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:

10ml plastic container

Prescription type:

OTC

Authorization status:

Registered

Authorization date:

2022-01-10

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);
-
Allergic conjunctivitis caused by pollen, grass, animal hair etc.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Usually 1-2 eye drops should be instilled in the eye(s) up to 4 times
a day.
Recommended treatment duration is 3-4 days.
4.3
CONTRA-INDICATION
-
Hypersensitivity to any component of this preparation;
-
Presence of an anatomically narrow angle or narrow-angle glaucoma.
4.4
SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE
The drug should be used with caution in patients with eye infection or
injury,
heart disease,
high blood pressure, diabetes, hyperthyroidism and in patients
receiving MAO – inhibitors.
Safety and effectiveness in pediatric patients have not been
established. Use in children,
especially infants, may result in CNS depression leading to marked
reduction in body
temperature and coma.
Patients should be advised to discontinue the drug and consult a
physician if relief is not
obtained within 48 hours of therapy, if irritation, blurring or
redness persists or increases, or if
symptoms of systemic absorption occur (dizziness, headache, nausea,
decrease in body
PROCULIN
®
0.3 mg/ ml
eye drops, solution
_Summary of Product Characteristics _
2
temperature or drowsiness). Prolonged treatment is not recommended.
Prolonged tre