TIOPEX Eye gel Ref.[7532] Active ingredients: Timolol

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 tip and the eye or eyelids,
• to use the eye gel immediately after first opening the single-dose container and to discard the single-dose after use.

When using nasolacrimal occlusion or closing the eyelids for 2 minutes, the systemic absorption is reduced. This may result in a decrease in systemic side effects and an increase in local activity.

Replacement of a previous treatment

When TIOPEX 1 mg/g is used to replace another anti-glaucoma eye drops, this eye drops should be discontinued after a full day of therapy, and TIOPEX 1 mg/g should be started the next day at the dosage of one drop in the affected eye (or eyes) once a day, in the morning.

If TIOPEX 1 mg/g is replacing a combination of anti-glaucoma treatments, only one drug should be withdrawn at a time.

If the anti-glaucoma drug being replaced is not a beta-blocker eye drops, it should be continued and one drop of TIOPEX 1 mg/g should be instilled in the affected eye (or eyes), once a day. The following day, stop taking the previous drug completely.

When TIOPEX 1 mg/g is used to replace miotic eye drops, testing of refraction may prove necessary when the effects of the miotics have disappeared.

Medical prescription should be combined with the monitoring of intraocular pressure, particularly when the treatment is initiated.

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.

If overdosage occurs, the following measures should be considered:

1. Administration of activated charcoal, if the preparation has been taken orally. Studies have shown that timolol maleate cannot be removed by haemodialysis.
2. Symptomatic bradycardia: Atropine sulphate, 0.25 to 2 mg intravenously, should be used to induce vagal blockade. If bradycardia persists, intravenous isoprenaline hydrochloride should be administered cautiously. In refractory cases, the use of a cardiac pacemaker should be considered.
3. Hypotension: A sympathomimetic agent such as dopamine, dobutamine or noradrenaline should be given. In refractory cases, the use of glucagon has been useful.
4. Bronchospasm: Isoprenaline hydrochloride

should be given. Concomitant therapy with aminophylline may be considered.

1. Acute cardiac failure: Conventional therapy with digitalis, diuretics and oxygen should be instituted immediately. In refractory cases, the use of intravenous aminophylline is recommended. This may be followed, if necessary, by glucagon, which has been found useful.

Heart blocks: Isoprenaline hydrochloride or a pacemaker should be used.

30 months.

After opening of the single-dose container: use immediately and discard the single-dose container after use.

After opening of the sachet: use the single-dose containers within 1 month.

Keep the single-dose containers in the sachet and the outer carton in order to protect from light.

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 sizes may be marketed.

No special requirements.