OLOPATADINE 1 MG / ML EYE DROPS SOLUTION - patient leaflet, side effects, dosage

if you get any side effects, talk to your doctor or pharmacist. this includes any possible side effects not listed in this leaflet. see section 4.

What is in this leaflet

• 1. What Olopatadine Eye drops, Solution is and what it is used for

• 2. What you need to know before you use Olopatadine Eye drops, Solution

• 3. How to use Olopatadine Eye drops, Solution

• 4. Possible side effects

• 5. How to store Olopatadine Eye drops, Solution

• 6. Contents of the pack and other information

1. what olopatadine eye drops, solution is and what it is used for

Olopatadine Eye drops, Solution is used for the treatment of signs and symptoms of seasonal allergic conjunctivitis.

Allergic conjunctivitis. Some materials (allergens) like pollens, house dust or animal fur may cause allergic reactions resulting in itching, redness as well as swelling of the surface of your eye.

Olopatadine Eye drops, Solution is a medicine for treatment of allergic conditions of the eye. It works by reducing the intensity of the allergic reaction.

2. what you need to know before you use olopatadine eye drops, solution

Do not use Olopatadine Eye drops, Solution:

• If you are allergic (hypersensitive) to olopatadine or any of the other ingredients of this medicine (listed in section 6).
• You should not use Olopatadine Eye drops, Solution if you are breast-feeding.

Warning and precautions

Talk to your doctor, pharmacist before taking Olopatadine Eye drops, Solution.

You should remove contact lenses that are in your eyes before using Olopatadine Eye drops, Solution.

Children

• Do not use Olopatadine Eye drops, Solution in children under the age of 3 years. Do not give this medicine to children under the ages of 3 years because there is no data to indicate that it is safe and work in children under 3 years.

Other medicines and Olopatadine eye drops

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

If you are using other eye drops or eye ointment medicines, leave at least 5 minutes between each medicine. Eye ointments should be administered last.

Pregnancy, breast-feeding 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 using this medicine.

You should not use Olopatadine Eye drops, Solution if you are breast-feeding, ask your doctor for advice before using this medicine.

Driving and using machines

You may find that your vision is blurred for a time just after you use Olopatadine Eye drops, Solution. Do not drive or use machines until this has worn off.

Olopatadine Eye drops, Solution contains Benzalkonium chloride

This medicine contains 0.1 mg benzalkonium chloride in each ml.

Benzalkonium chloride may be absorbed by soft contact lenses and may change the colour of the contact lenses. You should remove contact lenses before using this medicine and put them back 15 minutes afterwards.

Benzalkonium chloride may also cause eye irritation, especially if you have dry eyes or disorders of the cornea (the clear layer at the front of the eye). If you feel abnormal eye sensation, stinging or pain in the eye after using this medicine, talk to your doctor.

3. how to use olopatadine eye drops

Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

The recommended dose is one drop in the eye or eyes, twice a day – morning and evening.

Use this much unless your doctor tells you to do differently. Only use Olopatadine Eye drops, Solution in both eyes if your doctor told you to. Use it for as long as your doctor told you to.

Olopatadine Eye drops, Solution should only be used as an eye drop.

INSTRUCTIONS FOR USE

Using the dropper bottle for the first time:

Opening the dropper bottle before first use

• 1. Check to make sure that the tamper evident ring between the dropper bottle and the cap is not broken (See Fig. 1). You must not use the bottle if the tamper evident ring on the bottle neck is broken.

• Bring the dropper bottle tip close to the eye. Use the mirror if it helps.
• Don't touch your eye or eyelid, surrounding areas or other surfaces with the dropper. It could infect the drops left in the dropper bottle.
• Gently press on the base of the dropper bottle to release one drop of Olopatadine eye drops at a time.
• Don't squeeze the dropper bottle; it is designed so that just a gentle press on the bottom is needed (picture 2).

2

• If you use drops in both eyes, repeat the steps for your other eye.
• Put the dropper bottle cap back on firmly immediately after use.

If a drop misses your eye, try again.

If you use more Olopatadine Eye drops, Solution than you should

Rinse it all out with warm water. Do not put in any more drops until it's time for your next regular dose.

If you forget to use Olopatadine Eye drops, Solution

Use a single drop as soon as you remember, and then go back to your regular dosing routine.

However, if it is almost time for your next dose, skip the missed dose before going back to your regular dosing routine. Do not use a double dose to make up for the one missed.

If you stop using Olopatadine Eye drops, Solution

Do not stop using this medicine without first speaking to your doctor.

If you have any further questions on 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.

The following side effects have been seen with Olopatadine Eye drops, Solution

Common: may affect up to 1 in 10 people

Effects in the eye: eye pain, eye irritation, dry eye, abnormal eye sensation, eye discomfort

General side effects: headache, fatigue, dry nose, bad taste

Uncommon: may affect up to 1 in 100 people

Effects in the eye : blurred, reduced, or abnormal vision, corneal disorder, eye surface inflammation with or without surface damage, inflammation or infection of the conjunctiva, eye discharge, sensitivity to light, increased tear production, itchy eye, redness of the eye, eyelid abnormality, itching, redness, swelling, or crusting of the eyelid.

General side effects: abnormal or decreased sensation, dizziness, runny nose, dry skin, skin inflammation.

Not known: frequency cannot be estimated from the available data

Effects in the eye: eye swelling, corneal swelling, change in pupil size

General side effects: shortness of breath, increased allergic symptoms, facial swelling, drowsiness, generalized weakness, nausea, vomiting, sinus infection, skin redness and itching.

In very rare cases, some patients with severe damage to the clear layer at the front of the eye(the cornea) have developed cloudy patches on the cornea due to calcium build-up during treatment.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

5. how to store olopatadine eye drops, solution

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the bottle and the box after ‚Exp.‘. The expiry date refers to the last day of the month.

This medicine does not require any special storage conditions.

You should throw away the bottle four weeks after you first opened it to prevent infections, and use a new bottle. Write down the date you opened it in the space on each bottle label and box.

Do not throw away medicines via waste water or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. contents of the pack and other information

What Olopatadine Eye drops, Solution contains

The active substance is olopatadine.

Each mL of solution contains 1 mg of olopatadine (as hydrochloride ).

The other ingredients are: benzalkonium chloride, sodium chloride, disodium phosphate anhydrous (E339), water for injections, hydrochloric acid (E507) and/or sodium hydroxide (E524) (for pH adjustment).

What Olopatadine Eye drops, Solution looks like and contents of the pack

Olopatadine Eye drops, Solution is a clear colourless solution practically free from particles supplied in a pack containing either one 5 ml plastic dropper bottle or three 5 ml dropper bottles with screw caps. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Brown and Burk UK Ltd

5 Marryat Close, Hounslow West, Middlesex, TW4 5DQ

United Kingdom

This leaflet was last revised in <{MM/YYYY}>

• 2. Before opening the bottle for the first time, tear off the tamper evident ring to break the seal (See Fig. 2).

  
  

• 3. To open the dropper bottle, remove the cap by turning it in the counterclockwise direction (See Fig. 3).

  
  

• 4. Tighten the cap on the container after every use (Fig.4).

  
  

Using your eye drops

• Wash your hands.
• Tilt your head back. Pull down your eyelid with a clean finger, until there is a ‚pocket‘ between the eyelid and your eye. The drop will go in here (picture 1).

BBUK Code Artwork Code

Size: 110 × 560 mm

Front Size