DORZOPT FORTE DROPS

Country: South Africa

Language: English

Source: South African Health Products Regulatory Authority (SAHPRA)

Available from:

Austell Pharmaceuticals (Pty) Ltd

Dosage:

20,0 mg & 5,0 mg

Pharmaceutical form:

DROPS

Composition:

EACH 1,0 ml SOLUTION CONTAINS DORZOLAMIDE HYDROCHLORIDE EQUIVALENT TO DORZOLAMIDE 20,0 mg TIMOLOL MALEATE EQUIVALENT TO TIMOLOL 5,0 mg

Authorization status:

Registered

Patient Information leaflet

Austell Pharmaceuticals (Pty) Ltd, 540257, DORZOPT FORTE, Eye drops
Solution, (2,0 + 0,5) %
_w/v_
05 September 2023 (v1)
Page 1 of 15
APPROVED PATIENT INFORMATION LEAFLET FOR MEDICINES FOR HUMAN USE:
DORZOPT FORTE
SCHEDULING STATUS: S3
DORZOPT FORTE (2,0 + 0,5) % _W/V_ EYE DROPS SOLUTION
DORZOLAMIDE (AS HYDROCHLORIDE) AND TIMOLOL (AS MALEATE)
CONTAINS PRESERVATIVE: BENZALKONIUM CHLORIDE, 0,0075 % _(M/V) _
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING DORZOPT
FORTE_ _
•
Keep this leaflet. You may need to read it again.
•
If you have further questions, please ask your health care provider.
•
DORZOPT FORTE has been prescribed for you personally and you should
not share your medicine with other people. It may harm them, even if
their
symptoms are the same as yours.
WHAT IS IN THIS LEAFLET:
1. What DORZOPT FORTE is and what it is used for
2. What you need to know before you use DORZOPT FORTE
3. How to use DORZOPT FORTE
4. Possible side effects
5. How to store DORZOPT FORTE
6. Contents of the pack and other information
1. WHAT DORZOPT FORTE IS AND WHAT IT IS USED FOR
DORZOPT FORTE is a sterile eye drops solution.
The active substances are dorzolamide and timolol.
Austell Pharmaceuticals (Pty) Ltd, 540257, DORZOPT FORTE, Eye drops
Solution, (2,0 + 0,5) %
_w/v_
05 September 2023 (v1)
Page 2 of 15
Dorzolamide belongs to a group of medicines called "carbonic anhydrase
inhibitors"
and Timolol belongs to a group of medicines called “Nonselective
beta-adrenergic
receptor blocking medicines”.
DORZOPT FORTE is prescribed to lower raised pressure in the eye in the
treatment
of glaucoma and ocular hypertension.
Elevated pressure in the eye may damage the optic nerve resulting in
deterioration of
vision and possible blindness. There generally are few symptoms that
you can feel to
tell you whether you have elevated pressure within your eye. Your
health care
provider's examination is needed to determine this. If you have raised
pressure in
your eye, regular eye examinations and measurements of the pressure
with

Summary of Product characteristics

Austell Pharmaceuticals (Pty) Ltd, 540257, DORZOPT FORTE, Eye drops
Solution, (2,0 + 0,5) % _w/v_
05 September 2023 (v2)
Page 1 of 23
APPROVED PROFESSIONAL INFORMATION FOR MEDICINES FOR HUMAN USE:
DORZOPT FORTE
SCHEDULING STATUS
S3
1. NAME OF THE MEDICINE
DORZOPT FORTE (2,0 + 0,5) % _w/v_ Eye drops Solution
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each mL of solution contains:
22,26 mg dorzolamide hydrochloride equivalent to 20 mg dorzolamide and
6,83 mg timolol maleate equivalent to 5,0 mg timolol.
Preservative: Benzalkonium chloride 0,0075 % _(m/v)._
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Eye drops solution
Slightly opalescent, nearly colourless, slightly viscous solution.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
DORZOPT FORTE is indicated in the treatment of elevated intra-ocular
pressure (IOP) in patients with ocular hypertension, open-angle
glaucoma,
pseudo exfoliative glaucoma or other secondary open-angle glaucomas
when
concomitant therapy is appropriate.
Austell Pharmaceuticals (Pty) Ltd, 540257, DORZOPT FORTE, Eye drops
Solution, (2,0 + 0,5) % _w/v_
05 September 2023 (v2)
Page 2 of 23
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
The dose is one drop of DORZOPT FORTE in the affected eye(s) two times
daily.
_ _
PAEDIATRIC POPULATION
Safety and efficacy in paediatric patients below the age of 2 years
have not
been established. Although DORZOPT FORTE has been used in children 2
to
6 years of age, however data on safety and efficacy are insufficient
to
recommend a safe and effective dose.
METHOD OF ADMINISTRATION
DORZOPT FORTE is for ocular use only.
When substituting DORZOPT FORTE for another ophthalmic antiglaucoma
medicine, discontinue the other medicine after proper dosing on one
day, and
start DORZOPT FORTE on the next day.
If another topical ophthalmic medicine is being used, DORZOPT FORTE
and
the other medicine should be administered at least ten minutes apart.
4.3 CONTRAINDICATIONS
•
Hypersensitivity to dorzolamide and/or timolol or to any of the