Drynol 20 mg Tablets

País: Irlanda

Idioma: anglès

Font: HPRA (Health Products Regulatory Authority)

ingredients actius:

Bilastine

Disponible des:

Menarini International Operations Luxembourg S.A.

Codi ATC:

R06AX; R06AX29

Designació comuna internacional (DCI):

Bilastine

Dosis:

20 milligram(s)

formulario farmacéutico:

Tablet

tipo de receta:

Product subject to prescription which may be renewed (B)

Área terapéutica:

Other antihistamines for systemic use; bilastine

Estat d'Autorització:

Marketed

Data d'autorització:

2011-02-18

Informació per a l'usuari

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
DRYNOL 20 MG TABLETS
bilastine
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 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).
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE DRYNOL 20 MG TABLETS
DO NOT TAKE DRYNOL:
if you are 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 you have
moderate or severe
renal impairment and in addition you are taking other medicines (see
”Other medicines
and Drynol”).
CHILDREN
DO NOT GIVE THIS MEDICINE TO CHILDREN UNDER 12 YEARS OF AGE.
DO NOT
exceed the recommended dose. If symptoms persist, consult your doctor.
OTHER MEDICINES AND DRYNOL
Tell your doctor or pharmacist if you are taking, have recently taken
or might take any
other medicines, including medicines obtained without a prescription.
In particular, please discuss with your doctor if you are taking any
of the following
medicines:
•
Ketoconazole

Fitxa tècnica

Health Products Regulatory Authority
07 April 2021
CRN00C32Q
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Drynol 20 mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 20 mg of bilastine.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet.
Oval biconvex scored white tablets (length 10 mm, width 5 mm).
The score line is only to facilitate breaking for ease of swallowing
and not to divide into equal doses.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Symptomatic treatment of allergic rhino-conjunctivitis (seasonal and
perennial) and urticaria.
Drynol is indicated in adults and adolescents (12 years of age and
over).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
_Adults and adolescents (12 years of age and over)_
20 mg bilastine (1 tablet) once daily for the relief of symptoms of
allergic rhinoconjunctivitis (SAR and PAR) and urticaria.
The tablet should be taken one hour before or two hours after intake
of food or fruit juice (see section 4.5).
_ _
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 populations_
Elderly
No dosage adjustments are required in elderly patients (see sections
5.1 and 5.2).
Renal impairment
Studies conducted in adults in special risk groups (renally impaired
patients) indicate that it is not necessary to adjust the dose
of bilastine in adults (see section 5.2).
Hepatic impairment
There is no clinical experience in adult patients with hepatic
impairment. However, since bilastine is not metabolized and is
eliminated as unchanged in urine and faeces, hepatic imp