Proculin drops eye (solution)

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

naphazoline (naphazoline hydrochloride)

Available from:

Alkaloid AD Skopje

ATC code:

S01GA01

INN (International Name):

naphazoline (naphazoline hydrochloride)

Dosage:

0,3mg/ml

Pharmaceutical form:

drops eye (solution)

Units in package:

plastic container 10ml

Prescription type:

OTC

Authorization status:

Registered

Authorization date:

2023-04-07

Summary of Product characteristics

PROCULIN
®
0.3 mg/ ml
eye drops, solution
_Summary of Product Characteristics _
1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
PROCULIN
® 0.3 MG/ML EYE DROPS, SOLUTION
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml of the solution contains 0.3 mg naphazoline hydrochloride.
Preservative: benzalkonium chloride 0.06 mg/ ml.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
* eye drops, solution
* clear, colourless solution
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
-
Conjunctival hyperemia (the preparation enables temporary relief of
the minor eye
symptoms of itching and redness caused by irritants like dust, smoke,
smog, chill, wind,
sun, TV rays, swimming, wearing of contact lenses, working with
objects close to the
eyes such as welding, polishing/grinding);
-
Allergic conjunctivitis caused by pollen, grass, animal hair etc.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_Posology in adults_
Usually 1-2 eye drops should be instilled in the affected eye(s) up to
4 times a day.
Recommended treatment duration is 3-4 days.
_Posology in children and adolescents_
PROCULIN should not be used in children and adolescents due to a lack
of data on safety and
efficacy (see sections 4.3 and 4.4).
_ _
_Posology in elderly patients_
PROCULIN should be used with caution in elderly patients (see section
4.4).
Method of administration
for ocular use
PROCULIN must be used aseptically.
To avoid contamination the dropper should not come into contact with
any surface and the
bottle should be well closed after using.
PROCULIN
®
0.3 mg/ ml
eye drops, solution
_Summary of Product Characteristics _
2
4.3
CONTRA-INDICATION
-
Hypersensitivity to naphazoline hydrochloride, or to any of the
excipients listed in
section 6.1;
-
Presence of an anatomically narrow angle or narrow-angle glaucoma.
The safety of PROCULIN in paediatric patients has not been
established, therefore it should
not be used in children and adolescents.
4.4
SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE
The drug should b