Desloratadine 5mg tablets

Pays: Royaume-Uni

Langue: anglais

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingrédients actifs:

Desloratadine

Disponible depuis:

Mylan

Code ATC:

R06AX27

DCI (Dénomination commune internationale):

Desloratadine

Dosage:

5mg

forme pharmaceutique:

Tablet

Mode d'administration:

Oral

classe:

No Controlled Drug Status

Type d'ordonnance:

Valid as a prescribable product

Descriptif du produit:

BNF: 03040100; GTIN: 5016695004792

Notice patient

PAGE 1 OF 6
PACKAGE LEAFLET
PAGE 2 OF 6
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
DESLORATADINE MYLAN 5 MG FILM-COATED TABLETS
desloratadine
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Desloratadine Mylan is and what it is used for
2.
What you need to know before you take Desloratadine Mylan
3.
How to take Desloratadine Mylan
4.
Possible side effects
5.
How to store Desloratadine Mylan
6.
Contents of the pack and other information
1. WHAT DESLORATADINE MYLAN IS AND WHAT IT IS USED FOR
Desloratadine Mylan is an antiallergy medicine that does not make you
drowsy. It helps control your
allergic reaction and its symptoms.
Desloratadine Mylan is indicated for adults and adolescents (12 years
of age and older) to:
relieve symptoms associated with allergic rhinitis (inflammation of
the nasal passages caused by an
allergy, for example, hay fever or allergy to dust mites). These
symptoms include sneezing, runny or
itchy nose, itchy palate, and itchy, red or watery eyes.
Desloratadine Mylan is also used to relieve the symptoms associated
with urticaria (a skin condition
caused by an allergy). These symptoms include itching and hives.
Relief of these symptoms lasts a full day and helps you to resume your
normal daily activities and
sleep.
You must talk to a doctor if you do not feel better or if you feel
worse.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE DESLORATADINE MYLAN
DO NOT TAKE DESLORATADINE MYLAN:
-
if you are allergic to desloratadine, to any of the other ingredients
of this medicine (listed

Résumé des caractéristiques du produit

OBJECT 1
DESLORATADINE MYLAN 5 MG FILM-COATED TABLETS
Summary of Product Characteristics Updated 07-Jun-2018 | Generics UK
T/A Mylan
1. Name of the medicinal product
Desloratadine Mylan 5 mg film-coated tablets
2. Qualitative and quantitative composition
Each tablet contains 5 mg of desloratadine.
Excipient with known effect
Each tablet contains 4.4 micrograms of Sunset Yellow Aluminium Lake
(E110).
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Film-coated tablets
A blue, film-coated, round, biconvex, bevelled edge tablet marked
“DE 5” on one side of the tablet and
“M” on the reverse.
4. Clinical particulars
4.1 Therapeutic indications
Desloratadine Mylan is indicated in adults and adolescents aged 12
years and older for the relief of
symptoms associated with:
- allergic rhinitis (see section 5.1).
- urticaria (see section 5.1).
4.2 Posology and method of administration
Posology
_Adults and adolescents (12 years of age and over)_
The recommended dose is one tablet once a day.
Intermittent allergic rhinitis (presence of symptoms for less than 4
days per week or for less than 4 weeks)
should be managed in accordance with the evaluation of patient's
disease history and the treatment could
be discontinued after symptoms are resolved and reinitiated upon their
reappearance. In persistent allergic
rhinitis (presence of symptoms for 4 days or more per week and for
more than 4 weeks), continued
treatment may be proposed to the patients during the allergen exposure
periods.
_Paediatric population_
There is limited clinical trial efficacy experience with the use of
desloratadine in adolescents 12 through
17 years of age (see sections 4.8 and 5.1).
The safety and efficacy of desloratadine film-coated tablets in
children below the age of 12 years have not
been established. No data are available.
Method of administration
Oral use. The tablets can be taken with or without food.
4.3 Contraindications
Hypersensitivity to the active substance, or to any of the excipients
listed in section 6.1 or