NOTICE
ANSM - Updated on : 10/06/2025
Product name
DESLORATADINE URGO 5 mg, film-coated tablet
Desloratadine
Sidebar
Please read this leaflet carefully before taking this medicine, as it contains important information for you.
Always take this medicine exactly as it is prescribed by your doctor, pharmacist or pharmacist.
- Keep this leaflet. You may need to read it again.
- Ask your pharmacist or doctor for any advice or information.
- If you experience any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this leaflet. See section 4.
- You should contact your doctor if you do not feel any improvement or if your symptoms worsen.
What does this leaflet contain?
1. What is DESLORATADINE URGO 5 mg, film-coated tablet and what is it used for?
2. What do I need to know before taking DESLORATADINE URGO 5 mg, film-coated tablet?
3. How should DESLORATADINE URGO 5 mg, film-coated tablet be taken?
4. What are the possible side effects?
5. How do I keep DESLORATADINE URGO 5 mg, film-coated tablet?
6. Package contents and other information.
1. WHAT IS DESLORATADINE URGO 5 mg, film-coated tablet AND WHAT IS IT USED FOR?
Pharmacotherapeutic class: anti-H1 antihistamines ATC code: R06AX27.
What is DESLORATADINE URGO?
DESLORATADINE URGO contains desloratadine, an antihistamine.
How does DESLORATADINE URGO work?
DESLORATADINE URGO is an allergy medication that won't make you drowsy. It helps control your allergic reaction and its symptoms.
When should DESLORATADINE URGO be used?
DESLORATADINE URGO relieves symptoms associated with allergic rhinitis (nasal inflammation caused by an allergy, for example, hay fever or house dust mite allergy) in adults. Symptoms include sneezing, runny or itchy nose, itchy palate, itchy, red or watery eyes.
DESLORATADINE URGO is also used to relieve symptoms associated with chronic idiopathic urticaria (hives of unknown cause) after the diagnosis has been made by your doctor. These symptoms include itching and hives.
Relief from these symptoms lasts throughout the day, helping you to carry on with your normal daily activities and preserving your sleep.
If your symptoms worsen, or if you experience difficulty in breathing or swelling of the lips, tongue or throat, you should contact a doctor immediately.
2. WHAT DO I HAVE TO KNOW BEFORE TAKING DESLORATADINE URGO 5 mg, film-coated tablet?
Never take DESLORATADINE URGO:
- if you are allergic to desloratadine, loratadine or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor or pharmacist before taking DESLORATADINE URGO 5 mg, film-coated tablet:
- if you have kidney disease or severe liver disease,
- if you have a personal or family history of convulsions,
- if you are depressed or have a history of depression.
If you experience depressed mood or symptoms while taking this drug, you should discontinue treatment and consult your physician.
The diagnosis of chronic idiopathic hives must be confirmed by your doctor before taking DESLORATADINE URGO 5 mg, film-coated tablet.
Children and adolescents
This medicine is intended for adults only.
Other drugs and DESLORATADINE URGO 5 mg, film-coated tablet
There are no known interactions of DESLORATADINE URGO 5 mg, film-coated tablet with other drugs.
This medicine contains an H1 antihistamine. Other drugs contain them. Do not combine them. Ask your pharmacist for advice.
Tell your doctor or pharmacist if you are taking, have recently taken or may take any other medicines.
DESLORATADINE URGO 5 mg, film-coated tablet with food, drink and alcohol
DESLORATADINE URGO 5 mg, film-coated tablet may be taken with or without meals.
Extreme caution is recommended if you are taking alcohol at the same time as taking DESLORATADINE URGO 5 mg, film-coated tablet.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.
DESLORATADINE URGO 5 mg, film-coated tablet is not recommended if you are pregnant or breast-feeding.
Fertility
No data are available on fertility in humans.
Driving and use of machinery
At the recommended dose, this drug is unlikely to affect your ability to drive or operate machinery. Although most people do not experience drowsiness, it is nevertheless advisable to test your response to this drug before engaging in activities requiring alertness, such as driving a vehicle or operating machinery.
DESLORATADINE URGO 5 mg, film-coated tablet contains
Not applicable.
3. HOW DO I TAKE DESLORATADINE URGO 5 mg, film-coated tablet?
Always take this medicine exactly as instructed in this leaflet or as directed by your doctor or pharmacist. Check with your doctor or pharmacist if in doubt.
The recommended adult dose is one tablet once a day with water, with or without meals.
This medicine is intended for oral use.
Swallow the tablet whole.
The duration of treatment depends on the type, duration and evolution of your symptoms. You should contact your doctor if you feel no improvement or if your symptoms worsen.
If you experience difficulty in breathing or swelling of the lips, tongue or throat, you should contact a doctor immediately.
The duration of treatment for allergic rhinitis depends on the duration of symptoms.
In the case of chronic idiopathic urticaria, the duration of treatment may vary from patient to patient, and you should therefore follow your doctor's instructions.
If you have taken more DESLORATADINE URGO than you should have
No serious problems are expected from accidental overdosage. However, if you have taken more DESLORATADINE URGO than you should have, tell your doctor, pharmacist or nurse immediately.
If you forget to take DESLORATADINE URGO
If you forget to take your dose on time, take it as soon as possible, then continue your treatment as normal. Do not take a double dose to make up for the one you forgot to take.
If you stop taking DESLORATADINE URGO
Not applicable.
If you have any further questions about the use of this medicine, please ask your doctor or pharmacist.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Like all medicines, this drug may cause undesirable effects, but they do not occur systematically in everyone.
The following side effects are very rare, but you should stop taking this drug and consult a doctor immediately if you experience them:
- severe allergic reactions (difficulty breathing, bronchial wheezing, itching, hives and swelling).
Other adverse reactions that may occur:
Common: affecting up to 1 in 10 people
- Fatigue
- Dry mouth
- Headache
Very rare: may affect up to 1 in 10,000 people
- Rash
- Irregular or more intense heartbeat
- Rapid heartbeat
- Stomach pain
- Nausea
- Vomiting
- Stomach heaviness
- Diarrhea
- Vertigo
- Drowsiness
- Insomnia
- Muscle pain
- Hallucinations
- Convulsions
- Agitation with increased body movements
- Hepatitis
- Abnormal liver function tests
Frequency undetermined: the frequency of occurrence cannot be estimated on the basis of available data.
- Unusual weakness
- Yellow discoloration of the skin and/or eyes
- Increased skin sensitivity to sunlight, including veiled sunlight, and to ultraviolet (UV) radiation, e.g. from UV lamps in solariums
- Change in heartbeat rhythm
- Behavioral abnormalities
- Aggressiveness
- Weight gain, increased appetite
- Depressive mood
- Dry eyes
Reporting side effects
If you experience any side effects, please tell your doctor or pharmacist. This also applies to any side effects not mentioned in this leaflet. You can also report adverse reactions directly via the national reporting system: Agence nationale de sécurité du médicament et des produits de santé (ANSM) and the network of Centres Régionaux de Pharmacovigilance - Website: https: //signalement.social-sante.gouv.fr/
By reporting adverse reactions, you are helping to provide more information on drug safety.
5. HOW TO CONSERVE DESLORATADINE URGO 5 mg, film-coated tablet
Keep out of sight and reach of children.
Do not use this medicine after the expiration date indicated on the box and blister packs.
The expiration date refers to the last day of this month.
No special storage precautions.
Do not dispose of any medicine with your household waste . Ask your pharmacist to dispose of any medicines you no longer use. These measures will help protect the environment.
6. CONTENTS AND OTHER INFORMATION
What DESLORATADINE URGO 5 mg, film-coated tablet contains
- The active substance is :
desloratadine. Each tablet contains 5 mg desloratadine.
- The other components are
Core: microcrystalline cellulose, pregelatinized corn starch, mannitol, talc, magnesium stearate.
Film coating: OPADRY II 03F20404 blue: hypromellose, titanium dioxide (E171), macrogol 6000, dindigotine aluminium lake (E132).
What DESLORATADINE URGO 5 mg, film-coated tablet is and what it contains
This medicine takes the form of a blue film-coated tablet,
1, 2, 3, 5, 7 film-coated tablets in aluminium/aluminium blister packs.
Not all presentations may be marketed.
Marketing authorization holder
LABORATOIRES URGO HEALTHCARE
42 RUE DE LONGVIC
21300 CHENOVE
FRANCE
Marketing authorization holder
LABORATOIRES URGO HEALTHCARE
42 RUE DE LONGVIC
21300 CHENOVE
FRANCE
Manufacturer
ACTAVIS LTD
BLB016, BULEBEL INDUSTRIAL ESTATE
ZEJTUN ZTN 3000
MALTA
Product names in member states of the European Economic Area
Not applicable.
The last date on which this leaflet was revised was :
[to be completed subsequently by the holder].
Other
Detailed information on this drug is available on the ANSM (France) website.
Health education advice
a) What is allergy and what is an allergic reaction?
Allergy is an excessive reaction by the body to substances it considers harmful, known as allergens. Allergens are the factors and substances that trigger allergy and the associated disorders.
Allergic reactions are triggered by repeated, intensive contact with allergens.
The allergic reaction refers to the set of symptoms that appear minutes or hours after exposure to allergens. These allergens may come from plants, animal hair, food, dust mites, molds or substances of occupational origin.
This allergic reaction causes the body to release substances such as histamine, which are responsible for the symptoms experienced.
As with any illness of an allergic nature, it's important to consult a doctor at least once. HE OR SHE WILL DETERMINE THE NEED FOR AN ALLERGY TEST.
b) How to recognize allergic rhinitis, seasonal or non-seasonal allergic conjunctivitis and acute localized urticaria?
Allergic rhinitis is characterized by the following symptoms: successive sneezing, colorless nasal discharge, nasal obstruction (blocked nose), itching and tingling of the nose. It can be accompanied by irritation of both eyes (tearing, redness), throat and nose.
A distinction is made between :
- Seasonal allergic rhinitis or hay fever: occurs every year at the same time of year, when the concentration of pollens in the air increases. Allergies to pollens are very common, and usually first appear during adolescence. They recur every year at the same time, depending on the presence of the pollen(s) responsible. However, you are not allergic to all pollens, but to one or more of them.
- Perennial allergic rhinitis occurs all year round, and most often depends on household allergens such as dust mites, molds and pets.
- Allergic conjunctivitis is characterized by tearing and stinging of both eyes.
- Acute localized urticaria is characterized by itching, redness and swelling.
c) Practical advice
Eliminating the allergen (eviction) is the best way to eliminate or reduce allergy symptoms.
For household allergens: it is essential to take measures to reduce the presence of the allergen:
- mattresses and pillows should be completely encased in anti-dust mite plastic covers. The bed base, unless slatted or metal, should be encased in plastic. All bedding should be washed twice a month at 60°C if possible;
- The bedroom should be regularly aired and cleaned;
- on the floor, avoid bedspreads and carpets;
- avoid pets;
- during the pollen season, it is possible to reduce exposure to pollens:
o in your garden, diversify your planting, avoiding the most allergenic species (cypress, cedar, birch, etc.);
o avoid mowing the lawn yourself during the pollen season;
o garden preferably with protective goggles and mask.