Softacor 3.35 mg/ml eye drops sol. single-dose cont.

Nazione: Belgio

Lingua: inglese

Fonte: AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

Principio attivo:

Hydrocortisone Sodium Phosphate 3,35 mg/ml

Commercializzato da:

Laboratoires Théa

Codice ATC:

S01BA02

INN (Nome Internazionale):

Hydrocortisone Sodium Phosphate

Dosaggio:

3,35 mg/ml

Forma farmaceutica:

Eye drops, solution in single-dose container

Composizione:

Hydrocortisone Sodium Phosphate 3.35 mg/ml

Via di somministrazione:

Ocular use

Area terapeutica:

Hydrocortisone

Dettagli prodotto:

CTI code: 509173-04 - Pack size: 60 x 0.4 ml - Commercialisation status: NO - Delivery mode: Medical prescription; CTI code: 509173-02 - Pack size: 20 x 0.4 ml - Commercialisation status: NO - Delivery mode: Medical prescription; CTI code: 509173-03 - Pack size: 30 x 0.4 ml - Commercialisation status: YES - FMD code: 03662042999390 - CNK code: 3690963 - Delivery mode: Medical prescription; CTI code: 509173-01 - Pack size: 10 x 0.4 ml - Commercialisation status: NO - Delivery mode: Medical prescription

Stato dell'autorizzazione:

Commercialised: Yes

Data dell'autorizzazione:

2017-05-09

Foglio illustrativo

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
Softacort
®
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 Softacort is and what it is used for
2. What you need to know before you use Softacort
3. How to use Softacort
4. Possible side effects
5. How to store Softacort
6. Contents of the pack and other information
1. What Softacort 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 Softacort).
2. What you need to know before you use Softacort
Do not use Softacort:
•
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 th

Scheda tecnica

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
SOFTACORT 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 compression of lacrimal ducts for one minute
may reduce
systemic absorption.
In