TRUSOPT

Pays: Israël

Langue: anglais

Source: Ministry of Health

Ingrédients actifs:

DORZOLAMIDE AS HYDROCHLORIDE

Disponible depuis:

RAFA LABORATORIES LTD

Code ATC:

S01EC03

forme pharmaceutique:

OPHTHALMIC SOLUTION

Composition:

DORZOLAMIDE AS HYDROCHLORIDE 20 MG/ML

Mode d'administration:

OCULAR

Type d'ordonnance:

Required

Fabriqué par:

FAREVA MIRABEL, FRANCE

Groupe thérapeutique:

DORZOLAMIDE

Domaine thérapeutique:

DORZOLAMIDE

indications thérapeutiques:

For the treatment of eleveated intraocular pressure in patients with ocular hypertension, open-angle glaucoma and in some patients secondary glaucoma.

Date de l'autorisation:

2022-07-31

Notice patient

1
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’
REGULATIONS (PREPARATIONS) – 1986
The medicine is dispensed with a doctor’s prescription only
Trusopt
Eye drops
Active ingredient:
Dorzolamide (as hydrochloride) 20 mg/ml
For the list of the additional ingredients, see section 6. See also
'Important information about some of the
medicine's ingredients' in section 2.
Read this entire leaflet carefully before using the medicine.
This leaflet contains concise information about the medicine. If you
have any further questions, please
refer to your doctor or pharmacist.
This medicine has been prescribed to treat your illness. Do not pass
it on to others. It may harm them,
even if it seems to you that their illness is similar to yours.
1. What is the medicine intended for?
The medicine is intended for lowering raised pressure in the eye and
for treating glaucoma.
Therapeutic Group: carbonic anhydrase inhibitors.
2. Before using the medicine
Do not use the medicine if:
•
You are sensitive (allergic) to the active ingredient or to any of the
additional
ingredients the medicine contains (for the list of the additional
ingredients, see section
6).
•
If you have a severe impairment of kidney function or kidney problems,
or if you have a
history of kidney stones.
Special warnings regarding the use of this medicine:
Before (and during) treatment with the medicine, tell your doctor if:
•
You suffer or have suffered in the past from any medical problem,
including eye problems
and/or eye surgeries.
•
You suffer from any allergy to medicines.
•
You suffer or have suffered in the past from liver problems.
•
You suffer or have suffered in the past from impaired kidney function
- see also the "Do
not use the medicine if" section.
Additional warnings
•
If you are sensitive to any food or medicine, including
sulfonamide-derived medicines, inform
your doctor before using this medicine.
•
If while using the medicine an eye allergic reaction, eye irritation
or any other new eye
problems such as redness of t

Résumé des caractéristiques du produit

DL-TRUSOPT- 22 March 2023 _02
1.
NAME OF THE MEDICINAL PRODUCT
TRUSOPT
®
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains 22.26 mg of dorzolamide hydrochloride equivalent to
20 mg of dorzolamide.
Excipient with known effect:
One ml of eye drops solution contains 0.075 mg benzalkonium chloride
and one drop contains about 0.002 mg of
benzalkonium chloride.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Eye drops, ophthalmic solution
Clear, colourless to nearly colourless, slightly viscous, solution.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the treatment of elevated intraocular pressure in patients with
ocular hypertension, open-angle glaucoma and in some
patients secondary glaucoma.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The dose is one drop of TRUSOPT Ophthalmic Solution in the affected
eye(s) three times daily.
TRUSOPT may be used concomitantly with other topical ophthalmic drug
products to lower intraocular pressure. If more
than one topical ophthalmic drug is being used, the drugs should be
administered at least ten minutes apart.
Patients should be instructed to wash their hands before use and avoid
allowing the tip of the container to come into
contact with the eye or surrounding structures.
Patients should also be instructed that ocular solutions,
if handled improperly, can become contaminated by common
bacteria known to cause eye infections. Serious damage to the eye and
subsequent loss of vision may result from using
contaminated ophthalmic medications.
Patients should be informed of the correct handling of the containers.
_Pediatric use _
Safety and effectiveness in pediatric patients have not been
established.
INSTRUCTIONS FOR USE -see at the end of this SPC.
4.3 CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1.
Dorzolamide has not been studied in patients with severe renal
impairment (CrCl < 30 ml/min) or with hyperchloraemic
acidosis. Because dorzolamide and its metabolites are