Hypromellose Eye Drops BPC 0.3%
البلد: مالطا
اللغة: الإنجليزية
المصدر: Medicines Authority
نشرة المعلومات
(PIL)
29-05-2024
خصائص المنتج
(SPC)
29-05-2024
العنصر النشط:
HYPROMELLOSE
متاح من:
Macarthys Laboratories Limited Bampton Road, Harold Hill, Romford Essex, RM3 8UG, United Kingdom
ATC رمز:
S01KA02
INN (الاسم الدولي):
HYPROMELLOSE 3 mg/ml
الشكل الصيدلاني:
EYE DROPS, SOLUTION
تركيب:
HYPROMELLOSE 3 mg/ml
نوع الوصفة الطبية :
OTC
المجال العلاجي:
OPHTHALMOLOGICALS
الوضع إذن:
Withdrawn
تاريخ الترخيص:
2007-07-09
خصائص المنتج
Page 1 of 3
SUMMARY OF PRODUCT CHARACTERISTICS
1.
TRADE NAME OF THE MEDICINAL PRODUCT
Hypromellose Eye Drops BPC 0.3%
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Hypromellose BP (4500)
3. PHARMACEUTICAL
FORM
Eye drops, Solution
4.
CLINICAL PARTICULARS
4.1. THERAPEUTIC
INDICATIONS
To provide tear-like lubrication for the symptomatic relief of
dry eyes and eye irritation
associated with deficient tear production.
As an ocular lubricant for artificial eyes.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
Adults, children and the elderly
The dose depends on the need for lubrication. Usually one or two
drops to each eye three
times daily or as prescribed.
4.3. CONTRA-INDICATIONS
Hypersensitivity to any component.
Contains benzalkonium chloride, soft contact should not be worn.
4.4.
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
If irritation persists or worsens, or headache, eye pain,
vision changes or continuous redness
occur, discontinue use and consult a physician.
Pharmacogenetic problems
None known.
4.5.
INTERACTIONS WITH OTHER MEDICAMENTS AND OTHER FORMS OF
INTERACTION
None known.
Page 2 of 3
4.6.
PREGNANCY AND LACTATION
There is insufficient evidence of safety in pregnancy and this
product should, therefore, only
be used in pregnancy if it is considered essential by the
physician.
4.7.
EFFECTS ON ABILITY TO DRIVE AND USE MACHINES
May cause transient mild stinging or temporary blurring
of vision.
Do not drive or operate machinery unless vision is clear.
4.8. UNDESIRABLE
EFFECTS
May cause transient mild stinging or temporary blurring of
vision.
4.9. OVERDOSE
Not applicable.
5.
PHARMACOLOGICAL PROPERTIES
5.1. PHARMACODYNAMIC
PROPERTIES
This product is a sterile, isotonic, buffered solution of
Hypromellose. It is used a
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