Package Insert: Information for the Patient

Xorox 30 mg/g Ophthalmic Ointment

Active Ingredient: Aciclovir

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

• Keep this package insert. 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 be harmful, even if they have the same symptoms of disease as you.
• If you experienceadverse effects, consult your doctor or pharmacist. This includes possible secondary effects not mentioned in this package insert. See section 4.

1. What is Xoroxand for what it is used

2. What you need to know before starting to useXorox

3. How to useXorox

4. Possible adverse effects

5. Storage of Xorox

6. Contents of the package and additional information

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

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

Do not use Xorox,

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

Warnings and precautions

Speak with 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 on 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 use contact lenses during treatment with this medication

Children and adolescents

The same as in adults.

Other medications and Xorox

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

No significant interactions have been observed to date when applied locally in the eyes.

However, there is insufficient information on the use of this medication simultaneously with the use of eye medications containing corticosteroids. The doctor will decide if it is appropriate for you.

Pregnancy and breastfeeding

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

This medication can be used during pregnancy and breastfeeding, as the recommended doses are not expected to have any side effects on the fetus or newborn.

Driving and operating machinery

Due to its characteristics, this medication may cause blurred vision immediately after application. Do not drive or use machinery until this effect has disappeared.Therefore, special care should be taken when driving, working in hazardous locations, and using machinery.

Usage Instructions

For ophthalmic use (eyes)

Use this medication exactly as directed by your doctor. If you are unsure, consult your doctor or pharmacist.

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

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

Pull the lower eyelid downwards and place the ointment strip inside the conjunctival sac. Close your eyes and rotate the eyeball to distribute the ointment better.

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

Use in children and adolescents

The same as in adults.

If you use more Xorox than you should

This medication is for use in the eyes. If you ingest a part, consult your doctor or pharmacist. In case of overdose or accidental ingestion, consult your doctor or pharmacist or call the Toxicological 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 the next application is almost due, ignore the missed application. Do not use a double dose to compensate for the missed dose.

If you stop using Xorox

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

Like all medications,this medicationmay cause side effects, although not everyone experiences them.

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

Allergic Reactionsvery rare (may affect fewer 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:

?skin rash, itching, or hives

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

?difficulty breathing, wheezing, or respiratory problems

?Fever (high temperature) without explanation and feeling weak, especially when standing.

Other side effects include:

Very frequent (may affect more than 1in10 people):

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

This usually does not require discontinuing treatment and improves immediately

Infrequent (may affect more than 1in100 people):

mild sensation of burning or irritation that occurs immediately after application

swollen eyes, tearing (conjunctivitis)

Rare (may affect more than 1in1000 people):

swollen, red, irritated, itchy eyelids (blepharitis)

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

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this prospectus. You can also report it directly to theSpanish System of Pharmacovigilance of

Medicines for Human Use:www.notificaRAM.es

By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

Conservebelow 25 °C.

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

Do not use this medicationafterthe expiration date that appears on the label and packaging. The expiration date is the last day of the month indicated.

Do not use it for more than 4 weeksafter openingfor the first time.

Medicines should not be disposed of through drainsnor intrash. Dispose of packaging and medications that you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications that you no longer need. By doing so, you will help protect the environment.

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 content of the packaging

1 box contains an aluminium tube with a nozzle (tip) and a white polyethylene cap with 4.5 g of white to greyish white ointment.

Holder of the marketing authorization and manufacturer

AGEPHA Pharma s.r.o

Dialnicná cesta 5

Senec

903 01

Slovakia

This leaflet was last reviewed in: March2019

Detailed and updated information on this medicine is available on the website of the Spanish Agency of Medicines and Medical Products (AEMPS)shttp://www.aemps.gob.es/