelherz

Desloratadine Doppelherz contains desloratadine, which is an antihistamine.

How Desloratadine Doppelherz works

Desloratadine Doppelherz is an anti-allergic medicine that does not cause drowsiness. It helps control allergic reactions and their symptoms.

When to use Desloratadine Doppelherz

Desloratadine Doppelherz relieves the symptoms associated with allergic rhinitis (inflammation of the nasal mucosa caused by an allergy, such as hay fever or allergy to dust mites) in adults and adolescents aged 12 years and older. The symptoms include: sneezing, runny or itchy nose, itchy palate, and itchy, red, or teary eyes. Desloratadine Doppelherz in the form of orally disintegrating tablets is also used to relieve the symptoms associated with urticaria (a skin condition caused by an allergy). The symptoms of this condition include: itchy skin and urticaria. The relief of these symptoms persists throughout the day, making it easier to return to normal daily activities and normal sleep. If after 3 days there is no improvement or you feel worse, you should consult a doctor.

2. Important information before taking Desloratadine Doppelherz

When not to take Desloratadine Doppelherz

• 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 Desloratadine Doppelherz, you should discuss it 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.

Desloratadine Doppelherz with other medicines

No interactions with other medicines are known. You should tell your doctor or pharmacist about all medicines you are taking or have recently taken, and about any medicines you plan to take.

Desloratadine Doppelherz with food, drink, and alcohol

It is not necessary to take Desloratadine Doppelherz with water or any other liquid. Additionally, Desloratadine Doppelherz can be taken with or without food. You should be cautious when taking Desloratadine Doppelherz 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 Desloratadine Doppelherz during pregnancy or breastfeeding. Fertility: There are no available data on the effect on fertility in males and females.

Driving and using machines

It is not expected that this medicine will affect your ability to drive or use machines. Although it does not usually cause drowsiness, it is recommended to avoid activities that require concentration, such as driving or using machines, until you know how you react to this medicine.

Desloratadine Doppelherz contains aspartame.

The medicine contains 3 mg of aspartame in each orally disintegrating tablet. Aspartame is a source of phenylalanine. It may be harmful to patients with phenylketonuria. This is a rare genetic disorder in which phenylalanine accumulates in the body due to its improper excretion.

3. How to take Desloratadine Doppelherz

Always take this medicine exactly as described in this patient information leaflet or as directed by your doctor or pharmacist. If you are not sure, ask your doctor or pharmacist.

Adults and adolescents aged 12 years and older

The recommended dose is one tablet once a day, taken with or without food. This medicine is intended for oral use. Before taking, carefully open the blister by tearing it. Remove the orally disintegrating tablet without crushing it. Place it in your mouth, where it will dissolve immediately. Water or any other liquid is not needed to swallow the dose. Take the dose immediately after opening the blister.

Duration of treatment

Do not take the medicine for longer than 10 days without consulting a doctor. If after 3 days there is no improvement or you feel worse, you should consult a doctor.

Taking a higher dose of Desloratadine Doppelherz than recommended

Desloratadine Doppelherz should only be taken as described in this patient information leaflet or as directed by your doctor or pharmacist. In case of accidental overdose, serious disorders are not expected to occur. However, if you take a higher dose of Desloratadine Doppelherz than recommended, you should consult a doctor or pharmacist.

Missing a dose of Desloratadine Doppelherz

If you miss a dose, take it as soon as possible, and then continue with your regular dosing schedule. Do not take a double dose to make up for a missed individual dose.

Stopping treatment with Desloratadine Doppelherz

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, urticaria, and swelling) have been reported. If you experience any of these severe side effects, you should stop taking the medicine and seek medical attention immediately. In clinical studies 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. In clinical studies of desloratadine, the following side effects were reported:

Common (may affect up to 1 in 10 people):

• fatigue
• dry mouth
• headache

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

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

• severe allergic reactions
• rash
• palpitations and irregular heartbeat
• rapid heartbeat
• abdominal pain
• nausea
• vomiting
• upset stomach
• diarrhea
• dizziness
• drowsiness
• insomnia
• muscle pain
• hallucinations
• seizures
• restlessness with excessive
• hepatitis
• abnormal liver function test results

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

• unusual weakness
• jaundice (yellowing of the skin and/or eyes)
• increased sensitivity of the skin to the sun, even in cloudy weather, and to UV (ultraviolet) radiation, such as in a solarium
• changes in heart rhythm
• abnormal behavior
• aggressive behavior

Additional side effects in children:

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

• slow heartbeat
• change in heart rhythm
• abnormal behavior
• aggressive behavior

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please inform your doctor or pharmacist. Side effects can be reported directly to the Department for Monitoring of Adverse Reactions to Medicinal Products 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. 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 Desloratadine Doppelherz

Keep this medicine out of the sight and reach of children. Do not take Desloratadine Doppelherz after the expiry date stated on the carton and blister after EXP. The expiry date refers to the last day of the month. There are no special precautions for storage. Do not take this medicine if you notice any visible signs of deterioration. 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 Doppelherz contains

• The active substance is desloratadine in a dose of 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 Doppelherz looks like and contents of the pack

Desloratadine Doppelherz, 5 mg, orally disintegrating tablets are brick-red, round, flat tablets with beveled edges, marked with "5". Desloratadine Doppelherz is packaged in blisters in packs containing 5, 6, or 10 orally disintegrating tablets. Not all pack sizes may be marketed.

Marketing authorization 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 more detailed information, please contact your local representative of the marketing authorization holder: Queisser Pharma Poland Sp. z o.o., ul. Domaniewska 39, 02-672 Warsaw, Poland, Tel.: (22) 487 52 54, E-mail: [email protected]

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

Poland Desloratadine Doppelherz

Date of last revision of the leaflet: