TIOPEX Eye gel (2018)
Βιβλιογραφική αναφορά
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Περιεχόμενα
Name of the medicinal product
TIOPEX 1 mg/g, eye gel in single-dose container.
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.
Pharmaceutical form
Eye gel in single-dose container. Opalescent, colourless to slightly yellow gel.
Therapeutic indications
Reduction of the elevated intraocular pressure in patients with: ocular hypertension, chronic open angle glaucoma.
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 ...
Contraindications
As with all products containing beta-receptor blocking agents, Timolol is contraindicated in patients with: Hypersensitivity to the active substance (timolol maleate) or to any the excipients listed in ...
Special warnings and precautions for use
Like other topically applied ophthalmic agents timolol maleate is absorbed systemically. Due to beta-adrenergic component, timolol maleate, the same types of cardiovascular, pulmonary and other adverse ...
Interaction with other medicinal products and other forms of interaction
No specific drug interaction studies have been performed with timolol maleate. Although the quantity of beta-blockers, which passes into the systemic circulation is low after ocular instillation, the risk ...
Fertility, pregnancy and lactation
Pregnancy There are no adequate data for the use of timolol maleate in pregnant women. Timolol maleate should not be used during pregnancy unless clearly necessary. To reduce the systemic absorption, see ...
Effects on ability to drive and use machines
TIOPEX 1 mg/g has minor influence on the ability to drive and use machines. No studies on the effect of this medicinal product on the ability to drive have been conducted. While driving vehicles or operating ...
Undesirable effects
Like other topically applied ophthalmic drugs, timolol maleate is absorbed into the systemic circulation. This may cause similar undesirable effects as seen with systemic betablocking agents. Incidence ...
Overdose
No data specific to this preparation are available. The most common side effects caused by beta-blocker overdosage are symptomatic bradycardia, hypotension, bronchospasm, and acute cardiovascular insufficiency. ...
Pharmacodynamic properties
Pharmacotherapeutic group: Anriglaucoma preparations and miotics; Beta-blocking agents ATC code: S01ED01 General Timolol can be characterised by three pharmacological properties: non-cardioselective beta-blockade, ...
Pharmacokinetic properties
TIOPEX 1 mg/g eye gel is a preservative free formulation. Negligible systemic exposure has been observed in patients treated with TIOPEX 1 mg/g given once daily. Data from a recent comparative pharmacokinetic ...
Preclinical safety data
None of the mutagenesis studies carried out in vivo and in vitro on timolol have produced any evidence of mutagenic potential. Cancerogenic potential in timolol has been shown in animals, at exposure levels ...
List of excipients
Sorbitol Polyvinyl alcohol Carbomer 974 P Sodium acetate trihydrate Lysine monohydrate Water for injections
Incompatibilities
Not applicable.
Shelf life
30 months. <u>After opening of the single-dose container:</u> use immediately and discard the single-dose container after use. <u>After opening of the sachet:</u> use the single-dose containers within ...
Special precautions for storage
Keep the single-dose containers in the sachet and the outer carton in order to protect from light.
Nature and contents of container
10 single-dose containers (PEBD) containing 0.4 g of gel are packed in sachet (paper/aluminium), box of 3 or 9 sachets. A pack size contains 30 (3x10) or 90 (9x10) single-dose containers. Not all pack ...
Special precautions for disposal and other handling
No special requirements.
Marketing authorization holder
Laboratoires THEA, 12 Rue Louis Blériot, 63017 Clermont-Ferrand Cedex 2, FRANCE
Marketing authorization number(s)
PL 20162/0010
Date of first authorization / renewal of the authorization
16/04/2010
Date of revision of the text
15/10/2018
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