Desloratadine 5mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Desloratadine

Available from:

Consilient Health Ltd

ATC code:

R06AX27

INN (International Name):

Desloratadine

Dosage:

5mg

Pharmaceutical form:

Tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 03040100; GTIN: 5391512451431

Patient Information leaflet

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 is and what it is used for
2. What you need to know before you take Desloratadine
3. How to take Desloratadine
4. Possible side effects
5. How to store Desloratadine
6. Contents of the pack and other information
1. WHAT DESLORATADINE IS AND WHAT IT IS USED FOR
WHAT DESLORATADINE IS
Desloratadine is an antihistamine.
HOW DESLORATADINE WORKS
Desloratadine is an anti-allergy medicine that does not
make you drowsy. It helps control your allergic reaction
and its symptoms.
WHEN DESLORATADINE SHOULD BE USED
Desloratadine 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 or older. These
symptoms include sneezing, runny or itchy nose, itchy
palate, and itchy, red or watery eyes.
Desloratadine 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
DO NOT TAKE DESLORATADINE
•
if you are allergic to desloratadine, to 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
•
if you have poor kidney function.
US

Summary of Product characteristics

OBJECT 1
DESLORATADINE 5 MG FILM-COATED TABLETS
Summary of Product Characteristics Updated 19-Jan-2016 | Consilient
Health Ltd
1. Name of the medicinal product
Desloratadine 5 mg film-coated tablets
2. Qualitative and quantitative composition
Each film-coated tablet contains 5 mg desloratadine.
Excipient (s) with known effect:
- lactose: 16.15 mg/tablet
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Film-coated tablet.
Light blue, round, film-coated tablets with bevelled edges (diameter
6.5 mm).
4. Clinical particulars
4.1 Therapeutic indications
Desloratadine is indicated in adults and adolescents aged 12 years or
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 adolescent s 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 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 severe renal insufficiency, deslorat