Tiopex 1mg/g eye gel 0.4g unit dose

Šalis: Didžioji Britanija

kalba: anglų

Šaltinis: MHRA (Medicines & Healthcare Products Regulatory Agency)

Veiklioji medžiaga:

Timolol maleate

Prieinama:

Thea Pharmaceuticals Ltd

INN (Tarptautinis Pavadinimas):

Timolol maleate

Dozė:

1mg/1gram

Vaisto forma:

Eye drops

Vartojimo būdas:

Ocular

Klasė:

No Controlled Drug Status

Recepto tipas:

Valid as a prescribable product

Produkto santrauka:

BNF: 11060000; GTIN: 3662042000454

Prekės savybės

OBJECT 1
TIOPEX TIMOLOL 1 MG/G, EYE GEL IN SINGLE-DOSE
CONTAINER
Summary of Product Characteristics Updated 09-Jan-2015 | Thea
Pharmaceuticals Ltd
1. Name of the medicinal product
TIOPEX 1 mg/g, eye gel in single-dose container
2. Qualitative and quantitative composition
1 g of gel contains 1 mg of timolol as timolol maleate.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Eye gel in single-dose container.
Opalescent, colourless to slightly yellow gel.
4. Clinical particulars
4.1 Therapeutic indications
Reduction of the elevated intraocular pressure in patients with:
- ocular hypertension,
- chronic open angle glaucoma.
4.2 Posology and method of administration
Ocular use.
_Adults_
The recommended dosage regimen is 1 drop of TIOPEX 1 mg/g in the
affected eye (or eyes), once a day,
in the morning.
_Elderly:_
There has been wide experience with the use of timolol eye drops in
elderly patients.
The dosage recommendations given above reflect the clinical data
derived from this experience.
_Children and adolescents_
There is no experience in children and adolescents. This eye gel is
therefore not recommended in such
patients.
If the ophthalmologist considers it necessary, TIOPEX 1 mg/g may be
combined with one or more other
anti-glaucoma treatments (local and/or systemic route of
administration).
However, the combination of two beta-blocker eye drops is not
recommended (see section 4.4.).
The other eye drops should be administered at least 15 minutes before
TIOPEX 1mg/g. The eye gel
should be the last medication instilled.
Nonetheless, response to TIOPEX 1 mg/g may take several weeks to
stabilise intraocular pressure,
therefore the monitoring of the treatment should include intraocular
pressure assessment after a treatment
period of approximately four weeks.
_Method of administration_
Timolol eye gel should be instilled into the conjunctival sac.
A single-dose contains enough gel to treat both eyes.
For single use only.
_Patients should be instructed:_
• to avoid contact between the dropper t