Oftagel

Patient Information Leaflet: User Manual

Oftagel, 2.5 mg/g, Eye Gel

Carbomer

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

This medicine should always be used exactly as described in the patient information leaflet or as directed by a doctor, pharmacist, or nurse.

• Keep this leaflet, you may need to read it again.
• If you need advice or additional information, consult a pharmacist.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.
• If there is no improvement or the patient feels worse, they should contact their doctor.

Table of Contents of the Leaflet

• 1. What is Oftagel and what is it used for
• 2. Important information before using Oftagel
• 3. How to use Oftagel
• 4. Possible side effects
• 5. How to store Oftagel
• 6. Contents of the pack and other information

1. What is Oftagel and what is it used for

Oftagel, eye gel, is a clear or slightly opalescent solution. It contains carbomer as the active substance. It is used to treat dry keratoconjunctivitis and symptomatic treatment of other forms of dry eye syndrome, i.e., in situations where the tear glands produce less or no secretions, and the drying of the cornea causes undesirable symptoms on the surface of the eye. The important properties of eye drops that alleviate dry eye syndrome symptoms are: a long contact time with the cornea and good lubricating properties. Carbomer, being a cross-linked polymer with a high molecular weight, increases the viscosity of the eye drops and creates a protective layer on the cornea.

2. Important information before using Oftagel

When not to use Oftagel

• if the patient is allergic to carbomer or any of the other ingredients of Oftagel (listed in section 6).

Warnings and precautions

Before starting to use Oftagel, the patient should discuss it with their doctor, pharmacist, or nurse.

Children and adolescents

The safety and efficacy of Oftagel in children and adolescents at the recommended dose for adults have been established based on clinical experience, however, there are no available data from clinical trials.

Oftagel and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. If other medicines are administered to the conjunctival sac, Oftagel should be administered last, 15 minutes after the previous medicine.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before using this medicine. There have been no adequate clinical trials in pregnant or breastfeeding women. The use of this medicine during pregnancy and breastfeeding is only justified if the benefits to the mother outweigh the potential risk to the fetus or breastfed infant.

Driving and using machines

Oftagel, eye gel, may temporarily blur vision. Before driving or operating machinery, the patient should wait until their vision clears.

Oftagel contains benzalkonium chloride

The medicine contains approximately 0.002 mg of benzalkonium chloride per drop, which corresponds to 0.06 mg/g. Benzalkonium chloride may be absorbed by soft contact lenses and change their color. The patient should remove their contact lenses before administering the drops and wait at least 15 minutes before putting them back. Benzalkonium chloride may also cause eye irritation, especially in patients with dry eye syndrome or corneal disorders (the transparent layer at the front of the eye). If the patient experiences any abnormal sensations in the eye, stinging, or pain after using this medicine, they should contact their doctor.

3. How to use Oftagel

This medicine should always be used exactly as described in the patient information leaflet or as directed by a doctor, pharmacist, or nurse. In case of doubt, the patient should consult their doctor, pharmacist, or nurse. Adults (including the elderly): The recommended dose of Oftagel is 1 drop into the conjunctival sac 1 to 4 times a day, depending on the severity of the symptoms. Use in children and adolescents: The safety and efficacy of Oftagel in children and adolescents at the recommended dose for adults have been established based on clinical experience, however, there are no available data from clinical trials. If the patient feels that the effect of Oftagel is too strong or too weak, they should consult their doctor. Before administering Oftagel, the patient should wash their hands. To avoid contaminating the bottle, the patient should not touch the tip of the dropper to the eye or its surroundings or any other surface. The patient should tilt their head back, gently pull down the lower eyelid, and put a drop of the medicine into the conjunctival sac between the lower eyelid and the eye. After each use, the patient should close the bottle. The bottle is for individual use.

4. Possible side effects

Like all medicines, Oftagel can cause side effects, although not everybody gets them. After administering the medicine, the patient may temporarily experience blurred vision, burning, or local irritation.

Reporting side effects

If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should inform their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181 C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder. By reporting side effects, it is possible to gather more information on the safety of the medicine.

5. How to store Oftagel

The medicine should be stored out of sight and reach of children. Do not use this medicine after the expiry date stated on the label. The expiry date refers to the last day of the month. After opening the bottle, the medicine retains its potency for 28 days. After this period, the medicine should be discarded in accordance with local regulations. Store in a temperature below 25°C. Do not freeze. Protect from light. Between administrations, the bottle should be stored in the carton in an inverted position to facilitate administration of the gel. Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Oftagel contains

• The active substance of Oftagel is carbomer. 1 g of gel contains 2.5 mg of carbomer.
• The other ingredients are benzalkonium chloride, sorbitol, lysine monohydrate, sodium acetate trihydrate, polyvinyl alcohol, and water for injections.

What Oftagel looks like and contents of the pack

Oftagel, eye gel, is a clear or slightly opalescent solution. Oftagel, eye gel, is packaged in transparent polyethylene bottles with a dropper for the eyes and a white polyethylene cap. Pack size: 10 g bottle

Marketing authorization holder and manufacturer

Marketing authorization holder

Santen Oy, Niittyhaankatu 20, 33720 Tampere, Finland

Manufacturer

Santen Oy, Kelloportinkatu 1, 33100 Tampere, Finland

Date of last revision of the leaflet: