Prospect: information for the patient

Olopatadina Abamed1 mg/ml eye drop solution

Olopatadina

Read the entire prospect carefully before starting to use this medication, because it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed only to you, and you must not give it to other people even if they have the same symptoms as you, as it may harm them.
• If you experience adverse effects, consult your doctor or pharmacist, even if they do not appear in this prospect. See section 4.

Content of the prospect

1. What Olopatadina Abamed is and for what it is used
2. What you need to know before starting to use Olopatadina Abamed
3. How to use Olopatadina Abamed
4. Possible adverse effects
5. Storage of Olopatadina Abamed

Contents of the package and additional information

Olopatadina Abamed belongs to the group of medications used for the treatment of allergic eye conditions. It acts by reducing the intensity of the allergic reaction.

Olopatadina Abamed is indicated for the treatment of the signs and symptoms of seasonal allergic conjunctivitis.

In seasonal allergic conjunctivitissome elements (called allergens) such as pollen, household dust, or pet hair can cause allergic reactions that lead to itching and redness, as well as inflammation of the surface of their eyes.

Do not use Olopatadina Abamed

- If you are allergic (hypersensitive) to olopatadine or to any of the other components of this medication (listed in section 6).

- If you are breastfeeding.

Warnings and precautions

Consult your doctor or pharmacist before starting to use Olopatadina Abamed.

If you wear contact lenses, you must remove them before using Olopatadina Abamed.

Children

Do not administer this medication to children under 3 years of age, as its safety and efficacy have not been established.

Using Olopatadina Abamed with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

If you are using another eye drop or ointment, wait at least 5 minutes between the application of each medication. Eye ointments should be administered last.

Pregnancy, breastfeeding, and fertility

If you are pregnant, think you may be pregnant, or intend to become pregnant, consult your doctor or pharmacist before using this medication.

Do not use Olopatadina Abamed if you are breastfeeding, consult your doctor before using this medication.

Driving and operating machinery

Immediately after applying Olopatadina Abamed, you may notice that your vision is blurry. Do not drive or use machines until this effect has disappeared.

Olopatadina Abamed contains benzalkonium chloride, which may:

• cause eye irritation
• change the color of soft contact lenses

It is recommended:

• to avoid contact with soft contact lenses

to remove contact lenses before applying the eye drop and wait at least 15 minutes before reinserting them.

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again. Remember to use your medication.

The recommended dose is one drop in one eye or in both eyes, two times a day: in the morning and in the afternoon.

Use this amount unless your doctor tells you otherwise. Olopatadina Abamed should only be applied in both eyes if your doctor has instructed you to do so. Follow the treatment for the period of time indicated by your doctor.

Remember that this medication should only be applied in the eyes.

Instructions for the proper use of Olopatadina Abamed:

To facilitate the application of the eye drops, it may be helpful to sit in front of a mirror the first few times, so you can see what you are doing.

If a drop falls outside the eye, try again.

If you use more Olopatadina Abamed than you should

If you have administered too much Olopatadina Abamed in your eyes, you can remove it by rinsing your eyes with warm water. In that case, do not administer more drops until the next application.

In case of accidental ingestion, consult your doctor immediately, the nearest hospital emergency room, or call the Toxicological Information Service (91) 562 04 20, indicating the medication and the amount administered.

If you forget to use Olopatadina Abamed

Apply one drop of eye drops as soon as you remember and administer the next dose at your usual time.

However, if it is almost time for the next dose, do not apply the missed dose and continue with the next dose. Do not apply a double dose to make up for the missed dose.

If you interrupt treatment with Olopatadina Abamed

Do not stop using this medication without first consulting your doctor.

If you have any other questions about the use of this medication, consult your doctor or pharmacist.

Like all medications, Olopatadina Abamed may produce adverse effects, although not everyone will experience them.

The adverse effects observed during the use of this eye drop are:

Frequent(may affect up to 1 in 10 people):

• Eye effects: eye pain, eye irritation, dry eye, abnormal sensation in the eye, eye discomfort.
• General effects: headache, fatigue, dry nose, bad taste in the mouth.

Less frequent(may affect up to 1 in 100 people):

• Eye effects:blurred, decreased, or abnormal vision, corneal alteration, inflammation of the eye surface with or without damage to the surface, conjunctival infection or inflammation, eye discharge, light sensitivity, increased tear production, eye itching, eye redness, abnormality in the eyelid, itching, redness, swelling, or crust on the eyelid.
• General effects:diminished or abnormal perception of stimuli, dizziness, runny nose, dry skin, skin inflammation.

Frequency not known(cannot be estimated from available data):

• Eye effects:eye swelling, corneal swelling, change in pupil size.
• General effects:difficulty breathing, increased allergic symptoms, facial swelling, numbness, generalized weakness, nausea, vomiting, paranasal sinus infection, skin redness and itching.

In very rare cases, some patients with severe injury to the transparent layer at the front of the eye (the cornea) have developed dark spots on the cornea due to calcium accumulation during treatment.

Reporting Adverse Effects

If you experienceany type of adverse effect, consult your doctor or pharmacist, even if it ispossibleadverse effects that do not appear in this prospectus.You can also report them directly to theSpanish System for Pharmacovigilance of Medicinal Products for Human Use:www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

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

No special storage conditions are required.

To prevent infections, discard the bottle four weeks after it has been opened for the first time and use a new bottle. Note the opening date in the space provided on the label of each bottle and on the box.

Do not usethis medication afterthe expiration date that appears on the bottle (after CAD.:). The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Deposit containers and medications that you no longer need at the SIGREpointofyour pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medications that you no longer need. By doing so, you will help protect the environment.

Composition of olopatadina abamed

- The active principle is olopatadina. Each milliliter of eye drops contains 1 mg of olopatadina (as hydrochloride).

- The other components are benzalkonium chloride, sodium chloride, disodium dodecahydrogenephosphate (E-339), hydrochloric acid (E-507) and/or sodium hydroxide (E-524) and injection water.

Appearance of the product and content of the container

Olopatadina Abamed is a colorless, transparent solution. Each bottle contains 5 ml of eye drops.

Holder of the marketing authorization:

Qualix Pharma, S.L

c/ Botánica, 137-139

08908 L’Hospitalet de Llobregat

(Barcelona)

Spain

Responsible for manufacturing:

Labiana Pharmaceuticals, S.L.U.

c/ Casanova 27-31

08757 Corbera de Llobregat

(Barcelona)

Spain

Date of the last review of this leaflet:November 2018

The detailed and updated information of this medicine is available on the webpage of the Spanish Agency of Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/