País: Reino Unido
Idioma: inglés
Fuente: MHRA (Medicines & Healthcare Products Regulatory Agency)
Antazoline sulfate; Xylometazoline hydrochloride
Thea Pharmaceuticals Ltd
S01GA53
Antazoline sulfate; Xylometazoline hydrochloride
5mg/1ml ; 500microgram/1ml
Eye drops
Ocular
No Controlled Drug Status
Valid as a prescribable product
BNF: 11040200; GTIN: 0000050487172
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 Leer el documento completo