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Timolol (Drops) Instructions for Use

ATC Code

S01ED01 (Timolol)

Active Substance

Timolol (Rec.INN registered by WHO)

Clinical-Pharmacological Group

Antiglaucoma drug – beta-adrenoblocker

Pharmacotherapeutic Group

Drugs used in ophthalmology; antiglaucoma drugs and miotic agents; beta-adrenergic blockers

Pharmacological Action

Non-selective beta-adrenergic blocker. When applied topically in ophthalmology, it reduces both normal and elevated intraocular pressure by decreasing the production of intraocular fluid and improving its outflow; it does not affect accommodation and pupil size.

It possesses antianginal, hypotensive, and antiarrhythmic effects, which are manifested during systemic use. It reduces sinus node automaticity, decreases heart rate, slows AV conduction, and reduces myocardial contractility and oxygen demand.

Pharmacokinetics

When applied topically, it rapidly penetrates the cornea and enters the systemic circulation in small amounts due to absorption through the conjunctival vessels, nasal mucosa, and lacrimal tract.

Indications

For use in ophthalmology: elevated intraocular pressure, chronic open-angle glaucoma, angle-closure glaucoma (as an adjunct in combination with miotics), secondary glaucoma (including aphakic), congenital glaucoma (when other therapeutic measures are ineffective).

ICD codes

ICD-10 code Indication
H40.0 Glaucoma suspect (ocular hypertension)
H40.1 Primary open-angle glaucoma
H40.2 Primary angle-closure glaucoma
H40.3 Secondary post-traumatic glaucoma
H40.4 Glaucoma secondary to inflammatory eye disease
H40.5 Glaucoma secondary to other eye disorders
Q15.0 Congenital glaucoma
ICD-11 code Indication
9C60 Glaucoma suspect
9C61.0Z Primary open-angle glaucoma, unspecified
9C61.1Z Primary angle-closure glaucoma, unspecified
9C61.24 Glaucoma due to ocular inflammation
9C61.29 Traumatic glaucoma
9C61.2Z Secondary open-angle glaucoma, unspecified
9C61.4Z Congenital glaucoma, unspecified

Dosage Regimen

The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen.

Instill one drop into the conjunctival sac of the affected eye(s) twice daily. The recommended dosage for chronic open-angle glaucoma is one drop of a 0.25% solution twice daily. If the clinical response is inadequate, increase to one drop of a 0.5% solution twice daily.

For angle-closure glaucoma, use as an adjunct to a miotic. The dosage for secondary and aphakic glaucoma is one drop of a 0.25% solution twice daily, titrating to 0.5% if necessary. Monitor intraocular pressure 4 weeks after any dosage change.

For ocular hypertension, initiate therapy with one drop of a 0.25% solution twice daily. Do not exceed one drop of the 0.5% solution twice daily. The maximum recommended frequency is one drop twice daily; more frequent administration may decrease the hypotensive effect.

If using other topical ophthalmic agents, administer them at least 10 minutes apart. To minimize systemic absorption, apply gentle pressure to the lacrimal sac at the inner corner of the eye for 1-2 minutes after instillation. This technique reduces drainage into the nasopharynx.

Discard the container 28 days after first opening to prevent contamination. Do not touch the dropper tip to any surface, including the eye. The dosage for congenital glaucoma in pediatric patients must be determined by a specialist, as safety and efficacy are not established.

Adverse Reactions

From the organ of vision: with topical application, irritation and hyperemia of the conjunctiva, eyelid skin, burning and itching in the eyes, lacrimation, photophobia, corneal epithelium edema, punctate superficial keratopathy, corneal hypoesthesia, diplopia, ptosis, dry eyes are possible. When performing fistulizing antiglaucoma surgeries, the development of retinal detachment in the postoperative period is possible.

With systemic use: heart failure, bradycardia, AV block, arterial hypotension; headache, sleep disorders, nightmares, asthenia, agitation, depression, paresthesia and cold extremities; nausea, vomiting, diarrhea; dyspnea, bronchospasm; muscle weakness; skin allergic reactions, exacerbation of psoriasis, conjunctival dryness are possible.

Contraindications

AV block II and III degree, sinoatrial block, bradycardia, sick sinus syndrome, arterial hypotension, chronic heart failure stage IIB-III, acute heart failure, vasomotor rhinitis, Raynaud’s disease and other obliterative vascular diseases, metabolic acidosis, lactation.

Use in Pregnancy and Lactation

The safety and efficacy of use during pregnancy have not been studied.

Use in Hepatic Impairment

Use with caution in patients with impaired liver function.

Use in Renal Impairment

Use with caution in patients with impaired renal function.

Pediatric Use

The safety and efficacy of use in children have not been studied.

Special Precautions

Use with caution in patients with impaired liver function, renal function, diabetes mellitus (especially of labile course). With long-term use, it increases plasma triglyceride levels.

The safety and efficacy of use in children have not been studied.

In ophthalmology, it is used for a long time, therefore, during treatment, the cornea should be examined at least once every 6 months, and tear production function and visual field status should be monitored.

Effect on the ability to drive vehicles and mechanisms

During treatment, one should refrain from engaging in potentially hazardous activities that require increased attention and rapid psychomotor reactions.

When used in ophthalmology, immediately after instillation, a decrease in visual acuity and slowing of psychomotor reactions are possible, so one should refrain from engaging in potentially hazardous activities that require increased attention for 30 minutes.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.

Medical Disclaimer

Brand (or Active Substance), Marketing Authorisation Holder, Dosage Form

Marketing Authorization Holder

Micro Labs Limited (India)

Dosage Form

Bottle Rx Icon Timolol Ophthalmic drops 0.5%: dropper bottle 5 ml 1 pc.

Dosage Form, Packaging, and Composition

Ophthalmic drops transparent, colorless or light yellow in color.

1 ml
Timolol (as maleate) 5 mg

Excipients: benzalkonium chloride 50% solution (calculated as 100% substance) – 0.1 mg, sodium dihydrogen phosphate dihydrate – 6.1 mg, disodium hydrogen phosphate dodecahydrate – 30.42 mg, sodium hydrochloride – q.s. to pH 6.0-7.5, hydrochloric acid – q.s. to pH 6.0-7.5, water for injections – up to 1 ml.

5 ml – polyethylene dropper bottles (1) – cardboard packs.

Marketing Authorization Holder

S.C. Rompharm Company S.R.L. (Romania)

Dosage Form

Bottle Rx Icon Timolol Eye drops 0.25%: 5 ml bottle, 1 pc. with dropper cap

Dosage Form, Packaging, and Composition

Eye drops 0.25% transparent, colorless.

1 ml
Timolol maleate 3.4 mg,
   Corresponding to timolol content 2.5 mg

Excipients: disodium phosphate dodecahydrate, sodium dihydrogen phosphate monohydrate, disodium edetate dihydrate, sodium chloride, benzalkonium chloride, sodium hydroxide, purified water.

5 ml – plastic bottles with dropper cap (1) – cardboard packs.

Marketing Authorization Holder

S.C. Rompharm Company S.R.L. (Romania)

Dosage Form

Bottle Rx Icon Timolol Eye drops 0.5%: 5 ml bottle, 1 pc. with dropper cap

Dosage Form, Packaging, and Composition

Eye drops 0.5% transparent, colorless.

1 ml
Timolol maleate 6.8 mg,
   Corresponding to timolol content 5 mg

Excipients: disodium phosphate dodecahydrate, sodium dihydrogen phosphate monohydrate, disodium edetate dihydrate, sodium chloride, benzalkonium chloride, sodium hydroxide, purified water.

5 ml – plastic bottles with dropper cap (1) – cardboard packs.

Marketing Authorization Holder

Belmedpreparaty RUP (Republic of Belarus)

Dosage Form

Bottle Rx Icon Timolol Eye drops 0.25%: 5 ml bottle, 1 ml. dropper tube 1 or 2 pcs., 5 ml bottle

Dosage Form, Packaging, and Composition

Eye drops 1 ml
Timolol 2.5 mg

1 ml – dropper tubes (1) – cardboard packs.
1 ml – dropper tubes (2) – contour cell packs (1) – cardboard packs.

Marketing Authorization Holder

Belmedpreparaty RUP (Republic of Belarus)

Dosage Form

Bottle Rx Icon Timolol Eye drops 0.5%: 5 ml bottle, 1 ml. dropper tube 1 or 2 pcs.

Dosage Form, Packaging, and Composition

Eye drops 1 ml
Timolol 5 mg

1 ml – dropper tubes (1) – cardboard packs.
1 ml – dropper tubes (2) – contour cell packs (1) – cardboard packs.
5 ml – bottles with dropper cap (1) – cardboard packs.

Marketing Authorization Holder

Medical Leasing-Consulting, LLC (Russia)

Manufactured By

Dalkhimpharm, JSC (Russia)

Dosage Form

Bottle Rx Icon Timolol Eye drops 0.5%: bottle or dropper bottle 5 ml or 10 ml

Dosage Form, Packaging, and Composition

Eye drops in the form of a transparent colorless solution.

1 ml
Timolol maleate 6.8 mg,
   Corresponding to timolol content 5 mg

Excipients: benzalkonium chloride solution 50% – 0.2 mg (calculated as 100% substance – 0.1 mg), sodium dihydrogen phosphate dihydrate (sodium phosphate monobasic dihydrate) – 0.11 mg, disodium phosphate dodecahydrate (sodium phosphate dibasic dodecahydrate) – 2.9 mg, disodium edetate (Trilon B) – 0.02 mg, sodium chloride – 7.1 mg, sodium hydroxide solution 2M – to pH 6.5-7.5, water for injections – up to 1 ml.

5 ml – polyethylene bottles (1) with dropper caps – cardboard packs.
10 ml – polyethylene bottles (1) with dropper caps – cardboard packs.
5 ml – polyethylene dropper bottles (1) – cardboard packs.
10 ml – polyethylene dropper bottles (1) – cardboard packs.

Marketing Authorization Holder

Obnovlenie Pfc, JSC (Russia)

Dosage Form

Bottle Rx Icon Timolol Eye drops 0.25%: dropper tube 1ml, 1.5 ml, 2 ml, 5 ml or 10 ml

Dosage Form, Packaging, and Composition

Eye drops 0.25% 1 ml
Timolol (as maleate) 2.5 mg

1 ml – dropper tubes (1) – cardboard packs.
1 ml – dropper tubes (5) – cardboard packs.
1 ml – dropper tubes (10) – cardboard packs.
5 ml – dropper tubes (1) – cardboard packs.
10 ml – dropper tubes (1) – cardboard packs.
1 ml – dropper tubes (2) – cardboard packs.
1 ml – dropper tubes (50) – cardboard packs.
1 ml – dropper tubes (100) – cardboard packs.
1.5 ml – dropper tubes (1) – cardboard packs.
1.5 ml – dropper tubes (2) – cardboard packs.
1.5 ml – dropper tubes (5) – cardboard packs.
1.5 ml – dropper tubes (10) – cardboard packs.
1.5 ml – dropper tubes (50) – cardboard packs.
1.5 ml – dropper tubes (100) – cardboard packs.
10 ml – dropper tubes (2) – cardboard packs.
10 ml – dropper tubes (5) – cardboard packs.
10 ml – dropper tubes (10) – cardboard packs.
10 ml – dropper tubes (50) – cardboard packs.
10 ml – dropper tubes (100) – cardboard packs.
5 ml – dropper tubes (2) – cardboard packs.
5 ml – dropper tubes (5) – cardboard packs.
5 ml – dropper tubes (10) – cardboard packs.
5 ml – dropper tubes (50) – cardboard packs.
5 ml – dropper tubes (100) – cardboard packs.
2 ml – dropper tubes (1) – cardboard packs.
2 ml – dropper tubes (2) – cardboard packs.
2 ml – dropper tubes (5) – cardboard packs.
2 ml – dropper tubes (10) – cardboard packs.
2 ml – dropper tubes (50) – cardboard packs.
2 ml – dropper tubes (100) – cardboard packs.

Marketing Authorization Holder

Obnovlenie Pfc, JSC (Russia)

Dosage Form

Bottle Rx Icon Timolol Ophthalmic drops 0.5%: tube-dropper 1 ml, 1.5 ml, 2 ml, 5 ml, or 10 ml

Dosage Form, Packaging, and Composition

Eye drops 0.5% 1 ml
Timolol (as maleate) 5 mg

1 ml – dropper tubes (1) – cardboard packs.
1 ml – dropper tubes (5) – cardboard packs.
1 ml – dropper tubes (10) – cardboard packs.
5 ml – dropper tubes (1) – cardboard packs.
10 ml – polymer dropper bottles (1) – cardboard packs.
1 ml – dropper tubes (2) – cardboard packs.
1 ml – dropper tubes (50) – cardboard packs.
1 ml – dropper tubes (100) – cardboard packs.
1.5 ml – dropper tubes (1) – cardboard packs.
1.5 ml – dropper tubes (2) – cardboard packs.
1.5 ml – dropper tubes (5) – cardboard packs.
1.5 ml – dropper tubes (10) – cardboard packs.
1.5 ml – dropper tubes (50) – cardboard packs.
1.5 ml – dropper tubes (100) – cardboard packs.
2 ml – dropper tubes (1) – cardboard packs.
2 ml – dropper tubes (2) – cardboard packs.
2 ml – dropper tubes (5) – cardboard packs.
2 ml – dropper tubes (10) – cardboard packs.
2 ml – dropper tubes (50) – cardboard packs.
2 ml – dropper tubes (100) – cardboard packs.
5 ml – dropper tubes (2) – cardboard packs.
5 ml – dropper tubes (5) – cardboard packs.
5 ml – dropper tubes (10) – cardboard packs.
5 ml – dropper tubes (50) – cardboard packs.
5 ml – dropper tubes (100) – cardboard packs.
10 ml – polymer dropper bottles (2) – cardboard packs.
10 ml – polymer dropper bottles (5) – cardboard packs.
10 ml – polymer dropper bottles (10) – cardboard packs.
10 ml – polymer dropper bottles (50) – cardboard packs.
10 ml – polymer dropper bottles (100) – cardboard packs.

Marketing Authorization Holder

Slavic Pharmacy, LLC (Russia)

Dosage Form

Bottle Rx Icon Timolol Solution-eye drops 0.25%: 5 or 10 ml bottle

Dosage Form, Packaging, and Composition

Solution-eye drops 0.25% 1 ml
Timolol maleate 3.42 mg,
   Including Timolol 2.5 mg

5 ml – bottles (1) with a dropper – cardboard packs.
10 ml – bottles (1) with a dropper – cardboard packs.
5 ml – bottles (5) with a dropper – cardboard packs.
5 ml – bottles (50) with a dropper – cardboard packs.
5 ml – dark glass bottles (50) – cardboard packs.
5 ml – dark glass bottles (5) – cardboard packs.
5 ml – dark glass bottles (1) – cardboard packs.
10 ml – bottles (5) with a dropper – cardboard packs.
10 ml – bottles (50) with a dropper – cardboard packs.
10 ml – bottles (1) – cardboard packs.
10 ml – bottles (5) – cardboard packs.
10 ml – bottles (50) – cardboard packs.

Marketing Authorization Holder

Slavic Pharmacy, LLC (Russia)

Dosage Form

Bottle Rx Icon Timolol Solution-eye drops 0.5%: 5 or 10 ml bottle

Dosage Form, Packaging, and Composition

Solution-eye drops 0.5% 1 ml
Timolol maleate 6.84 mg,
   Including Timolol 5 mg

5 ml – bottles (1) with a dropper – cardboard packs.
10 ml – bottles (1) with a dropper – cardboard packs.
5 ml – bottles (5) with a dropper – cardboard packs.
5 ml – bottles (50) with a dropper – cardboard packs.
5 ml – bottles (50) – cardboard packs.
5 ml – bottles (5) – cardboard packs.
5 ml – bottles (1) – cardboard packs.
10 ml – bottles (5) with a dropper – cardboard packs.
10 ml – bottles (50) with a dropper – cardboard packs.
10 ml – bottles (50) – cardboard packs.
10 ml – bottles (5) – cardboard packs.
10 ml – bottles (1) – cardboard packs.

Marketing Authorization Holder

Obnovlenie Pfc, JSC (Russia)

Dosage Form

Bottle Rx Icon Timolol Bufus Eye drops 0.25%: dropper tube 1ml, 1.5 ml, 2 ml, 5 ml or 10 ml

Dosage Form, Packaging, and Composition

Eye drops 0.25% 1 ml
Timolol (as maleate) 2.5 mg

1 ml – dropper tubes (1) – cardboard packs.
1 ml – dropper tubes (5) – cardboard packs.
1 ml – dropper tubes (10) – cardboard packs.
5 ml – dropper tubes (1) – cardboard packs.
10 ml – dropper tubes (1) – cardboard packs.
1 ml – dropper tubes (2) – cardboard packs.
1 ml – dropper tubes (50) – cardboard packs.
1 ml – dropper tubes (100) – cardboard packs.
1.5 ml – dropper tubes (1) – cardboard packs.
1.5 ml – dropper tubes (2) – cardboard packs.
1.5 ml – dropper tubes (5) – cardboard packs.
1.5 ml – dropper tubes (10) – cardboard packs.
1.5 ml – dropper tubes (50) – cardboard packs.
1.5 ml – dropper tubes (100) – cardboard packs.
10 ml – dropper tubes (2) – cardboard packs.
10 ml – dropper tubes (5) – cardboard packs.
10 ml – dropper tubes (10) – cardboard packs.
10 ml – dropper tubes (50) – cardboard packs.
10 ml – dropper tubes (100) – cardboard packs.
5 ml – dropper tubes (2) – cardboard packs.
5 ml – dropper tubes (5) – cardboard packs.
5 ml – dropper tubes (10) – cardboard packs.
5 ml – dropper tubes (50) – cardboard packs.
5 ml – dropper tubes (100) – cardboard packs.
2 ml – dropper tubes (1) – cardboard packs.
2 ml – dropper tubes (2) – cardboard packs.
2 ml – dropper tubes (5) – cardboard packs.
2 ml – dropper tubes (10) – cardboard packs.
2 ml – dropper tubes (50) – cardboard packs.
2 ml – dropper tubes (100) – cardboard packs.

Marketing Authorization Holder

Obnovlenie Pfc, JSC (Russia)

Dosage Form

Bottle Rx Icon Timolol Bufus Ophthalmic drops 0.5%: tube-dropper 1 ml, 1.5 ml, 2 ml, 5 ml, or 10 ml

Dosage Form, Packaging, and Composition

Eye drops 0.5% 1 ml
Timolol (as maleate) 5 mg

1 ml – dropper tubes (1) – cardboard packs.
1 ml – dropper tubes (5) – cardboard packs.
1 ml – dropper tubes (10) – cardboard packs.
5 ml – dropper tubes (1) – cardboard packs.
10 ml – polymer dropper bottles (1) – cardboard packs.
1 ml – dropper tubes (2) – cardboard packs.
1 ml – dropper tubes (50) – cardboard packs.
1 ml – dropper tubes (100) – cardboard packs.
1.5 ml – dropper tubes (1) – cardboard packs.
1.5 ml – dropper tubes (2) – cardboard packs.
1.5 ml – dropper tubes (5) – cardboard packs.
1.5 ml – dropper tubes (10) – cardboard packs.
1.5 ml – dropper tubes (50) – cardboard packs.
1.5 ml – dropper tubes (100) – cardboard packs.
2 ml – dropper tubes (1) – cardboard packs.
2 ml – dropper tubes (2) – cardboard packs.
2 ml – dropper tubes (5) – cardboard packs.
2 ml – dropper tubes (10) – cardboard packs.
2 ml – dropper tubes (50) – cardboard packs.
2 ml – dropper tubes (100) – cardboard packs.
5 ml – dropper tubes (2) – cardboard packs.
5 ml – dropper tubes (5) – cardboard packs.
5 ml – dropper tubes (10) – cardboard packs.
5 ml – dropper tubes (50) – cardboard packs.
5 ml – dropper tubes (100) – cardboard packs.
10 ml – polymer dropper bottles (2) – cardboard packs.
10 ml – polymer dropper bottles (5) – cardboard packs.
10 ml – polymer dropper bottles (10) – cardboard packs.
10 ml – polymer dropper bottles (50) – cardboard packs.
10 ml – polymer dropper bottles (100) – cardboard packs.

Marketing Authorization Holder

Obnovlenie Pfc, JSC (Russia)

Dosage Forms

Bottle Rx Icon Timolol Renewal Eye drops 0.5%
Eye drops 0.25%

Dosage Form, Packaging, and Composition

Eye drops

Timolol 0.5%

1 ml – dropper tubes (10 pcs.) – cardboard packs – By prescription
1 ml – dropper tubes (5 pcs.) – cardboard packs – By prescription
10 ml – dropper tubes – cardboard packs – By prescription
15 ml – dropper tubes – cardboard packs – By prescription
2 ml – dropper tubes (10 pcs.) – cardboard packs – By prescription
2 ml – dropper tubes (5 pcs.) – cardboard packs – By prescription
5 ml – dropper tubes – cardboard packs – By prescription

Eye drops

1 ml
Timolol (as maleate) 5 mg

1 ml – dropper tubes (10 pcs.) – cardboard packs – By prescription
1 ml – dropper tubes (5 pcs.) – cardboard packs – By prescription
10 ml – dropper tubes – cardboard packs – By prescription
15 ml – dropper tubes – cardboard packs – By prescription
2 ml – dropper tubes (10 pcs.) – cardboard packs – By prescription
2 ml – dropper tubes (5 pcs.) – cardboard packs – By prescription
5 ml – dropper tubes – cardboard packs – By prescription


Eye drops

1 ml
Timolol (as maleate) 2.5 mg

1 ml – dropper tubes (10 pcs.) – cardboard packs – By prescription
1 ml – dropper tubes (5 pcs.) – cardboard packs – By prescription
10 ml – dropper tubes – cardboard packs – By prescription
15 ml – dropper tubes – cardboard packs – By prescription
2 ml – dropper tubes (10 pcs.) – cardboard packs – By prescription
2 ml – dropper tubes (5 pcs.) – cardboard packs – By prescription
5 ml – dropper tubes – cardboard packs – By prescription

Marketing Authorization Holder

Beta-Lek LLC (Russia)

Dosage Form

Bottle Rx Icon Timolol-Betalek Eye drops 0.25%: bottle 10 ml

Dosage Form, Packaging, and Composition

Eye drops 0.25% transparent, colorless.

1 ml
Timolol (as maleate) 2.5 mg

10 ml – polymer dropper bottles (1) – cardboard packs.

Marketing Authorization Holder

Beta-Lek LLC (Russia)

Dosage Form

Bottle Rx Icon Timolol-Betalek Eye drops 0.5%: bottle 10 ml

Dosage Form, Packaging, and Composition

Eye drops 0.5% transparent, colorless.

1 ml
Timolol (as maleate) 5 mg

10 ml – polymer dropper bottles (1) – cardboard packs.

Marketing Authorization Holder

Diafarm, JSC (Russia)

Dosage Form

Bottle Rx Icon Timolol-DIA Eye drops 0.25%: bottles or dropper bottle 5 ml or 10 ml.

Dosage Form, Packaging, and Composition

Eye drops 0.25% 1 ml
Timolol maleate 3.42 mg,
   Including Timolol 2.5 mg

5 ml – bottles (1) with a dropper – cardboard packs.
5 ml – polyethylene bottles with a dropper.
5 ml – bottles (50) with a dropper – cardboard packs.
5 ml – bottles (1) – cardboard packs.
5 ml – bottles (50) – cardboard packs.
10 ml – bottles (1) with a dropper – cardboard packs.
10 ml – bottles (50) with a dropper – cardboard packs.
10 ml – bottles (50) – cardboard packs.
10 ml – bottles (1) – cardboard packs.

Marketing Authorization Holder

Diafarm, JSC (Russia)

Dosage Form

Bottle Rx Icon Timolol-DIA Eye drops 0.5%: bottles or dropper bottle 5 ml or 10 ml.

Dosage Form, Packaging, and Composition

Eye drops 0.5% 1 ml
Timolol maleate 6.84 mg,
   Including Timolol 5 mg

5 ml – bottles (1) with a dropper – cardboard packs.
5 ml – polyethylene bottles (1) with a dropper – cardboard packs.
5 ml – bottles (50) with a dropper – cardboard packs.
5 ml – bottles (50) – cardboard packs.
5 ml – bottles (1) – cardboard packs.
10 ml – bottles (1) – cardboard packs.
10 ml – bottles (50) – cardboard packs.
10 ml – dropper bottles (50) – cardboard packs.
10 ml – dropper bottles (1) – cardboard packs.

Marketing Authorization Holder

Veropharm, LLC (Russia)

Dosage Form

Bottle Rx Icon Timolol-LANS Eye drops 0.25%: bottle 5 ml 1 or 70 pcs., bottle 10 ml 1 or 70 pcs.

Dosage Form, Packaging, and Composition

Eye drops 0.25% in the form of a colorless, transparent liquid.

1 ml
Timolol (as maleate) 2.5 mg

Excipients: sodium phosphate dibasic dodecahydrate – 8.35 mg, sodium phosphate monobasic dihydrate – 1.56 mg, sodium chloride – 3.75 mg, disodium edetate (Trilon B) – 0.2 mg, benzalkonium chloride – 0.1 mg, water for injections – up to 1 ml.

5 ml – bottles (1) of neutral glass – cardboard packs.
5 ml – bottles with a dropper cap (1) of neutral glass – cardboard packs.
5 ml – bottles (70) of neutral glass – cardboard boxes.
5 ml – polymer dropper bottles (70) – cardboard boxes.
10 ml – bottles (1) of neutral glass – cardboard packs.
10 ml – bottles with a dropper cap (1) of neutral glass – cardboard packs.
10 ml – bottles (70) of neutral glass – cardboard boxes.
10 ml – polymer dropper bottles (70) – cardboard boxes.

Marketing Authorization Holder

Veropharm, LLC (Russia)

Dosage Form

Bottle Rx Icon Timolol-LANS Ophthalmic drops 0.5%: bottle 5 ml 1 or 70 pcs., bottle 10 ml 1 or 70 pcs.

Dosage Form, Packaging, and Composition

Eye drops 0.5% in the form of a colorless, transparent liquid.

1 ml
Timolol (as maleate) 5 mg

Excipients: sodium phosphate dibasic dodecahydrate – 8.35 mg, sodium phosphate monobasic dihydrate – 1.56 mg, sodium chloride – 3.75 mg, disodium edetate (Trilon B) – 0.2 mg, benzalkonium chloride – 0.1 mg, water for injections – up to 1 ml.

5 ml – bottles (1) of neutral glass – cardboard packs.
5 ml – bottles with a dropper cap (1) of neutral glass – cardboard packs.
5 ml – bottles (70) of neutral glass – cardboard boxes.
5 ml – polymer dropper bottles (70) – cardboard boxes.
10 ml – bottles (1) of neutral glass – cardboard packs.
10 ml – bottles with a dropper cap (1) of neutral glass – cardboard packs.
10 ml – bottles (70) of neutral glass – cardboard boxes.
10 ml – polymer dropper bottles (70) – cardboard boxes.

Marketing Authorization Holder

Moscow Endocrine Plant FSUE (Russia)

Dosage Form

Bottle Rx Icon Timolol-MEZ Eye drops 0.25%: bottle 5 ml, dropper bottle 5 ml or 10 ml, dropper tube 1.3 ml, 1.5 ml, 2 ml or 5 ml 5 or 10 pcs.

Dosage Form, Packaging, and Composition

Eye drops 0.25% 1 ml
Timolol maleate 3.42 mg,
   Which corresponds to the timolol content 2.5 mg

5 ml – bottles (1) with a dropper – cardboard packs.
1.5 ml – dropper tubes (5) – cardboard packs.
1.3 ml – dropper tubes (5) – cardboard packs.
10 ml – dropper bottles (1) – cardboard packs.
1.5 ml – dropper tubes (10) – cardboard packs.
1.3 ml – dropper tubes (10) – cardboard packs.
2 ml – dropper tubes (5) – cardboard packs.
2 ml – dropper tubes (10) – cardboard packs.
5 ml – dropper tubes (10) – cardboard packs.
5 ml – dropper tubes (5) – cardboard packs.
5 ml – bottles (1) – cardboard packs.

Marketing Authorization Holder

Moscow Endocrine Plant FSUE (Russia)

Dosage Form

Bottle Rx Icon Timolol-MEZ Eye drops 0.5%: bottle 5 ml, dropper bottle 5 or 10 ml, dropper tubes 1.3 ml, 1.5 ml, 2 ml or 5 ml 5 or 10 pcs.

Dosage Form, Packaging, and Composition

Eye drops 0.5% 1 ml
Timolol maleate 6.84 mg,
   Which corresponds to timolol content 5 mg

5 ml – bottles (1) complete with a dropper – carton packs.
1.5 ml – tube-droppers (5) – carton packs.
5 ml – bottles (1) – carton packs.
10 ml – bottles (1) complete with a dropper – carton packs.
1.5 ml – tube-droppers (10) – carton packs.
1.3 ml – tube-droppers (10) – carton packs.
1.3 ml – tube-droppers (5) – carton packs.
2 ml – tube-droppers (5) – carton packs.
2 ml – tube-droppers (10) – carton packs.
5 ml – tube-droppers (10) – carton packs.
5 ml – tube-droppers (5) – carton packs.

Marketing Authorization Holder

Ursapharm Arzneimittel, GmbH & Co. KG (Germany)

Dosage Form

Bottle Rx Icon Timolol-Pos® Eye drops 0.25%: dropper bottle 5 ml 1 or 3 pcs.

Dosage Form, Packaging, and Composition

Eye drops 0.25% colorless, transparent.

1 ml
Timolol maleate 3.42 mg,
   Which corresponds to timolol content 2.5 mg

Excipients: benzalkonium chloride, sodium dihydrogen phosphate dihydrate, disodium hydrogen phosphate dodecahydrate, purified water.

5 ml – polyethylene dropper bottles (1) – carton packs.
5 ml – polyethylene dropper bottles (3) – carton packs.

Marketing Authorization Holder

Ursapharm Arzneimittel, GmbH & Co. KG (Germany)

Dosage Form

Bottle Rx Icon Timolol-Pos® Eye drops 0.5%: dropper bottle 5 ml 1 or 3 pcs.

Dosage Form, Packaging, and Composition

Eye drops 0.5% colorless, transparent.

1 ml
Timolol maleate 6.84 mg,
   Which corresponds to timolol content 5 mg

Excipients: benzalkonium chloride, sodium dihydrogen phosphate dihydrate, disodium hydrogen phosphate dodecahydrate, purified water.

5 ml – polyethylene dropper bottles (1) – carton packs.
5 ml – polyethylene dropper bottles (3) – carton packs.

Marketing Authorization Holder

Ursapharm Arzneimittel, GmbH (Germany)

Dosage Form

Bottle Rx Icon Timolol-Pos® Eye drops (preservative-free) 0.25%: dropper bottle 10 ml 1 pc.

Dosage Form, Packaging, and Composition

Eye drops (preservative-free) 0.25% colorless, transparent.

1 ml
Timolol maleate 3.42 mg,
   Which corresponds to timolol content 2.5 mg

Excipients: sodium dihydrogen phosphate dihydrate – 8 mg, disodium hydrogen phosphate dodecahydrate – 32 mg, purified water – up to 1 ml.

10 ml – plastic multidose dropper bottles (1) – carton packs.

Marketing Authorization Holder

Ursapharm Arzneimittel, GmbH (Germany)

Dosage Form

Bottle Rx Icon Timolol-Pos® Eye drops (preservative-free) 0.5%: dropper bottle 10 ml 1 pc.

Dosage Form, Packaging, and Composition

Eye drops (preservative-free) 0.5% colorless, transparent.

1 ml
Timolol maleate 6.84 mg,
   Which corresponds to timolol content 5 mg

Excipients: sodium dihydrogen phosphate dihydrate – 8 mg, disodium hydrogen phosphate dodecahydrate – 32 mg, purified water – up to 1 ml.

10 ml – plastic multidose dropper bottles (1) – carton packs.

Marketing Authorization Holder

Grotex, LLC (Russia)

Dosage Form

Bottle Rx Icon Timolol-SOLOpharm Eye drops 0.5%: bottle 5 ml 1 pc.

Dosage Form, Packaging, and Composition

Eye drops colorless, transparent or with a slight brownish tint.

1 ml
Timolol maleate 6.84 mg,
   Which corresponds to timolol content 5 mg

Excipients: benzalkonium chloride – 0.1 mg, sodium dihydrogen phosphate dihydrate – 6.1 mg, disodium hydrogen phosphate dihydrate – 15.16 mg, purified water – up to 1 ml.

5 ml – low-density polyethylene bottles (1) with a dropper – carton packs.

Table of Contents

TABLE OF CONTENTS