Neoclarityn 2.5mg5ml oral solution

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Desloratadine

Available from:

Merck Sharp & Dohme Ltd

ATC code:

R06AX27

INN (International Name):

Desloratadine

Dosage:

500microgram/1ml

Pharmaceutical form:

Oral solution

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: ; GTIN: 5012376131405 5012376131436

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
NEOCLARITYN® 0.5 MG/ML ORAL SOLUTION
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 Neoclarityn oral solution is and what it is used for
2.
What you need to know before you take Neoclarityn oral solution
3.
How to take Neoclarityn oral solution
4.
Possible side effects
5.
How to store Neoclarityn oral solution
6.
Contents of the pack and other information
1.
WHAT NEOCLARITYN ORAL SOLUTION IS AND WHAT IT IS USED FOR
WHAT NEOCLARITYN IS
Neoclarityn contains desloratadine which is an antihistamine.
HOW NEOCLARITYN WORKS
Neoclarityn oral solution is an antiallergy medicine that does not
make you drowsy. It helps control
your allergic reaction and its symptoms.
WHEN NEOCLARITYN SHOULD BE USED
Neoclarityn oral solution 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,
adolescents and children 1 year of age and older. These symptoms
include sneezing, runny or itchy
nose, itchy palate, and itchy, red or watery eyes.
Neoclarityn oral solution 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 NEOCLARITYN ORAL SOLUTION
DO NOT TAKE NEOCLARITYN ORAL SOLUTION
-
if you are all

Summary of Product characteristics

OBJECT 1
NEOCLARITYN ORAL SOLUTION
Summary of Product Characteristics Updated 21-Dec-2017 | Merck Sharp &
Dohme Limited
1. Name of the medicinal product
Neoclarityn® 0.5 mg/ml oral solution
2. Qualitative and quantitative composition
Each ml of oral solution contains 0.5 mg desloratadine.
Excipient(s) with known effect:
This medicinal product contains 150 mg/ml of sorbitol
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Oral solution
4. Clinical particulars
4.1 Therapeutic indications
Neoclarityn is indicated in adults, adolescents and children over the
age of 1 year 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 Neoclarityn is 10 ml (5 mg) oral solution once
a day.
_Paediatric population_
The prescriber should be aware that most cases of rhinitis below 2
years of age are of infectious origin
(see section 4.4) and there are no data supporting the treatment of
infectious rhinitis with Neoclarityn.
Children 1 through 5 years of age: 2.5 ml (1.25 mg) Neoclarityn oral
solution once a day.
Children 6 through 11 years of age: 5 ml (2.5 mg) Neoclarityn oral
solution once a day.
The safety and efficacy of Neoclarityn 0.5 mg/ml oral solution in
children below the age of 1 year have
not been established. No data are available.
There is limited clinical trial efficacy experience with the use of
desloratadine in children 1 through 11
years of age and adolescents 12 through 17 years of age (see sections
4.8 and 5.1).
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
w