Desloratadine 5mg tablets

국가: 영국

언어: 영어

출처: MHRA (Medicines & Healthcare Products Regulatory Agency)

유효 성분:

Desloratadine

제공처:

Aspire Pharma Ltd

ATC 코드:

R06AX27

INN (International Name):

Desloratadine

복용량:

5mg

약제 형태:

Tablet

관리 경로:

Oral

수업:

No Controlled Drug Status

처방전 유형:

Valid as a prescribable product

제품 요약:

BNF: 03040100; GTIN: 5060209730851

환자 정보 전단

Package leaflet: Information for the user
Desloratadine 5mg
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 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
This medicine contains desloratadine which 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 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), to peanut,
to soya or to loratadine.

제품 특성 요약

OBJECT 1
DESLORATADINE 5MG FILM-COATED TABLETS
Summary of Product Characteristics Updated 07-Jun-2018 | Aspire Pharma
Ltd
1. Name of the medicinal product
Desloratadine Gedeon Richter 5 mg film-coated tablets
2. Qualitative and quantitative composition
Each film-coated tablet contains 5 mg desloratadine (as desloratadine
hemisulphate).
Excipient with known effect:
Each film-coated tablet contains 0.080 mg of soya lecithin.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Film-coated tablet.
Yellow, round, biconvex film-coated tablets, of about 6 mm diameter,
one side engraved with “R03”.
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 Gedeon
Richter 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. 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 or to any of the excipients