Država: Irska
Jezik: angleščina
Source: HPRA (Health Products Regulatory Authority)
Aciclovir
AGEPHA Pharma s.r.o.
S01AD03
Aciclovir
30 milligram(s)/gram
Eye ointment
aciclovir
Marketed
2019-08-19
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT ACICLOVIR AGEPHA 30 MG/G EYE OINTMENT Aciclovir READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. • Keep this leaflet. You may need to read it again. • If you have any further questions, ask your doctor or pharmacist. • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. • If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET? 1. What Aciclovir Agepha 30 mg/g eye ointment is and what it is used for? 2. What you need to know before you use Aciclovir Agepha 30 mg/g eye ointment ? 3. How to use Aciclovir Agepha 30 mg/g eye ointment ? 4. Possible side effects 5. How to store Aciclovir Agepha 30 mg/g eye ointment ? 6. Contents of the pack and other information 1. WHAT ACICLOVIR AGEPHA 30 MG/G EYE OINTMENT IS AND WHAT IT IS USED FOR? Aciclovir Agepha 30 mg/g Eye Ointment (called Aciclovir Agepha in this leaflet) 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 killing or stopping the growth of viruses on the front of your eyeball (cornea) 2. WHAT YOU NEED TO KNOW BEFORE YOU USE ACICLOVIR AGEPHA 30 MG/G EYE OINTMENT? DO NOT USE ACICLOVIR AGEPHA, If you are allergic to aciclovir or valaciclovir or any of the other ingredients of this medicine (listed in Section 6). WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before using Aciclovir Agepha • Use Aciclovir Agepha 30 mg/g eye ointment only on eye • You may immediately experience a mild stinging and burning sensation after the application. • Immediate hypersensitivity reactions, including angioedema, swelling of the face etc. can occur. Contact a doctor immediately in case of such hypersensitivi Preberite celoten dokument
Health Products Regulatory Authority 22 April 2021 CRN00C61V Page 1 of 4 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Aciclovir Agepha 30 mg/g eye ointment 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1 g ointment contains 30 mg aciclovir. For the full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Eye ointment White to whitish grey, homogeneous eye ointment. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Aciclovir "Agepha" 30 mg/g eye ointment is indicated for the treatment of herpes simplex keratitis. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Adults: Unless otherwise prescribed, a 1cm ribbon of ointment should be placed inside the lower conjunctival sac five times a day (at approximately 4 hourly intervals). The treatment should continue for at least 3 days after the healing is complete. Paediatric population: As for adults Use in elderly people (≥ 65 years): No adjustment in dosage is required. Use in people with impaired renal and liver function: No adjustment in dosage is required. Method of administration: Ocular use. 4.3 CONTRAINDICATIONS - Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 - Hypersensitivity to Valaciclovir. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE For ocular use only. Not for injection or oral intake. There is insufficient clinical data on the use of Xorox eye ointment for deep corneal defects and the combined use of Xorox eye ointment with topical corticosteroids. In case of a bacterial coinfection, an additional antibiotic therapy must be carried out. Patients should be informed that transient mild stinging immediately following application may occur. Health Products Regulatory Authority 22 April 2021 CRN00C61V Page 2 of 4 Patients should avoid wearing contact lenses when using Aciclovir "Agepha" eye ointment. 4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTIONS No clinically significant interactions have been identified when applied topically. 4.6 FERTILITY, PREGNANCY AND LACTATIO Preberite celoten dokument