Desloratadine aurovitas

Package leaflet: Information for the patient

Desloratadine Aurovitas, 5 mg, coated tablets
Desloratadine
Read the entire leaflet carefully before taking this medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, please consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents

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

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

What Desloratadine Aurovitas is
Desloratadine Aurovitas contains desloratadine, which is an antihistamine medicine.
How Desloratadine Aurovitas works
Desloratadine Aurovitas is an antiallergic medicine that does not cause drowsiness. It helps control allergic reactions and their symptoms.
When to use Desloratadine Aurovitas
Desloratadine Aurovitas 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, runny or itchy nose, itchy palate, and itchy, red, or watery eyes.
Desloratadine Aurovitas is also used to relieve symptoms associated with urticaria (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 normally.

2. Important information before using Desloratadine Aurovitas

When not to use Desloratadine Aurovitas:

• 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 taking Desloratadine Aurovitas, talk to your doctor or
pharmacist:

• if the patient has kidney function disorders,
• 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.
Desloratadine Aurovitas and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take.
No interactions between Desloratadine Aurovitas and other medicines are known.
Taking Desloratadine Aurovitas with food, drink and alcohol
Desloratadine Aurovitas can be taken with or without food.
Caution is advised when taking Desloratadine Aurovitas with alcohol.
Pregnancy, breastfeeding and fertility
If the patient is pregnant, 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 Desloratadine Aurovitas is not recommended during pregnancy or breastfeeding.
Fertility
There is no available data on the effect of the medicine on fertility in men and women.
Driving and operating machinery
This medicine, when used at the recommended dose, is not expected to affect 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 patient knows how this medicine affects them.

3. How to take Desloratadine Aurovitas

This medicine should always be taken as directed by your doctor or pharmacist. If you have any doubts,
please consult your doctor or pharmacist.
Adults and adolescents aged 12 years and over
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 Desloratadine Aurovitas will be determined by your doctor based on the type of
allergic rhinitis the patient has.
If the patient has intermittent allergic rhinitis (symptoms lasting less than 4 days per week or less than 4 weeks),
your doctor 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),
your doctor may recommend longer-term treatment.
In the case of urticaria, the duration of treatment may vary between individual patients. Therefore,
the patient should follow the doctor's instructions.
Taking more Desloratadine Aurovitas than recommended
Desloratadine Aurovitas should only be taken as prescribed. Serious adverse effects are unlikely after accidental
overdose. However, if you take more Desloratadine Aurovitas than recommended, inform your doctor or
pharmacist immediately.
If you forget to take Desloratadine Aurovitas
If you miss a dose at the scheduled time, take it as soon as possible and then return to your regular dosing schedule.
Do not take a double dose to make up for a missed dose.
Stopping Desloratadine Aurovitas
If you have any further questions about the use of this medicine, please consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Since the introduction of Desloratadine Aurovitas to the market, 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 immediately and consult a doctor without delay.

In clinical trials in adult patients, adverse reactions were almost the same as with placebo tablets (tablets without active ingredient). However, fatigue, dry mouth, and headache were reported more frequently than with placebo tablets. In adolescents, headache was the most commonly reported adverse reaction.

The following adverse reactions have been reported during clinical trials with Desloratadine Aurovitas:

Common: may occur in fewer than 1 in 10 people

• fatigue
• dry mouth
• headache

Adults
Since the introduction of Desloratadine Aurovitas to the market, the following adverse reactions have been reported:

Very rare: may occur in fewer than 1 in 10,000 people

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

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 from sunbeds
• unusual behaviour
• aggressive behaviour
• changes in heartbeat rhythm
• weight gain, increased appetite
• depressed mood
• dry eyes

Children
Frequency not known: frequency cannot be estimated from available data

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

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

5. How to store Desloratadine Aurovitas

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton, blister, or bottle after "EXP". The expiry date refers to the last day of the stated month.
Store in the original packaging to protect from moisture.
Blister: Do not store above 30°C.
Bottle: No special requirements for storage temperature. Shelf life after first opening the bottle: 18 months.
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. These measures will help protect the environment.

6. Contents of the pack and other information

What Desloratadine Aurovitas contains

• The active substance is desloratadine. Each film-coated tablet contains 5 mg of desloratadine.
• Other components are:
  Tablet core: microcrystalline cellulose (PH-102), pregelatinized starch, corn starch, colloidal anhydrous silica, and magnesium stearate.
  Tablet coating: hypromellose 6 cp (E 464), titanium dioxide (E 171), microcrystalline cellulose (E 460), stearic acid (E 570), and indigo carmine (E 132), lacquer.

What Desloratadine Aurovitas looks like and contents of the pack
Film-coated tablets.
Desloratadine Aurovitas 5 mg film-coated tablets
Light blue, round, biconvex film-coated tablets, embossed with "D" on one side and "5" on the other. Diameter is 6.6 mm.
Film-coated tablets are available in blisters and white, opaque HDPE bottles.
Pack sizes:
Blisters: 20, 28, 30, 50, 60, 90 and 100 film-coated tablets,
Bottle: 250 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder:
Aurovitas Pharma Polska Sp. z o.o.
Sokratesa 13D, lok. 27
01-909 Warsaw
e-mail: [email protected]

Manufacturer/Importer:
APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate, Hal Far
Birzebbugia, BBG 3000
Malta
Generis Farmaceutica, S.A.
Rua Joao de Deus, 19
2700-487 Amadora
Portugal

This medicinal product is authorised in the European Economic Area countries under the following names:
Belgium: Desloratadine AB 5 mg filmomhulde tabletten
Czech Republic: Desloratadin Aurovitas
Germany: Desloratadin PUREN 5 mg Filmtabletten
Italy: Desloratadina Aurobindo Italia
Netherlands: Desloratadine Aurobindo 5 mg, filmomhulde tabletten
Poland: Desloratadine Aurovitas
Portugal: Desloratadina Generis
Romania: Desloratadină Aurobindo 5 mg comprimate filmate
Spain: Desloratadina Aurovitas 5 mg comprimidos recubiertos con película EFG