Leaflet: information for the user

Aciclovir Brill Pharma 30 mg/g ophthalmic ointment

Read this leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1. What Aciclovir Brill Pharma is and what it is used for

2. What you need to know before using Aciclovir Brill Pharma

3. How to use Aciclovir Brill Pharma

4. Possible side effects

5. Storage of Aciclovir Brill Pharma

6. Contents of the pack and additional information

This medication contains aciclovir, an active ingredient that belongs to a group of medicines called antivirals.

It is indicated for the treatment of keratitis (inflammation of the cornea) caused by the herpes simplex virus.

Do not use Aciclovir Brill Pharma

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

If you think this applies to you, do not use this medication until you consult with your doctor.

Warnings and precautions

Consult your doctor or pharmacist before starting to use this medication.

You may experience a mild and transient burning sensation immediately after applying this medication.

Be especially careful with this medication. Before using Aciclovir Brill Pharma, your doctor must know if you wear contact lenses. Stop using contact lenses during treatment with this medication. If unsure, consult with your doctor or pharmacist before using this medication.

Other medications and Aciclovir Brill Pharma

Inform your doctor or pharmacist if you are using, have used recently or may need to use any other medication, including those acquired without a prescription.

Although no interactions of this medication have been described through topical administration, consult with your doctor before using other medications.

Pregnancy and breastfeeding

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

Pregnancy

Your doctor will assess the benefit for you and the risk to your baby of using this medication during pregnancy.

Breastfeeding

Although after topical administration of this medication, systemic absorption is minimal, your doctor will assess the benefit for you and the risk to your baby of using this medication during breastfeeding.

Driving and operating machines

You may experience blurred vision immediately after applying this medication. Do not drive or use machines until this effect has disappeared.

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

Adults and children:

• Apply approximately 10 mm of Aciclovir Brill Pharma to the infected eye 5 times a day.
• This medication should be applied at intervals of 4 hours. The suggested hours are: 7 h, 11 h, 15 h, 19 h, and 23 h.
• Your vision may be blurry for 5 or 10 minutes after applying this medication.
• Treatment should be continued for at least 3 days after the eye has shown improvement.

If you are using more than one eye medication, you must space the applications of the medications at least 5 minutes or as indicated by your doctor. Eye ointments should be administered last.

How to apply Aciclovir Brill Pharma to the eye

This medication should be administered only by the ocular route.

1. Wash your hands

2. Use your finger to gently lower your lower eyelid of the infected eye

3. Tilt your head slightly backward and look up

4. Apply 10 mm of Aciclovir Brill Pharma to the inner side of the lower eyelid. Try to avoid letting the tip of the tube touch any part of the eye.

5. Keep your eye closed for 30 seconds.

6. Wash your hands after applying the ointment.

If you use more Aciclovir Brill Pharma than you should

If you use more Aciclovir Brill Pharma than you should, carefully remove the excess. It is unlikely that overdose cases will occur with this medication.

However, no adverse effects are expected in the case of ingesting the 135 mg of aciclovir contained in the package.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to use Aciclovir Brill Pharma

In case you forget an application, apply it as soon as possible and continue treatment as prescribed.However, if it is close to the time of your next application, omit the missed application.

Do not use a double dose to compensate for the missed doses.

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

Ifyouinterruptthe treatment with Aciclovir Brill Pharma

Do not interrupt treatment with Aciclovir Brill Pharma without consulting your doctor.

It is essential to use this medication for the indicated time to completely eliminate the infection.

Like all medications, this medication may produce adverse effects, although not all people will experience them.

Very frequent adverse effects (may affect more than1 in 10people):

• Irritation or sensation of a foreign body in the eye (feeling like something is in the eye)

• Effects on the surface of the cornea (transparent layer in front of the iris and pupil) that may cause changes in vision (blurred vision) and/or uncomfortable sensitivity to light.

No treatment interruption is required and it heals without apparent sequelae.

Frequent adverse effects (may affect up to1 in 10people):

• Mild and transient eye burning immediately after application.
• Red, itchy, and watery eyes (conjunctivitis).

Rare adverse effects (may affect up to1 in 1,000people):

• Swelling of the eyelid (blepharitis).

Very rare adverse effects (may affect up to1 in 10,000people):

• Immediate hypersensitivity reactions (allergic reactions).

The signs of allergic reactions may include:

• Swelling of the face, lips, tongue, or other parts of the body (angioedema).
• Rash, itching, or urticaria on the skin.
• Shortness of breath, difficulty breathing, or wheezing.
• Unexplained fever and feeling of fainting, particularly when standing.

Contact a doctor immediately if you experience any of these symptoms. Stop using Aciclovir Brill Pharma.

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 them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

Keep out of the sight and reach of children.

Store below 25 °C.

Do not use this medication after the expiration date that appears on the packaging after “CAD”. The expiration date is the last day of the month indicated.

Dispose of within 4 weeks after the first opening.

Medicines should not be thrown down the drains or in the trash. Deposit the containers and medicines you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medicines you no longer need. By doing so, you will help protect the environment.

Composition of Aciclovir Brill Pharma

- The active ingredient is aciclovir. Each gram of ointment contains 30 mg of aciclovir.

- The other components (excipients) are: white petrolatum.

Appearance of the product and content of the container

Tube (aluminum) with a screw cap (polyethylene) packaged in cardboard boxes. Each box contains a tube of 4.5 grams of ointment.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

BRILL PHARMA, S.L.

C/ Munner, 8

08022 Barcelona

Spain

Responsible for manufacturing

URSAPHARM Arzneimittel GmbH
Industriestraße 35
66129 Saarbrücken

Germany

Last review date of this leaflet: June 2020

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