Aciclovir Brill Pharma 30 mg/g ophthalmic ointment

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Aciclovir Brill Pharma 30 mg/g ophthalmic ointment

Read the entire 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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

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. How to store Aciclovir Brill Pharma
6. Contents of the pack and other information

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

This medicine contains aciclovir, an active substance 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.

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

Do not use Aciclovir Brill Pharma

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

If you think this applies to you, do not use this medicine until you have consulted your doctor.

Warnings and precautions

Talk to your doctor or pharmacist before using this medicine.

A mild, temporary stinging sensation may occur immediately after applying this medicine.

Take special care with this medicine. Before using Aciclovir Brill Pharma, your doctor should know if you wear contact lenses. Stop wearing contact lenses during treatment with this medicine. If you are unsure, consult your doctor or pharmacist before using this medicine.

Other medicines and Aciclovir Brill Pharma

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription.

Although interactions with this medicine have not been reported following ophthalmic administration, consult your doctor before using other medicines.

Pregnancy and breastfeeding

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

Pregnancy

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

Breastfeeding

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

Driving and using machines

You may experience blurred vision immediately after applying this medicine. Do not drive or operate machinery until this effect has disappeared.

3. How to use Aciclovir Brill Pharma

Follow exactly the instructions for use of this medicine given by your doctor or pharmacist. If in 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 medicine should be applied at 4-hour intervals. Suggested times are: 7 a.m., 11 a.m., 3 p.m., 7 p.m., and 11 p.m.
• Your vision may be blurred for 5 to 10 minutes after applying this medicine.
• Treatment should continue for at least 3 days after the eye has shown signs of improvement.

If you are using more than one ophthalmic medicine, you should space the applications by at least 5 minutes, or as directed by your doctor. Ophthalmic ointments should be administered last.

How to apply Aciclovir Brill Pharma to the eye

This medicine must be used only by ophthalmic route.

1. Wash your hands.
2. Gently pull down the lower eyelid of the infected eye with your finger.
3. Tilt your head slightly backward and look upward.
4. Apply 10 mm of Aciclovir Brill Pharma along the inner side of the lower eyelid. Try to avoid touching any part of the eye with the tip of the tube.
5. Keep the 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 recommended, carefully wipe away the excess. Overdose symptoms are unlikely with this medicine.

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

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to use Aciclovir Brill Pharma

If you forget a dose, apply it as soon as possible and continue treatment as prescribed. However, if it is almost time for your next dose, skip the missed dose.

Do not use a double dose to make up for forgotten doses.

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

If you stop treatment with Aciclovir Brill Pharma

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

It is important that you use this medicine for the full prescribed duration in order to completely eliminate the infection.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

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

• Eye irritation or sensation of a foreign body in the eye (feeling as if something is in the eye)

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

These do not require discontinuation of treatment and resolve without apparent sequelae.

Common adverse effects (may affect up to 1 in 10 people):

• Mild, transient stinging of the eye immediately after application.
• Red, watery, itchy eyes (conjunctivitis).

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

• Inflammation of the eyelid (blepharitis).

Very rare adverse effects (may affect up to 1 in 10,000 people):

• Immediate hypersensitivity reactions (allergic reactions).

Signs of allergic reactions may include:

• Swelling of the face, lips, tongue, or other parts of the body (angioedema).
• Skin rash, itching, or hives.
• Shortness of breath, difficulty breathing, or wheezing.
• Unexplained fever and feeling faint, particularly when standing.

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

Reporting of 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 leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Aciclovir Brill Pharma

Keep out of the sight and reach of children.

Store below 25 °C.

Do not use this medicine after the expiry date stated on the packaging after "EXP". The expiry date refers to the last day of the month indicated.

Discard 4 weeks after first opening.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at a SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused containers and medicines. This will help protect the environment.

6. Contents of the container and additional information

Composition of Aciclovir Brill Pharma

• The active substance is aciclovir. Each gram of ointment contains 30 mg of aciclovir.
• The other components (excipients) are: white petroleum.

Appearance of the product and contents of the container

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

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

BRILL PHARMA, S.L.

C/ Munner, 8

08022 Barcelona

Spain

Manufacturer

URSAPHARM Arzneimittel GmbH
Industriestraße 35
66129 Saarbrücken

Germany

Date of the most recent review of this summary: June 2020

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es