Skip to Content

OLOPATADINE ZENTIVA 1 MG/ML EYE DROPS SOLUTION

Active substance(s): OLOPATADINE HYDROCHLORIDE

View full screen / Print PDF » Download PDF ⇩
Transcript
EPAR update

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
Olopatadine 1mg/ml eye drops, solution
Read all of this leaflet carefully before you start using this medicine because it
contains important information for you.
 Keep this leaflet. You may need to read it again.
 If you have any further questions, ask your doctor or pharmacist
 This medicine has been prescribed for you only. Do not pass it on to others. It may
harm them, even if their signs of illness are the same as yours.
 If you get any side effects, gets serious, 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 is and what it is used for
2. What you need to know before you use Olopatadine
3. How to use Olopatadine
4. Possible side effects
5. How to store Olopatadine
6. Contents of the pack and other information
1.

WHAT OLOPATADINE IS AND WHAT IT IS USED FOR

Olopatadine 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 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

Do not use Olopatadine:
 if you are allergic to olopatadine or any of the other ingredients of this medicine
(listed in section 6).
Warnings and precautions
Talk to your doctor or pharmacist before using Olopatadine.
You should remove the contact lenses that are in your eyes before using Olopatadine.
Children
Do not use Olopatadine in children under the age of 3 years. Do not give this medicine to
children under 3 years of age because there is no data to indicate that it is safe and works in
children under 3 years.

EPAR update

Other medicines and Olopatadine
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, think you may be pregnant or planning to have a baby, talk to your
doctor or pharmacist for advice before using this medicine.
You should not use Olopatadine if you are breastfeeding. 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. Do not
drive or use machines until this has worn off.
Olopatadine contains benzalkonium chloride
Benzalkonium chloride may cause eye irritation and is known to discolour soft contact
lenses, therefore contact with soft contact lenses should be avoided. If you wear contact
lenses you should remove contact lenses prior to application and wait at least 15 minutes
before putting your lenses back in.
3.

HOW TO USE OLOPATADINE

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 in both
eyes if your doctor told you to. Use it for a long as your doctor told you to. Only use
Olopatadine as an eye drop.
Instructions on using Olopatadine


Get the Olopatadine bottle and a mirror.



Wash your hands.



Take the bottle and twist off the cap.



Hold the bottle, pointing down, between your thumb and middle finger.



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.



Bring the bottle top close to the eye. Use the mirror if it helps.

EPAR update



Don’t touch your eye or eyelid, surrounding areas or other surfaces with the dropper. It
could infect the drops left in the bottle.



Gently press on the base of the bottle to release one drop of Olopatadine at a time.



Don’t squeeze the bottle, it is designed so that just a gentle press on the bottom is
needed.



If you use drops in both eyes, repeat the steps for your other eye.



Put the bottle cap back on firmly immediately after use.



Use up one bottle before opening the next bottle.



If a drop misses your eye, try again.

If you use more Olopatadine 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
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
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:
Common side effects (may affect up to 1 in 10 people)
Effects in the eye: eye pain or swelling, eye irritation, dry eye, abnormal eye sensation, eye
discomfort
General side effects: headache, fatigue, dry nose, bad taste.
Uncommon side effects (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.

EPAR update

General side effects: shortness of breath, increased allergic symptoms, facial swelling,
drowsiness, generalised 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: www.mhra.gov.uk/yellowcard. By reporting side effects, you can help
provide more information on the safety of this medicine.
5.

HOW TO STORE OLOPATADINE

Keep this medicine out of the sight and reach of children.
Store in the original package in order to protect from light.
Do not use this medicine after the expiry date which is stated on the label (EXP). The
expiry date refers to the last day of that month.
You must 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 use this medicine if you notice a change in colour or smell.
Do not throw away any medicines via wastewater 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 contains:



The active substance is olopatadine 1mg/ml (as hydrochloride).
The other ingredients are benzalkonium chloride; hydrochloric acid (E507) (for pH
adjustment); disodium phosphate dodecahydrate (E339); sodium chloride; water for
injections.

What Olopatadine looks like and contents of the pack:
Clear to almost clear colourless solution, practically free from particles.
5 ml opaque LDPE bottle with LDPE dropper and HDPE tamper-proof screw-cap.
1 x 5 ml (1 bottle, which contains 5 ml of solution).
Marketing Authorisation Holder and Manufacturer
Zentiva, One Onslow Street, Guildford, Surrey, GU1 4YS, UK
This medicinal product is authorised in the Member States of the EEA under the
following names:
Cyprus and Poland: OLOPATADINE Zentiva,
United Kingdom: Olopatadine Zentiva 1 mg/ml eye drops solution
Czech Republic: OLOPATADINE Zentiva 1 mg/ml
Bulgaria: Олопатадин Зентива 1 mg/ml капки за очи, разтвор

EPAR update

Romania: OLOPATADINĂ Zentiva 1mg/ml picături oftalmice, soluţie
This leaflet was last revised in 07/2014

Expand view ⇕

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide