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Oftagel gel for eyes 2.5 mg / 10 g.

Product Code: Oftagel gel for eyes 2.5 mg / 10 g.
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What OFTAGEL is and what it is used for
OFTAGEL is a tear substitute and contains carbomer. Carbomer increases the viscosity of the eye drops and prolongs their contact time with the eye, thus reducing irritation in the eye.

OFTAGEL eye gel is intended for use when the eye's own tear production is reduced or blocked so that drying of the cornea causes symptoms on the surface of the eye (such as pain, burning, irritation or dryness). Important properties of products designed to alleviate the symptoms of "dry eye" are: maintaining the integrity of the tear layer, protecting the eye and good lubricating properties.

2. What you need to know before you use Oftagel
Do not use OFTAGEL
if you are allergic to carbomer or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor or pharmacist before using OFTAGEL.

Children and adolescents
The safety and efficacy of OFTAGEL eye gel in children and adolescents at the recommended dose for adults have been established in clinical experience, but data from clinical studies are lacking.

Other medicines and OFTAGEL
You should tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.

When using more than one ophthalmic medicinal product, the medicines should be applied at intervals of at least 15 minutes, with OFTAGEL applied last.

Pregnancy, lactation and fertility
The safety of OFTAGEL in pregnant and lactating women has not been specifically studied. If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before using this medicine.

Driving and using machines
Oftagel can temporarily reduce visual acuity. You should not drive or operate machinery until normal vision is restored.

Oftagel contains benzalkonium chloride
This medicine contains about 0.002 mg of benzalkonium chloride in each drop, which is equivalent to 0.06 mg/g.

Benzalkonium chloride can be absorbed by soft contact lenses and can change the color of the lenses. You should remove your contact lenses before using this medicine and wait at least 15 minutes before putting them back in.

Benzalkonium chloride can also cause eye irritation, especially if you have "dry eye" or a disorder of the cornea (the clear layer at the front of the eye). If you have an unusual sensation in the eye, such as burning or pain in the eye after using this medicine, talk to your doctor

3. How to use OFTAGEL
Always use OFTAGEL exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.

One drop of OFTAGEL is placed in the eye from 1 to 4 times a day, depending on the severity of the symptoms.

Use in children and adolescents
The safety and efficacy of OFTAGEL eye gel in children and adolescents at the recommended dose for adults have been established in clinical experience, but data from clinical studies are lacking.

Instructions for use
Wash your hands before applying Oftagel. Tilt your head back.
Pull the lower lid down gently and place one drop in the space between the lower lid and the eye. Do not touch the eye or eyelid with the tip of the bottle.
Close the bottle. Remember that the eye gel bottle is always for personal use only. If you have any further questions related to the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.

Temporary blurring of vision, slight burning or local irritation in the eye may occur when using OFTAGEL.
5. How to store OFTAGEL
Keep out of the reach of children.

Do not use this medicine after the expiry date which is stated on the bottle and carton. The expiration date corresponds to the last day of the specified month.

The shelf life of the opened bottle is one month.

To be stored below 25°C. Store the bottle in the carton in order to protect from light.

Between individual applications, store the bottle upside down in the carton for easier use of the gel.

Do not dispose of medicines down the drain or in the household waste container. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help protect the environment.

6. Contents of the package and additional information
What OFTAGEL contains
Active substance: carbomer 2.5 mg/g.
Excipients: benzalkonium chloride, sorbitol, lysine monohydrate, sodium acetate trihydrate, polyvinyl alcohol and water for injections.
What OFTAGEL looks like and what it contains
OFTAGEL is a clear or slightly opalescent viscous solution packaged in a transparent polyethylene bottle containing 10 g of gel.

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