XOROX 30 MG/G OPHTHALMIC OINTMENT

Introduction

Patient Information Leaflet

Xorox 30 mg/g Ophthalmic Ointment

Active ingredient: Aciclovir

Read this entire leaflet carefully before starting to use this medication, as it will provide you with important information.

• Keep this leaflet. You may need to read it again.
• If you have questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you. Do not pass it on to others. It may harm them, even if they have the same symptoms of illness as you.
• If you experience side effects, consult your doctor or pharmacist. This includes possible side effects not mentioned in this leaflet. See section 4.

Contents of the Leaflet

1. What Xorox is and what it is used for
2. What you need to know before starting to use Xorox
3. How to use Xorox
4. Possible side effects
5. Storage of Xorox
6. Package contents and additional information

1. What Xorox is and what it is used for

This medication contains a medicine called aciclovir, which belongs to a group of medicines called antivirals.

It is used to treat eye infections caused by the Herpes simplex virus. It works by eliminating or stopping the growth of viruses in the front part of the eyeball (cornea).

2. What you need to know before starting to use Xorox

Do not use Xorox,

• If you are allergic to aciclovir or valaciclovir or any of the other ingredients of this medication (listed in Section 6).

Warnings and precautions

Talk to your doctor or pharmacist before using this medication.

• Use this medication only in the eyes.
• You may experience a mild sensation of burning or stinging immediately after application.
• Immediate hypersensitivity reactions, including angioedema, facial swelling, etc., may occur. Contact a doctor immediately if you experience these hypersensitivity reactions.
• If you experience allergic reactions such as itching of the eyelids, swelling, or redness of the eyes, discontinue treatment with this medication and consult a doctor.
• Contact a doctor immediately for advice if any of the symptoms worsen or recur.

Do not wear contact lenses during treatment with this medication.

Children and adolescents

Same as in adults.

Other medications and Xorox

Tell your doctor or pharmacist if you are using, have recently used, or might use other medications.

No significant interactions have been observed so far when applied locally to the eyes.

However, there is not enough information on the use of this medication simultaneously with the use of ophthalmic medications containing corticosteroids. Your doctor will decide if it is suitable for you.

Pregnancy and breastfeeding

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

This medication can be used during pregnancy and breastfeeding, as no side effects are expected during pregnancy, for the fetus, or the newborn, with the recommended doses.

Driving and using machines

Due to its characteristics, this medication may cause blurred vision immediately after application. Do not drive or use machines until this effect has disappeared. Therefore, be especially careful when driving, working in unsafe places, and using machines.

3. How to use Xorox

Instructions for use

For ophthalmic use (eyes)

Always use this medication exactly as your doctor has told you. If you are not sure, consult your doctor or pharmacist.

Unless your doctor has given you other instructions, the recommended dose is:

Apply a 1 cm strip of ointment into the lower conjunctival sac 5 times a day (every 4 hours). The suggested times are: 7:00, 11:00, 15:00, 19:00, and 23:00.

Pull the lower eyelid down and place the strip of ointment inside the conjunctival sac. Close your eyes and rotate the eyeball so that the ointment is distributed better.

It is very important that you apply this medication during the day at regular 4-hour intervals to ensure the success of the treatment. Once the corneal inflammation has healed, you should continue treatment for at least 3 more days.

Use in children and adolescents

Same as in adults.

If you use more Xorox than you should

This medication is for use in the eyes. If you swallow some, consult your doctor or pharmacist. In case of overdose or accidental ingestion, consult your doctor or pharmacist or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to use Xorox

If you forget to use this medication, use it as soon as you remember. However, if it is almost time for the next application, skip the missed application. Do not use a double dose to make up for the missed dose.

If you stop using Xorox

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone gets them.

Immediately after applying the ointment to the eye, a mild sensation of stinging or burning may occur. If you experience facial swelling, angioedema, etc., discontinue use of this medication and consult your doctor immediately.

Allergic reactionsvery rare (may affect less than 1 in 10,000 people)

If you have an allergic reaction or acute hypersensitivity reactions, discontinue use of this medication and consult your doctor immediately.

The symptoms may include:

? rash, itching, or hives on the skin

? swelling of the face, lips, tongue, or other parts of the body

? difficulty breathing, wheezing, or breathing problems

? fever (high temperature) without explanation and feeling of weakness, especially when standing.

Other side effects include:

Very common (may affect more than 1 in 10 people):

burning or irritation, photophobia/sensitivity to light, or feeling of having something in the eye (superficial punctate keratopathy)

This usually does not require discontinuation of treatment and improves immediately.

Uncommon (may affect more than 1 in 100 people):

mild sensation of burning or stinging that occurs immediately after application.

swollen eyes, tearing (conjunctivitis)

Rare (may affect more than 1 in 1,000 people):

swollen, red, irritated eyes, itching of the eyelids (blepharitis)

If any of these effects worsen, or if you notice side effects not mentioned in this leaflet, consult your doctor or pharmacist.

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are possible side effects not listed in this leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency (AEMPS) website: http://www.aemps.gob.es/

By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Xorox

Store below 25 °C.

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date stated on the label and packaging. The expiration date is the last day of the month indicated.

Do not use it for more than 4 weeks after opening it for the first time.

Medications should not be disposed of via wastewater or household waste. Deposit the packaging and any unused medication in the pharmacy's SIGRE point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Package contents and additional information

What Xorox contains:

• The active substance is aciclovir. 1 g of ointment contains 30 mg of aciclovir. The excipient is white soft paraffin.

Appearance of Xorox and package contents

1 box contains an aluminum tube with a cannula (tip) and a white polyethylene cap with 4.5 g of white to grayish-white ointment.

Marketing authorization holder and manufacturer

AGEPHA Pharma s.r.o.

Dialnicná cesta 5

Senec

903 01

Slovakia

This patient information leaflet was last revised in: March2019

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS) http://www.aemps.gob.es/