Zoftacot 3.35 mg/ml eye drops, solution in single-dose container

Land: Irland

Språk: engelska

Källa: HPRA (Health Products Regulatory Authority)

Aktiva substanser:

Hydrocortisone sodium phosphate

Tillgänglig från:

Laboratoires Thea

ATC-kod:

S01BA; S01BA02

INN (International namn):

Hydrocortisone sodium phosphate

Dos:

3.35 milligram(s)/millilitre

Läkemedelsform:

Eye drops, solution in single-dose container

Receptbelagda typ:

Product subject to prescription which may be renewed (B)

Terapiområde:

Corticosteroids, plain; hydrocortisone

Bemyndigande status:

Marketed

Tillstånd datum:

2017-06-23

Bipacksedel

2
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ZOFTACOT 3.35 MG/ML EYE DROPS, SOLUTION IN SINGLE-DOSE CONTAINER
_ _
Hydrocortisone sodium phosphate
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, 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 Zoftacot is and what it is used for
2.
What you need to know before you use Zoftacot
3.
How to use Zoftacot
4.
Possible side effects
5.
How to store Zoftacot
6.
Contents of the pack and other information
1.
WHAT ZOFTACOT IS AND WHAT IT IS USED FOR
This medicine is an eye drops solution in single-dose containers,
which contains a substance called
hydrocortisone. This substance is a corticosteroid which reduces
inflammatory symptoms.
It is used to treat mild allergic or inflammation conditions that
affect the clear lining that covers the whites of
your eye(s) and the insides of your eyelids (your conjunctiva).
The eye should not be infected (see Do not use Zoftacot).
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE ZOFTACOT
DO NOT USE ZOFTACOT:

If you are allergic to the active substance (hydrocortisone) or any of
the other ingredients of this medicine
(listed in section 6).

If you have high pressure inside the eye (ocular hypertension), known
to be due to glucosteroids (family
of corticosteroid medicines) or to other causes.

If you have an eye infection caused by viruses (acute herpes or most
other viruses while there are ulcers,
unless the infection is being treated with an anti-infective treatment
for herpes virus).

If you have conjunctivitis with inflammation and ulcers on the clea

Produktens egenskaper

Health Products Regulatory Authority
15 August 2022
CRN00CFHV
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Zoftacot 3.35 mg/ml eye drops, solution in single-dose container
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml eye drops, solution contains 3.35 mg of hydrocortisone sodium
phosphate.
One drop contains approximately 0.12 mg of hydrocortisone sodium
phosphate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Eye drops, solution in single-dose container.
The solution is a practically clear, colourless to slightly yellow
solution, practically free from particles.
pH: 6.9 - 7.5
Osmolality: 280-320 mosmol/kg
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of mild non-infectious allergic or inflammatory conjunctival
diseases.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The recommended dosage is 2 drops 2 to 4 times daily in the affected
eye.
The duration of this dosing regimen will generally vary from a few
days to a maximum of 14 days. Gradual tapering off up to
one administration every other day may be recommended in order to
avoid a relapse.
In case of insufficient response, a more potent corticosteroid should
be used.
_Paediatric population_
The safety and efficacy have not been established in the paediatric
population. See section 4.4.
_Elderly_
No dose adjustment is necessary in elderly patients.
Method of administration
Ocular use.
A single-dose container contains enough solution to treat both eyes.
For single use only.
This medicinal product is a sterile solution that does not contain a
preservative. The solution from one individual single-dose
container is to be used immediately after opening for administration
to the affected eye(s) (see section 6.3).
Patients should be instructed:
- to avoid contact between the dropper tip and the eye or eyelids,
- to use the eye drops, solution immediately after first opening of
the single-dose container and to discard the single-dose
container after use.
Nasolacrimal occlusion by compressio