Drynol 10 mg orodispersible tablet

Land: Irland

Språk: engelska

Källa: HPRA (Health Products Regulatory Authority)

Aktiva substanser:

Bilastine

Tillgänglig från:

Menarini International Operations Luxembourg S.A.

ATC-kod:

R06AX; R06AX29

INN (International namn):

Bilastine

Dos:

10 milligram(s)

Läkemedelsform:

Orodispersible tablet

Receptbelagda typ:

Product subject to prescription which may be renewed (B)

Terapiområde:

Other antihistamines for systemic use; bilastine

Bemyndigande status:

Marketed

Tillstånd datum:

2017-07-14

Bipacksedel

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
DRYNOL 10 MG ORODISPERSIBLE TABLETS
FOR CHILDREN AGED 6 TO 11 YEARS WITH A BODY WEIGHT OF AT LEAST 20 KG
bilastine
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOUR CHILD STARTS 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 your child. Do not pass it on to
others. It may harm them, even
if their signs of illness are the same as your child’s.
-
If your child gets 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 Drynol is and what it is used for
2.
What you need to know before you take Drynol
3.
How to take Drynol
4.
Possible side effects
5.
How to store Drynol
6.
Contents of the pack and other information
1.
WHAT DRYNOL
IS AND WHAT IT IS USED FOR
Drynol contains the active substance bilastine which is an
antihistamine.
Drynol is used to relieve the symptoms of hayfever (sneezing, itchy,
runny, blocked-up nose and red and
watery eyes) and other forms of allergic rhinitis. It may also be used
to treat itchy skin rashes (hives or
urticaria).
Drynol 10 mg orodispersible tablets are indicated in children aged 6
to 11 years with a body weight of at
least 20 kg.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE DRYNOL
DO NOT USE DRYNOL:
-
if your child is allergic to bilastine or any of the other ingredients
of this medicine (listed in section 6).
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before using Drynol if your child
has moderate or severe renal or hepatic
impairment or if your child is taking other medicines (see”Other
medicines and Drynol”).
CHILDREN
Do not give this medicine to children under 6 years of age with a body
weight below 20 kg since no
sufficient data are available.
OTHER MEDICINES AND DRYNOL
Tell your doctor or pharmacist if your child is taking, h

Produktens egenskaper

Health Products Regulatory Authority
02 March 2023
CRN00D8FK
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Drynol 10 mg orodispersible tablet
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each orodispersible tablet contains 10 mg of bilastine.
Excipient with known effect: each orodispersible tablet contains
0,0015 mg of ethanol.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Orodispersible tablet.
Round, slightly biconvex white tablets of 8 mm diameter.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Symptomatic treatment of allergic rhino-conjunctivitis (seasonal and
perennial) and urticaria. Drynol is indicated in children
aged 6 to 11 years with a body weight of at least 20 kg.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Paediatric population_
- Children 6 to 11 years of age with a body weight of at least 20 kg
10 mg bilastine (1 orodispersible tablet) once daily for the relief of
symptoms of allergic rhino-conjunctivitis (seasonal allergic
rhinitis and perennial allergic rhinitis) and urticaria.
The orodispersible tablet should be taken one hour before or two hours
after intake of food or fruit juice (see section 4.5).
- Children under 6 years of age and under 20 kg
Currently available data are described in section 4.4, 4.8, 5.1 and
5.2 but no recommendation on a posology can be made.
Therefore bilastine should not be used in this age group.
In adults and adolescents (over 12 years of age) the administration of
bilastine 20 mg tablets is appropriate.
Duration of treatment:
For allergic rhino-conjunctivitis the treatment should be limited to
the period of exposure to allergens. For seasonal allergic
rhinitis treatment could be discontinued after the symptoms have
resolved and reinitiated upon their reappearance. In
perennial allergic rhinitis continued treatment may be proposed to the
patients during the allergen exposure periods. For
urticaria the duration of treatment depends on the type, duration and
course of the complaints.
_Special populat