TIMABAK EYEDROPS 0.5% [SIN11054P]

Product Info

TIMABAK EYEDROPS 0.5%

[SIN11054P]

4.1. Clinical indications
Intra-ocular hypertension.
Chronic wide-angle glaucoma.

4.2. Dosage and route of administration
Ophthalmic route.
Dosage
It is recommended to start the treatment by instilling 1 drop of TIMABAK 0.25% in the afflicted eye twice daily.
In cases of insufficient effectiveness, 1 drop of the higher concentration TIMABAK 0.50% should be used twice daily in the afflicted eye.
If they deem necessary, the ophthalmologist can combine TIMABAK with one or more other anti-glaucoma treatments (ocular and/or other route of administration).
However, it is not recommended to combine two beta-blocking eye drop solutions (see section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).
The other eye drop solutions should be administered at least 15 minutes before TIMABAK.
In any case, it may take several weeks before ocular pressure returns to normal with TIMABAK eye drops. An assessment of the treatment should also include measurement of the intraocular eye pressure after approximately 4 weeks of treatment.
In certain cases, a daily administration of just 1 drop of TIMABAK eye drops may prove sufficient, in particular when the intraocular pressure is maintained at satisfactory levels.
The systemic passage may be reduced by nasolacrimal occlusion or by closing the eyelids for 2 minutes. This method may help to reduce systemic side effects and increase local effectiveness.

Replacement of a previous treatment
When TIMABAK is used to replace other anti-glaucoma eye drops, the latter should be stopped at the end of one full day of treatment and TIMABAK should be administered the next day on the basis of 1 drop at 0.25% twice daily in the afflicted eye.
In cases of insufficient effectiveness, switch to TIMABAK 0.50% on the basis of 1 drop in the afflicted eye twice daily.
When TIMABAK substitutes for a combination of anti-glaucoma treatments only one drug at a time should be withdrawn.
When TIMABAK is used to replace myotic eye drops, a refraction test may prove necessary when the effects of the myotic eye drops are no longer apparent.
Upon prescribing the eye drops, an examination of intraocular pressure should be performed, especially at the onset of treatment.

4.3. Contraindications
The contraindications of beta-blockers administered by other routes should be borne in mind, even though systemic effects of beta-blockers have seldom been observed after ocular instillation.

• asthma and chronic obstructive pulmonary disease,

• second and third degree atrioventricular block in the absence of a device,

• poorly controlled heart insufficiency,

• cardiogenic shock,

• Prinzmetal's angina,

• sinus diseases (including sino-auriculaire blocks),

• bradycardia (45–50 contractions per minute),

• Raynaud's disease and peripheral circulatory disturbances,

• untreated phaeochromocytoma,

• hypotension,

• hypersensitivity to one of the components of the medicinal product,

• in combination with floctafenine (see section 4.5 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information),

• in combination with sultopride (see section 4.5 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

This drug should not generally be taken in combination with amiodarone, certain calcium antagonists (bepridil, verapamil, diltiazem) and beta-blockers used to treat heart failure. (see section 4.5 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).