Desloratadine Aurovitas 5 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Desloratadine Aurovitas 5 mg film-coated tablets EFG

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

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse reactions, consult your doctor, pharmacist or nurse, even if they are adverse reactions not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Desloratadine Aurovitas is and what it is used for
2. What you need to know before taking Desloratadine Aurovitas
3. How to take Desloratadine Aurovitas
4. Possible adverse 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 is a type of antihistamine.

How Desloratadine Aurovitas works

Desloratadine is an antiallergic medicine that does not cause drowsiness. It helps control the allergic reaction and its symptoms.

When Desloratadine Aurovitas should be used

Desloratadine relieves symptoms associated with allergic rhinitis (inflammation of the nasal passages caused by an allergy, for example, hay fever or dust mite allergy) in adults and adolescents aged 12 years and older. These symptoms include sneezing, runny or itchy nose, itchy palate, and itchy, red or watery eyes.

Desloratadine is also used to relieve symptoms associated with urticaria (a skin condition caused by an allergy). These symptoms include itching and skin rashes.

Relief from these symptoms lasts for a full day, helping you continue your daily activities and normal sleep periods.

2. What you need to know before taking Desloratadine Aurovitas

Do not 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

Talk to your doctor or pharmacist before taking Desloratadine Aurovitas:

• if you have impaired kidney function.
• if you have a personal or family history of seizures.

Use in children and adolescents

Do not give this medicine to children under 12 years of age.

Other medicines and Desloratadine Aurovitas

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

There are no known interactions between desloratadine and other medicines.

Taking Desloratadine Aurovitas with food, drinks and alcohol

Desloratadine may be taken with or without food.

Be cautious when taking desloratadine with alcohol.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Desloratadine is not recommended if you are pregnant or breastfeeding.

Fertility

No data are available on male/female fertility.

Driving and using machines

At the recommended dose, this medicine is not expected to affect your ability to drive or operate machinery. Although most people do not experience drowsiness, it is recommended not to perform activities requiring mental alertness, such as driving a car or operating machinery, until you have determined how you react to the medicine.

3. How to take Desloratadine Aurovitas

Follow exactly the instructions for use of this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Adults and adolescents aged 12 years and older

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

This medicine is for oral use.

Swallow the tablet whole.

Regarding duration of treatment, your doctor will determine the type of allergic rhinitis you have and how long you should take desloratadine.

If you have intermittent allergic rhinitis (symptoms present for less than 4 days per week or for less than 4 weeks), your doctor will recommend a treatment regimen based on an assessment of your medical history.

If you have persistent allergic rhinitis (symptoms present for 4 or more days per week and for more than 4 weeks), your doctor may recommend long-term treatment.

For urticaria, the duration of treatment may vary from patient to patient, so you should follow your doctor's instructions.

If you take more Desloratadine Aurovitas than you should

Take desloratadine only as directed by your doctor. Accidental overdose is not expected to cause serious problems. However, if you take more desloratadine than prescribed, inform your doctor, pharmacist, or nurse immediately.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, stating the medicine and the amount ingested.

If you forget to take Desloratadine Aurovitas

If you forget to take your dose at the scheduled time, take it as soon as possible and then continue with your usual dosing schedule. Do not take a double dose to make up for forgotten doses.

If you stop taking Desloratadine Aurovitas

If you have any further questions about the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

During the marketing of desloratadine, very rare cases of severe allergic reactions (difficulty breathing, wheezing, itching, hives and swelling) have been reported. If you experience any of these serious adverse effects, stop taking this medicine immediately and consult your doctor without delay.

In clinical trials in adults, adverse effects were approximately the same as with a tablet containing no active ingredient. However, fatigue, dry mouth and headache were reported more frequently than with a tablet containing no active ingredient. In adolescents, headache was the most frequently reported adverse reaction.

In clinical trials with desloratadine, the following adverse effects were reported:

Common: may affect up to 1 in 10 people

• Fatigue.
• Dry mouth.
• Headache.

Adults

During the marketing of desloratadine, the following adverse effects were reported:

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

• Severe allergic reactions.
• Skin rash.
• Strong or irregular heartbeats.
• Rapid heartbeats.
• Stomach pain.
• Feeling of nausea.
• Vomiting.
• Upset stomach.
• Diarrhoea.
• Dizziness.
• Drowsiness.
• Difficulty sleeping.
• Muscle pain.
• Hallucinations.
• Seizures.
• Liver inflammation.
• Abnormal liver function tests.
• Restlessness with increased body movement.

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

• Unusual weakness.
• Yellowing of the skin and/or eyes.
• Increased sensitivity of the skin to sunlight, even on cloudy days, and to ultraviolet light, for example, ultraviolet light from a sunbed.
• Abnormal behaviour.
• Aggressiveness.
• Change in heart rhythm.
• Weight gain, increased appetite.
• Depressed mood.
• Dry eyes.

Children

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

• Slow heartbeat.
• Abnormal behaviour.
• Aggressiveness.
• Change in heart rhythm.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of 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 packaging after EXP. The expiry date refers to the last day of the month indicated.

Keep in the original packaging to protect from moisture.

Blister pack: Do not store above 30°C.

HDPE bottle: This medicine has no special storage temperature requirements. After opening the bottle, the tablets should be used within 18 months.

Do not use this medicine if you notice any changes in the appearance of the tablets.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE point in your pharmacy. If in doubt, ask your pharmacist how to properly dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Desloratadine Aurovitas

• The active substance is desloratadine. Each film-coated tablet contains 5 mg of desloratadine.
• The other components are:

Tablet core: microcrystalline cellulose (PH 102), pregelatinized corn starch, anhydrous colloidal silica, and magnesium stearate.

Tablet coating: hypromellose 2910 (6 cp), titanium dioxide (E171), microcrystalline cellulose, stearic acid, indigo carmine aluminium lake (E132).

Appearance of the product and contents of the pack

Film-coated tablets, light blue in colour, round, biconvex, marked with “D” on one side and “5” on the other.

Desloratadine Aurovitas film-coated tablets are available in blisters and in high-density polyethylene (HDPE) bottles.

Pack sizes:

Blisters: 20, 28, 30, 50, 60, 90 and 100 tablets.

HDPE bottles: 250 tablets.

Only some pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Manufacturer:

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

Or

Generis Farmacêutica, S.A.

Rua João de Deus, 19

Amadora 2700-487

Portugal

This medicinal product is authorised in the European Economic Area member states under the following names:

Germany: Desloratadin PUREN 5 mg Filmtabletten

Belgium: Desloratadine AB 5 mg filmomhulde tabletten

Spain: Desloratadina Aurovitas 5 mg comprimidos recubiertos con película EFG

Italy: Desloratadina Aurobindo Italia

Netherlands: Desloratadine Aurobindo 5 mg, filmomhulde tabletten

Poland: Desloratadine Aurovitas

Portugal: Desloratadina Generis

Czech Republic: Desloratadin Aurovitas

Romania: Desloratadina Aurobindo 5 mg comprimate filmate

Date of the most recent revision of this leaflet: January 2023

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) (http://www.aemps.gob.es).