Drynol 6 mg/mL eye drops, solution

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Bilastine

Available from:

Menarini International Operations Luxembourg S.A.

ATC code:

S01GX13; decongestant

INN (International Name):

Bilastine

Pharmaceutical form:

Eye drops, solution

Therapeutic area:

ophthalmologicals; and antiallergics

Authorization status:

Not marketed

Authorization date:

2022-07-22

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
DRYNOL 6 MG/ML EYE DROPS, SOLUTION
bilastine
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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 use Drynol
3.
How to use 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
This medicine contains bilastine which belongs to a group of medicines
called antihistamines.
Antihistamines work by preventing the effects of a substance called
histamine that the body produces
as part of an allergic reaction.
This medicine is used to treat signs and symptoms of eye disorders
which you get with
SEASONAL
ALLERGIC CONJUNCTIVITIS
in adults.
This medicine is also used to treat signs and symptoms of eye
disorders caused by an allergy to
substances such as house dust mites or animal hair
(PERENNIAL ALLERGIC CONJUNCTIVITIS)
in adults.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE DRYNOL
DO NOT USE 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 during the
treatment adverse events, such as
eye irritation, pain, redness or change in vision occur or if your
condition is worsened. It might be
necessary to discontinue the treatment.
After dropping Drynol anti-allergic eye drops into the conjunctival
sac of the eye, the visual acuity can
deteriorate for a few minutes due to the form

Summary of Product characteristics

Health Products Regulatory Authority
22 July 2022
CRN00C5LX
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Drynol 6 mg/mL eye drops, solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 mL solution contains 6 mg of bilastine.
Each drop contains 0.2 mg of bilastine.
For thefull list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Eye drops, solution.
Clear, colourless solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of ocular signs and symptoms of seasonal and perennial
allergic conjunctivitis.
Drynol is indicated in adults.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The recommended daily dosage in adults is: one drop in the affected
eye(s) once daily.
Duration of treatment
Improvements in signs and symptoms in response to Drynol therapy are
usually evident within a few days, but longer
treatment for up to 8 weeks is sometimes required. Once symptomatic
improvement has been established, therapy should be
continued for as long as needed to sustain improvement. Therapy should
not be used for more than 8 weeks without seeking
medical advice.
_Special populations_
Elderly
No dosage adjustments are required in elderlypatients (see sections5.1
and 5.2).
Hepatic and renal impairment
Bilastine in the form of eye drops has not been studied in patients
with renal or hepatic impairment. However, no dosage
adjustment is expected to be necessary in hepatic or renal impairment
(see section 5.2).
_Paediatric population_
The safety and efficacy of bilastine eye drops in children and
adolescents have not yet been established. No data are available.
METHOD OF ADMINISTRATION
Ocular use.
The tip of the nozzle should be wiped with a clean tissue after use to
remove any residual liquid.
4.3 CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1.
Health Products Regulatory Authority
22 July 2022
CRN00C5LX
Page 2 of 6
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Bilastine is an antiallergic/antihistaminic active subs