Desloratadine 5mg tablets

Negara: Inggris

Bahasa: Inggris

Sumber: MHRA (Medicines & Healthcare Products Regulatory Agency)

Bahan aktif:

Desloratadine

Tersedia dari:

Actavis UK Ltd

Kode ATC:

R06AX27

INN (Nama Internasional):

Desloratadine

Dosis:

5mg

Bentuk farmasi:

Tablet

Rute administrasi :

Oral

Kelas:

No Controlled Drug Status

Jenis Resep:

Valid as a prescribable product

Ringkasan produk:

BNF: 03040100; GTIN: 5690528378115

Selebaran informasi

T00075-01 Malta Zejtun 190x380 PIL
PACKAGE LEAFLET:
INFORMATION FOR THE PATIENT
DESLORATADINE ACTAVIS 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,
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 signs of illness 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.
WHAT IS IN THIS LEAFLET
1.
What Desloratadine Actavis is and what it is used
for
2.
What you need to know before you take
Desloratadine Actavis
3.
How to take Desloratadine Actavis
4.
Possible side effects
5.
How to store Desloratadine Actavis
6.
Contents of the pack and other information
1. WHAT DESLORATADINE ACTAVIS IS AND WHAT IT IS
USED FOR
WHAT DESLORATADINE ACTAVIS IS
Desloratadine Actavis contains desloratadine which
is an antihistamine.
HOW DESLORATADINE ACTAVIS WORKS
Desloratadine Actavis is an antiallergy medicine that
does not make you drowsy. It helps control your
allergic reaction and its symptoms.
WHEN DESLORATADINE ACTAVIS SHOULD BE USED
Desloratadine Actavis relieves symptoms associated
with allergic rhinitis (inflammation of the nasal
passages caused by an allergy, for example, hay fever
or allergy to dust mites) in adults and adolescents
12 years of age and older. These symptoms include
sneezing, runny or itchy nose, itchy palate, and itchy,
red or watery eyes.
Desloratadine Actavis 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.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE
DESLORATADINE ACTAVIS
DO NOT T

Karakteristik produk

OBJECT 1
DESLORATADINE ACTAVIS 5 MG FILM-COATED TABLETS
Summary of Product Characteristics Updated 14-Feb-2018 | Accord-UK Ltd
1. Name of the medicinal product
Desloratadine Actavis 5 mg film-coated tablets
2. Qualitative and quantitative composition
Each tablet contains 5 mg desloratadine.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Film-coated tablet (tablet).
Blue coloured, round, with diameter of 6 mm, biconvex, film-coated
tablets with the marking 'LT'
engraved on one side.
4. Clinical particulars
4.1 Therapeutic indications
Desloratadine Actavis 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 of Desloratadine Actavis 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 Actavis 5 mg 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 dose can be taken with or without food.
4.3 Contraindications
Hypersensitivity to the active substance, to any of the excipients
listed in section 6.1, or to loratadine.
4.4 Special warnings and precautions for use
In the case of sever