Desloratadine Aurovitas

Package Leaflet: Information for the Patient

Desloratadine Aurovitas, 5 mg, Film-Coated Tablets

Desloratadine

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

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• 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 you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet

• 1. What is Desloratadine Aurovitas and what is it used for
• 2. Before you take 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 is Desloratadine Aurovitas and what is it used for

What is Desloratadine Aurovitas

Desloratadine Aurovitas contains desloratadine, which is an antihistamine.

How Desloratadine Aurovitas works

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

When to use Desloratadine Aurovitas

Desloratadine Aurovitas 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 watery eyes. Desloratadine Aurovitas 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, allowing for normal daily activities and normal sleep.

2. Before you take Desloratadine Aurovitas

When not to take Desloratadine Aurovitas:

• 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 Aurovitas, tell your doctor or pharmacist:

• 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 Aurovitas with other medicines

Tell your doctor or pharmacist about all the medicines you are taking, or have recently taken, and those you plan to take.

Taking Desloratadine Aurovitas with food, drink, and alcohol

Desloratadine Aurovitas can be taken with or without food.

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.

Fertility

There is no available data on the effect of the medicine on fertility in men and women.

Driving and using machines

Desloratadine Aurovitas is not expected to affect your ability to drive or use machines. However, as with all medicines, it is recommended to avoid driving or operating machinery until you know how you react to the medicine.

3. How to take Desloratadine Aurovitas

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, check with your doctor or pharmacist.

Adults and adolescents aged 12 years and older

The recommended dose is one tablet once daily, swallowed with water, with or without food.

If you take more Desloratadine Aurovitas than you should

Desloratadine Aurovitas should be taken only as directed. If you accidentally take more than the recommended dose, contact your doctor or pharmacist immediately.

If you forget to take Desloratadine Aurovitas

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

If you stop taking Desloratadine Aurovitas

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Desloratadine Aurovitas can cause side effects, although not everybody gets them.

Very common: may affect more than 1 in 10 people

• fatigue
• dry mouth
• headache

Uncommon: may affect up to 1 in 100 people

• nausea
• vomiting
• diarrhea
• abdominal pain

Rare: may affect up to 1 in 1,000 people

• seizures
• abnormal liver function tests
• allergic reactions, including anaphylaxis

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

• severe allergic reactions, including anaphylaxis
• rash
• palpitations and irregular heartbeat
• fast heartbeat
• abdominal pain
• nausea
• vomiting
• diarrhea
• dizziness
• drowsiness
• insomnia
• muscle pain
• hallucinations
• seizures
• hepatitis
• abnormal liver function tests
• restlessness with increased motor activity

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 when cloudy, and to UV (ultraviolet) radiation, for example, to the UV radiation in a solarium
• abnormal behavior
• aggressive behavior
• changes in heart rhythm
• weight gain, increased appetite
• low mood
• dry eyes

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 which is stated on the carton and blister or bottle after "EXP". The expiry date refers to the last day of that month.

Store in the original package in order to protect from moisture.

Blister: Do not store above 30°C.

Bottle: No special storage precautions.

Shelf-life after first opening: 18 months.

Do not use 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. These measures will help to 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.
• The other ingredients are: Tablet core: microcrystalline cellulose (PH-102), maize starch, colloidal anhydrous silica, and magnesium stearate. Film 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 with "D" engraved on one side and "5" on the other side. Diameter: 6.6 mm.

The film-coated tablets are available in blisters and white, non-transparent HDPE bottles.

Pack sizes:

Blister: 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.

ul. Sokratesa 13D lok. 27

01-909 Warszawa

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 Member States of the European Economic Area 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

Date of last revision of the package leaflet: 06/2022