Otrivine Antistin 0.5%/0.05% eye drops

מדינה: הממלכה המאוחדת

שפה: אנגלית

מקור: MHRA (Medicines & Healthcare Products Regulatory Agency)

מרכיב פעיל:

Antazoline sulfate; Xylometazoline hydrochloride

זמין מ:

Thea Pharmaceuticals Ltd

קוד ATC:

S01GA53

INN (שם בינלאומי):

Antazoline sulfate; Xylometazoline hydrochloride

כמות:

5mg/1ml ; 500microgram/1ml

טופס פרצבטיות:

Eye drops

מסלול נתינה (של תרופות):

Ocular

סיווג:

No Controlled Drug Status

סוג מרשם:

Valid as a prescribable product

leaflet_short:

BNF: 11040200; GTIN: 0000050487172

מאפייני מוצר

OBJECT 1
OTRIVINE ANTISTIN EYE DROPS
Summary of Product Characteristics Updated 04-Jun-2015 | Thea
Pharmaceuticals Ltd
1. Name of the medicinal product
Otrivine Antistin Eye Drops Xylometazoline 0.05% w/v Antazoline 0.5%
w/v
2. Qualitative and quantitative composition
Xylometazoline hydrochloride
Antazoline sulphate
0.05%
0.5%
For excipients see Section 6.1.
3. Pharmaceutical form
Eye drops solution
A clear colourless solution.
4. Clinical particulars
4.1 Therapeutic indications
For the temporary relief of redness and itching of the eye due to
seasonal and perennial allergies such as
hay fever or house dust allergy.
4.2 Posology and method of administration
For local administration to the eye.
_Adults: _1 or 2 drops instilled 2 - 3 times a day.
_Children_: No specific studies are available in this patient group.
Due to possible systemic effects,
Otrivine-Antistin is not recommended for use in children younger than
12 years of age.
_Elderly: _One drop instilled 2 to 3 times a day.
Otrivine Antistin Eye Drops should not be used for more than seven
consecutive days.
The dispenser remains sterile until the original closure is broken.
Patients must be instructed to avoid
allowing the tip of the dispensing container to contact the eye or
surrounding structures as this may
contaminate the solution.
If more than one medication needs to be instilled in the eye, an
interval of at least 5 minutes between
application of the different medicinal products must be allowed.
4.3 Contraindications
• Hypersensitivity to any of the ingredients of the formulation
• Presence of narrow angle glaucoma
• Use with contact lenses
• Use in patients receiving monoamine oxidase inhibitors or within
14 days of stopping such treatment
(See section 4.5)
4.4 Special warnings and precautions for use
Like other topically applied ophthalmic drugs, Otrivine-Antistin may
be absorbed systemically and
occasionally cause systemic sympathomimetic effects such as
hypertension, nervousness, nausea,
dizziness, headache, insomnia, palpitation, tachycar