Gosall 20mg tablets

Country: Malta

Language: English

Source: Medicines Authority

Available from:

Menarini International Operations Luxembourg S.A 1 Avenue de la Gare, L-1611, Luxembourg

ATC code:

R06AX29

INN (International Name):

BILASTINE 20 mg

Pharmaceutical form:

TABLET

Composition:

BILASTINE 20 mg

Prescription type:

OTC

Therapeutic area:

ANTIHISTAMINES FOR SYSTEMIC USE

Product summary:

Licence number in the source country: NOT APPLICAPABLE

Authorization status:

Authorised

Authorization date:

2023-04-03

Patient Information leaflet

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PACKAGE LEAFLET
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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
GOSALL 20 MG TABLETS
BILASTINE
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
Always take this medicine exactly as described in this leaflet or as
your doctor or pharmacist have told you.
−
Keep this leaflet. You may need to read it again.
−
Ask your pharmacist if you need more information or advice.
−
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.
−
You must talk to a doctor if you do not feel better or if you feel
worse after 3 days.
WHAT IS IN THIS LEAFLET:
1.
What Gosall is and what it is used for
2.
What you need to know before you take Gosall
3.
How to take Gosall
4.
Possible side effects
5.
How to store Gosall
6.
Contents of the pack and other information
1.
WHAT GOSALL IS AND WHAT IT IS USED FOR
Gosall contains the active substance bilastine which is an
antihistamine. Gosall 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 GOSALL
DO NOT TAKE
GOSALL:
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 Gosall if you have
moderate or severe renal
impairment and in addition you are taking other medicines (see
“Other medicines and Gosall”).
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 GOSALL
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 doc

Summary of Product characteristics

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SUMMARY OF PRODUCT CHARACTERISTICS
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1.
NAME OF THE MEDICINAL PRODUCT
Gosall 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.
Gosall 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 feces,
hepatic impairment is not expecte