Desloratadine 5mg tablets

מדינה: הממלכה המאוחדת

שפה: אנגלית

מקור: MHRA (Medicines & Healthcare Products Regulatory Agency)

מרכיב פעיל:

Desloratadine

זמין מ:

Lupin Healthcare (UK

קוד ATC:

R06AX27

INN (שם בינלאומי):

Desloratadine

כמות:

5mg

טופס פרצבטיות:

Tablet

מסלול נתינה (של תרופות):

Oral

סיווג:

No Controlled Drug Status

סוג מרשם:

Valid as a prescribable product

leaflet_short:

BNF: 03040100; GTIN: 8901107021894

עלון מידע

PACKAGE LEAFLET: INFORMATION FOR THE USER
DESLORATADINE 5 MG FILM-COATED TABLETS
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 which worry you, 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 antiallergy 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 and 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 YOUR TAKE DESLORATADINE
DO NOT TAKE DESLORATADINE
-
if you are allergic to desloratadine or any of the other ingredients
of the medicine
(listed in section 6) or to loratadine.
WARNINGS AND PRECAUTIONS
Talk to your d

מאפייני מוצר

OBJECT 1
DESLORATADINE 5MG FILM-COATED TABLETS
Summary of Product Characteristics Updated 18-Dec-2015 | Lupin
Healthcare (UK) Ltd
1. Name of the medicinal product
Desloratadine 5mg Film-coated Tablets
2. Qualitative and quantitative composition
Each tablet contains 5 mg desloratadine.
Excipient(s) with known effect:
This tablet contains lactose.
For a full list of excipients, see section 6.1.
3. Pharmaceutical form
Film coated tablet
Light blue, circular biconvex film coated tablet plain on both sides.
4. Clinical particulars
4.1 Therapeutic indications
Desloratadine 5mg Film-coated Tablets 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 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_
The safety and efficacy of these tablets in children below 12 years of
age have not been established. No
data is available.
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).
_Method of administration:_
For oral use.
The tablet 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, the