0.12 mg/ml eye drops, solution 
naphazoline hydrochloride

Read all of this leaflet carefully before you start using this medicine. It contains information that is important to you.

Cleari 0.12 mg/ml eye drops, the solution is called Cleari throughout this package leaflet.

– Save this information, you may need to read it again.

– Contact the pharmacy staff if you need more information or advice.

– If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.

– Stop using the drops and contact a doctor if you do not get better or the condition worsens after 24 hours.

In this leaflet: 
1. What Cleari is and what it is used for 
2. What you need to know before you use Cleari 
3. How to use Cleari 
4. Possible side effects 
5. How to store Cleari 
6. Contents of the packaging and other information 

1. What Cleari is and what it is used for

This medicine contains the active substance naphazoline hydrochloride which belongs to a group of medicines called local vasoconstrictors. These drugs work by narrowing the blood vessels in the eye and thereby reducing redness and swelling.

Cleari is an eye drop solution. It is used to relieve temporary, mild redness and irritation of the eyes.

Cleari starts to work within a few minutes and the effect lasts for at least 3 hours.

This product is intended for temporary use only.

Cleari can be used by adults and children from 12 years.

Naphazoline hydrochloride contained in Cleari may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions and always follow their instructions.

2. What you need to know before using Cleari

Do not use Cleari

– if you are allergic to naphazoline hydrochloride or any of the other ingredients of this medicine (listed in section 6)

– if you have increased pressure inside the eyeball ( glaucoma )

– if the ventricular angle in your eyes is narrow (you are at risk of acute glaucoma )

– if you have damage to the cornea (the outer membrane of the eye)

– if you have inflammation of the iris (the colored part of the eye)

If your eyes have a tendency to a narrow ventricular angle, do not use this product before a peripheral iridectomy (surgery to treat glaucoma , which removes part of the iris).

Warnings and cautions

This product is intended for temporary use only and should not be used for more than 7 consecutive days.

After prolonged or excessive use, naphazoline chloride may not work as effectively or may make redness worse.

Talk to your doctor or pharmacist before using Cleari if you have an eye disease that causes the following symptoms: constant redness, pain, or blurred vision.

Children

Cleari is not recommended for children under 12 years of age.

Other drugs and Cleari

You should wait about 15 minutes between using Cleari and any other product in the eye. Any eye ointment should always be used last.

Use of contact lenses

Cleari contains benzalkonium chloride, which is known to discolor soft contact lenses. Remove the contact lenses before using these eye drops. You can insert your lenses for about 15 minutes after applying the drops to the eyes.

Pregnancy, breastfeeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

If you get blurred vision, do not drive or use machines until your vision is clear.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

Cleari contains benzalkonium chloride

This product contains benzalkonium chloride which may cause eye irritation in some people. If you are sensitive to this ingredient, do not use this product.

3. How to use Cleari

Always use this medicine exactly as described in this leaflet or as directed by your pharmacist. If you are not sure, talk to a pharmacist.

This medicine is for eye use only.

Instructions for use:

Adults and children from 12 years:

• Wash your hands before use.

• Do not allow the drip tip to touch anything.

Drop-in 1 or 2 drops in each eye 2 or 3 times daily.

This product is intended for temporary use only and should not be used for more than 7 consecutive days.

Stop using the drops and contact a doctor if you do not get better or if the condition worsens after 24 hours.

Overuse can cause increased redness in the eye. If this happens, stop using the eye drops. Contact a doctor if the redness does not disappear.

4. Possible side effects

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

After using the eye drops, you may occasionally notice a slight irritation such as burning, slightly blurred vision, or slight dilation of the pupil (the black ring in the middle of the eye). These side effects are expected and temporary.

You should stop using this medicine and contact a doctor if you experience eye pain, vision changes, photosensitivity, continued redness or irritation of the eye, if you do not get better or if the condition worsens after 24 hours.

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 to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information. 

5. How to store Cleari

The bottle is stored at a maximum of 25 ° C.

Store in a cold place. Do not freeze.

Dispose of any unused contents one month after opening the bottle.

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

Do not use this medicine if the solution changes color or becomes cloudy.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

– The active substance is naphazoline hydrochloride 0.12 mg/ml.

The other ingredients are benzalkonium chloride solution, boric acid (E284), borax (E285), disodium edetate and purified water

What the medicine looks like and the contents of the pack

The eye drop solution is a clear, colorless liquid provided in a white HDPE plastic bottle with an LDPE plastic drip tip and polypropylene plastic cap. Each bottle contains 5 ml.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Clear Eyes Pharma Limited, 46 High Street, Yatton, Somerset BS49 4EQ, UK.

Agent

Evolan Pharma AB, Danderyd

Manufacturer

Tubilux Pharma SpA, Via Costarica 20/22, 00071 Pomezia (Rome), Italy.

Muhammad Nadeem

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