Pharmaceutical form: Eye drops, solution, 5ml.
Active ingredient: Timolol 0,5% (as timolol maleate)
Excipients:Sodium Phosphate Monobasic Monohydrate, Sodium Phosphate Dibasic Dihydrate, Benzalkonium Chloride, Edetate
Pharmaceutical category
β-adrenoreceptor blocking agent.
General information
Timolol maleate, the active ingredient of U-TIM eye drops (timolol 0.50 %),
is a known β-adrenoreceptor blocking agent with β-adrenolytic action without either a significant local anaesthetic action,
or myocardial repressive action, or intrinsic sympathomimetic activity.
In topical eye application it exerts considerable anti-glaucoma action.
Indications
Increased intraocular pressure, irrespective of etiology
(open or closed angle glaucoma, chronic or acute, secondary glaucoma, aphakic patients with glaucoma etc.).
Contraindications
Hypersensitivity to the medicinal product.
Special precautions and warnings for use
General:
Timolol maleate may be absorbed systemically. The same adverse reactions found with systemic β-blockers may occur with topical use.
Administer with caution.
1. Cardiovascular problems: bradycardia (irrespective of etiology), cardiac failure, hypotension, ischemia.
2. Respiratory problems: chronic obstructive pulmonary disease, bronchia I asthma or chronic bronchitis.
3. Diabetes mellitus, insulin - dependent diabetics.
4. CNS disturbances.
5. Allergic response to timolol.
6. In acute close - angle glaucoma, timolol should be given concomitantly with a miotic, to avoid any timolol induced mydriasis.
7. Pregnancy: The complete safety to the fetus is not entirety known.
8. Children: There is little use in children and if their low weight is taken into account, it should be administered with great caution.
9. In subjects who wear contact lenses hard or soft, the local administration of medicines is only permitted after their removal.
Dosage
Instill 1-2 drops into the conjunctival sac 3-6 times daily.
In severe cases, every hour during the day and every two hours during the night.
When favourable response is observed, reduce dosage to 1 drop every 4 hours. Later,
1 drop every 6 or 8 hours may suffice to control symptoms. The duration of therapy varies
and can last from a few days to several weeks depending on the clinical response. Relapses,
more common in chronic active lesions, usually respond to retreatment and is therefore recommended.
Overdosage and treatment.
There are no symptoms of overdosage following ocular administration of prednisolone eye drops.
Side effects
Topical:
In general, timolol topical ophthalmic solution is well tolerated.
Rarely and only occasionally mydriasis, signs of ocular irritation (redness- burning),
decreased corneal sensitivity, dry eye symptoms, punctuate keratitis,
allergic blepharoconjunctivitis and visual disturbances, eyelid ptosis have been reported.
The ophthalmologist should decide on the withdrawal of therapy after occurrence of one of these side effects.
Systemic:
Topical ophthalmic timolol is absorbed into the systemic circulation and may cause systemic side effects,
such as: bradycardia, hypotension, exacerbation of latent or overt cardiac failure,
aggravation of pre-existing myasthenia, bronchospasm, CNS symptoms (anxiety, depression,
confusion, and hallucinations), anorexia, gastrointestinal disturbances, nausea,
hypoglycemia in diabetics treated with oral hypoglycemic agents. Rarely, it can cause allergic rash and urticaria.
Reporting of side effects:
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible side effects not listed in this leaflet.
You can also report side effects directly via the national reporting system.
By reporting side effects, you can help provide more information on the safety of this medicine.
What you must know in case you omit a dose:
If the eye drops are to be administered continuously and you omit a dose,
you should take this dose as soon as possible. However, if the time to administer the next dose is close,
do not take the omitted dose before consulting your physician, and continue the normal treatment instead. Do not double doses.
What you must know for the expiration date of the product:
The expiration date is stated on the outer box and the inner container.
Do not use the medicine after its expiration date.
Special precautions for the storage of the product:
Do not touch your affected eye or eyelid, surrounding areas or other surfaces with the tip of the dropper vial,
to avoid contamination of the solution. Store at room temperature ≤25°C). Protect from light.
Keep out of the reach of children. Stop using the solution 28 days after first opening of the vial.
