Desloratadine 5mg Film-coated tablets

Երկիր: Իռլանդիա

Լեզու: անգլերեն

Աղբյուրը: HPRA (Health Products Regulatory Authority)

Ակտիվ բաղադրիչ:

Desloratidine

Հասանելի է:

Accord Healthcare Ireland Ltd.

ATC կոդը:

R06AX; R06AX27

INN (Միջազգային անվանումը):

Desloratidine

Դոզան:

5 milligram(s)

Դեղագործական ձեւ:

Film-coated tablet

Թերապեւտիկ տարածք:

Other antihistamines for systemic use; desloratadine

Լիազորման կարգավիճակը:

Marketed

Հաստատման ամսաթիվը:

2019-09-13

Տեղեկատվական թերթիկ

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 TABLETS
3
HOW TO TAKE DESLORATADINE TABLETS
4
POSSIBLE SIDE EFFECTS
5
HOW TO STORE DESLORATADINE TABLETS
6
CONTENTS OF THE PACK AND OTHER
INFORMATION
1
WHAT DESLORATADINE IS AND WHAT IT IS
USED FOR
WHAT DESLORATADINE IS
Desloratadine contains desloratadine which 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 YOU
TAKE DESLORATADINE
DO NOT TAKE DESLORATADINE
• if you are allergic to desloratadine, or any of
the other ingredients of this medicine (listed in
section 6) or to loratadine.
WARNINGS AND PRECAUTIONS
Talk to your doctor, pharmacist or nurse before
taking De

Ապրանքի հատկությունները

Health Products Regulatory Authority
16 August 2023
CRN00DKLC
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Desloratadine 5mg 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, round shaped, biconvex, film-coated tablets debossed with "J7"
on one side and plain on other side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Desloratadine 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_
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 5 mg film-coated tablets in
children below the age of 12 years have not been
established.
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.
Health Products Regulatory Authority
16 August 2023
CRN00DKLC
Page 2 of 7
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
In the case of severe renal insuffici